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 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. Ten 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:	10
Bulk Api Vendors:	77
Clinical Trials:	57
Patent Applications:	4,198
Formulation / Manufacturing:	see details
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
RenJi Hospital	Phase 1/Phase 2
Cambridge University Hospitals NHS Foundation Trust	Phase 2/Phase 3
Noorik Biopharmaceuticals AG	Phase 2

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

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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
Gilead	LETAIRIS	ambrisentan	TABLET;ORAL	022081-002	Jun 15, 2007	AB	RX	Yes	Yes	Start Trial	Start Trial				Start Trial
Gilead	LETAIRIS	ambrisentan	TABLET;ORAL	022081-001	Jun 15, 2007	AB	RX	Yes	No	Start Trial	Start Trial				Start Trial
Gilead	LETAIRIS	ambrisentan	TABLET;ORAL	022081-001	Jun 15, 2007	AB	RX	Yes	No	Start Trial	Start Trial				Start Trial
Gilead	LETAIRIS	ambrisentan	TABLET;ORAL	022081-001	Jun 15, 2007	AB	RX	Yes	No	Start Trial	Start Trial				Start Trial
>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	022081-002	Jun 15, 2007	Start Trial	Start Trial
Gilead	LETAIRIS	ambrisentan	TABLET;ORAL	022081-001	Jun 15, 2007	Start Trial	Start Trial
Gilead	LETAIRIS	ambrisentan	TABLET;ORAL	022081-001	Jun 15, 2007	Start Trial	Start Trial
Gilead	LETAIRIS	ambrisentan	TABLET;ORAL	022081-002	Jun 15, 2007	Start Trial	Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

International Patents for ambrisentan

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Country	Patent Number	Estimated Expiration
Slovenia	2101777	Start Trial
Portugal	2101777	Start Trial
Japan	5806320	Start Trial
Spain	2627944	Start Trial
>Country	>Patent Number	>Estimated Expiration

Supplementary Protection Certificates for ambrisentan

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2101777	2016C/032	Belgium	Start Trial	PRODUCT NAME: AMBRISENTAN EN COMBINAISON AVEC LE TADALAFIL; AUTHORISATION NUMBER AND DATE: EU/1/08/451 20151125
2101777	CA 2016 00024	Denmark	Start Trial	PRODUCT NAME: AMBRISENTAN USED IN COMBINATION TREATMENT WITH TADALAFIL; REG. NO/DATE: EU/1/08/451 (001-004) 20151125
2101777	300813	Netherlands	Start Trial	PRODUCT NAME: AMBRISENTAN TOEGEPAST IN COMBINATIEBEHANDELING MET TADALAFIL; REGISTRATION NO/DATE: EU/1/08/451 (C(2008) 1637) 20151125
2101777	122016000039	Germany	Start Trial	PRODUCT NAME: AMBRISENTAN IN VERWENDUNG IN DER KOMBINATIONSTHERAPIE MIT TADALAFIL; REGISTRATION NO/DATE: EU/1/08/451 20151120
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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