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1. 5,8,11,14,17-eicosapentaenoic Acid
2. 5,8,11,14,17-icosapentaenoic Acid
3. Acid, Eicosapentanoic
4. Eicosapentanoic Acid
5. Icosapent
6. Omega 3 Eicosapentaenoic Acid
7. Omega-3-eicosapentaenoic Acid
8. Timnodonic Acid
1. Timnodonic Acid
2. Icosapent
3. 10417-94-4
4. Icosapentaenoic Acid
5. Epa
6. Cis-5,8,11,14,17-eicosapentaenoic Acid
7. (5z,8z,11z,14z,17z)-icosa-5,8,11,14,17-pentaenoic Acid
8. Icosapento
9. Icosapentum
10. 5,8,11,14,17-eicosapentaenoic Acid
11. Eicosapentaenoate
12. 5z,8z,11z,14z,17z-eicosapentaenoic Acid
13. (all-z)-5,8,11,14,17-eicosapentaenoic Acid
14. Icosapent [inn]
15. (5z,8z,11z,14z,17z)-5,8,11,14,17-eicosapentaenoic Acid
16. 5,8,11,14,17-icosapentaenoic Acid
17. Ropufa 70
18. Ccris 3279
19. Incromega E 7010sr
20. Aan7qov9ea
21. (5z,8z,11z,14z,17z)-icosapentaenoic Acid
22. (5z,8z,11z,14z,17z)-eicosapentaenoic Acid
23. Omega-3-carboxylic Acids
24. Epa 45g
25. Chembl460026
26. (5z,8z,11z,14z,17z)-eicosapentaenoate
27. All-cis-5,8,11,14,17-icosapentaenoic Acid
28. Chebi:28364
29. All-cis-5,8,11,14,17-eicosapentaenoic Acid
30. All-cis-icosa-5,8,11,14,17-pentaenoic Acid
31. Icosapent (inn)
32. Cis-delta(5,8,11,14,17)-eicosapentaenoic Acid
33. 5,8,11,14,17-eicosapentaenoic Acid, (all-z)-
34. All-cis-fatty Acid 20:5 Omega-3
35. Eicosapentaenoic Acid (c20:5 N3)
36. Epa;timnodonic Acid
37. Icosapentaenoate
38. (all-z)-delta5,8,11,14,17-eicosapentaenoic Acid
39. C20:5n-3,6,9,12,15
40. Cis-5,8,11,14,17-epa
41. Fa 20:5
42. Ncgc00161344-03
43. C20:5 (n-3)
44. Eicosapentaenoic Acid (20:5 N-3)
45. Eicosa-5z,8z,11z,14z,17z-pentaenoic Acid (20:5, N-3)
46. Miraxion
47. Eicosapentanoic Acid
48. Eye Q
49. Eye-q
50. 5,8,11,14,17-eicosapentaenoic Acid, (5z,8z,11z,14z,17z)-
51. Epa [drug]
52. Unii-aan7qov9ea
53. 1553-41-9
54. Icosapentum [inn-latin]
55. Icosapento [inn-spanish]
56. (5z,8z,11z,14z,17z)-icosapentaenoate
57. Timnodonate
58. 3gwx
59. All Cis-5,8,11,14,17-eicosapentaenoic Acid
60. Mfcd00065716
61. All-cis-icosapentaenoate
62. All-cis-icosapentaenoic Acid
63. Dsstox_cid_21023
64. Dsstox_rid_79612
65. Dsstox_gsid_41023
66. Schembl20469
67. Bspbio_001328
68. Bml3-b01
69. Gtpl3362
70. Dtxsid9041023
71. Eicosapentaenoic Acid [mi]
72. Hms1361c10
73. Hms1791c10
74. Hms1989c10
75. Hms3402c10
76. Hms3649d19
77. Hy-b0660
78. Zinc4474603
79. 5,8,11,14,17-icosapentaenoate
80. Eicosapentaenoic Acid [inci]
81. Tox21_111991
82. 5,8,11,14,17-eicosapentaenoate
83. Bdbm50242349
84. Eicosapentaenoic Acid [vandf]
85. Lmfa01030759
86. S6476
87. Eicosapentaenoic Acid [mart.]
88. Akos027470327
89. Eicosapentaenoic Acid [usp-rs]
90. Eicosapentaenoic Acid [who-dd]
91. Ccg-207957
92. Ccg-208136
93. Db00159
94. Cis-5,8,11,14,17-eicosapentaenoate
95. Idi1_033798
96. Ncgc00161344-01
97. Ncgc00161344-02
98. Ncgc00161344-04
99. Ncgc00161344-07
100. 5z,8z,11z,14z,17z-eicosapentaenoate
101. Ac-31072
102. As-53730
103. Cas-10417-94-4
104. E0441
105. 5,8,11,14,17-eicosapentaenoic Acid (6ci)
106. All Cis-5,8,11,14,17-icosapentaenoic Acid
107. C06428
108. D08061
109. P16966
110. (all-cis)-5,8,11,14,17-eicosapentaenoic Acid
111. Eicosapentaenoic Acid (epa) (c20:5 N3)
112. L001256
113. Q409990
114. Sr-01000946647
115. Fa(20:5(5z,8z,11z,14z,17z))
116. J-001125
117. Sr-01000946647-1
118. Z,z,z,z,z-eicosa-5,8,11,14,17-pentaenoic Acid
119. (z,z,z,z,z)-5,8,11,14,17-eicosapentaenoic Acid
120. Brd-k47192521-001-02-1
121. Cis-5,8,11,14,17-eicosapentaenoic Acid, >=99%
122. 7f8bf016-b146-4f72-a52e-b9298ba3a9ab
123. C20h30o2 (cis-5,8,11,14,17-eicosapentaenoic Acid)
124. Eicosapentaenoic Acid, 5,8,11,14,17-(z,z,z,z,z)-
125. 5,8,11,14,17-eicosapentaenoic Acid, (all-z)- (8ci)
126. Cis-5,8,11,14,17-eicosapentaenoic Acid, >=85%, Liquid
127. Cis-5,8,11,14,17-eicosapentaenoic Acid, Analytical Standard
128. (5z,8z,11 Z,14z,17z)-icosa-5,8,11,14,17-pentaenoic Acid
129. (5z,8z,11z,14z,17z)-eicosa-5,8,11,14,17-pentaenoic Acid
130. Cis, Cis, Cis, Cis, Cis-eicosa-5,8,11,14,17-pentaenoic Acid
131. 5,8,11,14,17-eicosapentaenoic Acid, (5z,8z,11z,14z,17z)- (9ci)
132. Eicosapentaenoic Acid (epa) (c20:5) (constituent Of Krill Oil) [dsc]
133. Cis-5,8,11,14,17-eicosapentaenoic Acid, 500 Mug/ml In Ethanol, Certified Reference Material
Molecular Weight | 302.5 g/mol |
---|---|
Molecular Formula | C20H30O2 |
XLogP3 | 5.6 |
Hydrogen Bond Donor Count | 1 |
Hydrogen Bond Acceptor Count | 2 |
Rotatable Bond Count | 13 |
Exact Mass | 302.224580195 g/mol |
Monoisotopic Mass | 302.224580195 g/mol |
Topological Polar Surface Area | 37.3 Ų |
Heavy Atom Count | 22 |
Formal Charge | 0 |
Complexity | 398 |
Isotope Atom Count | 0 |
Defined Atom Stereocenter Count | 0 |
Undefined Atom Stereocenter Count | 0 |
Defined Bond Stereocenter Count | 5 |
Undefined Bond Stereocenter Count | 0 |
Covalently Bonded Unit Count | 1 |
EPA can be used for lowering elevated triglycerides in those who are hyperglyceridemic. In addition, EPA may play a therapeutic role in patients with cystic fibrosis by reducing disease severity and may play a similar role in type 2 diabetics in slowing the progression of diabetic nephropathy.
