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Last Updated: June 21, 2024

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, Mylan, Par Pharm Inc, 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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Drug patent expirations by year for AMBRISENTAN
Drug Prices for AMBRISENTAN

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Recent Clinical Trials for AMBRISENTAN

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SponsorPhase
Merck Sharp & Dohme Corp.Phase 2
Nanjing First Hospital, Nanjing Medical UniversityN/A
Tianjin Medical University General HospitalN/A

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Pharmacology 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
Mylan AMBRISENTAN ambrisentan TABLET;ORAL 208441-001 Mar 28, 2019 AB RX 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

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