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 |
| UCB Pharma | Phase 4 |
| Derm Research, PLLC | 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 |
|---|---|---|---|
| European Patent Office | 1078633 | ⤷ Sign Up | |
| World Intellectual Property Organization (WIPO) | 9620708 | ⤷ Sign Up | |
| Singapore | 183573 | DESLORATADINE SOLID DOSAGE COMPOSITIONS | ⤷ Sign Up |
| Spain | 8800679 | ⤷ Sign Up | |
| New Zealand | 509034 | Extended release oral bilayer dosage composition comprising a layer of desloratadine and a layer of pseudoephedrine | ⤷ Sign Up |
| Finland | 87648 | ⤷ Sign Up | |
| Norway | 973023 | ⤷ 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 |
|---|---|---|---|---|
| 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 |
| 1110543 | 318 | Finland | ⤷ Sign Up | |
| 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 |
| 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 | C 2008 001 | Romania | ⤷ Sign Up | 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 | SPC063/2007 | Ireland | ⤷ Sign Up | SPC063/2007: 20081105, EXPIRES: 20220729 |
| 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 |
| >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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