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Generic Elidel Availability

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

ELIDEL (pimecrolimus - cream;topical)

  • Manufacturer: VALEANT BERMUDA
    Approval date: December 13, 2001
    Strength(s): 1% [RLD]

Has a generic version of Elidel been approved?

An Authorized Generic version of Elidel has been approved. An Authorized Generic is a prescription drug that is produced by a brand company under a New Drug Application (NDA) and marketed as a generic under a private label. It is identical to the branded product in appearance, and unlike a generic, the Authorized Generic has exactly the same inactive ingredients.

List of authorized generic versions:

  • Pimecrolimus TOPICAL CREAM 10 mg/g
    Oceanside Pharmaceuticals
    NDC Code: 686820110
  • Pimecrolimus TOPICAL CREAM 10 mg/g
    Oceanside Pharmaceuticals
    NDC Code: 686820111
  • Pimecrolimus TOPICAL CREAM 10 mg/g
    Oceanside Pharmaceuticals
    NDC Code: 686820112

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

  • Crystalline macrolides and process for their preparation
    Patent 6,423,722
    Issued: July 23, 2002
    Inventor(s): Cornelia; Dosenbach & Maximilian; Grassberger & Otto; Hartmann & Amarylla; Horvath & Jean-Paul; Mutz & Gerhard; Penn & Sabine; Pfeffer & Dierk; Wieckhusen
    Assignee(s): Novartis AG

    33-Epichloro-33-desoxyascomycin of formula I and various tautomeric or forms thereof, in crystalline form, such as Form A and Form B. Their preparation involves appropriately converting amorphous compound of formula I, or compound of formula I in other than Form A, or compound of formula I in other than Form B, respectively, from a solution thereof under crystallization-inducing conditions or conditions inducing preferential crystallization of Form A or B, respectively. Such crystals are particularly indicated for use in the preparation of topical galenical forms of the compound for pharmaceutical use, e.g. creams, emulsions and ointments.

    Patent expiration dates:

    • June 26, 2018
    • December 26, 2018
      Pediatric exclusivity

Further information

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

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.