FDA Label
OM3-CA is indicated as an adjunct to diet to reduce triglycerides levels in adults patients with severe hypertriglyceridemia (>500 mg/dL). The patients involved in this treatment should be laced with an appropriate lipid-lowering diet. Hypertriglyceridemia is defined as an elevated plasma triglyceride concentration. It is usually correlated to other secondary conditions such as poor diet, alcohol use, obesity, metabolic syndrome and type 2 diabetes.
FDA Label
Treatment of Familial Adenomatous Polyposis
Treatment of dyslipidaemia
Eicosanoids are chemical messengers derived from 20-carbon polyunsaturated fatty acids that play critical roles in immune and inflammatory responses. Both 20-carbon omega-6 fatty acids (arachidonic acid) and 20-carbon omega-3 fatty acids (EPA) can be found in cell membranes. During an inflammatory response, arachidonic acid and EPA are metabolized by enzymes known as cyclooxygenases and lipoxygenases to form eicosanoids. Increasing omega-3 fatty acid intake increases the EPA content of cell membranes and decreases the arachidonic acid content, resulting in higher proportions of eicosanoids derived from EPA. Physiologic responses to arachidonic acid-derived eicosanoids differ from responses to EPA-derived eicosanoids. In general, eicosanoids derived from EPA are less potent inducers of inflammation, blood vessel constriction, and clotting than eicosanoids derived from arachidonic acid.
OM3-CA is very effective in reducing triglyceride levels. After 14 days of treatment, it is possible to observe even a 21% reduction. The reduction of the triglycerides could reach even to 25% in cases with the maximal used concentration of 4 g.
Absorption
When compared to omega-3 -acid ethyl esters, OM3-CA present a 4-fold higher bioavailability. OM3-CA is absorbed directly in the small intestine and the maximal plasma concentration is reached between 4.5-5 hours after initial administration. The absorbed dosage is transferred to the general circulation via the lymphatic system and distributed within tissues throughout the body. The absorption speed and extent is highly promoted by the bile. In preclinical studies performed in dogs, the Cmax, tmax and AUC were reported to be 15.1 mcg/ml, 24 hours and 1210.3 mcg.h/ml, respectively.
Route of Elimination
OM3-CA does not go under renal excretion. After the metabolism, all the dose is excreted as CO2 and water in the form of expelled air and the rest is excreted in feces.
Volume of Distribution
This pharmacokinetic property is not available.
Clearance
The registered clearance rate at steady-state is of 548 ml/h for eicosapentaenoic acid and 518 ml/h for docohexaenoic acid.
OM3-CA is metabolized in the liver following the normal fatty acid oxidation. Once absorbed, they are incorporated into triglycerides, cholesterol esters and phospholipids in tissues. The metabolism is marked by beta-oxidation followed by tricarboxylic acid cycle. It is reported that OM3-CA is an inhibitor of several enzymes such as CYP2C9, CYP2C19 and to a lesser extent to CYP1A2, CYP2E1, CYP3A4. It is thought that the metabolism of OM3-CA is mainly done by CYP3A and CYP4F3B.
Eicosapentaenoic acid has known human metabolites that include Juniperonic acid.
S73 | METXBIODB | Metabolite Reaction Database from BioTransformer | DOI:10.5281/zenodo.4056560
The half-life of OM3-CA depends on the type of component in which for eicosapentaenoic acid it is estimated to be of approximately 4.7-10.8 hours while for docosahexaenoic acid is reported to be of about 7 hours. The half-life of baseline-adjusted at steady-state is of 36 and 46 hours respectively for eicosapentaenoic acid and docosahexaenoic acid.
The anti-inflammatory, antithrombotic and immunomodulatory actions of EPA is probably due to its role in eicosanoid physiology and biochemistry. Most eicosanoids are produced by the metabolism of omega-3 fatty acids, specifically, arachidonic acid. These eicosanoids, leukotriene B4 (LTB4) and thromboxane A2 (TXA2) stimulate leukocyte chemotaxis, platelet aggregation and vasoconstriction. They are thrombogenic and artherogenic. On the other hand, EPA is metabolized to leukotriene B5 (LTB5) and thromboxane A3 (TXA3), which are eicosanoids that promote vasodilation, inhibit platelet aggregation and leukocyte chemotaxis and are anti-artherogenic and anti-thrombotic. The triglyceride-lowering effect of EPA results from inhibition of lipogenesis and stimulation of fatty acid oxidation. Fatty acid oxidation of EPA occurs mainly in the mitochondria. EPA is a substrate for Prostaglandin-endoperoxide synthase 1 and 2. It also appears to affect the function and bind to the Carbohydrate responsive element binding protein (ChREBP) and to a fatty acid receptor (G-coupled receptor) known as GP40.
The reduction of the synthesis of triglycerides in the liver may be caused because the main components of OM3-CA, eicosapentaenoic acid, and docosahexaenoic acid, are poor substrates for the enzymes responsible for the synthesis of triglycerides. These two major components inhibit the esterification of other fatty acids. OM3-CA is also thought to enhance the clearance of triglycerides from the circulating very low-density lipoprotein particles by different potential effects such as inhibition of acyl-CoA:1,2-diacylglycerol acyltransferase, increase in mitochondrial and peroxisomal beta-oxidation in the liver, decrease lipogenesis in the liver and increase lipoprotein lipase activity.
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DMF Review : Reviewed
Rev. Date : 2013-04-01
Pay. Date : 2012-11-20
DMF Number : 26271
Submission : 2012-08-01
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DMF Number : 23911
Submission : 2010-07-07
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DMF Number : 27182
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Chunghwa provides cost-effective APIs & advanced intermediates with complete DMF or COS, ensuring quality & reliable production.
