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Generic Cosopt Availability

See also: Generic Cosopt PF

Cosopt is a brand name of dorzolamide/timolol ophthalmic, approved by the FDA in the following formulation(s):

COSOPT (dorzolamide hydrochloride; timolol maleate - solution/drops;ophthalmic)

  • Manufacturer: AKORN
    Approval date: April 7, 1998
    Strength(s): EQ 2% BASE;EQ 0.5% BASE [RLD] [AT]

Has a generic version of Cosopt been approved?

Yes. The following products are equivalent to Cosopt:

DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE (dorzolamide hydrochloride; timolol maleate solution/drops;ophthalmic)

  • Manufacturer: AKORN INC
    Approval date: September 22, 2014
    Strength(s): EQ 2% BASE;EQ 0.5% BASE [AT]
  • Manufacturer: AUROBINDO PHARMA LTD
    Approval date: July 24, 2018
    Strength(s): EQ 2% BASE;EQ 0.5% BASE [AT]
  • Manufacturer: BAUSCH AND LOMB
    Approval date: July 14, 2009
    Strength(s): EQ 2% BASE;EQ 0.5% BASE [AT]
  • Manufacturer: SANDOZ
    Approval date: November 6, 2008
    Strength(s): EQ 2% BASE;EQ 0.5% BASE [AT]
  • Manufacturer: SANDOZ INC
    Approval date: November 18, 2009
    Strength(s): EQ 2% BASE;EQ 0.5% BASE [AT]
  • Manufacturer: SOMERSET
    Approval date: June 25, 2019
    Strength(s): EQ 2% BASE;EQ 0.5% BASE [AT]
  • Manufacturer: TEVA PHARMS
    Approval date: September 28, 2009
    Strength(s): EQ 2% BASE;EQ 0.5% BASE [AT]

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

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.

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