Generic Taclonex Availability

Taclonex is a brand name of betamethasone/calcipotriene topical, approved by the FDA in the following formulation(s):

TACLONEX (betamethasone dipropionate; calcipotriene hydrate - ointment;topical)

  • Manufacturer: LEO PHARMA AS
    Approval date: January 9, 2006
    Strength(s): 0.064%;0.005% [RLD] [AB]

TACLONEX (betamethasone dipropionate; calcipotriene hydrate - suspension;topical)

  • Manufacturer: LEO PHARMA AS
    Approval date: May 9, 2008
    Strength(s): 0.064%;0.005% [RLD]

Has a generic version of Taclonex been approved?

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

CALCIPOTRIENE AND BETAMETHASONE DIPROPIONATE (betamethasone dipropionate; calcipotriene hydrate ointment;topical)

  • Manufacturer: TOLMAR
    Approval date: January 14, 2013
    Strength(s): 0.064%;0.005% [AB]

Note: No generic formulation of the following product is available.

  • betamethasone dipropionate; calcipotriene hydrate - suspension;topical

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

  • Crystalline form of a vitamin D analogue
    Patent 5,763,426
    Issued: June 9, 1998
    Inventor(s): Hansen; Erik Torngaard & Rastrup Andersen; Niels Smidt & Ringborg; Lene Hoffmeyer
    Assignee(s): Leo Pharmaceutical Products Ltd.
    The present invention relates to calcipotriol hydrate--a new crystalline form of calcipotriol--with superior technical properties and with superior stability.
    Patent expiration dates:
    • June 9, 2015
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      Drug substance
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      Drug product
  • Pharmaceutical composition
    Patent 6,753,013
    Issued: June 22, 2004
    Inventor(s): Erik; Didriksen & Gert; Høy
    Assignee(s): Leo Pharmaceutical Products, Ltd. A/S
    A pharmaceutical composition for dermal use, wherein the composition has a first pharmacologically active component A consisting of at least one vitamin D or vitamin D analogue, and a second pharmacologically active component B consisting of at least one corticosteroid, wherein the difference between the maximum stability pH of said first component A and the maximum stability pH of said second component B is at least 1. The composition can also have at least one solvent component C, where component C is compounds of the general formula R3 (OCH2C(R1)H)xOR2 (I), wherein x is in the range of 2-60, R1 in each of the x units independently is H or CH3, R2 is straight chain or branched C1-20alkyl or benzoyl, and R3 is H or phenylcarbonyloxy; di-(straight or branched)-C4-10alkyl esters of C4-C8dicarboxylic acids; straight or branched C12-18-alkyl benzoates; straight or branched C2-4-alkyl esters of straight or branched C10-18-alkanoic or -alkenoic acids; propylenglycol diesters with C8-14-alkanoic acids; and branched primary C18-24alkanols.
    Patent expiration dates:
    • January 27, 2020
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      Patent use: TREATMENT OF MODERATE PLAQUE PSORIASIS
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      Drug product
    • January 27, 2020
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      Patent use: PSORIASIS
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      Drug product
  • Topical composition
    Patent 6,787,529
    Issued: September 7, 2004
    Inventor(s): Gert; Høy & Erik Johannes; Didriksen
    Assignee(s): Leo Pharmaceutical Products Ltd. A/S
    The present invention relates to a pharmaceutical gel composition for application on skin, said composition comprising at least one vitamin D or vitamin D analogue and at least one corticosteroid as well as a viscosity-increasing excipient.
    Patent expiration dates:
    • January 27, 2020
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      Patent use: PSORIASIS
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      Drug product
    • January 27, 2020
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      Patent use: TREATMENT OF MODERATE PLAQUE PSORIASIS
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      Drug product
  • Crystalline form of a vitamin D analogue
    Patent RE39706
    Issued: June 26, 2007
    Inventor(s): Hansen; Erik Torngaard & Andersen; Niels Smidt Rastrup & Ringborg; Lene Hoffmeyer
    Assignee(s): Leo Pharma A/S
    The present invention relates to calcipotriol hydrate—a new crystalline form of calcipotriol—with superior technical properties and with superior stability.
    Patent expiration dates:
    • June 9, 2015
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      Drug substance
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      Drug product

Related Exclusivities

Exclusivity is exclusive marketing rights granted by the FDA upon approval of a drug and can run concurrently with a patent or not. Exclusivity is a statutory provision and is granted to an NDA applicant if statutory requirements are met.

  • Exclusivity expiration dates:
    • October 17, 2015 - PLAQUE PSORIASIS OF THE BODY

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.
ABProducts 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.
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