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1. 3-methyl-n-(2-oxo-2-((2,2,2-trifluoroethyl)amino)ethyl)-5-((5s)-5-(3,4,5-trichlorophenyl)-5-(trifluoromethyl)-4,5-dihydro-1,2-oxazol-3-yl)-2-thiophenecarboxamide
2. Credelio
1. 1369852-71-0
2. Lotilaner [inn]
3. Credelio
4. Heh4938d7k
5. Lotilaner (ema Epar: Veterinary)
6. (s)-5-[5-(3,4,5-trichlorophenyl)-5-trifluoromethyl-4,5-dihydroisoxazol-3-yl]-3-methylthiophene-2-carboxylic Acid [(2,2,2-trifluoroethyl Carbamoyl) Methyl] Amide
7. 3-methyl-n-[2-oxo-2-(2,2,2-trifluoroethylamino)ethyl]-5-[(5s)-5-(3,4,5-trichlorophenyl)-5-(trifluoromethyl)-4h-1,2-oxazol-3-yl]thiophene-2-carboxamide
8. 2-thiophenecarboxamide, 5-((5s)-4,5-dihydro-5-(3,4,5-trichlorophenyl)-5-(trifluoromethyl)-3-isoxazolyl)-3-methyl-n-(2-oxo-2-((2,2,2-trifluoroethyl)amino)ethyl)-
9. Lotilaner [usan:inn]
10. Unii-heh4938d7k
11. Lotilaner [mi]
12. Lotilaner (usan/inn)
13. Lotilaner [usan]
14. Lotilaner [green Book]
15. Chembl3707310
16. Schembl16860871
17. Dtxsid701027551
18. Ex-a3269
19. Ac-36763
20. Hy-116564
21. Cs-0065903
22. D11212
23. Q27279888
24. 3-methyi-n-(2-oxo-2-((2,2,2-trifluoroethyl)amino)ethyl)-5-((55)-5-(3,4,5-trichlorophenyl)-5-(trifluoromethyl)-4,5-dihydro-1,2-oxazol-3-yl)thiophene-2-carboxamide
Molecular Weight | 596.8 g/mol |
---|---|
Molecular Formula | C20H14Cl3F6N3O3S |
XLogP3 | 6.6 |
Hydrogen Bond Donor Count | 2 |
Hydrogen Bond Acceptor Count | 11 |
Rotatable Bond Count | 6 |
Exact Mass | 594.972565 g/mol |
Monoisotopic Mass | 594.972565 g/mol |
Topological Polar Surface Area | 108 Ų |
Heavy Atom Count | 36 |
Formal Charge | 0 |
Complexity | 868 |
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 | 1 |
For the treatment of flea and tick infestations.
Fleas and ticks must attach to the host and commence feeding in order to be exposed to the active substance.
The veterinary medicinal product can be used as part of a treatment strategy for the control of flea allergy dermatitis (FAD).
* Dogs:
This veterinary medicinal product provides immediate and persistent killing activity for 1 month for fleas (Ctenocephalides felis and C. canis) and ticks (Rhipicephalus sanguineus, Ixodes ricinus, I. hexagonus and Dermacentor reticulatus).
* Cats:
This veterinary medicinal product provides immediate and persistent killing activity for 1 month against fleas (Ctenocephalides felis and C. canis) and ticks (Ixodes ricinus).
QP53BE04
Metrochem has been delivering customized volume & quality products to customers across the world, taking utmost care of their needs.
Seqens is an integrated global leader in pharmaceutical solutions & specialty ingredients, & custom-made solutions to our customers.
China's leading API and intermediate manufacturer, offering CMO/CDMO services and exports to 70+ countries, enhancing global health.
TAPI, a leading global supplier of APIs, provides over 350 products and customized CDMO solutions for every stage of development.
Maithri Drugs: Delivering Trusted, High-Quality APIs to 35+ Countries with Innovation, Compliance, and Excellence.
NDC Package Code : 17205-629
Start Marketing Date : 2023-08-14
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
VMF Number : 6306
Submission : 2019-04-30
Status : Active
Type : II
Metrochem has been delivering customized volume & quality products to customers across the world, taking utmost care of their needs.
About the Company : Established in 2004, Metrochem API is one of the fastest-growing APIs, pellets & intermediates manufacturers. It has 6 dedicated manufacturing facilities for its 3 core product gro...
