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Last Updated: August 8, 2020

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CLARINEX Drug Profile

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When do Clarinex patents expire, and when can generic versions of Clarinex launch?

Clarinex is a drug marketed by Merck Sharp Dohme and is included in five NDAs. There are seven patents protecting this drug and four Paragraph IV challenges.

This drug has seventy-three patent family members in thirty-seven countries.

The generic ingredient in CLARINEX is desloratadine; pseudoephedrine sulfate. There are sixteen drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the desloratadine; pseudoephedrine sulfate profile page.

US ANDA Litigation and Generic Entry Outlook for Clarinex

Clarinex was eligible for patent challenges on December 21, 2005.

There are four Paragraph IV patent challenges for this drug. This may lead to patent invalidation or a license for generic production.

Indicators of Generic Entry

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Summary for CLARINEX
Drug patent expirations by year for CLARINEX
Drug Prices for CLARINEX

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Drug Sales Revenue Trends for CLARINEX

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Recent Clinical Trials for CLARINEX

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Derm Research, PLLCPhase 4
UCB PharmaPhase 4
Dr. Reddy's Laboratories LimitedPhase 1

See all CLARINEX clinical trials

Pharmacology for CLARINEX
Paragraph IV (Patent) Challenges for CLARINEX
Tradename Dosage Ingredient NDA Submissiondate
CLARINEX SOLUTION;ORAL desloratadine 021300 2008-05-08
CLARINEX TABLET;ORAL desloratadine 021165 2006-06-21

US Patents and Regulatory Information for CLARINEX

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Merck Sharp Dohme CLARINEX desloratadine SOLUTION;ORAL 021300-001 Sep 1, 2004 AA RX Yes Yes   Start Trial   Start Trial   Start Trial
Merck Sharp Dohme CLARINEX desloratadine TABLET;ORAL 021165-001 Dec 21, 2001 AB RX Yes Yes   Start Trial   Start Trial   Start Trial
Merck Sharp Dohme CLARINEX desloratadine TABLET, ORALLY DISINTEGRATING;ORAL 021312-001 Jun 26, 2002 AB RX Yes Yes   Start Trial   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for CLARINEX

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Merck Sharp Dohme CLARINEX desloratadine TABLET, ORALLY DISINTEGRATING;ORAL 021312-002 Jul 14, 2005   Start Trial   Start Trial
Merck Sharp Dohme CLARINEX desloratadine TABLET, ORALLY DISINTEGRATING;ORAL 021312-002 Jul 14, 2005   Start Trial   Start Trial
Merck Sharp Dohme CLARINEX desloratadine TABLET;ORAL 021165-001 Dec 21, 2001   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Supplementary Protection Certificates for CLARINEX

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1110543 122008000001 Germany   Start Trial PRODUCT NAME: DESLORATADIN MIT PSEUDOEPHEDRIN ODER EINEM PHARMAZEUTISCH VERTRAEGLICHEN SALZ VON PSEUDOEPHEDRIN; REGISTRATION NO/DATE: EU/1/07/399/001-006 20070730
0152897 SPC/GB01/012 United Kingdom   Start Trial PRODUCT NAME: DESLORATADINE AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF; REGISTERED: UK EU/1/00/157/001-013 20010115; UK EU/1/00/158/001-013 20010115; UK EU/1/00/159/001-013 20010115; UK EU/1/00/160/001-013 20010115; UK EU/1/00/161/001-013 20010115
1110543 SPC/GB08/005 United Kingdom   Start Trial SUPPLEMENTARY PROTECTION CERTIFICATE NO SPC/GB08/005 GRANTED TO MERCK SHARP + DOHME CORP. IN RESPECT OF THE PRODUCT DESLORATADINE OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT, IN COMBINATION WITH PSEUDOEPHEDRINE OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT OR ESTER, THE GRANT OF WHICH WAS ADVERTISED IN JOURNAL NO 6322 DATED 21 JULY 2010 HAS HAD ITS MAXIMUM PERIOD OF DURATION CORRECTED, SUBJECT TO THE PAYMENT OF THE PRESCRIBED FEES IT WILL EXPIRE ON 31 JULY 2022.
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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