Generic Clarinex-D 12 Hour Availability

Clarinex-D 12 Hour is a brand name of desloratadine/pseudoephedrine, approved by the FDA in the following formulation(s):

CLARINEX-D 12 HOUR (desloratadine; pseudoephedrine sulfate - tablet, extended release;oral)

Has a generic version of Clarinex-D 12 Hour been approved?

No. There is currently no therapeutically equivalent version of Clarinex-D 12 Hour available in the United States.

Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Clarinex-D 12 Hour. 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.

  • 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
    • January 7, 2020
      ✓ 
      Pediatric exclusivity
  • Extended release oral dosage composition
    Patent 6,709,676
    Issued: March 23, 2004
    Inventor(s): Wing-Kee Philip; Cho
    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:
    • February 18, 2021
      ✓ 
      Patent use: ALLERGIC RHINITIS
      ✓ 
      Drug product
  • 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
  • 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
  • Extended release oral dosage composition
    Patent 8,187,630
    Issued: May 29, 2012
    Inventor(s): Cho; Wing-Kee Philip
    Assignee(s): Schering-Plough 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

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.
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