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

Summary for ambrisentan

International Patents:	50
US Patents:	3
Tradenames:	2
Applicants:	8
NDAs:	8
Drug Master File Entries:	9
Suppliers / Packagers:	9
Bulk Api Vendors:	73
Clinical Trials:	55
Patent Applications:	2,057
Formulation / Manufacturing:	see details
Drug Prices:	Drug price trends for ambrisentan
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for ambrisentan
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
Cambridge University Hospitals NHS Foundation Trust	Phase 2/Phase 3
Noorik Biopharmaceuticals AG	Phase 2
United Therapeutics	Phase 3

See all ambrisentan clinical trials

Pharmacology for ambrisentan

Drug Class	Endothelin Receptor Antagonist
Mechanism of Action	Endothelin Receptor Antagonists

Paragraph IV (Patent) Challenges for AMBRISENTAN

Tradename	Dosage	Ingredient	NDA	Submissiondate
LETAIRIS	TABLET;ORAL	ambrisentan	022081	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
Gilead	LETAIRIS	ambrisentan	TABLET;ORAL	022081-001	Jun 15, 2007	AB	RX	Yes	No
Gilead	LETAIRIS	ambrisentan	TABLET;ORAL	022081-002	Jun 15, 2007	AB	RX	Yes	Yes
Cipla	AMBRISENTAN	ambrisentan	TABLET;ORAL	210715-002	Apr 26, 2019	AB	RX	No	No
Gilead	LETAIRIS	ambrisentan	TABLET;ORAL	022081-001	Jun 15, 2007	AB	RX	Yes	No
Zydus Pharms	AMBRISENTAN	ambrisentan	TABLET;ORAL	210058-002	Mar 28, 2019	AB	RX	No	No

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
Gilead	LETAIRIS	ambrisentan	TABLET;ORAL	022081-002	Jun 15, 2007
Gilead	LETAIRIS	ambrisentan	TABLET;ORAL	022081-002	Jun 15, 2007
Gilead	LETAIRIS	ambrisentan	TABLET;ORAL	022081-001	Jun 15, 2007
Gilead	LETAIRIS	ambrisentan	TABLET;ORAL	022081-002	Jun 15, 2007

International Patents for ambrisentan

Country	Patent Number	Estimated Expiration
Spain	2627944
Portugal	2101777
World Intellectual Property Organization (WIPO)	2008073928
European Patent Office	3106163
Poland	2101777

Supplementary Protection Certificates for ambrisentan

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0785926	SPC/GB08/047	United Kingdom		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	CA 2016 00024	Denmark		PRODUCT NAME: AMBRISENTAN USED IN COMBINATION TREATMENT WITH TADALAFIL; REG. NO/DATE: EU/1/08/451 (001-004) 20151125
0785926	08C0041	France		PRODUCT NAME: AMBRISENTAN; REGISTRATION NO/DATE: EU/1/08/451/001-004 20080421
2101777	93081	Luxembourg		PRODUCT NAME: AMBRISENTAN UTILISE EN TRAITEMENT COMBINE AVEC TADALAFIL; FRIST REGISTRATION: 20151125
2101777	122016000039	Germany		PRODUCT NAME: AMBRISENTAN IN VERWENDUNG IN DER KOMBINATIONSTHERAPIE MIT TADALAFIL; REGISTRATION NO/DATE: EU/1/08/451 20151120