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Generic Tyrvaya Availability

Last updated on Jan 11, 2023.

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

TYRVAYA (varenicline tartrate - spray;nasal)

  • Manufacturer: OYSTER POINT PHARMA
    Approval date: October 15, 2021
    Strength(s): EQ 0.03MG BASE/SPRAY [RLD]

Has a generic version of Tyrvaya been approved?

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

Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Tyrvaya. 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 FAQ.

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.

  • Patent 10,456,396

    Patent expiration dates:

    • October 19, 2035
      ✓ 
      Patent use: TREATMENT OF THE SIGNS AND SYMPTOMS OF DRY EYE DISEASE (DED)
      ✓ 
      Drug product
  • Patent 11,224,598

    Patent expiration dates:

    • October 19, 2035
      ✓ 
      Patent use: TREATMENT OF THE SIGNS AND SYMPTOMS OF DRY EYE DISEASE (DED)
  • Methods of increasing tear production
    Patent 9,504,644
    Issued: November 29, 2016
    Assignee(s): OYSTER POINT PHARMA, INC.

    Described herein are methods and pharmaceutical formulations for increasing tear production.

    Patent expiration dates:

    • October 19, 2035
      ✓ 
      Patent use: TREATMENT OF THE SIGNS AND SYMPTOMS OF DRY EYE DISEASE (DED)
  • Pharmaceutical formulations for treating ocular conditions
    Patent 9,504,645
    Issued: November 29, 2016
    Assignee(s): OYSTER POINT PHARMA, INC.

    Described herein are pharmaceutical formulations for treating ocular conditions.

    Patent expiration dates:

    • October 19, 2035
      ✓ 
      Drug product
  • Methods of improving ocular discomfort
    Patent 9,532,944
    Issued: January 3, 2017
    Assignee(s): OYSTER POINT PHARMA, INC.

    Described herein are methods and pharmaceutical formulations for improving ocular discomfort.

    Patent expiration dates:

    • October 19, 2035
      ✓ 
      Patent use: TREATMENT OF THE SIGNS AND SYMPTOMS OF DRY EYE DISEASE (DED)
  • Dry eye treatments
    Patent 9,597,284
    Issued: March 21, 2017
    Assignee(s): Oyster Point Pharma, Inc.

    Described herein are methods and pharmaceutical formulations for treating dry eye disease.

    Patent expiration dates:

    • October 19, 2035
      ✓ 
      Patent use: TREATMENT OF THE SIGNS AND SYMPTOMS OF DRY EYE DISEASE (DED)

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 15, 2024 - NEW PRODUCT

Glossary

Term Definition
Drug Patent A 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 Exclusivity Exclusivity 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.
RLD A 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.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.