Skip to main content

Generic Welireg Availability

Last updated on Nov 8, 2022.

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

WELIREG (belzutifan - tablet;oral)

Has a generic version of Welireg been approved?

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

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

  • Aryl ethers and uses thereof
    Patent 9,908,845
    Issued: March 6, 2018
    Assignee(s): PELOTON THERAPEUTICS, INC.

    The present disclosure relates to HIF-2α inhibitors and methods of making and using them for treating cancer. Certain compounds were potent in HIF-2α scintillation proximity assay, luciferase assay, and VEGF ELISA assay, and led to tumor size reduction and regression in 786-O xenograft bearing mice in vivo.

    Patent expiration dates:

    • September 5, 2034
      ✓ 
      Patent use: TREATMENT OF ADULT PATIENTS WITH VON HIPPEL-LINDAU DISEASE WHO REQUIRE THERAPY FOR ASSOCIATED RENAL CELL CARCINOMA, CENTRAL NERVOUS SYSTEM HEMANGIOBLASTOMAS, OR PANCREATIC NEUROENDOCRINE TUMORS, NOT REQUIRING IMMEDIATE SURGERY
      ✓ 
      Drug substance
      ✓ 
      Drug product
  • Aryl ethers and uses thereof
    Patent 9,969,689
    Issued: May 15, 2018
    Assignee(s): PELOTON THERAPEUTICS, INC.

    The present disclosure relates to HIF-2α inhibitors and methods of making and using them for treating cancer. Certain compounds were potent in HIF-2α scintillation proximity assay, luciferase assay, and VEGF ELISA assay, and led to tumor size reduction and regression in 786-O xenograft bearing mice in vivo.

    Patent expiration dates:

    • September 5, 2034
      ✓ 
      Patent use: TREATMENT OF ADULT PATIENTS WITH VON HIPPEL-LINDAU DISEASE WHO REQUIRE THERAPY FOR ASSOCIATED RENAL CELL CARCINOMA, CENTRAL NERVOUS SYSTEM HEMANGIOBLASTOMAS, OR PANCREATIC NEUROENDOCRINE TUMORS, NOT REQUIRING IMMEDIATE SURGERY
      ✓ 
      Drug substance
      ✓ 
      Drug product

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:

    • August 13, 2026 - NEW CHEMICAL ENTITY
    • August 13, 2028 - TREATMENT OF ADULT PATIENTS WITH VON HIPPEL-LINDAU (VHL) DISEASE WHO REQUIRE THERAPY FOR ASSOCIATED RENAL CELL CARCINOMA (RCC), CENTRAL NERVOUS SYSTEM (CNS) HEMANGIOBLASTOMAS, OR PANCREATIC NEUORENDOCRINE TUMORS (PNET), NOT REQUIRING IMMEDIATE SURGERY

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.