Generic Bystolic Availability

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

BYSTOLIC (nebivolol hydrochloride - tablet;oral)

  • Manufacturer: FOREST LABS
    Approval date: December 17, 2007
    Strength(s): EQ 2.5MG BASE, EQ 5MG BASE, EQ 10MG BASE
  • Manufacturer: FOREST LABS
    Approval date: October 8, 2008
    Strength(s): EQ 20MG BASE [RLD]

Has a generic version of Bystolic been approved?

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

Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Bystolic. 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 containing micronized nebivolol
    Patent 5,759,580
    Issued: June 2, 1998
    Inventor(s): Jans; Eugeen Marie Jozef & Smans; Guido Franciscus & Gilis; Paul Marie Victor
    Assignee(s): Janssen Pharmaceutica, N.V.
    The present invention relates to pharmaceutical compositions containing as active ingredient micronized nebivolol of formula (I) and ways of preparing said compositions. ##STR1##
    Patent expiration dates:
    • June 2, 2015
      ✓ 
      Drug product
  • Method of lowering the blood pressure
    Patent 6,545,040
    Issued: April 8, 2003
    Inventor(s): Raymond Mathieu; Xhonneux & Guy Rosalia Eugène; Van Lommen
    Assignee(s): Janssen Pharmaceutica N.V.
    A method of potentiating the effects of blood pressure reducing agents in warm-blooded animals, said method comprising administering to said warm-blooded animals of an effective amount of a blood pressure reducing agent and a 2,2′-iminobisethanol derivative.
    Patent expiration dates:
    • December 17, 2021
      ✓ 
      Patent use: TREATMENT OF HYPERTENSION
      ✓ 
      Drug product

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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