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1. 3r)-3-cyclopentyl-3-(4-(7h-pyrrolo(2,3-d)pyrimidin-4-yl)pyrazol-1-yl)propanenitrile
2. Inc-424
3. Inc424
4. Inca24
5. Incb-018424
6. Incb-018424 Phosphate
7. Incb-018424 Salt
8. Incb-18424
9. Incb-18424 Phosphate
10. Incb018424
11. Incb018424 Phosphate
12. Jakafi
13. Jakavi
14. Opzelura
15. Ruxolitinib
16. Ruxolitinib (as Phosphate)
17. Ruxolitinib Monophosphate
1. 1092939-17-7
2. Jakafi
3. (r)-3-(4-(7h-pyrrolo[2,3-d]pyrimidin-4-yl)-1h-pyrazol-1-yl)-3-cyclopentylpropanenitrile Phosphate
4. Jakavi
5. Ruxolitinib (phosphate)
6. Ruxolitinib Monophosphate
7. Incb018424 Phosphate
8. Ruxolitinib (as Phosphate)
9. Incb-018424 Phosphate
10. Incb-018424 Salt
11. Ruxolitinib Phosphate [usan]
12. Incb-18424 Phosphate
13. Incb018424 Salt
14. Chebi:66917
15. 436lru32h5
16. 1092939-17-7 (phosphate)
17. (betar)-beta-cyclopentyl-4-(7h-pyrrolo[2,3-d]pyrimidin-4-yl)-1h-pyrazole-1-propanenitrile Phosphate
18. Incb-18424
19. Ruxolitinib Phosphate Salt
20. (3r)-3-cyclopentyl-3-[4-(7h-pyrrolo[2,3-d]pyrimidin-4-yl)-1h-pyrazol-1-yl]propanenitrile Phosphate
21. (3r)-3-cyclopentyl-3-(4-(7h-pyrrolo(2,3-d)pyrimidin-4-yl)-1h-pyrazol-1-yl)propanenitrile Phosphate (1:1)
22. Phosphenoperoxoic Acid Compound With (r)-3-(4-(7h-pyrrolo[2,3-d]pyrimidin-4-yl)- 1h-pyrazol-1-yl)-3-cyclopentylpropanenitrile And Dihydrogen (1:1:1)
23. Opzelura
24. Unii-436lru32h5
25. (3r)-3-cyclopentyl-3-[4-(7h-pyrrolo[2,3-d]pyrimidin-4-yl)-1h-pyrazol-1-yl]propanenitrilephosphoricacid
26. Jakafi (tn)
27. Jakavi (tn)
28. Ruxolitinib Phosphate(incb018424)
29. Inc 424 Phosphate
30. Incb 018424 Phosphate
31. Incb-424
32. Schembl1369365
33. Chembl1795071
34. Amy5620
35. Dtxsid00911086
36. Ruxolitinib Phosphate (jan/usan)
37. Ruxolitinib Phosphate [mi]
38. Ruxolitinib Phosphate [jan]
39. Ex-a2660
40. Cs1956
41. Mfcd18452860
42. S5243
43. Akos024464417
44. Ruxolitinib (incb-18424) Phosphate
45. Ruxolitinib Phosphate [who-dd]
46. Bcp9000783
47. Ccg-268687
48. Cs-0326
49. 1h-pyrazole-1-propanenitrile, Beta-cyclopentyl-4-(7h-pyrrolo(2,3-d)pyrimidin-4-yl)-,(betar)-, Phosphate (1:1)
50. Ac-30901
51. As-74723
52. Hy-50858
53. Ruxolitinib Phosphate [orange Book]
54. Ruxolitinib (as Phosphate) [ema Epar]
55. D09960
56. J-501793
57. Q27135517
58. (3r)-3-cyclopentyl-3-(4-{7h-pyrrolo[2,3-d]pyrimidin-4-yl}-1h-pyrazol-1-yl)propanenitrile; Phosphoric Acid
59. (3r)-3-cyclopentyl-3-[4-(7h-pyrrolo[2,3-d]pyrimidin-4-yl)pyrazol-1-yl]propanenitrile;phosphoric Acid
60. (r)-3-(4-(7h-pyrrolo[2,3-d]pyrimidin-4-yl)-1h-pyrazol-1-yl)-3-cyclopentylpropanenitrilephosphate
61. 1h-pyrazole-1-propanenitrile,.beta.-cyclopentyl-4-(7h-pyrrolo(2,3-d)pyrimidin-4-yl)-,(.beta.r)-,phosphate (1:1)
