Friday, September 23, 2016

Clarinex


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


CLARINEX (desloratadine - syrup; oral)



  • Manufacturer: SCHERING

    Approval date: September 1, 2004

    Strength(s): 0.5MG/ML [RLD]

CLARINEX (desloratadine - tablet, orally disintegrating; oral)



  • Manufacturer: SCHERING

    Approval date: June 26, 2002

    Strength(s): 5MG [RLD][AB]


  • Manufacturer: SCHERING

    Approval date: July 14, 2005

    Strength(s): 2.5MG [AB]

CLARINEX (desloratadine - tablet; oral)



  • Manufacturer: SCHERING PLOUGH

    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, orally disintegrating; oral



  • Manufacturer: REDDYS

    Approval date: July 12, 2010

    Strength(s): 2.5MG [AB], 5MG [AB]

desloratadine tablet; oral



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


  • desloratadine - syrup; 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: 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:

    • June 7, 2015
      ✓ 
      Drug product


    • 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


    • July 7, 2019
      ✓ 
      Drug product


    • 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




  • Methods for treating urticaria using descarboethoxyloratadine
    Patent 7,211,582
    Issued: May 1, 2007
    Inventor(s): Aberg; A. K. Gunnar & McCullough; John R. & Smith; Emil R.
    Assignee(s): Sepracor Inc.
    Methods are disclosed utilizing DCL, a metabolic derivative of loratadine, for the treatment of allergic rhinitis, and other disorders, while avoiding the concomitant liability of adverse side-effects associated with other non-sedating antihistamines.
    Patent expiration dates:

    • December 30, 2014
      ✓ 
      Patent use: TREATMENT OF CHRONIC IDIOPATHIC URTICARIA


    • June 30, 2015
      ✓ 
      Pediatric exclusivity




  • Compositions of descarboethoxyloratadine
    Patent 7,214,683
    Issued: May 8, 2007
    Inventor(s): Aberg; A. K. Gunnar & McCullough; John R. & Smith; Emil R.
    Assignee(s): Sepracor Inc.
    Methods are disclosed utilizing DCL, a metabolic derivative of loratadine, for the treatment of allergic rhinitis, and other disorders, while avoiding the concomitant liability of adverse side-effects associated with other non-sedating antihistamines.
    Patent expiration dates:

    • December 30, 2014
      ✓ 
      Drug product


    • June 30, 2015
      ✓ 
      Pediatric exclusivity




  • Methods for the treatment of allergic rhinitis
    Patent 7,214,684
    Issued: May 8, 2007
    Inventor(s): Aberg; A. K. Gunnar & McCullough; John R. & Smith; Emil R.
    Assignee(s): Sepracor Inc.
    Methods are disclosed utilizing DCL, a metabolic derivative of loratadine, for the treatment of allergic rhinitis, and other disorders, while avoiding the concomitant liability of adverse side-effects associated with other non-sedating antihistamines.
    Patent expiration dates:

    • December 30, 2014
      ✓ 
      Patent use: TREATMENT OF ALLERGIC RHINITIS


    • June 30, 2015
      ✓ 
      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



See also...

  • Clarinex Consumer Information (Drugs.com)
  • Clarinex Consumer Information (Wolters Kluwer)
  • Clarinex Syrup Consumer Information (Wolters Kluwer)
  • Clarinex Consumer Information (Cerner Multum)
  • Clarinex Advanced Consumer Information (Micromedex)
  • Clarinex AHFS DI Monographs (ASHP)
  • Desloratadine Consumer Information (Wolters Kluwer)
  • Desloratadine Orally Disintegrating Tablets Consumer Information (Wolters Kluwer)
  • Desloratadine Syrup Consumer Information (Wolters Kluwer)
  • Desloratadine Consumer Information (Cerner Multum)
  • Desloratadine Advanced Consumer Information (Micromedex)
  • Desloratadine AHFS DI Monographs (ASHP)

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