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Last Updated: July 2, 2022

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 Apotex, Cipla, Mylan, Par Pharm Inc, Sigmapharm Labs Llc, Sun Pharm, Watson Labs Inc, Zydus Pharms, and Gilead, and is included in nine 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. Ten suppliers are listed for this compound.

Drug Prices for ambrisentan

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Recent Clinical Trials for ambrisentan

Identify potential brand extensions & 505(b)(2) entrants

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

See all ambrisentan clinical trials

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
Zydus Pharms AMBRISENTAN ambrisentan TABLET;ORAL 210058-001 Mar 28, 2019 AB RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Watson Labs Inc AMBRISENTAN ambrisentan TABLET;ORAL 208252-001 Mar 28, 2019 AB RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Gilead LETAIRIS ambrisentan TABLET;ORAL 022081-002 Jun 15, 2007 AB RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Cipla AMBRISENTAN ambrisentan TABLET;ORAL 210715-001 Apr 26, 2019 AB RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Gilead LETAIRIS ambrisentan TABLET;ORAL 022081-001 Jun 15, 2007 AB RX Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Apotex AMBRISENTAN ambrisentan TABLET;ORAL 210701-002 May 19, 2022 AB RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
>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 See Plans and Pricing See Plans and Pricing
Gilead LETAIRIS ambrisentan TABLET;ORAL 022081-001 Jun 15, 2007 See Plans and Pricing See Plans and Pricing
Gilead LETAIRIS ambrisentan TABLET;ORAL 022081-001 Jun 15, 2007 See Plans and Pricing See Plans and Pricing
Gilead LETAIRIS ambrisentan TABLET;ORAL 022081-002 Jun 15, 2007 See Plans and Pricing See Plans and Pricing
Gilead LETAIRIS ambrisentan TABLET;ORAL 022081-001 Jun 15, 2007 See Plans and Pricing See Plans and Pricing
Gilead LETAIRIS ambrisentan TABLET;ORAL 022081-002 Jun 15, 2007 See Plans and Pricing See Plans and Pricing
>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
Luxembourg 93081 See Plans and Pricing
Australia 2016204638 Compositions and methods of treating pulmonary hypertension See Plans and Pricing
China 103458690 Compositions and methods of treating pulmonary hypertension See Plans and Pricing
Lithuania 2637664 See Plans and Pricing
Hungary S1600027 See Plans and Pricing
South Korea 20150002876 COMPOSITIONS AND METHODS OF TREATING PULMONARY HYPERTENSION See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for ambrisentan

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2101777 300813 Netherlands See Plans and Pricing PRODUCT NAME: AMBRISENTAN TOEGEPAST IN COMBINATIEBEHANDELING MET TADALAFIL; REGISTRATION NO/DATE: EU/1/08/451 (C(2008) 1637) 20151125
0785926 SPC/GB08/047 United Kingdom See Plans and Pricing PRODUCT NAME: AMBRISENTAN; REGISTERED: UK EU/1/08/451/001 20080421; UK EU/1/08/451/002 20080421; UK EU/1/08/451/003 20080421; UK EU/1/08/451/004 20080421
2101777 PA2016018 Lithuania See Plans and Pricing PRODUCT NAME: AMBRISENTANAS; REGISTRATION NO/DATE: EU/1/08/451 (001-004) 20151120
2101777 122016000039 Germany See Plans and Pricing PRODUCT NAME: AMBRISENTAN IN VERWENDUNG IN DER KOMBINATIONSTHERAPIE MIT TADALAFIL; REGISTRATION NO/DATE: EU/1/08/451 20151120
2101777 C20160017 00199 Estonia See Plans and Pricing PRODUCT NAME: AMBRISENTAAN;REG NO/DATE: EU/1/08/451 25.11.2015
2101777 2016C/032 Belgium See Plans and Pricing 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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