Generic Clarinex Availability
Clarinex is a brand name of desloratadine, approved by the FDA in the following formulation(s):
CLARINEX (desloratadine - solution;oral)
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Manufacturer: MERCK SHARP DOHME
Approval date: September 1, 2004
Strength(s): 0.5MG/ML [RLD] [AA]
CLARINEX (desloratadine - tablet, orally disintegrating;oral)
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Manufacturer: MERCK SHARP DOHME
Approval date: June 26, 2002
Strength(s): 5MG [RLD] [AB] -
Manufacturer: MERCK SHARP DOHME
Approval date: July 14, 2005
Strength(s): 2.5MG [RLD] [AB]
CLARINEX (desloratadine - tablet;oral)
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Manufacturer: MERCK SHARP DOHME
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 solution;oral
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Manufacturer: TARO PHARM
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
desloratadine tablet;oral
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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: Generic Drug FAQs.
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.
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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
- January 7, 2020✓
- July 7, 2019
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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✓
- December 1, 2018✓
- June 1, 2018
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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✓
- January 7, 2020✓
- July 7, 2019
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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✓✓
- June 19, 2021✓
- December 19, 2020
More about Clarinex (desloratadine)
- Side Effects
- During Pregnancy or Breastfeeding
- Dosage Information
- Drug Images
- Drug Interactions
- Support Group
- Pricing & Coupons
- En Español
- 5 Reviews – Add your own review/rating
- Generic Availability
- Drug class: antihistamines
Consumer resources
- Clarinex
- Clarinex (Desloratadine Syrup)
- Clarinex (Desloratadine Tablets)
- Clarinex (Advanced Reading)
Professional resources
Other Formulations
Related treatment guides
Glossary
Term | Definition |
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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. |
AA | Products 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. |
AB | Products 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. |