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Generic Clobex Availability

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

CLOBEX (clobetasol propionate - lotion;topical)

CLOBEX (clobetasol propionate - shampoo;topical)

  • Manufacturer: GALDERMA LABS
    Approval date: February 5, 2004
    Strength(s): 0.05% [RLD] [AB]

CLOBEX (clobetasol propionate - spray;topical)

Has a generic version of Clobex been approved?

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

clobetasol propionate lotion;topical

  • Manufacturer: ACTAVIS MID ATLANTIC
    Approval date: December 4, 2008
    Strength(s): 0.05% [AB]
  • Manufacturer: CADILA
    Approval date: September 24, 2019
    Strength(s): 0.05% [AB]
  • Manufacturer: LUPIN LTD
    Approval date: September 22, 2017
    Strength(s): 0.05% [AB]
  • Manufacturer: TARO
    Approval date: July 2, 2012
    Strength(s): 0.05% [AB]
  • Manufacturer: TELIGENT
    Approval date: November 29, 2016
    Strength(s): 0.05% [AB]

clobetasol propionate shampoo;topical

  • Manufacturer: ACTAVIS MID ATLANTIC
    Approval date: June 7, 2011
    Strength(s): 0.05% [AB]
  • Manufacturer: AKORN
    Approval date: October 27, 2017
    Strength(s): 0.05% [AB]
  • Manufacturer: ALEOR DERMACEUTICALS
    Approval date: May 18, 2020
    Strength(s): 0.05% [AB]
  • Manufacturer: PERRIGO ISRAEL
    Approval date: August 9, 2012
    Strength(s): 0.05% [AB]

clobetasol propionate spray;topical

  • Manufacturer: AKORN
    Approval date: April 28, 2017
    Strength(s): 0.05% [AT]
  • Manufacturer: ALEOR DERMACEUTICALS
    Approval date: October 2, 2019
    Strength(s): 0.05% [AT]
  • Manufacturer: GLENMARK PHARMS
    Approval date: March 26, 2018
    Strength(s): 0.05% [AT]
  • Manufacturer: LUPIN LTD
    Approval date: March 26, 2018
    Strength(s): 0.05% [AT]
  • Manufacturer: PADDOCK LLC
    Approval date: June 16, 2011
    Strength(s): 0.05% [AT]
  • Manufacturer: TARO
    Approval date: March 26, 2018
    Strength(s): 0.05% [AT]
  • Manufacturer: ZYDUS PHARMS
    Approval date: February 16, 2017
    Strength(s): 0.05% [AT]

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

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.

  • Foaming compositions for hair care
    Patent 7,700,081
    Issued: April 20, 2010
    Inventor(s): Preuilh; Isabelle & Guise; Anne-Emmanuelle & Willcox; Nathalie
    Assignee(s): Galderma S.A.

    The invention concerns a foaming composition for washing and treating hair and/or scalp essentially characterised in that it contains in an aqueous medium: at least an active principle selected among corticoids and retinoids; at least an anionic surfactant; at least an amphoteric surfactant; and a pro-penetrating agent.

    Patent expiration dates:

    • January 3, 2022
      ✓ 
      Patent use: TOPICAL TREATMENT OF SCALP PSORIASIS

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.
AB Products 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.
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.