Seqens is an integrated global leader in pharmaceutical solutions & specialty ingredients, & custom-made solutions to our customers.
About the Company : Since its inception in 2003, Seqens has evolved into a global leader in pharmaceutical solutions and specialty ingredients. With a strong focus on customer support, Seqens assists ...
China's leading API and intermediate manufacturer, offering CMO/CDMO services and exports to 70+ countries, enhancing global health.
About the Company : Shandong Chenghui Shuangda Pharmaceutical Co., Ltd. specializes in R&D and production of APIs and advanced intermediates, CDMO/CRO/OEM, and Technology Transfer of Finished Formulat...
About the Company : HRV Pharma is a leading global manufacturer, seller & exporter of a wide range of APIs, advanced intermediates, pellets, food grade chemicals, food additives & food ingredients. It...
TAPI, a leading global supplier of APIs, provides over 350 products and customized CDMO solutions for every stage of development.
About the Company : Founded in 1935, TAPI Technology & API Services has a long-standing tradition of advancing health through innovation and dedication. Today, we proudly build upon this legacy, drivi...
About the Company : Sichuan Qingmu Pharmaceutical Co., Ltd. is an innovation-driven pharmaceutical company focused on regulated markets. We specialize in the R&D and manufacturing of generic APIs and ...
Maithri Drugs: Delivering Trusted, High-Quality APIs to 35+ Countries with Innovation, Compliance, and Excellence.
About the Company : Maithri Drugs is one of India's fastest growing pharmaceutical companies, strategically focused on Active Pharmaceutical Ingredients (APIs). Backed by a strong R&D foundation, we h...
About the Company : Alembic Pharmaceuticals Limited is a leading pharmaceutical company in India. The Company is vertically integrated with the ability to develop, manufacture and market pharmaceutica...
About the Company : Alivira Animal Health Limited has emerged as India's largest and 1st Global integrated animal health company specialising in manufacturing of Active Pharmaceutical Ingredients (API...
About the Company : Flax Laboratories was established by a group of young and experienced professionals with the specific objective to develop and produce complex, small volume, technology driven bulk...
Details:
The net proceeds from the offering will be used to commercialize Xdemvy (lotilaner). It is being indicated for the treatment of Demodex blepharitis.
Lead Product(s): Lotilaner,Inapplicable
Therapeutic Area: Ophthalmology Brand Name: Xdemvy
Study Phase: Approved FDFProduct Type: Other Small Molecule
Sponsor: Goldman Sachs & Co
Deal Size: $100.0 million Upfront Cash: Undisclosed
Deal Type: Public Offering March 12, 2025
Lead Product(s) : Lotilaner,Inapplicable
Therapeutic Area : Ophthalmology
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Goldman Sachs & Co
Deal Size : $100.0 million
Deal Type : Public Offering
Tarsus Announces Proposed $100.0 Million Public Offering
Details : The net proceeds from the offering will be used to commercialize Xdemvy (lotilaner). It is being indicated for the treatment of Demodex blepharitis.
Product Name : Xdemvy
Product Type : Other Small Molecule
Upfront Cash : Undisclosed
March 12, 2025
Details:
The net proceeds from the offering will be used to commercialize Xdemvy (lotilaner). It is being indicated for the treatment of Demodex blepharitis.
Lead Product(s): Lotilaner,Inapplicable
Therapeutic Area: Ophthalmology Brand Name: Xdemvy
Study Phase: Approved FDFProduct Type: Other Small Molecule
Sponsor: Goldman Sachs & Co
Deal Size: $125.0 million Upfront Cash: Undisclosed
Deal Type: Public Offering March 12, 2025
Lead Product(s) : Lotilaner,Inapplicable
Therapeutic Area : Ophthalmology
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Goldman Sachs & Co
Deal Size : $125.0 million
Deal Type : Public Offering
Tarsus Announces Pricing of Upsized $125.0 Million Public Offering
Details : The net proceeds from the offering will be used to commercialize Xdemvy (lotilaner). It is being indicated for the treatment of Demodex blepharitis.
Product Name : Xdemvy
Product Type : Other Small Molecule
Upfront Cash : Undisclosed
March 12, 2025
Details:
Proceeds will be used for the U.S. commercialization of Xdemy (lotilaner), designed to target and kill Demodex mites causing Demodex blepharitis.