GDUFA
DMF Review : Complete
Rev. Date : 2013-04-01
Pay. Date : 2012-11-20
DMF Number : 26271
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Registrant Name : Kemport Co., Ltd.
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Registration Number : 20220822-211-J-1348
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Chunghwa provides cost-effective APIs & advanced intermediates with complete DMF or COS, ensuring quality & reliable production.
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Chunghwa provides cost-effective APIs & advanced intermediates with complete DMF or COS, ensuring quality & reliable production.
About the Company : Chunghwa Chemical Synthesis & Biotech Co. Ltd. (CCSB) offers global customers cost-effective APIs with speed, supported by our well-trained staff. As the first company in Southeast...
EICOSAPENTAENOIC ACID ETHYL ESTER (EPA-E)
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Details:
Dr Reddy's Laboratories announced the launch of Icosapent Ethyl Capsules, used to reduce triglyceride (TG) levels in adult patients, in the US market. Dr Reddy's Icosapent Ethyl is available in 1 gram capsules in bottle count size of 120's count.
Lead Product(s): Icosapent Ethyl
Therapeutic Area: Cardiology/Vascular Diseases Brand Name: Undisclosed
Study Phase: Approved FDFProduct Type: Other Small Molecule
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable June 22, 2021
Lead Product(s) : Icosapent Ethyl
Therapeutic Area : Cardiology/Vascular Diseases
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Dr Reddy's Laboratories launches Icosapent Ethyl Capsules in US
Details : Dr Reddy's Laboratories announced the launch of Icosapent Ethyl Capsules, used to reduce triglyceride (TG) levels in adult patients, in the US market. Dr Reddy's Icosapent Ethyl is available in 1 gram capsules in bottle count size of 120's count.
Product Name : Undisclosed
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
June 22, 2021
Details:
Icosapent ethyl capsules is an ethyl ester of eicosapentaenoic acid (EPA), which is indicated for the treatment of to reduce the risk of myocardial infarction, stroke, coronary revascularization, and unstable angina in adult patients with elevated triglyceride.
Lead Product(s): Icosapent Ethyl
Therapeutic Area: Cardiology/Vascular Diseases Brand Name: Vascepa-Generic
Study Phase: Approved FDFProduct Type: Other Small Molecule
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable March 10, 2023
Lead Product(s) : Icosapent Ethyl
Therapeutic Area : Cardiology/Vascular Diseases
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Strides Receives USFDA Approval for Icosapent Ethyl Capsules
Details : Icosapent ethyl capsules is an ethyl ester of eicosapentaenoic acid (EPA), which is indicated for the treatment of to reduce the risk of myocardial infarction, stroke, coronary revascularization, and unstable angina in adult patients with elevated trigly...
Product Name : Vascepa-Generic
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
March 10, 2023
Details:
Vascepa-Generic (icosapent ethyl) is an ethyl ester of eicosapentaenoic acid (EPA) which is indicated to reduce the risk of myocardial infarction, stroke, coronary revascularization, and unstable angina.
Lead Product(s): Icosapent Ethyl
Therapeutic Area: Cardiology/Vascular Diseases Brand Name: Vascepa-Generic
Study Phase: Approved FDFProduct Type: Other Small Molecule
Sponsor: Amneal Pharmaceuticals
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable February 12, 2023
Lead Product(s) : Icosapent Ethyl
Therapeutic Area : Cardiology/Vascular Diseases
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Amneal Pharmaceuticals
Deal Size : Inapplicable
Deal Type : Inapplicable
Strides Launches Icosapent Ethyl Acid Soft Gel Capsules in Partnership with Amneal
Details : Vascepa-Generic (icosapent ethyl) is an ethyl ester of eicosapentaenoic acid (EPA) which is indicated to reduce the risk of myocardial infarction, stroke, coronary revascularization, and unstable angina.
Product Name : Vascepa-Generic
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
February 12, 2023
Details:
Under the agreement, Amneal in-licensed Icosapent ethyl acid soft gel capsules, a product referencing Vascepa and an ethyl ester of eicosapentaenoic acid that is indicated as an adjunct to diet to reduce triglyceride levels in adult patients with severe hypertriglyceridemia.
Lead Product(s): Icosapent Ethyl
Therapeutic Area: Cardiology/Vascular Diseases Brand Name: Vascepa-Generic
Study Phase: Approved FDFProduct Type: Other Small Molecule
Sponsor: Amneal Pharmaceuticals
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Licensing Agreement January 12, 2023
Lead Product(s) : Icosapent Ethyl
Therapeutic Area : Cardiology/Vascular Diseases
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Amneal Pharmaceuticals
Deal Size : Undisclosed
Deal Type : Licensing Agreement
Amneal Expands Portfolio with Addition of Icosapent Ethyl Acid Soft Gel Capsules
Details : Under the agreement, Amneal in-licensed Icosapent ethyl acid soft gel capsules, a product referencing Vascepa and an ethyl ester of eicosapentaenoic acid that is indicated as an adjunct to diet to reduce triglyceride levels in adult patients with severe ...
Product Name : Vascepa-Generic
Product Type : Other Small Molecule
Upfront Cash : Undisclosed
January 12, 2023
Details:
Under the licensing agreement, Recordati will be responsible for commercialization of Vazkepa (Icosapent Ethyl) in Europe. It is being indicated to reduce the risk of myocardial infarction, stroke.
Lead Product(s): Icosapent Ethyl
Therapeutic Area: Cardiology/Vascular Diseases Brand Name: Vascepa
Study Phase: Approved FDFProduct Type: Other Small Molecule
Sponsor: Recordati
Deal Size: $175.0 million Upfront Cash: $25.0 million
Deal Type: Licensing Agreement June 24, 2025
Lead Product(s) : Icosapent Ethyl
Therapeutic Area : Cardiology/Vascular Diseases
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Recordati
Deal Size : $175.0 million
Deal Type : Licensing Agreement
Amarin Announces Exclusive License and Supply Agreement with Recordati
Details : Under the licensing agreement, Recordati will be responsible for commercialization of Vazkepa (Icosapent Ethyl) in Europe. It is being indicated to reduce the risk of myocardial infarction, stroke.
Product Name : Vascepa
Product Type : Other Small Molecule
Upfront Cash : $25.0 million
June 24, 2025
Details:
Vascepa (icosapent ethyl) is an ethyl ester of eicosapentaenoic acid (EPA) which is indicated to reduce the risk of myocardial infarction, stroke, coronary revascularization, and unstable angina.
