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Desloratadine - Generic Drug Details
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What are the generic drug sources for desloratadine and what is the scope of freedom to operate?
Desloratadine
is the generic ingredient in five branded drugs marketed by Merck Sharp Dohme, Taro, Taro Pharm Inds Ltd, Reddys, Belcher Pharms, Dr Reddys Labs Ltd, Lupin Pharms, Mylan Pharms Inc, Orchid Hlthcare, Perrigo, Sandoz, and Sun Pharm Inds, and is included in seventeen NDAs. There are seven patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.Desloratadine has seventy-three patent family members in thirty-seven countries.
There are sixteen drug master file entries for desloratadine. Seven suppliers are listed for this compound. There are two tentative approvals for this compound.
Summary for desloratadine
International Patents: | 73 |
US Patents: | 7 |
Tradenames: | 5 |
Applicants: | 12 |
NDAs: | 17 |
Drug Master File Entries: | 16 |
Suppliers / Packagers: | 7 |
Bulk Api Vendors: | 112 |
Clinical Trials: | 63 |
Patent Applications: | 6,741 |
Drug Prices: | Drug price trends for desloratadine |
What excipients (inactive ingredients) are in desloratadine? | desloratadine excipients list |
DailyMed Link: | desloratadine at DailyMed |
Recent Clinical Trials for desloratadine
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Xiangya Hospital of Central South University | Phase 1/Phase 2 |
National Institute of Allergy and Infectious Diseases (NIAID) | Phase 4 |
Johns Hopkins University | Phase 4 |
Generic filers with tentative approvals for DESLORATADINE
Applicant | Application No. | Strength | Dosage Form |
Start Trial | Start Trial | 5MG | TABLET; ORAL |
Start Trial | Start Trial | 5MG | TABLET; ORAL |
The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.
Pharmacology for desloratadine
Drug Class | Histamine-1 Receptor Antagonist |
Mechanism of Action | Histamine H1 Receptor Antagonists |
Paragraph IV (Patent) Challenges for DESLORATADINE
Tradename | Dosage | Ingredient | NDA | Submissiondate |
---|---|---|---|---|
CLARINEX | SOLUTION;ORAL | desloratadine | 021300 | 2008-05-08 |
CLARINEX | TABLET;ORAL | desloratadine | 021165 | 2006-06-21 |
US Patents and Regulatory Information for desloratadine
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Merck Sharp Dohme | CLARINEX D 24 HOUR | desloratadine; pseudoephedrine sulfate | TABLET, EXTENDED RELEASE;ORAL | 021605-001 | Mar 3, 2005 | DISCN | Yes | No | Start Trial | Start Trial | Start Trial | ||||
Dr Reddys Labs Ltd | DESLORATADINE | desloratadine | TABLET;ORAL | 078365-001 | Mar 8, 2011 | AB | RX | No | No | Start Trial | Start Trial | Start Trial | |||
Mylan Pharms Inc | DESLORATADINE | desloratadine | TABLET;ORAL | 078351-001 | Feb 10, 2012 | DISCN | No | No | Start Trial | Start Trial | Start Trial | ||||
Merck Sharp Dohme | CLARINEX D 24 HOUR | desloratadine; pseudoephedrine sulfate | TABLET, EXTENDED RELEASE;ORAL | 021605-001 | Mar 3, 2005 | DISCN | Yes | No | Start Trial | Start Trial | Y | Start Trial | |||
Merck Sharp Dohme | CLARINEX | desloratadine | TABLET;ORAL | 021165-001 | Dec 21, 2001 | AB | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | |||
Merck Sharp Dohme | CLARINEX-D 12 HOUR | desloratadine; pseudoephedrine sulfate | TABLET, EXTENDED RELEASE;ORAL | 021313-001 | Feb 1, 2006 | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | |||
>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 desloratadine
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Merck Sharp Dohme | CLARINEX | desloratadine | TABLET, ORALLY DISINTEGRATING;ORAL | 021312-001 | Jun 26, 2002 | Start Trial | Start Trial |
Merck Sharp Dohme | CLARINEX | desloratadine | TABLET;ORAL | 021165-001 | Dec 21, 2001 | Start Trial | Start Trial |
Merck Sharp Dohme | CLARINEX | desloratadine | TABLET;ORAL | 021165-001 | Dec 21, 2001 | Start Trial | Start Trial |
Merck Sharp Dohme | CLARINEX | desloratadine | TABLET, ORALLY DISINTEGRATING;ORAL | 021312-001 | Jun 26, 2002 | Start Trial | Start Trial |
Merck Sharp Dohme | CLARINEX | desloratadine | TABLET, ORALLY DISINTEGRATING;ORAL | 021312-002 | Jul 14, 2005 | Start Trial | Start Trial |
Merck Sharp Dohme | CLARINEX | desloratadine | TABLET, ORALLY DISINTEGRATING;ORAL | 021312-001 | Jun 26, 2002 | Start Trial | Start Trial |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for desloratadine
Country | Patent Number | Estimated Expiration |
---|---|---|
China | 100415223 | Start Trial |
Austria | 329584 | Start Trial |
Germany | 122008000001 | Start Trial |
Hungary | 0004989 | Start Trial |
Australia | 2276801 | Start Trial |
Hong Kong | 1034452 | Start Trial |
>Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for desloratadine
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
1110543 | C 2008 001 | Romania | Start Trial | 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 | 2001C/013 | Belgium | Start Trial | PRODUCT NAME: DESLORATADINE; REGISTRTION NO/DATE: EU/1/00/160/010 20010115 |
1110543 | 122008000001 | Germany | Start Trial | PRODUCT NAME: DESLORATADIN MIT PSEUDOEPHEDRIN ODER EINEM PHARMAZEUTISCH VERTRAEGLICHEN SALZ VON PSEUDOEPHEDRIN; REGISTRATION NO/DATE: EU/1/07/399/001-006 20070730 |
1110543 | SZ 1/2008 | Austria | Start Trial | PRODUCT NAME: DESLORATADIN, GEGEBENENFALLS IN FORM EINES PHARMAZEUTISCH ANNEHMBAREN SALZES, KOMBINIERT MIT PSEUDOEPHEDRIN, GEGEBENENFALLS IN FORM EINES PHARMAZEUTISCH ANNEHMBAREN SALZES ODER ESTERS |
1110543 | SPC/GB08/005 | United Kingdom | Start Trial | 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 | Start Trial | PRODUCT NAME: DESLORATADINE; PSEUDOEPHEDRINE SULFATE; REGISTRATION NO/DATE: EU/1/07/399/001 20070730 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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