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Generic Clarinex Availability

Last updated on Nov 9, 2021.

Clarinex is a brand name of desloratadine, approved by the FDA in the following formulation(s):

CLARINEX (desloratadine - solution;oral)

  • Manufacturer: MERCK SHARP DOHME
    Approval date: September 1, 2004
    Strength(s): 0.5MG/ML (discontinued) [RLD]

CLARINEX (desloratadine - tablet, orally disintegrating;oral)

  • Manufacturer: MERCK SHARP DOHME
    Approval date: June 26, 2002
    Strength(s): 5MG (discontinued) [RLD]
  • Manufacturer: MERCK SHARP DOHME
    Approval date: July 14, 2005
    Strength(s): 2.5MG (discontinued) [RLD]

CLARINEX (desloratadine - tablet;oral)

  • Manufacturer: ORGANON
    Approval date: December 21, 2001
    Strength(s): 5MG [RLD] [AB]

Has a generic version of Clarinex been approved?

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

desloratadine tablet;oral

  • Manufacturer: BELCHER PHARMS
    Approval date: April 19, 2012
    Strength(s): 5MG [AB]
  • Manufacturer: DR REDDYS LABS LTD
    Approval date: March 8, 2011
    Strength(s): 5MG [AB]
  • Manufacturer: LUPIN PHARMS
    Approval date: October 25, 2010
    Strength(s): 5MG [AB]
  • Manufacturer: ORBION PHARMS
    Approval date: February 19, 2010
    Strength(s): 5MG [AB]
  • Manufacturer: PERRIGO
    Approval date: December 22, 2011
    Strength(s): 5MG [AB]
  • Manufacturer: SANDOZ
    Approval date: December 3, 2010
    Strength(s): 5MG [AB]

Note: No generic formulation of the following products are available.

  • desloratadine - solution;oral
  • desloratadine - tablet, orally disintegrating;oral

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

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.

  • Extended release oral dosage composition
    Patent 7,618,649
    Issued: November 17, 2009
    Inventor(s): Cho; Wing-Kee Philip
    Assignee(s): Schering Corporation

    A bilayer solid composition comprising (a) an immediate release first layer comprising an anti-allergic effective amount of desloratadine and at least one pharmaceutically acceptable excipient and (b) a sustained release second layer comprising an effective amount of a nasal decongestant, e.g. pseudoephedrine sulfate and a pharmaceutically acceptable sustained release agent wherein the composition contains less than about 2% of desloratadine decomposition products is disclosed. A solid composition comprising an anti-allergic effective amount of desloratadine and at least one, and preferably two pharmaceutically acceptable antioxidants is also disclosed.

    Patent expiration dates:

    • June 19, 2021
      ✓ 
      Pediatric exclusivity

Glossary

Term Definition
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 (e.g. identical active ingredients, dosage form, and routes 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 (e.g. AB1, AB2, AB7). 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.

Further information

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

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