Lead Product(s): Icosapent Ethyl
Therapeutic Area: Cardiology/Vascular Diseases Brand Name: Vascepa
Study Phase: Approved FDFProduct Type: Other Small Molecule
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable August 07, 2024
Lead Product(s) : Icosapent Ethyl
Therapeutic Area : Cardiology/Vascular Diseases
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Amarin Partner EddingPharm Gets Approval for VASCEPA® in China for CVRR
Details : Vascepa (icosapent ethyl) is an ethyl ester of eicosapentaenoic acid (EPA) which is indicated to reduce the risk of myocardial infarction, stroke, coronary revascularization, and unstable angina.
Product Name : Vascepa
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
August 07, 2024
Details:
Under the terms of the agreement, Vianex will be the sole and exclusive distributor of Vazkepa (icosapent ethyl). it is an approved product indicated for the treatment of cardiovascular diseases.
Lead Product(s): Icosapent Ethyl
Therapeutic Area: Cardiology/Vascular Diseases Brand Name: Vazkepa
Study Phase: Approved FDFProduct Type: Other Small Molecule
Sponsor: Vianex S.A
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Agreement May 28, 2024
Lead Product(s) : Icosapent Ethyl
Therapeutic Area : Cardiology/Vascular Diseases
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Vianex S.A
Deal Size : Undisclosed
Deal Type : Agreement
Amarin Receives National Reimbursement for VAZKEPA® in Greece and Signs Marketing Deal
Details : Under the terms of the agreement, Vianex will be the sole and exclusive distributor of Vazkepa (icosapent ethyl). it is an approved product indicated for the treatment of cardiovascular diseases.
Product Name : Vazkepa
Product Type : Other Small Molecule
Upfront Cash : Undisclosed
May 28, 2024
Details:
Vazkepa (icosapent ethyl) is an ethyl ester of eicosapentaenoic acid that reduces synthesis and enhances clearance of triglycerides that is used to treat patients with severe hypertriglyceridemia.
Lead Product(s): Icosapent Ethyl
Therapeutic Area: Cardiology/Vascular Diseases Brand Name: Vazkepa
Study Phase: Approved FDFProduct Type: Other Small Molecule
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable September 08, 2023
Lead Product(s) : Icosapent Ethyl
Therapeutic Area : Cardiology/Vascular Diseases
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : Vazkepa (icosapent ethyl) is an ethyl ester of eicosapentaenoic acid that reduces synthesis and enhances clearance of triglycerides that is used to treat patients with severe hypertriglyceridemia.
Product Name : Vazkepa
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
September 08, 2023
Details:
Under the agreement, Amarin has appointed Neopharm as its sole and exclusive distributor of Vazkepa (icosapent ethyl) approved to reduce the risk of cardiovascular events in adult statin-treated patients at high cardiovascular risk with elevated triglycerides in Israel.
Lead Product(s): Icosapent Ethyl
Therapeutic Area: Cardiology/Vascular Diseases Brand Name: Vazkepa
Study Phase: Approved FDFProduct Type: Other Small Molecule
Sponsor: Amarin
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Agreement August 08, 2023
Lead Product(s) : Icosapent Ethyl
Therapeutic Area : Cardiology/Vascular Diseases
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Amarin
Deal Size : Undisclosed
Deal Type : Agreement
Amarin and Neopharm Announce Exclusive Commercialization Agreement for VAZKEPA® (Icosapent Ethyl)...
Details : Under the agreement, Amarin has appointed Neopharm as its sole and exclusive distributor of Vazkepa (icosapent ethyl) approved to reduce the risk of cardiovascular events in adult statin-treated patients at high cardiovascular risk with elevated triglyce...
Product Name : Vazkepa
Product Type : Other Small Molecule
Upfront Cash : Undisclosed
August 08, 2023
Details:
The partnership aims to distribute and commercialize Vazkepa (icosapent ethyl), approved and commercialized in a number of global markets, including the U.S. and European markets, across 10 countries, including nine in Southeast Asia and South Korea.
Lead Product(s): Icosapent Ethyl
Therapeutic Area: Cardiology/Vascular Diseases Brand Name: Vazkepa
Study Phase: Approved FDFProduct Type: Other Small Molecule
Sponsor: Lotus Pharmaceutical Industries
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Partnership July 31, 2023
Lead Product(s) : Icosapent Ethyl
Therapeutic Area : Cardiology/Vascular Diseases
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Lotus Pharmaceutical Industries
Deal Size : Undisclosed
Deal Type : Partnership
Details : The partnership aims to distribute and commercialize Vazkepa (icosapent ethyl), approved and commercialized in a number of global markets, including the U.S. and European markets, across 10 countries, including nine in Southeast Asia and South Korea.
Product Name : Vazkepa
Product Type : Other Small Molecule
Upfront Cash : Undisclosed
July 31, 2023
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
Regulatory Info : RX
Registration Country : USA
Brand Name : ICOSAPENT ETHYL
Dosage Form : CAPSULE;ORAL
Dosage Strength : 1GM
Packaging :
Approval Date : 2020-08-07
Application Number : 209499
Regulatory Info : RX
Registration Country : USA
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
Regulatory Info : RX
Registration Country : USA
Brand Name : ICOSAPENT ETHYL
Dosage Form : CAPSULE;ORAL
Dosage Strength : 500MG
Packaging :
Approval Date : 2023-03-08
Application Number : 209499
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Brand Name : ICOSAPENT ETHYL
Dosage Form : CAPSULE;ORAL
Dosage Strength : 1GM
Packaging :
Approval Date : 2024-02-16
Application Number : 216811
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Brand Name : VASCEPA
Dosage Form : CAPSULE;ORAL
Dosage Strength : 1GM
Packaging :
Approval Date : 2012-07-26
Application Number : 202057
Regulatory Info : RX
Registration Country : USA
Regulatory Info :
Registration Country : Norway
Brand Name : Vazkepa
Dosage Form : Kapsel, myk
Dosage Strength : 998 mg
Packaging : Boks 120item
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Norway
Regulatory Info :
Registration Country : India
Brand Name :
Dosage Form : Capsule
Dosage Strength : 90MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : India
Regulatory Info : RX
Registration Country : USA
Brand Name : ICOSAPENT ETHYL
Dosage Form : CAPSULE;ORAL
Dosage Strength : 1GM
Packaging :
Approval Date : 2020-05-21
Application Number : 209457
