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Generic Extina Availability

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

EXTINA (ketoconazole - aerosol, foam;topical)

Has a generic version of Extina been approved?

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

ketoconazole aerosol, foam;topical

  • Manufacturer: PERRIGO ISRAEL
    Approval date: August 25, 2011
    Strength(s): 2% [AT]

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

  • Topical antifungal composition
    Patent 7,553,835
    Issued: June 30, 2009
    Inventor(s): Davey; Greg & Abram; Albert Zorko
    Assignee(s): Stiefel Research Australia Pty Ltd
    The subject matter relates to a topical, foamable composition including at least one antifungal agent, said composition characterised in that said at least one antifungal agent is able to penetrate the upper layers of skin and is retained in or on an area to be treated for a prolonged period of time, and in that it has a residual non-volatile component content of less than 25%. The subject matter furthermore relates to a method of treating fungal diseases including jock itch, tinea, dandruff and sebborheic dermatitis by applying to the affected area of a patient requiring such treatment the antifungal composition.
    Patent expiration dates:
    • October 19, 2018
      ✓ 
      Patent use: TREATMENT OF SEBORRHEA DERMATITIS IN HUMANS
      ✓ 
      Drug product
  • Topical antifungal composition
    Patent 8,026,238
    Issued: September 27, 2011
    Inventor(s): Davey; Greg & Abram; Albert Zorko
    Assignee(s): Stiefel Research Australia, Pty Ltd
    A topical, foamable composition is provided that includes at least one antifungal agent that is able to penetrate the upper layers of skin and is retained in or on an area to be treated for a prolonged period of time, and that has a residual non-volatile component content of less than 25%. In addition, a method of treating fungal diseases including jock itch, tinea, dandruff and sebborheic dermatitis is provided, and includes applying to the affected area of a patient requiring such treatment an antifungal composition.
    Patent expiration dates:
    • October 19, 2018
      ✓ 
      Patent use: TOPICAL TREATMENT OF SEBORRHEIC DERMATITIS IN IMMUNOCOMPETETENT PATIENTS 12 YEARS OF AGE AND OLDER
      ✓ 
      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.
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.
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