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Generated: June 23, 2017
What are the generic drug sources for desloratadine and what is the scope of desloratadine patent protection?
Desloratadine is the generic ingredient in five branded drugs marketed by Merck Sharp Dohme, Taro Pharm, Mylan Pharms Inc, Lupin Pharms, Belcher Pharms, Orchid Hlthcare, Sun Pharm Inds, Perrigo R And D, Sandoz, Dr Reddys Labs Ltd, Reddys, and Taro Pharm Inds, and is included in seventeen NDAs. There are nine patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.| Tradenames: | 5 |
| Patents: | 9 |
| Applicants: | 12 |
| NDAs: | 17 |
| Drug Master File Entries: see list | 16 |
| Suppliers / Packagers: see list | 13 |
| Bulk Api Vendors: see list | 66 |
| Clinical Trials: see list | 60 |
| Patent Applications: see list | 5,377 |
| Therapeutic Class: | Respiratory Tract Agents |
| Drug Prices: | see low prices |
| DailyMed Link: | desloratadine at DailyMed |
| Drug Class | Histamine-1 Receptor Antagonist |
| Mechanism of Action | Histamine H1 Receptor Antagonists |
| Applicant | Application No. | Strength | Dosage Form |
| ► Subscribe | ► Subscribe | 5MG | TABLET; ORAL |
| ► Subscribe | ► Subscribe | 5MG | TABLET; ORAL |
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Dr Reddys Labs Ltd | DESLORATADINE | desloratadine | TABLET;ORAL | 078365-001 | Mar 8, 2011 | AB | RX | No | No | ► Subscribe | ► 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 | ||||||||||||||||
Dr Reddys Labs Ltd | DESLORATADINE AND PSEUDOEPHEDRINE SULFATE 24 HOUR | desloratadine; pseudoephedrine sulfate | TABLET, EXTENDED RELEASE;ORAL | 078366-001 | Apr 26, 2011 | AB | RX | No | No | ► Subscribe | ► Subscribe | ||||||||||||||||||
Sandoz | DESLORATADINE | desloratadine | TABLET;ORAL | 078364-001 | Dec 3, 2010 | AB | RX | No | No | ► Subscribe | ► Subscribe | ||||||||||||||||||
Merck Sharp Dohme | CLARINEX D 24 HOUR | desloratadine; pseudoephedrine sulfate | TABLET, EXTENDED RELEASE;ORAL | 021605-001 | Mar 3, 2005 | AB | RX | Yes | Yes | 6,100,274*PED | ► 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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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 | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Canada | 2333528 | ► Subscribe | |||||||||||||||||||||||||||
| Japan | 2002516860 | ► Subscribe | |||||||||||||||||||||||||||
| Netherlands | 1012191 | ► Subscribe | |||||||||||||||||||||||||||
| Taiwan | 589197 | ► Subscribe | |||||||||||||||||||||||||||
| Serbia | 49609 | ► 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 | ||||||||||||||||||||||||||
| C0004 | France | ► Subscribe | PRODUCT NAME: DESLORATADINE; PSEUDOEPHEDRINE SULFATE; REGISTRATION NO/DATE: EU/1/07/399/001 20070730 | ||||||||||||||||||||||||||
| 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. | ||||||||||||||||||||||||||
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