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Generic Letairis Availability

Letairis is a brand name of ambrisentan, approved by the FDA in the following formulation(s):

LETAIRIS (ambrisentan - tablet;oral)

  • Manufacturer: GILEAD
    Approval date: June 15, 2007
    Strength(s): 5MG [RLD], 10MG [RLD]

Has a generic version of Letairis been approved?

No. There is currently no therapeutically equivalent version of Letairis available in the United States.

Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Letairis. These medications may be counterfeit and potentially unsafe. If you purchase medications online, be sure you are buying from a reputable and valid online pharmacy. Ask your health care provider for advice if you are unsure about the online purchase of any medication.

See also: Generic Drug FAQs.

Related Patents

Patents are granted by the U.S. Patent and Trademark Office at any time during a drug's development and may include a wide range of claims.

  • Method for treating a pulmonary hypertension condition
    Patent 8,377,933
    Issued: February 19, 2013
    Assignee(s): Gilead Colorado, Inc.
    A method for treating a pulmonary hypertension condition such as pulmonary arterial hypertension (PAH) in a subject comprises administering to the subject a therapeutically effective amount of ambrisentan, wherein, at baseline, time from first diagnosis of the condition in the subject is not greater than about 2 years.
    Patent expiration dates:
    • December 11, 2027
      ✓ 
      Patent use: FOR THE TREATMENT OF PULMONARY HYPERTENSION (PAH) IN COMBINATION WITH TADALAFIL
  • Method for treating a pulmonary hypertension condition
    Patent 9,474,752
    Issued: October 25, 2016
    Assignee(s): Gilead Sciences, Inc.
    A method for treating a pulmonary hypertension condition such as pulmonary arterial hypertension (PAH) in a subject comprises administering to the subject a therapeutically effective amount of ambrisentan, wherein, at baseline, time from first diagnosis of the condition in the subject is not greater than about 2 years.
    Patent expiration dates:
    • December 11, 2027
      ✓ 
      Patent use: FOR THE TREATMENT OF PULMONARY HYPERTENSION (PAH) IN COMBINATION WITH TADALAFIL
  • Compositions and methods of treating pulmonary hypertension
    Patent 9,549,926
    Issued: January 24, 2017
    Assignee(s): Gilead Sciences, Inc.
    Provided are formulations comprising therapeutically effective amounts of ambrisentan or a pharmaceutically acceptable salt thereof and tadalafil or a pharmaceutically acceptable salt thereof and methods of treating and/or preventing pulmonary hypertension by administration of the formulations.
    Patent expiration dates:
    • October 14, 2031
      ✓ 
      Patent use: FOR THE TREATMENT OF PULMONARY ARTERIAL HYPERTENSION (PAH) IN COMBINATION WITH TADALAFIL, WHEREIN THE WEIGHT RATIO OF AMBRISENTAN TO TADALAFIL IS ABOUT 1:2 TO ABOUT 1:3
  • Carboxylic acid derivatives, their preparation and use
    Patent RE42462
    Issued: June 14, 2011
    Inventor(s): Riechers; Hartmut & Klinge; Dagmar & Amberg; Wilhelm & Kling; Andreas & Muller; Stefan & Baumann; Ernst & Rheinheimer; Joachim & Vogelbacher; Uwe Josef & Wernet; Wolfgang & Unger; Liliane & Raschack; Manfred
    Assignee(s): Abbott GmbH & Co. KG
    Carboxylic acid derivatives where R-R6, X, Y and Z have the meanings stated in the description, and the preparation thereof, are described. The novel compounds are suitable for controlling diseases.
    Patent expiration dates:
    • July 29, 2018
      ✓ 
      Drug substance

Related Exclusivities

Exclusivity is exclusive marketing rights granted by the FDA upon approval of a drug and can run concurrently with a patent or not. Exclusivity is a statutory provision and is granted to an NDA applicant if statutory requirements are met.

  • Exclusivity expiration dates:
    • October 2, 2018 - REVISED INDICATION TO INCLUDE LANGUAGE ABOUT THE BENEFITS OF USING LETAIRIS IN COMBINATION WITH TADALAFIL TO REDUCE THE RISK OF DISEASE PROGRESSION AND HOSPITALIZATION FOR WORSENING PAH AND TO IMPROVE EXERCISE ABILITY, BASED ON THE AMBITION STUDY
Glossary
TermDefinition
Drug PatentA drug patent is assigned by the U.S. Patent and Trademark Office and assigns exclusive legal right to the patent holder to protect the proprietary chemical formulation. The patent assigns exclusive legal right to the inventor or patent holder, and may include entities such as the drug brand name, trademark, product dosage form, ingredient formulation, or manufacturing process A patent usually expires 20 years from the date of filing, but can be variable based on many factors, including development of new formulations of the original chemical, and patent infringement litigation.
Drug ExclusivityExclusivity is the sole marketing rights granted by the FDA to a manufacturer upon the approval of a drug and may run simultaneously with a patent. Exclusivity periods can run from 180 days to seven years depending upon the circumstance of the exclusivity grant.
RLDA Reference Listed Drug (RLD) is an approved drug product to which new generic versions are compared to show that they are bioequivalent. A drug company seeking approval to market a generic equivalent must refer to the Reference Listed Drug in its Abbreviated New Drug Application (ANDA). By designating a single reference listed drug as the standard to which all generic versions must be shown to be bioequivalent, FDA hopes to avoid possible significant variations among generic drugs and their brand name counterpart.
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