Skip to Content

Generic Cleocin Vaginal Availability

See also: Generic Cleocin T

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

CLEOCIN (clindamycin phosphate - cream;vaginal)

  • Manufacturer: PHARMACIA AND UPJOHN
    Approval date: August 11, 1992
    Strength(s): EQ 2% BASE
  • Manufacturer: PHARMACIA AND UPJOHN
    Approval date: March 2, 1998
    Strength(s): EQ 2% BASE [RLD] [AB]

CLEOCIN (clindamycin phosphate - suppository;vaginal)

  • Manufacturer: PHARMACIA AND UPJOHN
    Approval date: August 13, 1999
    Strength(s): 100MG [RLD]

CLEOCIN (clindamycin phosphate - swab;topical)

  • Manufacturer: PHARMACIA AND UPJOHN
    Approval date: February 22, 1994
    Strength(s): EQ 1% BASE [AT]

Has a generic version of Cleocin Vaginal been approved?

A generic version of Cleocin Vaginal 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 Cleocin Vaginal and have been approved by the FDA:

clindamycin phosphate cream;vaginal

  • Manufacturer: FOUGERA PHARMS
    Approval date: December 27, 2004
    Strength(s): EQ 2% BASE [AB]

clindamycin phosphate swab;topical

  • Manufacturer: AKORN
    Approval date: June 17, 2010
    Strength(s): EQ 1% BASE [AT]
  • Manufacturer: PERRIGO NEW YORK
    Approval date: May 25, 2000
    Strength(s): EQ 1% BASE [AT]

CLINDETS (clindamycin phosphate swab;topical)

  • Manufacturer: PERRIGO CO
    Approval date: September 30, 1996
    Strength(s): EQ 1% BASE [AT]

Note: No generic formulation of the following product is available.

  • clindamycin phosphate - suppository;vaginal

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

  • Intravaginal clindamycin ovule composition
    Patent 6,495,157
    Issued: December 17, 2002
    Inventor(s): Lorraine Elisabeth; Pena & Phil Bryan; Bowman & Robert Shih-Liang; Chao & Carolyn V.; Pesheck
    Assignee(s): Pharmacia & Upjohn Company
    A highly storage-stable composition for vaginal administration of clindamycin is disclosed which is useful for the treatment of bacterial vaginosis. The composition is a vaginal suppository containing an antimicrobially effective amount of clindamycin dispersed in a Hard Fat NF suppository base. Hard Fat NF suppository bases provide a clindamycin product having long term storage stability while providing efficacy against bacterial vaginosis which is equivalent to clindamycin vaginal creams.
    Patent expiration dates:
    • July 20, 2020
      ✓ 
      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.
ABProducts meeting necessary bioequivalence requirements. Multisource drug products listed under the same heading (i.e., identical active ingredients(s), dosage form, and route(s) of administration) and having the same strength (see Therapeutic Equivalence-Related Terms, Pharmaceutical Equivalents) generally will be coded AB if a study is submitted demonstrating bioequivalence. In certain instances, a number is added to the end of the AB code to make a three character code (i.e., AB1, AB2, AB3, etc.). Three-character codes are assigned only in situations when more than one reference listed drug of the same strength has been designated under the same heading. Two or more reference listed drugs are generally selected only when there are at least two potential reference drug products which are not bioequivalent to each other. If a study is submitted that demonstrates bioequivalence to a specific listed drug product, the generic product will be given the same three-character code as the reference listed drug it was compared against.
ATTopical 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.
Hide