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Last Updated: September 25, 2021

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CLARINEX-D 12 HOUR Drug Patent Profile


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When do Clarinex-d 12 Hour patents expire, and what generic alternatives are available?

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: 17
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
Derm Research, PLLCPhase 4
UCB PharmaPhase 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

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 ⤷  Try it Free ⤷  Try it Free Y ⤷  Try it Free
Organon CLARINEX-D 12 HOUR desloratadine; pseudoephedrine sulfate TABLET, EXTENDED RELEASE;ORAL 021313-001 Feb 1, 2006 RX Yes Yes ⤷  Try it Free ⤷  Try it Free ⤷  Try it 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-D 12 HOUR

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Organon CLARINEX-D 12 HOUR desloratadine; pseudoephedrine sulfate TABLET, EXTENDED RELEASE;ORAL 021313-001 Feb 1, 2006 ⤷  Try it Free ⤷  Try it Free
Organon CLARINEX-D 12 HOUR desloratadine; pseudoephedrine sulfate TABLET, EXTENDED RELEASE;ORAL 021313-001 Feb 1, 2006 ⤷  Try it Free ⤷  Try it Free
Organon CLARINEX-D 12 HOUR desloratadine; pseudoephedrine sulfate TABLET, EXTENDED RELEASE;ORAL 021313-001 Feb 1, 2006 ⤷  Try it Free ⤷  Try it Free
Organon CLARINEX-D 12 HOUR desloratadine; pseudoephedrine sulfate TABLET, EXTENDED RELEASE;ORAL 021313-001 Feb 1, 2006 ⤷  Try it Free ⤷  Try it Free
Organon CLARINEX-D 12 HOUR desloratadine; pseudoephedrine sulfate TABLET, EXTENDED RELEASE;ORAL 021313-001 Feb 1, 2006 ⤷  Try it Free ⤷  Try it Free
Organon CLARINEX-D 12 HOUR desloratadine; pseudoephedrine sulfate TABLET, EXTENDED RELEASE;ORAL 021313-001 Feb 1, 2006 ⤷  Try it Free ⤷  Try it Free
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Supplementary Protection Certificates for CLARINEX-D 12 HOUR

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0152897 C00152897/01 Switzerland ⤷  Try it Free FORMER REPRESENTANTIVE: E. BLUM AND CO. PATENTANWAELTE, CH
1110543 SPC063/2007 Ireland ⤷  Try it Free SPC063/2007: 20081105, EXPIRES: 20220729
1110543 122008000001 Germany ⤷  Try it Free PRODUCT NAME: DESLORATADIN MIT PSEUDOEPHEDRIN ODER EINEM PHARMAZEUTISCH VERTRAEGLICHEN SALZ VON PSEUDOEPHEDRIN; REGISTRATION NO/DATE: EU/1/07/399/001-006 20070730
1110543 318 Finland ⤷  Try it Free
1110543 C 2008 001 Romania ⤷  Try it 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 SZ 1/2008 Austria ⤷  Try it Free PRODUCT NAME: DESLORATADIN, GEGEBENENFALLS IN FORM EINES PHARMAZEUTISCH ANNEHMBAREN SALZES, KOMBINIERT MIT PSEUDOEPHEDRIN, GEGEBENENFALLS IN FORM EINES PHARMAZEUTISCH ANNEHMBAREN SALZES ODER ESTERS
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Colorcon
McKesson
Merck
McKinsey
Dow
Boehringer Ingelheim

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