Generic Topicort Availability
TOPICORT (desoximetasone - cream;topical)
TOPICORT (desoximetasone - gel;topical)
TOPICORT (desoximetasone - ointment;topical)
Approval date: September 30, 1983
Strength(s): 0.25% [RLD]
Approval date: January 17, 1985
Strength(s): 0.05% [RLD] [AB]
TOPICORT (desoximetasone - spray;topical)
Has a generic version of Topicort been approved?
A generic version of Topicort 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 Topicort and have been approved by the FDA:
Manufacturer: LUPIN ATLANTIS
Approval date: December 12, 2016
Strength(s): 0.05% [AB]
Manufacturer: PERRIGO ISRAEL
Approval date: January 20, 2017
Strength(s): 0.25% [AT]
Note: No generic formulation of the following products are available.
- desoximetasone - cream;topical
- desoximetasone - gel;topical
Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Topicort. 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.
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.
Composition and method for treatment of psoriasis
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✓✓
- March 24, 2018
Stable liquid desoximethasone compositions with reduced oxidized impurity
Issued: October 2, 2012
Inventor(s): Rao; Srinivasa & Dixit; Suresh & Yacobi; Avraham & Bailey; Arthur
Assignee(s): Taro Pharmaceutical North America, Inc.
The present invention relates to a stable liquid formulation comprising desoximetasone, isopropyl myristate, a C2-C4 alcohol and a stabilizing agent. Specifically, the present invention provides a liquid formulation comprising: a) about 0.01 wt % to about 2.5 wt % desoximetasone; b) about 10 wt % to about 70 wt % isopropyl myristate; c) about 20 wt % to about 70 wt % C2-C4 alcohol; and d) a stabilizing agent selected from the group consisting of an oleaginous vehicle and a propellant, wherein the stabilizing agent is in an amount sufficient to reduce the formation of less than about 1 wt % 17-carboxy-9α-fluoro-11β-hydroxy-16a-methyl-androsta-1,4-diene-3-one under an accelerated storage condition.Patent expiration dates:
- September 1, 2028✓✓
- September 1, 2028
Stable liquid desoximethasone compositions with reduced oxidized impurity
Issued: May 6, 2014
Assignee(s): Taro Pharmaceuticals North America, Inc.
The present invention relates to a stable liquid formulation comprising desoximetasone, isopropyl myristate, a C2-C4 alcohol and a stabilizing agent. Specifically, the present invention provides a liquid formulation comprising: a) about 0.01 wt % to about 2.5 wt % desoximetasone; b) about 10 wt % to about 70 wt % isopropyl myristate; c) about 20 wt % to about 70 wt % C2-C4 alcohol; and d) a stabilizing agent selected from the group consisting of an oleaginous vehicle and a propellant, wherein the stabilizing agent is in an amount sufficient to reduce the formation of less than about 1 wt % 17-carboxy-9α-fluoro-11β-hydroxy-16α-methyl-androsta-1,4-diene-3-one under an accelerated storage condition.Patent expiration dates:
- May 26, 2026✓✓
- May 26, 2026
More about Topicort (desoximetasone topical)
- Side Effects
- During Pregnancy or Breastfeeding
- Dosage Information
- Drug Interactions
- Support Group
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- En Español
- 6 Reviews – Add your own review/rating
- Generic Availability
- Drug class: topical steroids
Other brands: Topicort LP
Related treatment guides
|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.|
|AT||Topical 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.|