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Generic Bylvay Availability

Last updated on Nov 8, 2022.

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

BYLVAY (odevixibat - capsule, pellets;oral)

  • Manufacturer: ALBIREO
    Approval date: July 20, 2021
    Strength(s): 0.2MG [RLD], 0.6MG [RLD]

BYLVAY (odevixibat - capsule;oral)

  • Manufacturer: ALBIREO
    Approval date: July 20, 2021
    Strength(s): 0.4MG [RLD], 1.2MG [RLD]

Has a generic version of Bylvay been approved?

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

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

  • IBAT inhibitors for the treatment of liver diseases
    Patent 10,011,633
    Issued: July 3, 2018
    Assignee(s): Albireo AB

    The present invention regards specific IBAT inhibitors useful in the prophylaxis and/or treatment of a liver disease. It also relates to compositions comprising these IBAT inhibitors, a method for treatment of the disorders and a kit comprising the substances or the compositions.

    Patent expiration dates:

    • November 8, 2031
      ✓ 
      Patent use: METHOD OF TREATING PRURITUS IN PATIENTS 3 MONTHS OR OLDER SUFFERING FROM PROGRESSIVE FAMILIAL INTRAHEPATIC CHOLESTASIS (PFIC)
  • IBAT inhibitors for the treatment of liver diseases
    Patent 10,093,697
    Issued: October 9, 2018
    Assignee(s): Albireo AB

    The present invention regards specific IBAT inhibitors useful in the prophylaxis and/or treatment of a liver disease. It also relates to compositions comprising these IBAT inhibitors, a method for treatment of the disorders and a kit comprising the substances or the compositions.

    Patent expiration dates:

    • November 8, 2031
      ✓ 
      Patent use: METHOD OF TREATING PRURITUS IN PATIENTS 3 MONTHS OR OLDER SUFFERING FROM PROGRESSIVE FAMILIAL INTRAHEPATIC CHOLESTASIS (PFIC)
  • Patent 10,487,111

    Patent expiration dates:

    • November 8, 2031
      ✓ 
      Patent use: METHOD OF REDUCING SERUM BILE ACIDS IN PATIENTS 3 MONTHS OR OLDER SUFFERING FROM PROGRESSIVE FAMILIAL INTRAHEPATIC CHOLESTASIS (PFIC)
    • November 8, 2031
      ✓ 
      Patent use: METHOD OF TREATING PRURITUS IN PATIENTS 3 MONTHS OR OLDER SUFFERING FROM PROGRESSIVE FAMILIAL INTRAHEPATIC CHOLESTASIS (PFIC)
  • Patent 10,975,046

    Patent expiration dates:

    • June 20, 2039
      ✓ 
      Drug substance
  • Patent 10,981,952

    Patent expiration dates:

    • November 8, 2031
      ✓ 
      Patent use: METHOD OF REDUCING SERUM BILE ACIDS IN PATIENTS 3 MONTHS OR OLDER SUFFERING FROM PROGRESSIVE FAMILIAL INTRAHEPATIC CHOLESTASIS (PFIC)
    • November 8, 2031
      ✓ 
      Patent use: METHOD OF TREATING PRURITUS IN PATIENTS 3 MONTHS OR OLDER SUFFERING FROM PROGRESSIVE FAMILIAL INTRAHEPATIC CHOLESTASIS (PFIC)
  • Patent 11,365,182

    Patent expiration dates:

    • June 20, 2039
      ✓ 
      Patent use: METHOD OF TREATING PRURITUS IN PATIENTS 3 MONTHS OR OLDER SUFFERING FROM PROGRESSIVE FAMILIAL INTRAHEPATIC CHOLESTASIS (PFIC)
    • June 20, 2039
      ✓ 
      Patent use: METHOD OF REDUCING SERUM BILE ACIDS IN PATIENTS 3 MONTHS OR OLDER SUFFERING FROM PROGRESSIVE FAMILIAL INTRAHEPATIC CHOLESTASIS (PFIC)
  • Benzothiazepine and benzothiazepine derivatives with ileal bile acid transport (IBAT) inhibotory activity for the treatment hyperlipidaemia
    Patent 7,132,416
    Issued: November 7, 2006
    Inventor(s): Starke; Ingemar & Dahlstrom; Mikael Ulf Johan & Blomberg; David & Alenfalk; Suzanne & Skjaret; Tore & Lemurell; Malin
    Assignee(s): AstraZeneca AB

    The present invention relates to compounds of formula (I) wherein Rv, R1, R2, Rx, Ry, M, Rz, v, R3, R4, R5 and R6 are as defined within; pharmaceutically acceptable salts, solvates, solvates of such salts and prodrugs thereof and their use as ileal bile acid transport (IBAT) inhibitors for the treatment of hyperlipidaemia. Processes for their manufacture and pharmaceutical compositions containing them are also described.

    Patent expiration dates:

    • September 5, 2022
      ✓ 
      Drug substance
      ✓ 
      Drug product
  • IBAT inhibitors for the treatment of liver disease
    Patent 9,694,018
    Issued: July 4, 2017
    Assignee(s): Albireo AB

    The present invention regards specific IBAT inhibitors useful in the prophylaxis and/or treatment of a liver disease. It also relates to compositions comprising these IBAT inhibitors, a method for treatment of the disorders and a kit comprising the substances or the compositions.

    Patent expiration dates:

    • November 8, 2031
      ✓ 
      Patent use: METHOD OF TREATING PRURITUS IN PATIENTS 3 MONTHS OR OLDER SUFFERING FROM PROGRESSIVE FAMILIAL INTRAHEPATIC CHOLESTASIS (PFIC)

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:

    • July 20, 2026 - NEW CHEMICAL ENTITY
    • July 20, 2028 - TREATMENT OF PRURITUS IN PATIENTS 3 MONTHS OF AGE AND OLDER WITH PROGRESSIVE FAMILIAL INTRAHEPATIC CHOLESTASIS (PFIC)

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.