LETAIRIS Drug Patent Profile

When do Letairis patents expire, and when can generic versions of Letairis launch?

Letairis is a drug marketed by Gilead and is included in one NDA. There are three patents protecting this drug and one Paragraph IV challenge.

This drug has fifty patent family members in twenty-six countries.

The generic ingredient in LETAIRIS is ambrisentan. There are nine drug master file entries for this compound. Ten suppliers are listed for this compound. Additional details are available on the ambrisentan profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Letairis

A generic version of LETAIRIS was approved as ambrisentan by MYLAN on March 28^th, 2019.

Summary for LETAIRIS

International Patents:	50
US Patents:	3
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	85
Clinical Trials:	23
Patent Applications:	3,170
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for LETAIRIS
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for LETAIRIS
What excipients (inactive ingredients) are in LETAIRIS?	LETAIRIS excipients list
DailyMed Link:	LETAIRIS at DailyMed

See drug prices for LETAIRIS

Recent Clinical Trials for LETAIRIS

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

Sponsor	Phase
Medical University of South Carolina	Phase 4
Ochsner Health System	Phase 4
Gilead Sciences	Phase 1

See all LETAIRIS clinical trials

Pharmacology for LETAIRIS

Drug Class	Endothelin Receptor Antagonist
Mechanism of Action	Endothelin Receptor Antagonists

Anatomical Therapeutic Chemical (ATC) Classes for LETAIRIS

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

Paragraph IV (Patent) Challenges for LETAIRIS

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 LETAIRIS

LETAIRIS is protected by three US patents.

Patents protecting LETAIRIS

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
Gilead	LETAIRIS	ambrisentan	TABLET;ORAL	022081-001	Jun 15, 2007	AB	RX	Yes	No
Gilead	LETAIRIS	ambrisentan	TABLET;ORAL	022081-001	Jun 15, 2007	AB	RX	Yes	No

Expired US Patents for LETAIRIS

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
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	022081-001	Jun 15, 2007

EU/EMA Drug Approvals for LETAIRIS

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

International Patents for LETAIRIS

When does loss-of-exclusivity occur for LETAIRIS?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Australia

Canada

Cyprus

Denmark

European Patent Office

Hong Kong

Hungary

Japan

Luxembourg

Poland

Portugal

Slovenia

Spain

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering LETAIRIS around the world.

Country	Patent Number	Title	Estimated Expiration
Lithuania	2637664
Poland	186850
Eurasian Patent Organization	201691759	КОМПОЗИЦИИ И СПОСОБЫ ЛЕЧЕНИЯ ЛЕГОЧНОЙ ГИПЕРТЕНЗИИ
China	1513844

Supplementary Protection Certificates for LETAIRIS

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0785926	300361	Netherlands		300361, 20151007, EXPIRES: 20201006
2101777	93081	Luxembourg		PRODUCT NAME: AMBRISENTAN UTILISE EN TRAITEMENT COMBINE AVEC TADALAFIL; FRIST REGISTRATION: 20151125
0785926	91487	Luxembourg		91487, EXPIRES: 20201007
2101777	122016000039	Germany		PRODUCT NAME: AMBRISENTAN IN VERWENDUNG IN DER KOMBINATIONSTHERAPIE MIT TADALAFIL; REGISTRATION NO/DATE: EU/1/08/451 20151120