62. Phosphoric Acid--3-cyclopentyl-3-[4-(1h-pyrrolo[2,3-d]pyrimidin-4-yl)-1h-pyrazol-1-yl]propanenitrile (1/1)
Molecular Weight | 404.4 g/mol |
---|---|
Molecular Formula | C17H21N6O4P |
Hydrogen Bond Donor Count | 4 |
Hydrogen Bond Acceptor Count | 8 |
Rotatable Bond Count | 4 |
Exact Mass | 404.13619017 g/mol |
Monoisotopic Mass | 404.13619017 g/mol |
Topological Polar Surface Area | 161 Ų |
Heavy Atom Count | 28 |
Formal Charge | 0 |
Complexity | 503 |
Isotope Atom Count | 0 |
Defined Atom Stereocenter Count | 1 |
Undefined Atom Stereocenter Count | 0 |
Defined Bond Stereocenter Count | 0 |
Undefined Bond Stereocenter Count | 0 |
Covalently Bonded Unit Count | 2 |
1 of 2 | |
---|---|
Drug Name | Jakafi |
PubMed Health | Ruxolitinib (By mouth) |
Drug Classes | Antineoplastic Agent |
Active Ingredient | Ruxolitinib phosphate |
Dosage Form | Tablet |
Route | Oral |
Strength | eq 5mg base; eq 20mg base; eq 15mg base; eq 10mg base; eq 25mg base |
Market Status | Prescription |
Company | Incyte |
2 of 2 | |
---|---|
Drug Name | Jakafi |
PubMed Health | Ruxolitinib (By mouth) |
Drug Classes | Antineoplastic Agent |
Active Ingredient | Ruxolitinib phosphate |
Dosage Form | Tablet |
Route | Oral |
Strength | eq 5mg base; eq 20mg base; eq 15mg base; eq 10mg base; eq 25mg base |
Market Status | Prescription |
Company | Incyte |
* Myelofibrosis (MF):
Jakavi is indicated for the treatment of disease related splenomegaly or symptoms in adult patients with primary myelofibrosis (also known as chronic idiopathic myelofibrosis), post polycythaemia vera myelofibrosis or post essential thrombocythaemia myelofibrosis.
* Polycythaemia vera (PV):
Jakavi is indicated for the treatment of adult patients with polycythaemia vera who are resistant to or intolerant of hydroxyurea.
* Graft versus host disease (GvHD):
Jakavi is indicated for the treatment of patients aged 12 years and older with acute graft versus host disease or chronic graft versus host disease who have inadequate response to corticosteroids or other systemic therapies (see section 5. 1).
Treatment of chronic Graft versus Host Disease (cGvHD)
Treatment of acute graft-versus-host disease (aGvHD)
Treatment of vitiligo
L01EJ01
NDC Package Code : 62009-1909
Start Marketing Date : 2014-02-01
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
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DMF Review : N/A
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DMF Number : 41012
Submission : 2024-12-31
Status : Active
Type : II
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GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 41012
Submission : 2024-12-31
Status : Active
Type : II
Granules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.