Lead Product(s): Lotilaner,Inapplicable
Therapeutic Area: Ophthalmology Brand Name: Undisclosed
Study Phase: Approved FDFProduct Type: Other Small Molecule
Sponsor: Goldman Sachs & Co
Deal Size: $100.0 million Upfront Cash: Undisclosed
Deal Type: Public Offering February 29, 2024
Lead Product(s) : Lotilaner,Inapplicable
Therapeutic Area : Ophthalmology
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Goldman Sachs & Co
Deal Size : $100.0 million
Deal Type : Public Offering
Tarsus Announces Pricing of $100.0 Million Public Offering
Details : Proceeds will be used for the U.S. commercialization of Xdemy (lotilaner), designed to target and kill Demodex mites causing Demodex blepharitis.
Product Name : Undisclosed
Product Type : Other Small Molecule
Upfront Cash : Undisclosed
February 29, 2024
Details:
TP-05 (lotilaner) is an oral, well-characterized anti-parasitic agent that selectively inhibits parasite-specific GABA-Cl channels. It is being evaluated for the prevention of Lyme Disease.
Lead Product(s): Lotilaner,Inapplicable
Therapeutic Area: Infections and Infectious Diseases Brand Name: Undisclosed
Study Phase: Phase IIProduct Type: Other Small Molecule
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable February 22, 2024
Lead Product(s) : Lotilaner,Inapplicable
Therapeutic Area : Infections and Infectious Diseases
Highest Development Status : Phase II
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Tarsus Reports Positive Results from Phase 2a Trial of TP-05 for Lyme Disease Prevention
Details : TP-05 (lotilaner) is an oral, well-characterized anti-parasitic agent that selectively inhibits parasite-specific GABA-Cl channels. It is being evaluated for the prevention of Lyme Disease.
Product Name : Undisclosed
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
February 22, 2024
Details:
Undisclosed
Lead Product(s): Lotilaner,Inapplicable
Therapeutic Area: Ophthalmology Brand Name: Undisclosed
Study Phase: Phase IVProduct Type: Other Small Molecule
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable December 26, 2023
Lead Product(s) : Lotilaner,Inapplicable
Therapeutic Area : Ophthalmology
Highest Development Status : Phase IV
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Impact of XDEMVY® on Demodex Blepharitis in Soft Contact Lens Wearers
Details : Undisclosed
Product Name : Undisclosed
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
December 26, 2023
Details:
TP-03 (lotilaner ophthalmic solution, 0.25%) is a novel small molecule, approved for Demodex blepharitis under the brand name Xdemvy. Now it is being evaluated as an investigational therapy for the treatment of Meibomian Gland Disease (MGD) in patients with Demodex mites.
Lead Product(s): Lotilaner,Inapplicable
Therapeutic Area: Ophthalmology Brand Name: Undisclosed
Study Phase: Phase IIProduct Type: Other Small Molecule
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable November 12, 2023
Lead Product(s) : Lotilaner,Inapplicable
Therapeutic Area : Ophthalmology
Highest Development Status : Phase II
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : TP-03 (lotilaner ophthalmic solution, 0.25%) is a novel small molecule, approved for Demodex blepharitis under the brand name Xdemvy. Now it is being evaluated as an investigational therapy for the treatment of Meibomian Gland Disease (MGD) in patients w...
Product Name : Undisclosed
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
November 12, 2023
Details:
TP-03 (lotilaner) is a novel investigational therapeutic designed to resolve the signs and symptoms of Demodex blepharitis via targeting and eradicating the root cause by selectively inhibiting the GABA-Cl channels.
Lead Product(s): Lotilaner,Inapplicable
Therapeutic Area: Ophthalmology Brand Name: Undisclosed
Study Phase: Phase IIIProduct Type: Other Small Molecule
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable October 30, 2023
Lead Product(s) : Lotilaner,Inapplicable
Therapeutic Area : Ophthalmology
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : TP-03 (lotilaner) is a novel investigational therapeutic designed to resolve the signs and symptoms of Demodex blepharitis via targeting and eradicating the root cause by selectively inhibiting the GABA-Cl channels.
Product Name : Undisclosed
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
October 30, 2023
Details:
TP-03 (lotilaner) is a novel investigational therapeutic designed to resolve the signs and symptoms of Demodex blepharitis by targeting and eradicating the root cause of the demodex mite infestation.
