DrugPatentWatch Database Preview
CLARINEX Drug Profile
» See Plans and Pricing
When do Clarinex patents expire, and when can generic versions of Clarinex launch?
Clarinex is a drug marketed by Merck Sharp Dohme and is included in five NDAs. There are seven patents protecting this drug and four Paragraph IV challenges.
This drug has seventy-three patent family members in thirty-seven countries.
The generic ingredient in CLARINEX 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.
US ANDA Litigation and Generic Entry Outlook for Clarinex
Clarinex was eligible for patent challenges on December 21, 2005.
There are four Paragraph IV patent challenges for this drug. This may lead to patent invalidation or a license for generic production.
Indicators of Generic Entry
Summary for CLARINEX
| International Patents: | 73 |
| US Patents: | 3 |
| Applicants: | 1 |
| NDAs: | 5 |
| Suppliers / Packagers: | 1 |
| Bulk Api Vendors: | 104 |
| Clinical Trials: | 17 |
| Patent Applications: | 4,106 |
| Drug Prices: | Drug price information for CLARINEX |
| DailyMed Link: | CLARINEX at DailyMed |
Recent Clinical Trials for CLARINEX
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Derm Research, PLLC | Phase 4 |
| UCB Pharma | Phase 4 |
| Dr. Reddy's Laboratories Limited | Phase 1 |
Pharmacology for CLARINEX
| Drug Class | Histamine-1 Receptor Antagonist |
| Mechanism of Action | Histamine H1 Receptor Antagonists |
Paragraph IV (Patent) Challenges for CLARINEX
| 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 CLARINEX
| 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 | desloratadine | SOLUTION;ORAL | 021300-001 | Sep 1, 2004 | AA | RX | Yes | Yes | Start Trial | Start Trial | 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 | desloratadine | TABLET, ORALLY DISINTEGRATING;ORAL | 021312-001 | Jun 26, 2002 | AB | RX | Yes | Yes | Start Trial | Start Trial | 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 CLARINEX
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| 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 | 021312-002 | Jul 14, 2005 | Start Trial | Start Trial |
| Merck Sharp Dohme | CLARINEX | desloratadine | TABLET;ORAL | 021165-001 | Dec 21, 2001 | Start Trial | Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for CLARINEX
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Japan | H0631220 | Start Trial |
| Germany | 10199025 | Start Trial |
| World Intellectual Property Organization (WIPO) | 0145676 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for CLARINEX
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 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 |
| 0152897 | SPC/GB01/012 | United Kingdom | Start Trial | 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 | 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. |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
