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Last Updated: December 3, 2022

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 patent family members in twenty-six countries.

There are nine drug master file entries for ambrisentan. Eleven suppliers are listed for this compound.

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
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
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
Sun Pharm AMBRISENTAN ambrisentan TABLET;ORAL 210784-001 Mar 28, 2019 AB RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Gilead LETAIRIS ambrisentan TABLET;ORAL 022081-001 Jun 15, 2007 AB RX Yes 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 022081-001 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
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

Supplementary Protection Certificates for ambrisentan

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2101777 93081 Luxembourg See Plans and Pricing PRODUCT NAME: AMBRISENTAN UTILISE EN TRAITEMENT COMBINE AVEC TADALAFIL; FRIST REGISTRATION: 20151125
0785926 08C0041 France See Plans and Pricing PRODUCT NAME: AMBRISENTAN; REGISTRATION NO/DATE: EU/1/08/451/001-004 20080421
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 2016C/032 Belgium See Plans and Pricing PRODUCT NAME: AMBRISENTAN EN COMBINAISON AVEC LE TADALAFIL; AUTHORISATION NUMBER AND DATE: EU/1/08/451 20151125
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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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