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Generic Clarinex Availability

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

CLARINEX (desloratadine - solution;oral)

CLARINEX (desloratadine - tablet, orally disintegrating;oral)

CLARINEX (desloratadine - tablet;oral)

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 solution;oral

  • Manufacturer: TARO
    Approval date: May 26, 2016
    Strength(s): 0.5MG/ML [AA]
  • Manufacturer: TARO PHARM INDS
    Approval date: June 30, 2015
    Strength(s): 0.5MG/ML [AA]

desloratadine tablet, orally disintegrating;oral

  • Manufacturer: REDDYS
    Approval date: July 12, 2010
    Strength(s): 2.5MG [AB], 5MG [AB]

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: MYLAN PHARMS INC
    Approval date: February 10, 2012
    Strength(s): 5MG [AB]
  • Manufacturer: ORCHID HLTHCARE
    Approval date: February 19, 2010
    Strength(s): 5MG [AB]
  • Manufacturer: PERRIGO R AND D
    Approval date: December 22, 2011
    Strength(s): 5MG [AB]
  • Manufacturer: SANDOZ
    Approval date: December 3, 2010
    Strength(s): 5MG [AB]
  • Manufacturer: SUN PHARM INDS
    Approval date: November 16, 2010
    Strength(s): 5MG [AB]

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: 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.

  • Taste masking microparticles for oral dosage forms
    Patent 5,607,697
    Issued: March 4, 1997
    Inventor(s): Alkire; Todd G. & Sanftleben; Ronald A. & Schuehle; Steven S.
    Assignee(s): Cima Labs, Incorporated
    The present invention relates to a solid dosage form including a new type of taste masking microparticle having an adsorbate of, for example, mannitol, in the core thereof.
    Patent expiration dates:
    • December 7, 2015
      ✓ 
      Pediatric exclusivity
  • 8-chloro-6,11-dihydro-11- ] (4-piperidylidine)-5H-benzo[5,6]cyclohepta[1,2-bpyridine oral compositions
    Patent 6,100,274
    Issued: August 8, 2000
    Inventor(s): Kou; Jim H.
    Assignee(s): Schering Corporation
    Stable pharmaceutical compositions containing 8-chloro-6,11-dihydro-11-(4-piperidylidene)-5H-benzo[5,6]cycloheptic[1,2-b ]pyridine("DCL") and a DCL protective amount of a pharmaceutically acceptable basic salt such as calcium dibasic phosphate and an amount of at least one disintegrant, preferably two disintegrates such as microcrystalline cellulose and starch sufficient to provide dissolution of at least about 80% by weight of the pharmaceutical composition in about 45 minutes and suitable for oral administration to treat allergic reactions in mammals such as man are disclosed.
    Patent expiration dates:
    • July 7, 2019
      ✓ 
      Drug product
    • July 7, 2019
    • January 7, 2020
      ✓ 
      Pediatric exclusivity
  • Stabilized antihistamine syrup
    Patent 6,514,520
    Issued: February 4, 2003
    Inventor(s): Farah J.; Munayyer & Frank; Guazzo & Elliot I.; Stupak & Imtiaz A.; Chaudry & Joel A.; Sequeira
    Assignee(s): Schering Corporation
    An antihistaminic syrup is stabilized against degradation of the active ingredient, by the addition of and about 0.05 to about 5 mg/mL of an aminopolycarboxylic acid such as a salt of ethylenediaminetetraacetic acid.
    Patent expiration dates:
    • June 1, 2018
      ✓ 
      Drug product
    • December 1, 2018
      ✓ 
      Pediatric exclusivity
  • Treating allergic and inflammatory conditions
    Patent 7,405,223
    Issued: July 29, 2008
    Inventor(s): Affrime; Melton B. & Banfield; Christopher R. & Gupta; Samir K. & Padhi; Desmond
    Assignee(s): Schering Corporation
    A method of treating and/or preventing allergic and inflammatory conditions of the skin or upper and lower airway passages, e.g. seasonal allergic rhinitis, perennial allergic rhinitis, or chronic idopathic urticaria, in a human more 12 years old, by administering an amount of desloratadine, e.g. 2×2.5 mg or 5 mg/day for a time sufficient to produce a geometric mean steady state maximum plasma concentration of desloratadine in the range of about 2.90 ng/mL to about 4.54 ng/mL, or a arithmetic mean steady state maximum plasma concentration of desloratadine in the range of about 3.2 ng/mL to about 5.0 ng/mL is disclosed.
    Patent expiration dates:
    • July 7, 2019
      ✓ 
      Patent use: ADMINISTERING DESLORATADINE TO TREAT THE SYMPTOMS OF PERENNIAL ALLERGIC RHINITIS, SEASONAL ALLERGIC RHINITIS, OR CHRONIC IDIOPATHIC URTICARIA
    • January 7, 2020
      ✓ 
      Pediatric exclusivity
  • 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:
    • December 19, 2020
      ✓ 
      Patent use: A METHOD OF TREATING NASAL AND NON-NASAL SYMPTOMS OF SEASONAL ALLERGIC RHINITIS
      ✓ 
      Drug product
    • June 19, 2021
      ✓ 
      Pediatric exclusivity
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More about Clarinex (desloratadine)

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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.
AAProducts in conventional dosage forms not presenting bioequivalence problems. Products coded as AA contain active ingredients and dosage forms that are not regarded as presenting either actual or potential bioequivalence problems or drug quality or standards issues. However, all oral dosage forms must, nonetheless, meet an appropriate in vitro bioequivalence standard that is acceptable to the Agency in order to be approved.
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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