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Ambrisentan - Generic Drug Details
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What are the generic sources for ambrisentan and what is the scope of patent protection?
Ambrisentan
is the generic ingredient in two branded drugs marketed by Cipla, Mylan, Par Pharm Inc, Sigmapharm Labs Llc, Sun Pharm, Watson Labs Inc, Zydus Pharms, and Gilead, and is included in eight NDAs. There are three patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.Ambrisentan has fifty patent family members in twenty-six countries.
There are nine drug master file entries for ambrisentan. Nine suppliers are listed for this compound.
Summary for ambrisentan
International Patents: | 50 |
US Patents: | 3 |
Tradenames: | 2 |
Applicants: | 8 |
NDAs: | 8 |
Drug Master File Entries: | 9 |
Suppliers / Packagers: | 9 |
Bulk Api Vendors: | 78 |
Clinical Trials: | 58 |
Patent Applications: | 4,345 |
Formulation / Manufacturing: | see details |
Drug Prices: | Drug price trends for ambrisentan |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for ambrisentan |
What excipients (inactive ingredients) are in ambrisentan? | ambrisentan excipients list |
DailyMed Link: | ambrisentan at DailyMed |
Recent Clinical Trials for ambrisentan
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
RenJi Hospital | Phase 1/Phase 2 |
Cambridge University Hospitals NHS Foundation Trust | Phase 2/Phase 3 |
Noorik Biopharmaceuticals AG | Phase 2 |
Pharmacology for ambrisentan
Drug Class | Endothelin Receptor Antagonist |
Mechanism of Action | Endothelin Receptor Antagonists |
Paragraph IV (Patent) Challenges for AMBRISENTAN
Tradename | Dosage | Ingredient | NDA | Submissiondate |
---|---|---|---|---|
LETAIRIS | TABLET;ORAL | ambrisentan | 022081 | 2015-02-09 |
US Patents and Regulatory Information for ambrisentan
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Gilead | LETAIRIS | ambrisentan | TABLET;ORAL | 022081-001 | Jun 15, 2007 | AB | RX | Yes | No | Start Trial | Start Trial | Start Trial | |||
Watson Labs Inc | AMBRISENTAN | ambrisentan | TABLET;ORAL | 208252-002 | Mar 28, 2019 | AB | RX | No | No | Start Trial | Start Trial | Start Trial | |||
Cipla | AMBRISENTAN | ambrisentan | TABLET;ORAL | 210715-001 | Apr 26, 2019 | AB | RX | No | No | Start Trial | Start Trial | Start Trial | |||
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
Expired US Patents for ambrisentan
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Gilead | LETAIRIS | ambrisentan | TABLET;ORAL | 022081-001 | Jun 15, 2007 | Start Trial | Start Trial |
Gilead | LETAIRIS | ambrisentan | TABLET;ORAL | 022081-001 | Jun 15, 2007 | Start Trial | Start Trial |
Gilead | LETAIRIS | ambrisentan | TABLET;ORAL | 022081-002 | Jun 15, 2007 | Start Trial | Start Trial |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for ambrisentan
Country | Patent Number | Estimated Expiration |
---|---|---|
Japan | 2014506870 | Start Trial |
Poland | 2101777 | Start Trial |
Japan | 5806320 | Start Trial |
>Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for ambrisentan
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
0785926 | 08C0041 | France | Start Trial | PRODUCT NAME: AMBRISENTAN; REGISTRATION NO/DATE: EU/1/08/451/001-004 20080421 |
2101777 | CA 2016 00024 | Denmark | Start Trial | PRODUCT NAME: AMBRISENTAN USED IN COMBINATION TREATMENT WITH TADALAFIL; REG. NO/DATE: EU/1/08/451 (001-004) 20151125 |
2101777 | 2016C/032 | Belgium | Start Trial | PRODUCT NAME: AMBRISENTAN EN COMBINAISON AVEC LE TADALAFIL; AUTHORISATION NUMBER AND DATE: EU/1/08/451 20151125 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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