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Last Updated: June 25, 2021

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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 four patents protecting this drug and two Paragraph IV challenges.

This drug has sixty-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.

DrugPatentWatch® Generic Entry Outlook for Clarinex

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

There are two 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
International Patents:63
US Patents:1
Applicants:1
NDAs:5
Finished Product Suppliers / Packagers: 2
Raw Ingredient (Bulk) Api Vendors: 115
Clinical Trials: 17
Patent Applications: 3,982
Drug Prices: Drug price information for CLARINEX
What excipients (inactive ingredients) are in CLARINEX?CLARINEX excipients list
DailyMed Link:CLARINEX at DailyMed
Drug patent expirations by year for CLARINEX
Drug Prices for CLARINEX

See drug prices for CLARINEX

Drug Sales Revenue Trends for CLARINEX

See drug sales revenues for CLARINEX

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 DISCN Yes No   Get Started Free   Get Started Free   Get Started Free
Merck Sharp Dohme CLARINEX D 24 HOUR desloratadine; pseudoephedrine sulfate TABLET, EXTENDED RELEASE;ORAL 021605-001 Mar 3, 2005 DISCN Yes No   Get Started Free   Get Started Free Y   Get Started Free
Merck Sharp Dohme CLARINEX desloratadine TABLET;ORAL 021165-001 Dec 21, 2001 AB RX Yes Yes   Get Started Free   Get Started Free   Get Started Free
Merck Sharp Dohme CLARINEX-D 12 HOUR desloratadine; pseudoephedrine sulfate TABLET, EXTENDED RELEASE;ORAL 021313-001 Feb 1, 2006 RX Yes Yes   Get Started Free   Get Started Free Y   Get Started Free
Merck Sharp Dohme CLARINEX desloratadine TABLET, ORALLY DISINTEGRATING;ORAL 021312-002 Jul 14, 2005 DISCN Yes No   Get Started Free   Get Started Free   Get Started Free
Merck Sharp Dohme CLARINEX desloratadine TABLET, ORALLY DISINTEGRATING;ORAL 021312-001 Jun 26, 2002 DISCN Yes No   Get Started Free   Get Started Free   Get Started Free
>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 SOLUTION;ORAL 021300-001 Sep 1, 2004   Get Started Free   Get Started Free
Merck Sharp Dohme CLARINEX desloratadine TABLET, ORALLY DISINTEGRATING;ORAL 021312-001 Jun 26, 2002   Get Started Free   Get Started Free
Merck Sharp Dohme CLARINEX desloratadine TABLET, ORALLY DISINTEGRATING;ORAL 021312-001 Jun 26, 2002   Get Started Free   Get Started Free
Merck Sharp Dohme CLARINEX desloratadine TABLET, ORALLY DISINTEGRATING;ORAL 021312-001 Jun 26, 2002   Get Started Free   Get Started Free
Merck Sharp Dohme CLARINEX desloratadine TABLET, ORALLY DISINTEGRATING;ORAL 021312-001 Jun 26, 2002   Get Started Free   Get Started Free
Merck Sharp Dohme CLARINEX desloratadine TABLET, ORALLY DISINTEGRATING;ORAL 021312-002 Jul 14, 2005   Get Started Free   Get Started Free
>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
0152897 2001C/013 Belgium   Get Started Free PRODUCT NAME: DESLORATADINE; REGISTRTION NO/DATE: EU/1/00/160/010 20010115
0152897 C00152897/01 Switzerland   Get Started Free FORMER REPRESENTANTIVE: E. BLUM AND CO. PATENTANWAELTE, CH
1110543 318 Finland   Get Started Free
1110543 122008000001 Germany   Get Started Free PRODUCT NAME: DESLORATADIN MIT PSEUDOEPHEDRIN ODER EINEM PHARMAZEUTISCH VERTRAEGLICHEN SALZ VON PSEUDOEPHEDRIN; REGISTRATION NO/DATE: EU/1/07/399/001-006 20070730
1110543 C 2008 001 Romania   Get Started Free PRODUCT NAME: COMBINATIE DE DESLORATADINA, OPTIONAL SUB FORMA DE SAREACCEPTABILA FARMACEUTIC SI PSEUDOEFEDRINA OPTIONAL SUB FORMA DE SARE SAU ESTER ACCEPTABILEFARMACEUTIC; NATIONAL AUTHORISATION NUMBER: RO EU/1/07/399/001, RO EU/1/07/399/002, RO EU/1/07/399/003, RO EU/1/07/399/004, RO EU/1/07/399/005, RO EU/1/07/399/006; DATE OF NATIONAL AUTHORISATION: 20070730; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/07/399/001, EU/1/07/399/002, EU/1/07/399/003, EU/1/07/399/004, EU/1/07/399/005, EU/1/07/399/006; DATE OF FIRST AUTHORISATION IN EEA: 20070730
1110543 CA 2008 00010 Denmark   Get Started Free PRODUCT NAME: KOMBINATION OMFATTENDE DESLORATADIN OG PSEUDOEPHEDRIN, EVENTUELT I FORM AF ET FYSIOLOGISK ACCEPTABELT SALT IFOELGE NEDENSTAENDE GRUNDPATENT, HERUNDER PSEUDOEPHEDRIN SOM SULFAT
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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