Generic Protopic Availability
PROTOPIC (tacrolimus - ointment;topical)
Approval date: December 8, 2000
Strength(s): 0.03% [RLD] [AB], 0.1% [RLD] [AB]
Has a generic version of Protopic been approved?
A generic version of Protopic 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 Protopic and have been approved by the FDA:
Manufacturer: FOUGERA PHARMS INC
Approval date: September 9, 2014
Strength(s): 0.03% [AB], 0.1% [AB]
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.
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›18.104.22.168.sup.4,9 !octacos-18-ene derivatives and pharmaceutical compositions containing them
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✓
- September 9, 2014
- Protopic Consumer Information (Drugs.com)
- Protopic ointment Consumer Information (Wolters Kluwer)
- Protopic Consumer Information (Cerner Multum)
- Protopic Topical Advanced Consumer Information (Micromedex®)
- Protopic topical AHFS DI Monographs (ASHP)
- Tacrolimus ointment Consumer Information (Wolters Kluwer)
- Tacrolimus topical Consumer Information (Cerner Multum)
- Tacrolimus Topical Advanced Consumer Information (Micromedex®)
- Tacrolimus topical AHFS DI Monographs (ASHP)
|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.|