Lead Product(s): Lotilaner,Inapplicable
Therapeutic Area: Ophthalmology Brand Name: Undisclosed
Study Phase: Phase IIIProduct Type: Other Small Molecule
Sponsor: Tarsus Pharmaceuticals
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable August 06, 2023
Lead Product(s) : Lotilaner,Inapplicable
Therapeutic Area : Ophthalmology
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Tarsus Pharmaceuticals
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : TP-03 (lotilaner) is a novel investigational therapeutic designed to resolve the signs and symptoms of Demodex blepharitis by targeting and eradicating the root cause of the demodex mite infestation.
Product Name : Undisclosed
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
August 06, 2023
Details:
The company intends to fund the commercial launch of Xdemvy (lotilaner) for the treatment of Demodex blepharitis in the United States and to develop its product pipeline including TP-03 for the treatment of Meibomian Gland Disease, or MGD, TP-04 and TP-05.
Lead Product(s): Lotilaner,Inapplicable
Therapeutic Area: Ophthalmology Brand Name: Undisclosed
Study Phase: Approved FDFProduct Type: Other Small Molecule
Sponsor: Goldman Sachs & Co
Deal Size: $100.0 million Upfront Cash: Undisclosed
Deal Type: Public Offering July 31, 2023
Lead Product(s) : Lotilaner,Inapplicable
Therapeutic Area : Ophthalmology
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Goldman Sachs & Co
Deal Size : $100.0 million
Deal Type : Public Offering
Details : The company intends to fund the commercial launch of Xdemvy (lotilaner) for the treatment of Demodex blepharitis in the United States and to develop its product pipeline including TP-03 for the treatment of Meibomian Gland Disease, or MGD, TP-04 and TP-0...
Product Name : Undisclosed
Product Type : Other Small Molecule
Upfront Cash : Undisclosed
July 31, 2023
Details:
Xdemvy (lotilaner ophthalmic solution), a novel prescription eye drop, is recently approved by FDA and is designed to treat demodex blepharitis by targeting and eradicating the root cause of the disease, demodex mite infestation.
Lead Product(s): Lotilaner,Inapplicable
Therapeutic Area: Ophthalmology Brand Name: Undisclosed
Study Phase: Approved FDFProduct Type: Other Small Molecule
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable July 25, 2023
Lead Product(s) : Lotilaner,Inapplicable
Therapeutic Area : Ophthalmology
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
FDA Approves XDEMVY™ (lotilaner ophthalmic solution) 0.25% for the Treatment of Demodex Blephari...
Details : Xdemvy (lotilaner ophthalmic solution), a novel prescription eye drop, is recently approved by FDA and is designed to treat demodex blepharitis by targeting and eradicating the root cause of the disease, demodex mite infestation.
Product Name : Undisclosed
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
July 25, 2023
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Patents & EXCLUSIVITIES
Exclusivity Code : NCE
Exclusivity Expiration Date : 2028-07-24
Application Number : 217603
Product Number : 1
Exclusivity Details :
ABOUT THIS PAGE
92
PharmaCompass offers a list of Lotilaner 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 Lotilaner manufacturer or Lotilaner supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Lotilaner manufacturer or Lotilaner supplier.
PharmaCompass also assists you with knowing the Lotilaner API Price utilized in the formulation of products. Lotilaner API Price is not always fixed or binding as the Lotilaner Price is obtained through a variety of data sources. The Lotilaner Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Lotilaner manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Lotilaner, including repackagers and relabelers. The FDA regulates Lotilaner manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Lotilaner 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 Lotilaner manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Lotilaner supplier is an individual or a company that provides Lotilaner active pharmaceutical ingredient (API) or Lotilaner finished formulations upon request. The Lotilaner suppliers may include Lotilaner API manufacturers, exporters, distributors and traders.
click here to find a list of Lotilaner suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information 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 Lotilaner as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Lotilaner 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 Lotilaner 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 Lotilaner and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Lotilaner NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Lotilaner suppliers with NDC on PharmaCompass.
Lotilaner 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 Lotilaner 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 Lotilaner GMP manufacturer or Lotilaner GMP API supplier for your needs.
A Lotilaner CoA (Certificate of Analysis) is a formal document that attests to Lotilaner's compliance with Lotilaner specifications and serves as a tool for batch-level quality control.
Lotilaner CoA mostly includes findings from lab analyses of a specific batch. For each Lotilaner 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.
Lotilaner may be tested according to a variety of international standards, such as European Pharmacopoeia (Lotilaner EP), Lotilaner JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Lotilaner USP).