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Brand Name : ICOSAPENT ETHYL
Dosage Form : CAPSULE;ORAL
Dosage Strength : 500MG
Packaging :
Approval Date : 2023-12-22
Application Number : 217919
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Brand Name : ICOSAPENT ETHYL
Dosage Form : CAPSULE;ORAL
Dosage Strength : 500MG
Packaging :
Approval Date : 2020-09-11
Application Number : 209525
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Brand Name : ICOSAPENT ETHYL
Dosage Form : CAPSULE;ORAL
Dosage Strength : 1GM
Packaging :
Approval Date : 2023-04-20
Application Number : 217656
Regulatory Info : RX
Registration Country : USA
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
RLD : No
TE Code : AB
Brand Name : ICOSAPENT ETHYL
Dosage Form : CAPSULE;ORAL
Dosage Strength : 1GM
Approval Date : 2020-08-07
Application Number : 209499
RX/OTC/DISCN : RX
RLD : No
TE Code : AB
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
RLD : No
TE Code : AB
Brand Name : ICOSAPENT ETHYL
Dosage Form : CAPSULE;ORAL
Dosage Strength : 500MG
Approval Date : 2023-03-08
Application Number : 209499
RX/OTC/DISCN : RX
RLD : No
TE Code : AB
RLD : No
TE Code : AB
Brand Name : ICOSAPENT ETHYL
Dosage Form : CAPSULE;ORAL
Dosage Strength : 1GM
Approval Date : 2020-05-21
Application Number : 209457
RX/OTC/DISCN : RX
RLD : No
TE Code : AB
RLD : No
TE Code : AB
Brand Name : ICOSAPENT ETHYL
Dosage Form : CAPSULE;ORAL
Dosage Strength : 500MG
Approval Date : 2023-03-08
Application Number : 209457
RX/OTC/DISCN : RX
RLD : No
TE Code : AB
RLD : No
TE Code : AB
Brand Name : ICOSAPENT ETHYL
Dosage Form : CAPSULE;ORAL
Dosage Strength : 500MG
Approval Date : 2023-12-22
Application Number : 217919
RX/OTC/DISCN : RX
RLD : No
TE Code : AB
RLD : No
TE Code : AB
Brand Name : ICOSAPENT ETHYL
Dosage Form : CAPSULE;ORAL
Dosage Strength : 1GM
Approval Date : 2023-12-22
Application Number : 217919
RX/OTC/DISCN : RX
RLD : No
TE Code : AB
RLD : No
TE Code : AB
Brand Name : ICOSAPENT ETHYL
Dosage Form : CAPSULE;ORAL
Dosage Strength : 500MG
Approval Date : 2020-09-11
Application Number : 209525
RX/OTC/DISCN : RX
RLD : No
TE Code : AB
RLD : No
TE Code : AB
Brand Name : ICOSAPENT ETHYL
Dosage Form : CAPSULE;ORAL
Dosage Strength : 1GM
Approval Date : 2020-09-11
Application Number : 209525
RX/OTC/DISCN : RX
RLD : No
TE Code : AB
RLD : No
TE Code : AB
Brand Name : ICOSAPENT ETHYL
Dosage Form : CAPSULE;ORAL
Dosage Strength : 1GM
Approval Date : 2023-04-20
Application Number : 217656
RX/OTC/DISCN : RX
RLD : No
TE Code : AB
Brand Name : ICOSAPENT ETHYL
Dosage Form : CAPSULE;ORAL
Dosage Strength : 500MG
Approval Date : 2023-09-22
Application Number : 217844
RX/OTC/DISCN : RX
RLD : No
TE Code : AB
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
Regulatory Info :
Registration Country : Norway
Brand Name : Vazkepa
Dosage Form : Kapsel, myk
Dosage Strength : 998 mg
Packaging : Boks 120item
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Norway
Regulatory Info :
Registration Country : Norway
Brand Name : Vazkepa
Dosage Form : Kapsel, myk
Dosage Strength : 998 mg
Packaging : Boks 120item
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Norway
Regulatory Info :
Registration Country : Canada
Brand Name : VASCEPA
Dosage Form : CAPSULE
Dosage Strength : 1G
Packaging :
Approval Date :
Application Number : 2495244
Regulatory Info :
Registration Country : Canada
Regulatory Info :
Registration Country : Australia
Brand Name : Vazkepa
Dosage Form :
Dosage Strength :
Packaging : 120
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Australia
Related Excipient Companies
Excipients by Applications
Dosage Form : Tablet, Orodispersible Tablet
Grade : Oral
Category : Chewable & Orodispersible Aids, Co-Processed Excipients, Direct Compression, Fillers, Diluents & Binders, Taste Masking
Application : Chewable & Orodispersible Aids, Co-Processed Excipients, Direct Compression, Fillers, Diluents & Binders, Taste Masking
Excipient Details : Compressol® SM, co-processed polyol, is a DC excipient of mannitol & sorbitol with superior compactibility, low disintegration time & hygroscopicity.
Application : Taste Masking
Excipient Details : Sucrex (Sucralose) is used as a sweetener and a taste masking agent in oral dosage forms such as tablets.
Pharmacopoeia Ref : USP-NF, BP, IP, EP, DMF, EXCiP...
Technical Specs : NA
Ingredient(s) : Sucralose
Dosage Form : Capsule, Orodispersible Tablet, Tablet
Grade : Oral
Category : Chewable & Orodispersible Aids, Coating Systems & Additives, Fillers, Diluents & Binders
Application : Taste Masking
Pharmacopoeia Ref : Not Available
Technical Specs : Pharma Grade/Food Grade
Ingredient(s) : Sorbitol
Dosage Form : Cream / Lotion / Ointment, Softgels, Syrup, Tablet
Grade : Oral and Topical
Category : Chewable & Orodispersible Aids, Film Formers & Plasticizers, Taste Masking
Application : Chewable & Orodispersible Aids, Film Formers & Plasticizers, Taste Masking
Dosage Form : Cream / Lotion / Ointment, Injectable / Parenteral
Grade : Topical, Parenteral
Category : Parenteral, Topical
Dosage Form : Capsule, Orodispersible Tablet, Tablet
Grade : Oral
Category : Chewable & Orodispersible Aids, Coating Systems & Additives, Fillers, Diluents & Binders
Dosage Form : Capsule, Cream / Lotion / Ointment, Emulsion, Gel, Injectable / Parenteral, Suspension, Tablet
Grade : Parenteral, Oral, Topical
Category : Emulsifying Agents, Film Formers & Plasticizers, Parenteral, Solubilizers, Surfactant & Foaming Agents, Thickeners and Stabilizers, Topical
Application : Emulsifying Agents, Film Formers & Plasticizers, Parenteral, Solubilizers, Surfactant & Foaming Agents, Thickeners and Stabilizers, Topical
Excipient Details : Polysorbate 80 is used as a plasticizer, solubilizer, emulsifier, surfactant, and suspension stabilizer. It is also used in parenteral products.
Dosage Form : Cream / Lotion / Ointment, Emulsion, Injectable / Parenteral, Softgels, Tablet
Grade : Oral, Topical, Parenteral
Category : Film Formers & Plasticizers, Parenteral, Topical
Dosage Form : Cream / Lotion / Ointment, Gel, Injectable / Parenteral, Softgels
Grade : Parenteral, Oral, Topical
Category : Film Formers & Plasticizers, Parenteral, Thickeners and Stabilizers, Topical
Dosage Form : Cream / Lotion / Ointment, Gel, Solution
Grade : Oral, Topical
Category : Emulsifying Agents, Solubilizers, Topical
Application : Emulsifying Agents, Solubilizers, Topical
Excipient Details : Hydrosol 50 is used as a solubilizer and emulsifying agent in oral and topical liquid and semi-solid dosage forms.
