Ambrisentan - Generic Drug Details
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What are the generic sources for ambrisentan and what is the scope of freedom to operate?
Ambrisentan
is the generic ingredient in two branded drugs marketed by Apotex, Aurobindo Pharma, Cipla, Mylan, Par Pharm Inc, Sigmapharm Labs Llc, Sun Pharm, Watson Labs Inc, Zydus Pharms, and Gilead, and is included in ten 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-one patent family members in twenty-six countries.
There are nine drug master file entries for ambrisentan. Eleven suppliers are listed for this compound.
Summary for ambrisentan
International Patents: | 51 |
US Patents: | 3 |
Tradenames: | 2 |
Applicants: | 10 |
NDAs: | 10 |
Drug Master File Entries: | 9 |
Finished Product Suppliers / Packagers: | 11 |
Raw Ingredient (Bulk) Api Vendors: | 88 |
Clinical Trials: | 65 |
Patent Applications: | 4,108 |
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 |
---|---|
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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Sun Pharm | AMBRISENTAN | ambrisentan | TABLET;ORAL | 210784-002 | Mar 28, 2019 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Watson Labs Inc | AMBRISENTAN | ambrisentan | TABLET;ORAL | 208252-001 | Mar 28, 2019 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Gilead | LETAIRIS | ambrisentan | TABLET;ORAL | 022081-002 | Jun 15, 2007 | AB | RX | Yes | Yes | ⤷ 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 | |||
>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 | 022081-002 | Jun 15, 2007 | ⤷ Sign Up | ⤷ Sign Up |
Gilead | LETAIRIS | ambrisentan | TABLET;ORAL | 022081-002 | Jun 15, 2007 | ⤷ Sign Up | ⤷ Sign Up |
Gilead | LETAIRIS | ambrisentan | TABLET;ORAL | 022081-001 | Jun 15, 2007 | ⤷ Sign Up | ⤷ Sign Up |
Gilead | LETAIRIS | ambrisentan | TABLET;ORAL | 022081-002 | Jun 15, 2007 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent 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 |
International Patents for ambrisentan
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Hungary | E025355 | ⤷ Sign Up | |
Croatia | P20170848 | ⤷ Sign Up | |
Hungary | S1600027 | ⤷ Sign Up | |
Hungary | E033346 | ⤷ Sign Up | |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for ambrisentan
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
2101777 | PA2016018 | Lithuania | ⤷ Sign Up | PRODUCT NAME: AMBRISENTANAS; REGISTRATION NO/DATE: EU/1/08/451 (001-004) 20151120 |
2101777 | CA 2016 00024 | Denmark | ⤷ Sign Up | PRODUCT NAME: AMBRISENTAN USED IN COMBINATION TREATMENT WITH TADALAFIL; REG. NO/DATE: EU/1/08/451 (001-004) 20151125 |
0785926 | 08C0041 | France | ⤷ Sign Up | PRODUCT NAME: AMBRISENTAN; REGISTRATION NO/DATE: EU/1/08/451/001-004 20080421 |
2101777 | 300813 | Netherlands | ⤷ Sign Up | PRODUCT NAME: AMBRISENTAN TOEGEPAST IN COMBINATIEBEHANDELING MET TADALAFIL; REGISTRATION NO/DATE: EU/1/08/451 (C(2008) 1637) 20151125 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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