GDUFA
DMF Review : Complete
Rev. Date : 2025-03-14
Pay. Date : 2025-03-06
DMF Number : 40874
Submission : 2025-02-12
Status : Active
Type : II
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DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 39763
Submission : 2024-03-27
Status : Active
Type : II
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DMF Review : Complete
Rev. Date : 2015-11-16
Pay. Date : 2015-07-31
DMF Number : 29480
Submission : 2015-05-29
Status : Active
Type : II
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DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 39494
Submission : 2024-03-29
Status : Active
Type : II
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DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 38506
Submission : 2023-07-13
Status : Active
Type : II
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DMF Review : Complete
Rev. Date : 2024-08-23
Pay. Date : 2024-06-28
DMF Number : 40066
Submission : 2024-07-24
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2021-12-16
Pay. Date : 2021-09-29
DMF Number : 32221
Submission : 2017-11-30
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2025-05-16
Pay. Date : 2025-04-03
DMF Number : 39789
Submission : 2024-03-28
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 39500
Submission : 2024-03-28
Status : Active
Type : II
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Average Price (USD/KGS) |
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RLD : Yes
TE Code :
Brand Name : JAKAFI
Dosage Form : TABLET;ORAL
Dosage Strength : EQ 5MG BASE
Approval Date : 2011-11-16
Application Number : 202192
RX/OTC/DISCN : RX
RLD : Yes
TE Code :
RLD : Yes
TE Code :
Brand Name : JAKAFI
Dosage Form : TABLET;ORAL
Dosage Strength : EQ 10MG BASE
Approval Date : 2011-11-16
Application Number : 202192
RX/OTC/DISCN : RX
RLD : Yes
TE Code :
RLD : Yes
TE Code :
Brand Name : JAKAFI
Dosage Form : TABLET;ORAL
Dosage Strength : EQ 15MG BASE
Approval Date : 2011-11-16
Application Number : 202192
RX/OTC/DISCN : RX
RLD : Yes
TE Code :
RLD : Yes
TE Code :
Brand Name : JAKAFI
Dosage Form : TABLET;ORAL
Dosage Strength : EQ 20MG BASE
Approval Date : 2011-11-16
Application Number : 202192
RX/OTC/DISCN : RX
RLD : Yes
TE Code :
RLD : Yes
TE Code :
Brand Name : JAKAFI
Dosage Form : TABLET;ORAL
Dosage Strength : EQ 25MG BASE
Approval Date : 2011-11-16
Application Number : 202192
RX/OTC/DISCN : RX
RLD : Yes
TE Code :
RLD : Yes
TE Code :
Brand Name : OPZELURA
Dosage Form : CREAM;TOPICAL
Dosage Strength : EQ 1.5% BASE
Approval Date : 2021-09-21
Application Number : 215309
RX/OTC/DISCN : RX
RLD : Yes
TE Code :
Regulatory Info :
Registration Country : Switzerland
Brand Name : Jakavi
Dosage Form : Tablet
Dosage Strength : 10mg
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Switzerland
Regulatory Info :
Registration Country : Switzerland
Brand Name : Jakavi
Dosage Form : Tablet
Dosage Strength : 15mg
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Switzerland
Regulatory Info :
Registration Country : Switzerland
Brand Name : Jakavi
Dosage Form : Tablet
Dosage Strength : 20mg
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Switzerland
Regulatory Info :
Registration Country : Switzerland
Brand Name : Jakavi
Dosage Form : Tablet
Dosage Strength : 5mg
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Switzerland
Regulatory Info :
Registration Country : Norway
Brand Name : Jakavi
Dosage Form : Antic-calc Tablet
Dosage Strength : 15 mg
Packaging : Blister
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Norway
Regulatory Info :
Registration Country : Norway
Brand Name : Jakavi
Dosage Form : Antic-calc Tablet
Dosage Strength : 20 mg
Packaging : Blister
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Norway
Regulatory Info :
Registration Country : Norway
Brand Name : Jakavi
Dosage Form : Antic-calc Tablet
Dosage Strength : 5 mg
Packaging : Blister
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Norway
Regulatory Info :
Registration Country : Australia
Brand Name : Jakavi
Dosage Form :
Dosage Strength :
Packaging : 56
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Australia
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
Regulatory Info :
Registration Country : Australia
Brand Name : Jakavi
Dosage Form :
Dosage Strength :
Packaging : 56
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Australia
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
Regulatory Info :
