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Last Updated: November 22, 2024

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 Llc and is included in one NDA.

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.

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Summary for CLARINEX-D 12 HOUR
US Patents:0
Applicants:1
NDAs:1
Finished Product Suppliers / Packagers: 1
Raw Ingredient (Bulk) Api Vendors: 4
Clinical Trials: 19
Patent Applications: 6
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
J. Uriach and CompanyPhase 1
Derm Research, PLLCPhase 4
UCB PharmaPhase 4

See all CLARINEX-D 12 HOUR clinical trials

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

International Patents for CLARINEX-D 12 HOUR

See the table below for patents covering CLARINEX-D 12 HOUR around the world.

Country Patent Number Title Estimated Expiration
Germany 60028710 ⤷  Sign Up
Denmark 1674084 ⤷  Sign Up
China 101322708 ⤷  Sign Up
Israel 140451 EXTENDED RELEASE ORAL DOSAGE COMPOSITION ⤷  Sign Up
Germany 69535234 ⤷  Sign Up
Canada 1307791 COMPOSES 6,11-DIHYDRO-11-(4-PIPERIDYLIDENE)-5H- BENZO (5,6)CYCLOHEPTA(1,2-B)PYRIDINE (-6,11-DIHYDRO-11-(4-PIPERIDYLIDENE)-5H-BENZO[5,6]CYCLOHEPTA [1,2-B]PYRIDINE COMPOUNDS) ⤷  Sign Up
New Zealand 509034 Extended release oral bilayer dosage composition comprising a layer of desloratadine and a layer of pseudoephedrine ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

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 PRODUCT NAME: DESLORATADINE; REGISTRTION NO/DATE: EU/1/00/160/010 20010115
1110543 SPC063/2007 Ireland ⤷  Sign Up SPC063/2007: 20081105, EXPIRES: 20220729
1110543 SZ 1/2008 Austria ⤷  Sign Up PRODUCT NAME: DESLORATADIN, GEGEBENENFALLS IN FORM EINES PHARMAZEUTISCH ANNEHMBAREN SALZES, KOMBINIERT MIT PSEUDOEPHEDRIN, GEGEBENENFALLS IN FORM EINES PHARMAZEUTISCH ANNEHMBAREN SALZES ODER ESTERS
0152897 C00152897/01 Switzerland ⤷  Sign Up FORMER REPRESENTANTIVE: E. BLUM AND CO. PATENTANWAELTE, CH
1110543 SPC/GB08/005 United Kingdom ⤷  Sign Up 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.
1110543 CA 2008 00010 Denmark ⤷  Sign Up PRODUCT NAME: KOMBINATION OMFATTENDE DESLORATADIN OG PSEUDOEPHEDRIN, EVENTUELT I FORM AF ET FYSIOLOGISK ACCEPTABELT SALT IFOELGE NEDENSTAENDE GRUNDPATENT, HERUNDER PSEUDOEPHEDRIN SOM SULFAT
1110543 122008000001 Germany ⤷  Sign Up PRODUCT NAME: DESLORATADIN MIT PSEUDOEPHEDRIN ODER EINEM PHARMAZEUTISCH VERTRAEGLICHEN SALZ VON PSEUDOEPHEDRIN; REGISTRATION NO/DATE: EU/1/07/399/001-006 20070730
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.