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Last Updated: January 24, 2022

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CLARINEX-D 12 HOUR Drug Patent Profile


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When do Clarinex-d 12 Hour patents expire, and when can generic versions of Clarinex-d 12 Hour launch?

Clarinex-d 12 Hour is a drug marketed by Organon and is included in one NDA. There are two 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-D 12 HOUR 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-d 12 Hour

Clarinex-d 12 Hour 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-D 12 HOUR
International Patents:63
US Patents:2
Applicants:1
NDAs:1
Finished Product Suppliers / Packagers: 1
Raw Ingredient (Bulk) Api Vendors: 1
Clinical Trials: 18
Formulation / Manufacturing:see details
What excipients (inactive ingredients) are in CLARINEX-D 12 HOUR?CLARINEX-D 12 HOUR excipients list
DailyMed Link:CLARINEX-D 12 HOUR at DailyMed
Drug patent expirations by year for CLARINEX-D 12 HOUR
Recent Clinical Trials for CLARINEX-D 12 HOUR

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

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

See all CLARINEX-D 12 HOUR clinical trials

Paragraph IV (Patent) Challenges for CLARINEX-D 12 HOUR
Tradename Dosage Ingredient NDA Submissiondate
CLARINEX-D 12 HOUR TABLET, EXTENDED RELEASE;ORAL desloratadine; pseudoephedrine sulfate 021313 2007-06-01
CLARINEX-D 12 HOUR TABLET, EXTENDED RELEASE;ORAL desloratadine; pseudoephedrine sulfate 021313 2006-06-21

US Patents and Regulatory Information for CLARINEX-D 12 HOUR

CLARINEX-D 12 HOUR is protected by one US patents.

Patents protecting CLARINEX-D 12 HOUR

Extended release oral dosage composition
Patent Number: ⤷  Sign up for a Free Trial
Patent Expiration: ⤷  Sign up for a Free Trial
Patented Use: ALLERGIC RHINITIS

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Organon CLARINEX-D 12 HOUR desloratadine; pseudoephedrine sulfate TABLET, EXTENDED RELEASE;ORAL 021313-001 Feb 1, 2006 RX Yes Yes ⤷  Sign up for a Free Trial ⤷  Sign up for a Free Trial Y ⤷  Sign up for a Free Trial
Organon CLARINEX-D 12 HOUR desloratadine; pseudoephedrine sulfate TABLET, EXTENDED RELEASE;ORAL 021313-001 Feb 1, 2006 RX Yes Yes ⤷  Sign up for a Free Trial ⤷  Sign up for a Free Trial ⤷  Sign up for a Free 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-D 12 HOUR

Supplementary Protection Certificates for CLARINEX-D 12 HOUR

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0152897 2001C/013 Belgium ⤷  Sign up for a Free Trial PRODUCT NAME: DESLORATADINE; REGISTRTION NO/DATE: EU/1/00/160/010 20010115
1110543 300328 Netherlands ⤷  Sign up for a Free Trial
0152897 SPC/GB01/012 United Kingdom ⤷  Sign up for a Free 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 C 2008 001 Romania ⤷  Sign up for a Free Trial 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 ⤷  Sign up for a Free Trial 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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