Registration Country : Australia
Brand Name : Jakavi
Dosage Form :
Dosage Strength :
Packaging : 56
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Australia
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
Regulatory Info :
Registration Country : Australia
Brand Name : Jakavi
Dosage Form :
Dosage Strength :
Packaging : 56
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Australia
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
Regulatory Info :
Registration Country : Australia
Brand Name : Jakavi
Dosage Form :
Dosage Strength :
Packaging : 56
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Australia
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
Regulatory Info :
Registration Country : Australia
Brand Name : Jakavi
Dosage Form :
Dosage Strength :
Packaging : 56
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Australia
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
Regulatory Info :
Registration Country : Australia
Brand Name : Jakavi
Dosage Form :
Dosage Strength :
Packaging : 56
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Australia
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
Regulatory Info :
Registration Country : Australia
Brand Name : Jakavi
Dosage Form :
Dosage Strength :
Packaging : 56
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Australia
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
Regulatory Info :
Registration Country : Australia
Brand Name : Jakavi
Dosage Form :
Dosage Strength :
Packaging : 56
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Australia
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
Regulatory Info :
Registration Country : Australia
Brand Name : Jakavi
Dosage Form :
Dosage Strength :
Packaging : 56
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Australia
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
Regulatory Info : Originator
Registration Country : South Africa
Brand Name : Jakavi 20 mg
Dosage Form : TAB
Dosage Strength : 20mg
Packaging : 56X1mg
Approval Date :
Application Number :
Regulatory Info : Originator
Registration Country : South Africa
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
Regulatory Info : Originator
Registration Country : South Africa
Brand Name : Jakavi 15 mg
Dosage Form : TAB
Dosage Strength : 15mg
Packaging : 56X1mg
Approval Date :
Application Number :
Regulatory Info : Originator
Registration Country : South Africa
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
Regulatory Info : Originator
Registration Country : South Africa
Brand Name : Jakavi 5 mg
Dosage Form : TAB
Dosage Strength : 5mg
Packaging : 56X1mg
Approval Date :
Application Number :
Regulatory Info : Originator
Registration Country : South Africa
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
Regulatory Info :
Registration Country : Iran
Brand Name : Relata
Dosage Form : Tablet
Dosage Strength : 5MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Iran
Packaging :
Regulatory Info :
Dosage : Tablet
Dosage Strength : 5MG
Brand Name : Relata
Approval Date :
Application Number :
Registration Country : Iran
Regulatory Info :
Registration Country : Iran
Brand Name : Relata
Dosage Form : Tablet
Dosage Strength : 10MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Iran
Packaging :
Regulatory Info :
Dosage : Tablet
Dosage Strength : 10MG
Brand Name : Relata
Approval Date :
Application Number :
Registration Country : Iran
Regulatory Info :
Registration Country : Iran
Brand Name : Relata
Dosage Form : Tablet
Dosage Strength : 15MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Iran
Packaging :
Regulatory Info :
Dosage : Tablet
Dosage Strength : 15MG
Brand Name : Relata
Approval Date :
Application Number :
Registration Country : Iran
Regulatory Info :
Registration Country : Iran
Brand Name : Relata
Dosage Form : Tablet
Dosage Strength : 20MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Iran
Packaging :
Regulatory Info :
Dosage : Tablet
Dosage Strength : 20MG
Brand Name : Relata
Approval Date :
Application Number :
Registration Country : Iran
Granules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.
Regulatory Info :
Registration Country : India
Brand Name : Ruxolitinib Phosphate
Dosage Form : Immediate Release Tabl...
Dosage Strength : 4.71%
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : India
Granules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.
Packaging :
Regulatory Info :
Dosage : Immediate Release Tabl...
