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Generic Byvalson Availability

Byvalson is a brand name of nebivolol/valsartan, approved by the FDA in the following formulation(s):

BYVALSON (nebivolol hydrochloride; valsartan - tablet;oral)

  • Manufacturer: FOREST LABS LLC
    Approval date: June 3, 2016
    Strength(s): EQ 5MG BASE;80MG [RLD]

Has a generic version of Byvalson been approved?

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

Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Byvalson. 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: About generic drugs.

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.

  • Compositions comprising nebivolol
    Patent 7,803,838
    Issued: September 28, 2010
    Inventor(s): Davis; Eric & O'Donnell; John & Bottini; Peter
    Assignee(s): Forest Laboratories Holdings Limited
    Nebivolol has been shown to be beneficial in the treatment of cardiovascular diseases such hypertension, congestive heart failure, arterial stiffness and endothelial dysfunction. The present invention features a pharmaceutical composition comprising nebivolol and at least one other active agent, wherein the at least one other active agent is a cardiovascular agent.
    Patent expiration dates:
    • August 29, 2026
      ✓ 
      Drug product
  • Compositions comprising nebivolol
    Patent 7,838,552
    Issued: November 23, 2010
    Inventor(s): Davis; Eric & O'Donnell; John P. & Bottini; Peter Bruce & Shaw; Andrew & Mason; R. Preston
    Assignee(s): Forest Laboratories Holdings Limited
    Nebivolol has been shown to be beneficial in the treatment of cardiovascular diseases such hypertension, congestive heart failure, arterial stiffness and endothelial dysfunction. The present invention features a pharmaceutical composition comprising nebivolol and at least one other active agent, wherein the at least one other active agent is a cardiovascular agent.
    Patent expiration dates:
    • October 4, 2027
      ✓ 
      Patent use: METHOD OF TREATING HYPERTENSION

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:
    • June 3, 2019 - NEW COMBINATION
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More about Byvalson (nebivolol / valsartan)

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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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