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, Endo Operations, Mylan, 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
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

See drug prices for AMBRISENTAN

Recent Clinical Trials for AMBRISENTAN

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

Sponsor	Phase
Juvenile Diabetes Research Foundation	Phase 2
University Medical Center Groningen	Phase 2
Lexicon Pharmaceuticals	Phase 2

See all AMBRISENTAN clinical trials

Pharmacology for AMBRISENTAN

Drug Class	Endothelin Receptor Antagonist
Mechanism of Action	Endothelin Receptor Antagonists

Anatomical Therapeutic Chemical (ATC) Classes for AMBRISENTAN

C02KX	Antihypertensives for pulmonary arterial hypertension
C02K	OTHER ANTIHYPERTENSIVES
C02	ANTIHYPERTENSIVES
C	Cardiovascular system

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

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Glossary

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Sigmapharm Labs Llc	AMBRISENTAN	ambrisentan	TABLET;ORAL	208354-001	Apr 10, 2019	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Zydus Pharms	AMBRISENTAN	ambrisentan	TABLET;ORAL	210058-001	Mar 28, 2019	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
Aurobindo Pharma	AMBRISENTAN	ambrisentan	TABLET;ORAL	216531-002	Jul 21, 2022	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Watson Labs Inc	AMBRISENTAN	ambrisentan	TABLET;ORAL	208252-002	Mar 28, 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

Expired US Patents for AMBRISENTAN

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
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
Gilead	LETAIRIS	ambrisentan	TABLET;ORAL	022081-001	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

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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

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Country	Patent Number	Title	Estimated Expiration
Taiwan	201219372	Compositions and methods of treating pulmonary hypertension	⤷ Sign Up
European Patent Office	2952193	COMPOSITION DE TRAITEMENT DE L'HYPERTENSION PULMONAIRE (COMPOSITION FOR TREATING A PULMONARY HYPERTENSION)	⤷ Sign Up
Brazil	112013008983	composições e métodos de tratamento da hipertensão pulmonar	⤷ Sign Up
Lithuania	2637664		⤷ Sign Up
Slovenia	2637664		⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for AMBRISENTAN

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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	2016C/032	Belgium	⤷ Sign Up	PRODUCT NAME: AMBRISENTAN EN COMBINAISON AVEC LE TADALAFIL; AUTHORISATION NUMBER AND DATE: EU/1/08/451 20151125
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	SPC/GB08/047	United Kingdom	⤷ Sign Up	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	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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