Dosage Strength : 4.71%
Brand Name : Ruxolitinib Phosphate
Approval Date :
Application Number :
Registration Country : India
Regulatory Info :
Registration Country : Spain
Brand Name :
Dosage Form : Tablet
Dosage Strength : 2MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Spain
Packaging :
Regulatory Info :
Dosage : Tablet
Dosage Strength : 2MG
Brand Name :
Approval Date :
Application Number :
Registration Country : Spain
Regulatory Info :
Registration Country : Spain
Brand Name :
Dosage Form : Tablet
Dosage Strength : 10MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Spain
Packaging :
Regulatory Info :
Dosage : Tablet
Dosage Strength : 10MG
Brand Name :
Approval Date :
Application Number :
Registration Country : Spain
Regulatory Info :
Registration Country : Spain
Brand Name :
Dosage Form : Tablet
Dosage Strength : 15MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Spain
Packaging :
Regulatory Info :
Dosage : Tablet
Dosage Strength : 15MG
Brand Name :
Approval Date :
Application Number :
Registration Country : Spain
Regulatory Info :
Registration Country : Spain
Brand Name :
Dosage Form : Tablet
Dosage Strength : 20MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Spain
Packaging :
Regulatory Info :
Dosage : Tablet
Dosage Strength : 20MG
Brand Name :
Approval Date :
Application Number :
Registration Country : Spain
Regulatory Info :
Registration Country : Spain
Brand Name :
Dosage Form : Cream
Dosage Strength : 1.5%
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Spain
Packaging :
Regulatory Info :
Dosage : Cream
Dosage Strength : 1.5%
Brand Name :
Approval Date :
Application Number :
Registration Country : Spain
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Dosage Form : Tablet
Grade : Oral
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Patents & EXCLUSIVITIES
Patent Expiration Date : 2028-12-12
US Patent Number : 8822481*PED
Drug Substance Claim :
Drug Product Claim :
Application Number : 202192
Patent Use Code :
Delist Requested :
Patent Use Description :
Patent Expiration Date : 2028-12-12
Patent Expiration Date : 2040-06-10
US Patent Number : 11590138
Drug Substance Claim :
Drug Product Claim :
Application Number : 215309
Patent Use Code : U-3551
Delist Requested :
Patent Use Description :
Patent Expiration Date : 2040-06-10
Patent Expiration Date : 2028-12-12
US Patent Number : 8722693*PED
Drug Substance Claim :
Drug Product Claim :
Application Number : 215309
Patent Use Code :
Delist Requested :
Patent Use Description :
Patent Expiration Date : 2028-12-12
Patent Expiration Date : 2027-12-24
US Patent Number : 7598257
Drug Substance Claim : Y
Drug Product Claim : Y
Application Number : 202192
Patent Use Code : U-3228
Delist Requested :
Patent Use Description :
Patent Expiration Date : 2027-12-24
Patent Expiration Date : 2028-06-12
US Patent Number : 8829013
Drug Substance Claim :
Drug Product Claim :
Application Number : 202192
Patent Use Code : U-1622
Delist Requested :
Patent Use Description : FOR THE TREATMENT OF P...
Patent Expiration Date : 2028-06-12
Patent Expiration Date : 2028-12-12
US Patent Number : 10016429*PED
Drug Substance Claim :
Drug Product Claim :
Application Number : 202192
Patent Use Code :
Delist Requested :
Patent Use Description :
Patent Expiration Date : 2028-12-12
Patent Expiration Date : 2027-12-24
US Patent Number : 7598257
Drug Substance Claim : Y
Drug Product Claim : Y
Application Number : 202192
Patent Use Code : U-3228
Delist Requested :
Patent Use Description :
Patent Expiration Date : 2027-12-24
Patent Expiration Date : 2026-12-12
US Patent Number : 9974790
Drug Substance Claim :
Drug Product Claim :
Application Number : 215309
Patent Use Code : U-3229
Delist Requested :
Patent Use Description :
Patent Expiration Date : 2026-12-12
Patent Expiration Date : 2027-06-12
US Patent Number : 9079912*PED
Drug Substance Claim :
Drug Product Claim :
Application Number : 202192
Patent Use Code :
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US Patent Number : 8822481
Drug Substance Claim :
Drug Product Claim :
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Delist Requested :
Patent Use Description :
Patent Expiration Date : 2028-06-12
Exclusivity Code : I-872
Exclusivity Expiration Date : 2024-09-22
Application Number : 202192
Product Number : 1
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Exclusivity Code : M-285
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Application Number : 202192
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Application Number : 202192
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Patent Expiration Date : 2026-12-12
Date Granted : 2013-09-24
Brand Name : JAKAVI
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Strength per Unit : 5 mg
Dosage Form : Tablet
Human Or VET : Human
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Patent Expiration Date : 2026-12-12
Date Granted : 2013-09-24
Brand Name : JAKAVI
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Strength per Unit : 15 mg
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Human Or VET : Human
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Patent Expiration Date : 2026-12-12
Date Granted : 2013-09-24
Patent Expiration Date : 2026-12-12
Date Granted : 2013-09-24
Brand Name : JAKAVI
Patent Number : 2632466
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Strength per Unit : 20 mg
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Human Or VET : Human
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Patent Expiration Date : 2026-12-12
Date Granted : 2013-09-24
Patent Expiration Date : 2026-12-12
Date Granted : 2013-09-24
Brand Name : JAKAVI
Patent Number : 2632466
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Dosage Form : TABLET
Human Or VET : Human
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Dosage Form : Tablet
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Strength per Unit : 10 mg
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Human Or VET : Human
Route of Administration : ORAL
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Date Granted : 2016-08-09
ABOUT THIS PAGE
41
PharmaCompass offers a list of Ruxolitinib Phosphate 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 Ruxolitinib Phosphate manufacturer or Ruxolitinib Phosphate supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Ruxolitinib Phosphate manufacturer or Ruxolitinib Phosphate supplier.