Pharmacopoeia Ref : USP/NF
Technical Specs : N/A
Ingredient(s) : Polyoxyl 40 Hydrogenated Castor Oil
Dosage Form : Capsule, Cream / Lotion / Ointment
Grade : Topical and Oral
Category : Film Formers & Plasticizers, Topical
Application : Film Formers & Plasticizers, Topical
Dosage Form : Capsule, Cream / Lotion / Ointment, Suspension, Tablet
Grade : Oral, Topical & Parenteral
Category : Solubilizers, Surfactant & Foaming Agents
Application : Solubilizers, Surfactant & Foaming Agents
Excipient Details : Polysorbate 80 acts as solubilizer, emulsifier and wetting agent.
Dosage Form : Cream / Lotion / Ointment, Tablet
Grade : Oral & Topical
Category : Chewable & Orodispersible Aids, Taste Masking, Topical
Application : Chewable & Orodispersible Aids, Taste Masking, Topical
Dosage Form : Capsule, Orodispersible Tablet, Tablet
Grade : Oral
Category : Chewable & Orodispersible Aids, Coating Systems & Additives, Fillers, Diluents & Binders
Dosage Form : Capsule, Granule / Pellet, Tablet
Grade : Oral
Category : Coating Systems & Additives, Coloring Agents
Brand Name : Titanium dioxide PRETIOX AV01FG
Application : Coating Systems & Additives, Coloring Agents
Excipient Details : Titanium dioxide Pretiox AV01FG is used as a coloring and coating agent in oral solid dosage forms such as capsules, tablets, granules, and pellets.
Pharmacopoeia Ref : Fami-QS, Kosher, Halal, OHSAS ...
Technical Specs : Ti 59.95% and O 40.05%
Ingredient(s) : Titanium Dioxide
Dosage Form : Capsule, Granule / Pellet, Tablet
Grade : Oral
Category : Coating Systems & Additives, Coloring Agents
Grade : Not Available
Category : Coating Systems & Additives, Film Formers & Plasticizers
Brand Name : ReadiLYCOAT® D CLEAR 110.01
Application : Coating Systems & Additives, Film Formers & Plasticizers
Excipient Details : A natural inert polymer and ready-to-use coating system for fast aqueous film coating saves up to 50% or more time.
Pharmacopoeia Ref : Not Available
Technical Specs : Not Available
Ingredient(s) : Hydroxypropyl Pea Starch, Sorbitol, Stearic Acid
Grade : Not Available
Category : Coating Systems & Additives, Film Formers & Plasticizers
Brand Name : ReadiLYCOAT® D CLEAR 110.01 MS
Application : Coating Systems & Additives, Film Formers & Plasticizers
Excipient Details : A natural inert polymer and ready-to-use coating system for fast aqueous film coating saves up to 50% or more time.
Pharmacopoeia Ref : Not Available
Technical Specs : Not Available
Ingredient(s) : Hydroxypropyl Pea Starch, Sorbitol, Stearic Acid
Dosage Form : Tablet
Grade : Oral
Category : Chewable & Orodispersible Aids, Coating Systems & Additives
Dosage Form : Cream / Lotion / Ointment, Tablet
Grade : Oral & Topical
Category : Chewable & Orodispersible Aids, Taste Masking, Topical
Application : Chewable & Orodispersible Aids, Taste Masking, Topical
Grade : Not Available
Category : Coating Systems & Additives, Film Formers & Plasticizers
Brand Name : ReadiLYCOAT® D WHITE 010.01 MS
Application : Coating Systems & Additives, Film Formers & Plasticizers
Excipient Details : A natural inert polymer and ready-to-use coating system for fast aqueous film coating saves up to 50% or more time.
Pharmacopoeia Ref : Not Available
Technical Specs : Not Available
Ingredient(s) : Hydroxypropyl Pea Starch, Sorbitol, Titanium Dioxide, Stearic Acid
Dosage Form : Capsule, Emulsion, Solution, Suspension, Syrup, Tablet
Grade : Oral
Category : Coating Systems & Additives, Taste Masking, Thickeners and Stabilizers
Brand Name : Sucrose Multi-Compendial
Application : Coating Systems & Additives, Taste Masking, Thickeners and Stabilizers
Excipient Details : A & C's Sucrose multi-compendial is a pharmaceutical excipient grade meeting the current specifications of USP-NF, EP and JP monographs.
Application : Coating Systems & Additives, Taste Masking
Excipient Details : Ready mix sugar coating system.
Pharmacopoeia Ref : USP, EP, JP & having US DMF
Technical Specs : Sprayable sugar coating system for solid oral dosage form
Ingredient(s) : Hydroxypropyl Methyl Cellulose
Application : Empty Capsules
Excipient Details : ACGCAPS™ GL / HL is available in gelatin and cellulose (HPMC) material options and can be used for liquids, semi-liquids, hot-melts and combination fills.
Pharmacopoeia Ref : Not Available
Technical Specs : Not Available
Ingredient(s) : Gelatin, Unspecified
Application : Empty Capsules
Excipient Details : ACGCAPS™ GR can fulfill immediate release needs and is available in 15 sizes (from # 000 to # 5).
Pharmacopoeia Ref : Not Available
Technical Specs : Not Available
Ingredient(s) : Gelatin, Unspecified
Application : Empty Capsules
Excipient Details : Quali-G™ is first preservative-free gelatin capsule, the market standard solid dosage form designed to meet the demanding requirements of the pharmaceutical industry.
Pharmacopoeia Ref : Not Available
Technical Specs : Not Available
Ingredient(s) : Gelatin, Unspecified
Application : Empty Capsules
Excipient Details : ACGCAPS™ GI / HI is available in gelatin and cellulose (HPMC) material options and is designed for optimal performance with DPI formulations and various inhalation devices.
Pharmacopoeia Ref : Not Available
Technical Specs : Not Available
Ingredient(s) : Gelatin, Unspecified
Application : Empty Capsules
Excipient Details : ACGCAPS™ GC is specially designed for use in clinical trials and comes in the available sizes: AA, A & B.
Pharmacopoeia Ref : Not Available
Technical Specs : Not Available
Ingredient(s) : Gelatin, Unspecified
Application : Empty Capsules
Excipient Details : DBcaps® capsules are developed with a tamper-evident design to specifically address the clinical trial challenges of testing without bias.
Pharmacopoeia Ref : Not Available
Technical Specs : Size # AAA- E
Ingredient(s) : Gelatin, Unspecified
Application : Empty Capsules
Pharmacopoeia Ref : Certified Vegan, Non-GMO, Vege...
