AMBRISENTAN Drug Patent Profile
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When do Ambrisentan patents expire, and when can generic versions of Ambrisentan launch?
Ambrisentan is a drug marketed by Apotex, Aurobindo Pharma, Cipla, Endo Operations, Mylan, Sigmapharm Labs Llc, Sun Pharm, Watson Labs Inc, and Zydus Pharms. and is included in nine NDAs.
The generic ingredient in AMBRISENTAN is ambrisentan. There are nine drug master file entries for this compound. Eleven suppliers are listed for this compound. Additional details are available on the ambrisentan profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Ambrisentan
A generic version of AMBRISENTAN was approved as ambrisentan by MYLAN on March 28th, 2019.
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Summary for AMBRISENTAN
Recent Clinical Trials for AMBRISENTAN
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| University Medical Center Groningen | Phase 2 |
| Lexicon Pharmaceuticals | Phase 2 |
| Juvenile Diabetes Research Foundation | Phase 2 |
Pharmacology for AMBRISENTAN
| Drug Class | Endothelin Receptor Antagonist |
| Mechanism of Action | Endothelin Receptor Antagonists |
Anatomical Therapeutic Chemical (ATC) Classes for AMBRISENTAN
Paragraph IV (Patent) Challenges for AMBRISENTAN
| Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
|---|---|---|---|---|---|---|
| LETAIRIS | Tablets | ambrisentan | 5 mg and 10 mg | 022081 | 1 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Apotex | AMBRISENTAN | ambrisentan | TABLET;ORAL | 210701-001 | May 19, 2022 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Zydus Pharms | AMBRISENTAN | ambrisentan | TABLET;ORAL | 210058-002 | Mar 28, 2019 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Endo Operations | AMBRISENTAN | ambrisentan | TABLET;ORAL | 209509-001 | Apr 10, 2019 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Aurobindo Pharma | AMBRISENTAN | ambrisentan | TABLET;ORAL | 216531-002 | Jul 21, 2022 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Sigmapharm Labs Llc | AMBRISENTAN | ambrisentan | TABLET;ORAL | 208354-002 | Apr 10, 2019 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
EU/EMA Drug Approvals for AMBRISENTAN
| Company | Drugname | Inn | Product Number / Indication | Status | Generic | Biosimilar | Orphan | Marketing Authorisation | Marketing Refusal |
|---|---|---|---|---|---|---|---|---|---|
| GlaxoSmithKline (Ireland) Limited | Volibris | ambrisentan | EMEA/H/C/000839 Volibris is indicated for treatment of pulmonary arterial hypertension (PAH) in adult patients of WHO Functional Class (FC) II to III, including use in combination treatment (see section 5.1). Efficacy has been shown in idiopathic PAH (IPAH) and in PAH associated with connective tissue disease.Volibris is indicated for treatment of PAH in adolescents and children (aged 8 to less than 18 years) of WHO Functional Class (FC) II to III including use in combination treatment. Efficacy has been shown in IPAH, familial, corrected congenital and in PAH associated with connective tissue disease (see section 5.1). |
Authorised | no | no | no | 2008-04-20 | |
| Mylan S.A.S | Ambrisentan Mylan | ambrisentan | EMEA/H/C/004985 Ambrisentan Mylan is indicated for the treatment of pulmonary arterial hypertension (PAH) in adult patients of WHO Functional Class (FC) II to III, including use in combination treatment. Efficacy has been shown in idiopathic PAH (IPAH) and in PAH associated with connective tissue disease.Ambrisentan Mylan is indicated for the treatment of pulmonary arterial hypertension (PAH) in adult patients of WHO Functional Class (FC) II to III, including use in combination treatment. Efficacy has been shown in idiopathic PAH (IPAH) and in PAH associated with connective tissue disease. |
Authorised | yes | no | no | 2019-06-20 | |
| >Company | >Drugname | >Inn | >Product Number / Indication | >Status | >Generic | >Biosimilar | >Orphan | >Marketing Authorisation | >Marketing Refusal |
