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Generic Bepreve Availability

Last updated on Oct 6, 2021.

Bepreve is a brand name of bepotastine ophthalmic, approved by the FDA in the following formulation(s):

BEPREVE (bepotastine besilate - solution/drops;ophthalmic)

  • Manufacturer: BAUSCH AND LOMB INC
    Approval date: September 8, 2009
    Strength(s): 1.5% [RLD] [AT]

Has a generic version of Bepreve been approved?

A generic version of Bepreve has been approved by the FDA. However, this does not mean that the product will necessarily be commercially available - possibly because of drug patents and/or drug exclusivity. The following products are equivalent to Bepreve and have been approved by the FDA:

bepotastine besilate solution/drops;ophthalmic

  • Manufacturer: APOTEX
    Approval date: March 5, 2019
    Strength(s): 1.5% [AT]
  • Manufacturer: MYLAN
    Approval date: March 18, 2019
    Strength(s): 1.5% [AT]

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

  • Aqueous liquid preparations and light-stabilized aqueous liquid preparations
    Patent 8,784,789
    Issued: July 22, 2014
    Assignee(s): Senju Pharmaceutical Co., Ltd.

    An aqueous liquid preparation containing (+)-(S)-4-[4-[(4-chlorophenyl)(2-pyridyl)methoxy]piperidino]butyric acid or a pharmacologically acceptable acid addition salt thereof, which is stabilized with a water-soluble metal chloride, is provided.

    Patent expiration dates:

    • January 13, 2025
      ✓ 
      Drug product
  • Aqueous liquid preparations and light-stabilized aqueous liquid preparations
    Patent 8,877,168
    Issued: November 4, 2014
    Assignee(s): Senju Pharmaceuticals Co., Ltd.

    An aqueous liquid preparation containing (+)-(S)-4-[4-[(4-chlorophenyl) (2-pyridyl)methoxy]piperidino]butyric acid or a pharmacologically acceptable acid addition salt thereof, which is stabilized with a water-soluble metal chloride, is provided.

    Patent expiration dates:

    • July 30, 2023
      ✓ 
      Drug 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.
AT Topical products. There are a variety of topical dosage forms available for dermatologic, ophthalmic, otic, rectal, and vaginal administration, including creams, gels, lotions, oils, ointments, pastes, solutions, sprays and suppositories. Even though different topical dosage forms may contain the same active ingredient and potency, these dosage forms are not considered pharmaceutically equivalent. Therefore, they are not considered therapeutically equivalent. All solutions and DESI drug products containing the same active ingredient in the same topical dosage form for which a waiver of in vivo bioequivalence has been granted and for which chemistry and manufacturing processes are adequate to demonstrate bioequivalence, are considered therapeutically equivalent and coded AT. Pharmaceutically equivalent topical products that raise questions of bioequivalence, including all post-1962 non-solution topical drug products, are coded AB when supported by adequate bioequivalence data, and BT in the absence of such data.

Further information

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