Generic Protopic Availability

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

PROTOPIC (tacrolimus - ointment;topical)

  • Manufacturer: ASTELLAS
    Approval date: December 8, 2000
    Strength(s): 0.03% [RLD], 0.1% [RLD]

Has a generic version of Protopic been approved?

No. There is currently no therapeutically equivalent version of Protopic available in the United States.

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

  • Use of 11,28-dioxa-4-azatricyclo›,9 !octacos-18-ene derivatives and pharmaceutical compositions containing them
    Patent 5,665,727
    Issued: September 9, 1997
    Inventor(s): Grassberger; Maximilian & Meingassner; Josef Gottfried & Stutz; Anton & Stutz; Peter
    Assignee(s): Sandoz Ltd.
    The compounds of formula I, ##STR1## have been found to have excellent topical activity. They are thus indicated for use in the topical treatment of inflammatory and hyperpoliferative skin diseases and of cutaneous manifestations of immunologically-induced illnesses, such as psoriasis.
    Patent expiration dates:
    • September 9, 2014


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.