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Generated: June 24, 2017
Which patents cover Clarinex, and what generic Clarinex alternatives are available?
Clarinex is a drug marketed by Merck Sharp Dohme and is included in five NDAs. There are eight patents protecting this drug and four Paragraph IV challenges.| Patents: | 4 |
| Applicants: | 1 |
| NDAs: | 5 |
| Suppliers / Packagers: see list | 1 |
| Bulk Api Vendors: see list | 75 |
| Clinical Trials: see list | 17 |
| Patent Applications: see list | 3,439 |
| Drug Prices: | see details |
| DailyMed Link: | CLARINEX at DailyMed |
| Drug Class | Histamine-1 Receptor Antagonist |
| Mechanism of Action | Histamine H1 Receptor Antagonists |
| 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 | 6,514,520*PED | ► Subscribe | Y | ► Subscribe | ||||||||||||||||
Merck Sharp Dohme | CLARINEX | desloratadine | TABLET;ORAL | 021165-001 | Dec 21, 2001 | AB | RX | Yes | Yes | 7,405,223*PED | ► Subscribe | Y | ► Subscribe | ||||||||||||||||
Merck Sharp Dohme | CLARINEX | desloratadine | TABLET, ORALLY DISINTEGRATING;ORAL | 021312-001 | Jun 26, 2002 | AB | RX | Yes | Yes | 6,100,274*PED | ► Subscribe | Y | ► Subscribe | ||||||||||||||||
Merck Sharp Dohme | CLARINEX-D 12 HOUR | desloratadine; pseudoephedrine sulfate | TABLET, EXTENDED RELEASE;ORAL | 021313-001 | Feb 1, 2006 | RX | Yes | Yes | 8,187,630 | ► Subscribe | Y | ► Subscribe | |||||||||||||||||
Merck Sharp Dohme | CLARINEX D 24 HOUR | desloratadine; pseudoephedrine sulfate | TABLET, EXTENDED RELEASE;ORAL | 021605-001 | Mar 3, 2005 | AB | RX | Yes | Yes | 6,979,463 | ► Subscribe | Y | ► Subscribe | ||||||||||||||||
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| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration | ||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Merck Sharp Dohme | CLARINEX | desloratadine | SOLUTION;ORAL | 021300-001 | Sep 1, 2004 | 7,214,684*PED | ► Subscribe | ||||||||||||||||||||||
Merck Sharp Dohme | CLARINEX | desloratadine | TABLET, ORALLY DISINTEGRATING;ORAL | 021312-001 | Jun 26, 2002 | 5,607,697*PED | ► Subscribe | ||||||||||||||||||||||
Merck Sharp Dohme | CLARINEX | desloratadine | TABLET, ORALLY DISINTEGRATING;ORAL | 021312-001 | Jun 26, 2002 | 5,595,997*PED | ► Subscribe | ||||||||||||||||||||||
Merck Sharp Dohme | CLARINEX | desloratadine | TABLET, ORALLY DISINTEGRATING;ORAL | 021312-001 | Jun 26, 2002 | 7,211,582*PED | ► Subscribe | ||||||||||||||||||||||
Merck Sharp Dohme | CLARINEX | desloratadine | TABLET, ORALLY DISINTEGRATING;ORAL | 021312-002 | Jul 14, 2005 | 5,178,878*PED | ► Subscribe | ||||||||||||||||||||||
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| Drugname | Dosage | Strength | RLD | Submissiondate |
|---|---|---|---|---|
| desloratadine | Oral Solution | 0.5 mg/mL | Clarinex Syrup | 5/8/2008 |
| desloratadine | Tablets | 5 mg | Clarinex | 6/21/2006 |
| desloratadine | Orally Disintegrating Tablets | 2.5 mg and 5 mg | Clarinex | 6/21/2006 |
| desloratadine and pseudoephedrine sulfate | Extended-release Tablets | 5mg/240mg | Clarinex-D 24 Hour | 6/21/2006 |
For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.
The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.
| Patent No. | Title | Estimated Patent Expiration | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 6,132,758 | Stabilized antihistamine syrup | ► Subscribe | |||||||||||||||||||||||||||
| 6,939,550 | Stabilized antihistamine syrup | ► Subscribe | |||||||||||||||||||||||||||
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.
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| Country | Document Number | Estimated Expiration | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Egypt | 23908 | ► Subscribe | |||||||||||||||||||||||||||
| Gulf Cooperation Council | 0000330 | ► Subscribe | |||||||||||||||||||||||||||
| Colombia | 5011119 | ► Subscribe | |||||||||||||||||||||||||||
| Malaysia | 123325 | ► Subscribe | |||||||||||||||||||||||||||
| Japan | 2002516860 | ► Subscribe | |||||||||||||||||||||||||||
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws,
it is advisable to have patent counsel verify freedom to operate.
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| Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description | ||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 01C/013 | Belgium | ► Subscribe | PRODUCT NAME: DESLORATADINE; REGISTRTION NO/DATE: EU/1/00/160/010 20010115 | ||||||||||||||||||||||||||
| C/GB01/012 | United Kingdom | ► Subscribe | 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 | ||||||||||||||||||||||||||
| C/GB08/005 | United Kingdom | ► Subscribe | 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. | ||||||||||||||||||||||||||
| C0004 | France | ► Subscribe | PRODUCT NAME: DESLORATADINE; PSEUDOEPHEDRINE SULFATE; REGISTRATION NO/DATE: EU/1/07/399/001 20070730 | ||||||||||||||||||||||||||
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Serving 500+ biopharmaceutical companies globally:
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 verifification 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.
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