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Generic Clindesse Availability

Last updated on Jan 11, 2023.

See also: Generic Clindagel

Clindesse is a brand name of clindamycin topical, approved by the FDA in the following formulation(s):

CLINDESSE (clindamycin phosphate - cream;vaginal)

  • Manufacturer: PADAGIS US
    Approval date: November 30, 2004
    Strength(s): EQ 2% BASE [RLD]

Has a generic version of Clindesse been approved?

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

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

  • Bioadhesive drug delivery system
    Patent 6,899,890
    Issued: May 31, 2005
    Inventor(s): Kirschner; Mitchell I. & Levinson; R. Saul & Riley; Thomas C. & Hermelin; Marc S.
    Assignee(s): KV Pharmaceutical Company

    The present invention relates to a novel essentially pH neutral vaginal drug delivery system suitable for modified delivery of a therapeutically active material in the vaginal cavity. The vaginal drug delivery system comprises an essentially pH neutral emulsion having globules having two phases, an internal water soluble phase and an external water-insoluble phase or film, wherein the water-soluble interior phase contains a therapeutically active drug or drugs. One novel aspect of the vaginal drug delivery system is that the internal water soluble phase comprises an acidic buffered phase.

    Patent expiration dates:

    • April 27, 2023
      ✓ 
      Patent use: METHOD OF TREATING BACTERIAL VAGINOSIS
      ✓ 
      Drug product
  • Pharmaceutical delivery system
    Patent 9,789,057
    Issued: October 17, 2017
    Assignee(s): Perrigo Pharma International Designated Activity Company

    A pharmaceutical formulation to treat vaginal conditions in a human patient comprises: at least one active agent; a modified release dosage form which provides extended release of the anti-infective agent upon vaginal administration to the patient; and wherein the formulation, when containing a total dose of the anti-infective agent of about 25 μg to about 500 mg based on the active agent will produce a plasma concentration versus time curve (ng/mL versus hours) having an area under the curve (AUC) of less than about 600 ng/mL·hr.

    Patent expiration dates:

    • December 2, 2026
      ✓ 
      Patent use: METHOD OF TREATING BACTERIAL VAGINOSIS
      ✓ 
      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.

Further information

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

Medical Disclaimer