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: TARO
    Approval date: July 2, 2012
    Strength(s): 0.05% [AB]

clobetasol propionate shampoo;topical

  • Manufacturer: ACTAVIS MID ATLANTIC
    Approval date: June 7, 2011
    Strength(s): 0.05% [AB]
  • Manufacturer: PERRIGO ISRAEL
    Approval date: August 9, 2012
    Strength(s): 0.05% [AB]

clobetasol propionate spray;topical

  • Manufacturer: PADDOCK LLC
    Approval date: June 16, 2011
    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: 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.

  • Formulation containing a carrier, active ingredient, and surfactant for treating skin disorders
    Patent 5,972,920
    Issued: October 26, 1999
    Inventor(s): Seidel; William E.
    Assignee(s): Dermalogix Partners, Inc.
    One or more formulations for treating psoriasis and other skin disorders characterized by redness, itching, flaking, scaling, and plaque-type growth. The formulation includes a carrier component, one or more active ingredient components, and a surfactant component. The carrier preferably includes an alcohol in substantially equal volume with isopropyl myristate. The active ingredient component preferably includes a superpotent or high-potency corticosteroid such as clobetasol propionate, an anti-flaking ingredient such as zinc pyrithione, or a combination of the two. It may also include an anti-fungal compound. The surfactant component preferably includes an alkyl sulfate such as sodium lauryl sulfate. The formulations made by applied topically either in spray form or as a direct-contact liquid.
    Patent expiration dates:
    • February 12, 2018
      ✓ 
      Drug product
  • Composition and method for treatment of psoriasis
    Patent 5,990,100
    Issued: November 23, 1999
    Inventor(s): Rosenberg; E. William & Glenn; Thomas M. & Skinner, Jr.; Robert B. & Noah; Patricia W.
    Assignee(s): Panda Pharmaceuticals, L.L.C. The University of Tennessee Research Corporation
    Pharmaceutical compositions and methods for use in the treatment of psoriasis, having isopropyl myristate as a first active ingredient and a different anti-psoriatic agent as a second active ingredient; preferably they are combined in the same pharmaceutical composition.
    Patent expiration dates:
    • March 24, 2018
      ✓ 
      Patent use: TWICE DAILY TOPICAL TREATMENT OF MODERATE TO SEVERE PLAQUE PSORIASIS.
      ✓ 
      Drug product
  • Topically applicable O/W emulsions having high glycol content and at least one biologically active agent
    Patent 6,106,848
    Issued: August 22, 2000
    Inventor(s): Preuilh; Isabelle & Willcox; Nathalie
    Assignee(s): Centre International de Recherches Dermatologiques
    Stable, topically applicable oil-in-water bioaffecting emulsions having intermediate viscosity, characteristically ranging from 3 to 10 Pa.multidot.s, comprise (a) from 30% to 50% by weight of at least one pro-penetrating glycol, (b) at least one emulsifying agent, advantageously an anionic amphiphilic polymer, and (c) at least one biologically active agent, for example an active agent that modulates skin differentiation and/or proliferation and/or pigmentation, an anti-inflammatory, an antibacterial, an antifungal, etc.
    Patent expiration dates:
    • September 22, 2017
  • Foaming composition for washing and treating hair and/or scalp based on an active principle
    Patent 7,316,810
    Issued: January 8, 2008
    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 characterized 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:
    • June 17, 2019
      ✓ 
      Drug product
  • 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
  • Foaming composition for washing and treating hair and/or scalp based on an active principle
    Patent 8,066,975
    Issued: November 29, 2011
    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 characterized 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:
    • June 17, 2019
      ✓ 
      Drug product
  • Foaming compositions for hair care
    Patent 8,066,976
    Issued: November 29, 2011
    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:
    • June 17, 2019
      ✓ 
      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
(web1)