Technical Specs : Size # 00el - 4
Ingredient(s) : Gelatin, Unspecified
Application : Empty Capsules
Pharmacopoeia Ref : Not Available
Technical Specs : Not Available
Ingredient(s) : Gelatin, Unspecified
Application : Emulsifying Agents
Excipient Details : HDK N20 Pharma is used as a pharmaceutical emulsifying agent in tablets, capsules, syrups, and solutions.
Dosage Form : Capsule, Cream / Lotion / Ointment, Emulsion, Gel, Injectable / Parenteral, Suspension, Tablet
Grade : Parenteral, Oral, Topical
Category : Emulsifying Agents, Film Formers & Plasticizers, Parenteral, Solubilizers, Surfactant & Foaming Agents, Thickeners and Stabilizers, Topical
Application : Emulsifying Agents, Film Formers & Plasticizers, Parenteral, Solubilizers, Surfactant & Foaming Agents, Thickeners and Stabilizers, Topical
Excipient Details : Polysorbate 80 is used as a plasticizer, solubilizer, emulsifier, surfactant, and suspension stabilizer. It is also used in parenteral products.
Dosage Form : Emulsion, Injectable / Parenteral
Grade : Parenteral
Category : Emulsifying Agents, Parenteral, Solubilizers
Dosage Form : Cream / Lotion / Ointment, Gel, Solution
Grade : Oral, Topical
Category : Emulsifying Agents, Solubilizers, Topical
Application : Emulsifying Agents, Solubilizers, Topical
Excipient Details : Hydrosol 50 is used as a solubilizer and emulsifying agent in oral and topical liquid and semi-solid dosage forms.
Pharmacopoeia Ref : USP/NF
Technical Specs : N/A
Ingredient(s) : Polyoxyl 40 Hydrogenated Castor Oil
Dosage Form : Capsule, Cream / Lotion / Ointment, Suspension, Tablet
Grade : Oral, Topical & Parenteral
Category : Solubilizers, Surfactant & Foaming Agents
Application : Solubilizers, Surfactant & Foaming Agents
Excipient Details : Polysorbate 80 acts as solubilizer, emulsifier and wetting agent.
Application : Emulsifying Agents, Lubricants & Glidants
Excipient Details : Glidant; Emulsion Stabilizer; Anti-caking Agent.
Dosage Form : Capsule, Cream / Lotion / Ointment, Emulsion, Gel, Paste, Shampoo, Solution, Syrup, Tablet
Grade : Topical, Oral
Category : Film Formers & Plasticizers, Solubilizers, Surfactant & Foaming Agents, Topical
Brand Name : MONTANOX 80 PHA PREMIUM
Application : Film Formers & Plasticizers, Solubilizers, Surfactant & Foaming Agents, Topical
Excipient Details : Non-Ionic Hydrophilic Surfactant, Emulsifier, Solubilizer
Pharmacopoeia Ref : Ph.Eur, USP-NF
Technical Specs : HLB: 15, EO: 20; EXCiPACT
Ingredient(s) : Polysorbate 80
Dosage Form : Capsule, Cream / Lotion / Ointment, Tablet
Grade : Oral, Topical
Category : Emulsifying Agents, Solubilizers, Surfactant & Foaming Agents, Topical
Brand Name : MONTANOX 80 PHA PREMIUM
Application : Emulsifying Agents, Solubilizers, Surfactant & Foaming Agents, Topical
Pharmacopoeia Ref : USP-NF, EP, JP
Technical Specs : Non-Ionic Hydrophilic surfactant, Emulsifier (o/w emulsion), Solu...
Ingredient(s) : Polysorbate 80
Dosage Form : Cream / Lotion / Ointment, Emulsion, Gel
Grade : Topical
Category : Rheology Modifiers, Thickeners and Stabilizers, Topical
Application : Rheology Modifiers, Thickeners and Stabilizers, Topical
Excipient Details : Thickener, Stabilizer / Emulsifier, Texturizing Agent
Pharmacopoeia Ref : IID
Technical Specs : EXCiPACT
Ingredient(s) : Acrylamide / Sodium Acryloyldimethyl Taurate Copolymer Isohexadecane and Polysorbate 80
Dosage Form : Cream / Lotion / Ointment, Emulsion
Grade : Topical
Category : Emulsifying Agents, Rheology Modifiers, Thickeners and Stabilizers, Topical
Application : Emulsifying Agents, Rheology Modifiers, Thickeners and Stabilizers, Topical
Excipient Details : Thickener, Emulsifier, Stabilizer, Texturizing agent, pH Independent & Non Thixotropic polymer for Topical Range (Skin,Vaginal & Anal mucosa)
Pharmacopoeia Ref : In house having US DMF Type IV...
Technical Specs : Ready to use liquid polymer for topical applications (Gel / Cream...
Ingredient(s) : Hydroxyethyl Acrylate
Global Sales Information
Market Place
Patents & EXCLUSIVITIES
Patent Expiration Date : 2027-09-25
US Patent Number : 9198892
Drug Substance Claim :
Drug Product Claim :
Application Number : 202057
Patent Use Code : U-2706
Delist Requested :
Patent Use Description :
Patent Expiration Date : 2027-09-25
Patent Expiration Date : 2033-06-28
US Patent Number : 9693984
Drug Substance Claim :
Drug Product Claim :
Application Number : 202057
Patent Use Code : U-2697
Delist Requested :
Patent Use Description :
Patent Expiration Date : 2033-06-28
Patent Expiration Date : 2030-02-09
US Patent Number : 8426399
Drug Substance Claim :
Drug Product Claim :
Application Number : 202057
Patent Use Code : U-1287
Delist Requested :
Patent Use Description : METHOD OF REDUCING TG ...
Patent Expiration Date : 2030-02-09
Patent Expiration Date : 2030-06-15
US Patent Number : 8710041
Drug Substance Claim :
Drug Product Claim :
Application Number : 202057
Patent Use Code : U-2690
Delist Requested :
Patent Use Description :
Patent Expiration Date : 2030-06-15
Patent Expiration Date : 2030-02-09
US Patent Number : 8415335
Drug Substance Claim :
Drug Product Claim :
Application Number : 202057
Patent Use Code : U-1287
Delist Requested :
Patent Use Description : METHOD OF REDUCING TG ...