PharmaCompass also assists you with knowing the Ruxolitinib Phosphate API Price utilized in the formulation of products. Ruxolitinib Phosphate API Price is not always fixed or binding as the Ruxolitinib Phosphate Price is obtained through a variety of data sources. The Ruxolitinib Phosphate Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Ruxolitinib manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Ruxolitinib, including repackagers and relabelers. The FDA regulates Ruxolitinib manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Ruxolitinib 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 Ruxolitinib manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Ruxolitinib supplier is an individual or a company that provides Ruxolitinib active pharmaceutical ingredient (API) or Ruxolitinib finished formulations upon request. The Ruxolitinib suppliers may include Ruxolitinib API manufacturers, exporters, distributors and traders.
click here to find a list of Ruxolitinib suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Ruxolitinib DMF (Drug Master File) is a document detailing the whole manufacturing process of Ruxolitinib active pharmaceutical ingredient (API) in detail. Different forms of Ruxolitinib DMFs exist exist since differing nations have different regulations, such as Ruxolitinib USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Ruxolitinib DMF submitted to regulatory agencies in the US is known as a USDMF. Ruxolitinib USDMF includes data on Ruxolitinib's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Ruxolitinib USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Ruxolitinib suppliers with USDMF on PharmaCompass.
In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.
Pharmaceutical companies submit a Ruxolitinib Drug Master File in Korea (Ruxolitinib KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Ruxolitinib. The MFDS reviews the Ruxolitinib KDMF as part of the drug registration process and uses the information provided in the Ruxolitinib KDMF to evaluate the safety and efficacy of the drug.
After submitting a Ruxolitinib 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 Ruxolitinib API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Ruxolitinib suppliers with KDMF on PharmaCompass.
A Ruxolitinib written confirmation (Ruxolitinib WC) is an official document issued by a regulatory agency to a Ruxolitinib manufacturer, verifying that the manufacturing facility of a Ruxolitinib active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Ruxolitinib APIs or Ruxolitinib finished pharmaceutical products to another nation, regulatory agencies frequently require a Ruxolitinib WC (written confirmation) as part of the regulatory process.
click here to find a list of Ruxolitinib suppliers with Written Confirmation (WC) on PharmaCompass.
National Drug Code is a comprehensive database maintained by the FDA that contains information on all drugs marketed in the US. This directory includes information about finished drug products, unfinished drug products, and compounded drug products, including those containing Ruxolitinib as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Ruxolitinib API and other APIs are published in this directory by the FDA.
The NDC unfinished drugs database includes product listing information submitted for all unfinished drugs, such as active pharmaceutical ingredients (APIs), drugs intended for further processing and bulk drug substances for compounding.
Pharmaceutical companies that manufacture Ruxolitinib as an active pharmaceutical ingredient (API) must furnish the FDA with an updated record of all drugs that they produce, prepare, propagate, compound, or process for commercial distribution in the US at their facilities.
The NDC directory also contains data on finished compounded human drug products that contain Ruxolitinib and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Ruxolitinib NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Ruxolitinib suppliers with NDC on PharmaCompass.
Ruxolitinib 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 Ruxolitinib 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 Ruxolitinib GMP manufacturer or Ruxolitinib GMP API supplier for your needs.
A Ruxolitinib CoA (Certificate of Analysis) is a formal document that attests to Ruxolitinib's compliance with Ruxolitinib specifications and serves as a tool for batch-level quality control.
Ruxolitinib CoA mostly includes findings from lab analyses of a specific batch. For each Ruxolitinib 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.
Ruxolitinib may be tested according to a variety of international standards, such as European Pharmacopoeia (Ruxolitinib EP), Ruxolitinib JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Ruxolitinib USP).