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 |
Recent Clinical Trials for CLARINEX-D 12 HOUR
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
J. Uriach and Company | Phase 1 |
Derm Research, PLLC | Phase 4 |
UCB Pharma | Phase 4 |
Pharmacology for CLARINEX-D 12 HOUR
Drug Class | Histamine-1 Receptor Antagonist alpha-Adrenergic Agonist |
Mechanism of Action | Adrenergic alpha-Agonists Histamine H1 Receptor Antagonists |
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
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 |