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 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.
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 |
Anatomical Therapeutic Chemical (ATC) Classes for CLARINEX-D 12 HOUR
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 |
---|---|---|---|
World Intellectual Property Organization (WIPO) | 9620708 | ⤷ Sign Up | |
Singapore | 149667 | EXTENDED RELEASE ORAL DOSAGE COMPOSITION | ⤷ Sign Up |
Finland | 972781 | ⤷ Sign Up | |
Slovakia | 19662000 | ZLISOVANí DVOJVRSTVOVí PEVNí PROSTRIEDOK (MOULDED TWO-LAYERED SOLID COMPOSITION) | ⤷ Sign Up |
Japan | S61501205 | ⤷ Sign Up | |
Australia | 570306 | ⤷ Sign Up | |
Hungary | T38332 | ⤷ 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 | 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 | 08C0004 | France | ⤷ Sign Up | PRODUCT NAME: DESLORATADINE; PSEUDOEPHEDRINE SULFATE; REGISTRATION NO/DATE: EU/1/07/399/001 20070730 |
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 |
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 |
0152897 | C00152897/01 | Switzerland | ⤷ Sign Up | FORMER REPRESENTANTIVE: E. BLUM AND CO. PATENTANWAELTE, CH |
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 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |