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 |
| 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 |
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 |
|---|---|---|---|
| Portugal | 82570 | PROCESSO PARA PREPARAR PIPERIDILIDENO DI-HIDRODIBENZO {A,D} CICLO HEPTENOS E SEUS DERIVADOS AZA | ⤷ Sign Up |
| World Intellectual Property Organization (WIPO) | 0145676 | ⤷ Sign Up | |
| Mexico | 9704793 | METODOS Y COMPOSICIONES PARA TRATAR RINITIS ALERGICA Y OTROS TRASTORNOS USANDO DESCARBOETOXILORATADINA. (METHODS AND COMPOSITIONS FOR TREATING ALLERGIC RHINITIS AND OTHER DISORDERS USING DESCARBOETHOXYLORATADINE.) | ⤷ Sign Up |
| Hong Kong | 1034452 | ⤷ Sign Up | |
| Japan | 4237822 | ⤷ Sign Up | |
| Canada | 1272480 | PROCEDE DE PREPARATION DE DIHYDRO-DIBENZO (A,D) CYCLOHEPTENES DE PIPERIDYLIDENE ET DE LEURS DERIVES AZA, COMPOSES OBTENUS PAR UN TEL PROCEDE ET UTILISATION DE CES COMPOSES POURPREPARER DES COMPOSITIONS PHARMACEUTIQUES ACTIVES (PROCESS FOR PREPARING PIPERIDYLIDENE DIHYDRO- DIBENZO[A,D,]CYCLOHEPTENES AND AZA DERIVATIVES THEREOF, COMPOUNDS OBTAINED BY SUCH PROCESS AND THE USE OF SUCH COMPOUNDS FOR PREPARING USEFUL PHARMACEUTICAL, COMPOSITIONS) | ⤷ 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 | SPC/GB01/012 | United Kingdom | ⤷ Sign Up | 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 |
| 0152897 | 2001C/013 | Belgium | ⤷ Sign Up | PRODUCT NAME: DESLORATADINE; REGISTRTION NO/DATE: EU/1/00/160/010 20010115 |
| 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 |
| 1110543 | 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; REGISTRATION NO/DATE: EU/1/07/399/001-006 20070730 |
| 1110543 | SPC063/2007 | Ireland | ⤷ Sign Up | SPC063/2007: 20081105, EXPIRES: 20220729 |
| 1110543 | 318 | Finland | ⤷ Sign Up | |
| >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.
ISSN: 2162-2639
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