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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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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.
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