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.

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Drug Used in Drug Patent Number Drug Patent Title Drug Patent Expiry Drug Owner
Letairis US9549926 Compositions and methods of treating pulmonary hypertension Oct 14, 2031 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 USRE42462 Carboxylic acid derivatives, their preparation and use Jul 29, 2018

(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 US5703017 3-(Het) arylcarboxylic acid derivatives, their preparation and intermediates for their preparation Dec 30, 2014

(Expired)

Gilead



Ambrisentan's Family Patents

Family Patents

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Clinical Trials

Recent Clinical Trials on Ambrisentan:

Sometimes companies keep conducting clinical trials even after the drug's approval to discover new formulations, methods of use, or new treatment indications, so they could file for additional patents or receive regulatory exclusivity extensions, such as pediatric exclusivity, potentially delaying generic competition. Based on these recent clinical trials, generic companies need to consider the potential for new intellectual property or regulatory hurdles. These strategic moves by the drug owner might delay generic substitution or lead to additional sales of the brand drug, even after patent expiry.

Title Lead Sponsor Collaborators Status Phases
Clinical Trials
Outcome Study Assessing a 75 Milligrams (mg) Dose of Macitentan in Patients With Pulmonary Arterial Hypertension Actelion NA ACTIVE NOT RECRUITING
(Aug 1, 2026)
PHASE3
COMMODITIES Trial: Initial Dual Oral Therapy vs Monotherapy in PAH With Cardiovascular Comorbidities Assistance Publique - Hôpitaux de Paris NA RECRUITING
(May 1, 2026)
PHASE3
Endothelin Receptor Antagonism With Ambrisentan to Treat Hepatorenal Syndrome Noorik Biopharmaceuticals AG NA ACTIVE NOT RECRUITING
(Apr 1, 2026)
PHASE2


Ambrisentan Generic API Manufacturers

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, along with the locations of their manufacturing plants worldwide.