Ambrisentan Patent Expiration

Ambrisentan is used for treating pulmonary arterial hypertension (PAH) in combination with tadalafil by inhibiting endothelin receptors. It was first introduced by Gilead Sciences Inc in its drug Letairis on Jun 15, 2007. 10 different companies have introduced drugs containing Ambrisentan.


Ambrisentan Patents

Given below is the list of patents protecting Ambrisentan, along with the drug name that holds that patent and the company name owning that drug.

Drug Used in Drug Patent Number Drug Patent Title Drug Patent Expiry Drug Owner
Letairis US5703017 3-(Het) arylcarboxylic acid derivatives, their preparation and intermediates for their preparation Dec 30, 2014

(Expired)

Gilead
Letairis US5840722 Use of carboxylic acid derivatives as drugs Nov 24, 2015

(Expired)

Gilead
Letairis US7109205 Carboxylic acid derivatives, their preparation and use Oct 07, 2015

(Expired)

Gilead
Letairis US7601730 Carboxylic acid derivatives, their preparation and use Oct 07, 2015

(Expired)

Gilead
Letairis US8349843 Carboxylic acid derivatives, their preparation and use Oct 07, 2015

(Expired)

Gilead
Letairis US8377933 Method for treating a pulmonary hypertension condition Dec 11, 2027 Gilead
Letairis US9474752 Method for treating a pulmonary hypertension condition Dec 11, 2027 Gilead
Letairis US9549926 Compositions and methods of treating pulmonary hypertension Oct 14, 2031 Gilead
Letairis USRE42462 Carboxylic acid derivatives, their preparation and use Jul 29, 2018

(Expired)

Gilead


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Ambrisentan Generics

Several generic applications have been filed for Ambrisentan. The first generic version for Ambrisentan was by Watson Laboratories Inc and was approved on Mar 28, 2019. And the latest generic version is by Aurobindo Pharma Ltd and was approved on Jul 21, 2022.

Given below is the list of companies who have filed for Ambrisentan generic.


1. ZYDUS PHARMS

Zydus Pharmaceuticals Usa Inc has filed for 2 different strengths of generic version for Ambrisentan. Given below are the details of the strengths of this generic introduced by Zydus Pharms.

Strength Dosage Form Availability Application Pathway TE code Launch Date
5MG tablet Prescription ORAL AB Mar 28, 2019
10MG tablet Prescription ORAL AB Mar 28, 2019


2. APOTEX

Apotex Inc has filed for 2 different strengths of generic version for Ambrisentan. Given below are the details of the strengths of this generic introduced by Apotex.

Strength Dosage Form Availability Application Pathway TE code Launch Date
5MG tablet Prescription ORAL AB May 19, 2022
10MG tablet Prescription ORAL AB May 19, 2022


3. AUROBINDO PHARMA

Aurobindo Pharma Ltd has filed for 2 different strengths of generic version for Ambrisentan. Given below are the details of the strengths of this generic introduced by Aurobindo Pharma.

Strength Dosage Form Availability Application Pathway TE code Launch Date
5MG tablet Prescription ORAL AB Jul 21, 2022
10MG tablet Prescription ORAL AB Jul 21, 2022


4. MYLAN

Mylan Pharmaceuticals Inc has filed for 2 different strengths of generic version for Ambrisentan. Given below are the details of the strengths of this generic introduced by Mylan.

Strength Dosage Form Availability Application Pathway TE code Launch Date
5MG tablet Prescription ORAL AB Mar 28, 2019
10MG tablet Prescription ORAL AB Mar 28, 2019


5. CIPLA

Cipla Ltd has filed for 2 different strengths of generic version for Ambrisentan. Given below are the details of the strengths of this generic introduced by Cipla.

Strength Dosage Form Availability Application Pathway TE code Launch Date
5MG tablet Prescription ORAL AB Apr 26, 2019
10MG tablet Prescription ORAL AB Apr 26, 2019


6. SIGMAPHARM LABS LLC

Sigmapharm Laboratories Llc has filed for 2 different strengths of generic version for Ambrisentan. Given below are the details of the strengths of this generic introduced by Sigmapharm Labs Llc.

Strength Dosage Form Availability Application Pathway TE code Launch Date
10MG tablet Prescription ORAL AB Apr 10, 2019
5MG tablet Prescription ORAL AB Apr 10, 2019


7. ENDO OPERATIONS

Endo Operations Ltd has filed for 2 different strengths of generic version for Ambrisentan. Given below are the details of the strengths of this generic introduced by Endo Operations.

Strength Dosage Form Availability Application Pathway TE code Launch Date
10MG tablet Discontinued ORAL N/A Apr 10, 2019
5MG tablet Discontinued ORAL N/A Apr 10, 2019


8. SUN PHARM

Sun Pharmaceutical Industries Ltd has filed for 2 different strengths of generic version for Ambrisentan. Given below are the details of the strengths of this generic introduced by Sun Pharm.

Strength Dosage Form Availability Application Pathway TE code Launch Date
5MG tablet Prescription ORAL AB Mar 28, 2019
10MG tablet Prescription ORAL AB Mar 28, 2019


9. WATSON LABS INC

Watson Laboratories Inc has filed for 2 different strengths of generic version for Ambrisentan. Given below are the details of the strengths of this generic introduced by Watson Labs Inc.

Strength Dosage Form Availability Application Pathway TE code Launch Date
10MG tablet Prescription ORAL AB Mar 28, 2019
5MG tablet Prescription ORAL AB Mar 28, 2019