Patent Expiration Date : 2030-02-09
Patent Expiration Date : 2030-06-15
US Patent Number : 10842768
Drug Substance Claim :
Drug Product Claim :
Application Number : 202057
Patent Use Code : U-2688
Delist Requested :
Patent Use Description :
Patent Expiration Date : 2030-06-15
Patent Expiration Date : 2030-04-29
US Patent Number : 10792267
Drug Substance Claim :
Drug Product Claim :
Application Number : 202057
Patent Use Code : U-2961
Delist Requested :
Patent Use Description :
Patent Expiration Date : 2030-04-29
Patent Expiration Date : 2033-06-28
US Patent Number : 10668042
Drug Substance Claim :
Drug Product Claim :
Application Number : 202057
Patent Use Code : U-2841
Delist Requested :
Patent Use Description :
Patent Expiration Date : 2033-06-28
Patent Expiration Date : 2030-04-29
US Patent Number : 11213504
Drug Substance Claim :
Drug Product Claim :
Application Number : 202057
Patent Use Code : U-3292
Delist Requested :
Patent Use Description :
Patent Expiration Date : 2030-04-29
Patent Expiration Date : 2033-06-28
US Patent Number : 11298333
Drug Substance Claim :
Drug Product Claim :
Application Number : 202057
Patent Use Code : U-3358
Delist Requested :
Patent Use Description :
Patent Expiration Date : 2033-06-28
REF. STANDARDS & IMPURITIES
ABOUT THIS PAGE
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PharmaCompass offers a list of Icosapent Ethyl API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, Price,and more, enabling you to easily find the right Icosapent Ethyl manufacturer or Icosapent Ethyl supplier for your needs.
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PharmaCompass also assists you with knowing the Icosapent Ethyl API Price utilized in the formulation of products. Icosapent Ethyl API Price is not always fixed or binding as the Icosapent Ethyl Price is obtained through a variety of data sources. The Icosapent Ethyl Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Eicosapentaenoic Acid Ethyl Ester manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Eicosapentaenoic Acid Ethyl Ester, including repackagers and relabelers. The FDA regulates Eicosapentaenoic Acid Ethyl Ester manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Eicosapentaenoic Acid Ethyl Ester API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
click here to find a list of Eicosapentaenoic Acid Ethyl Ester manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Eicosapentaenoic Acid Ethyl Ester supplier is an individual or a company that provides Eicosapentaenoic Acid Ethyl Ester active pharmaceutical ingredient (API) or Eicosapentaenoic Acid Ethyl Ester finished formulations upon request. The Eicosapentaenoic Acid Ethyl Ester suppliers may include Eicosapentaenoic Acid Ethyl Ester API manufacturers, exporters, distributors and traders.
click here to find a list of Eicosapentaenoic Acid Ethyl Ester suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Eicosapentaenoic Acid Ethyl Ester DMF (Drug Master File) is a document detailing the whole manufacturing process of Eicosapentaenoic Acid Ethyl Ester active pharmaceutical ingredient (API) in detail. Different forms of Eicosapentaenoic Acid Ethyl Ester DMFs exist exist since differing nations have different regulations, such as Eicosapentaenoic Acid Ethyl Ester USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Eicosapentaenoic Acid Ethyl Ester DMF submitted to regulatory agencies in the US is known as a USDMF. Eicosapentaenoic Acid Ethyl Ester USDMF includes data on Eicosapentaenoic Acid Ethyl Ester's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Eicosapentaenoic Acid Ethyl Ester USDMF is kept confidential to protect the manufacturer’s intellectual property.
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The Pharmaceuticals and Medical Devices Agency (PMDA) established the Japan Drug Master File (JDMF), also known as the Master File (MF), to permit Japanese and foreign manufacturers of drug substances, intermediates, excipients, raw materials, and packaging materials (‘Products’) to voluntarily register confidential information about the production and management of their products in Japan.
The Eicosapentaenoic Acid Ethyl Ester Drug Master File in Japan (Eicosapentaenoic Acid Ethyl Ester JDMF) empowers Eicosapentaenoic Acid Ethyl Ester API manufacturers to present comprehensive information (e.g., production methods, data, etc.) to the review authority, i.e., PMDA (Pharmaceuticals & Medical Devices Agency).
PMDA reviews the Eicosapentaenoic Acid Ethyl Ester JDMF during the approval evaluation for pharmaceutical products. At the time of Eicosapentaenoic Acid Ethyl Ester JDMF registration, PMDA checks if the format is accurate, if the necessary items have been included (application), and if data has been attached.
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In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.
Pharmaceutical companies submit a Eicosapentaenoic Acid Ethyl Ester Drug Master File in Korea (Eicosapentaenoic Acid Ethyl Ester KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Eicosapentaenoic Acid Ethyl Ester. The MFDS reviews the Eicosapentaenoic Acid Ethyl Ester KDMF as part of the drug registration process and uses the information provided in the Eicosapentaenoic Acid Ethyl Ester KDMF to evaluate the safety and efficacy of the drug.
After submitting a Eicosapentaenoic Acid Ethyl Ester KDMF to the MFDS, the registered manufacturer can provide importers or distributors with the registration number without revealing confidential information to Korean business partners. Applicants seeking to register their Eicosapentaenoic Acid Ethyl Ester API can apply through the Korea Drug Master File (KDMF).
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Eicosapentaenoic Acid Ethyl Ester Active pharmaceutical ingredient (API) is produced in GMP-certified manufacturing facility.
GMP stands for Good Manufacturing Practices, which is a system used in the pharmaceutical industry to make sure that goods are regularly produced and monitored in accordance with quality standards. The FDA’s current Good Manufacturing Practices requirements are referred to as cGMP or current GMP which indicates that the company follows the most recent GMP specifications. The World Health Organization (WHO) has its own set of GMP guidelines, called the WHO GMP. Different countries can also set their own guidelines for GMP like China (Chinese GMP) or the EU (EU GMP).
PharmaCompass offers a list of Eicosapentaenoic Acid Ethyl Ester GMP manufacturers, exporters & distributors, which can be sorted by USDMF, JDMF, KDMF, CEP (COS), WC, API price, and more, enabling you to easily find the right Eicosapentaenoic Acid Ethyl Ester GMP manufacturer or Eicosapentaenoic Acid Ethyl Ester GMP API supplier for your needs.
A Eicosapentaenoic Acid Ethyl Ester CoA (Certificate of Analysis) is a formal document that attests to Eicosapentaenoic Acid Ethyl Ester's compliance with Eicosapentaenoic Acid Ethyl Ester specifications and serves as a tool for batch-level quality control.
Eicosapentaenoic Acid Ethyl Ester CoA mostly includes findings from lab analyses of a specific batch. For each Eicosapentaenoic Acid Ethyl Ester CoA document that a company creates, the USFDA specifies specific requirements, such as supplier information, material identification, transportation data, evidence of conformity and signature data.
Eicosapentaenoic Acid Ethyl Ester may be tested according to a variety of international standards, such as European Pharmacopoeia (Eicosapentaenoic Acid Ethyl Ester EP), Eicosapentaenoic Acid Ethyl Ester JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Eicosapentaenoic Acid Ethyl Ester USP).