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Generated: September 25, 2017
What is the patent landscape for Sprycel, and when can generic versions of Sprycel launch?
Sprycel is a drug marketed by Bristol Myers Squibb and is included in one NDA. There are five patents protecting this drug and three Paragraph IV challenges.| Patents: | 5 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: see list | 2 |
| Bulk Api Vendors: see list | 94 |
| Clinical Trials: see list | 46 |
| Patent Applications: see list | 3,878 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | see details |
| DailyMed Link: | SPRYCEL at DailyMed |
| Drug Class | Kinase Inhibitor |
| Mechanism of Action | Protein Kinase Inhibitors Cytochrome P450 3A4 Inhibitors |
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| Drugname | Dosage | Strength | RLD | Submissiondate |
|---|---|---|---|---|
| dasatinib | Tablets | 80 mg and 140 mg | Sprycel | 6/17/2011 |
| dasatinib | Tablets | 80 mg and 140 mg | Sprycel | 6/16/2011 |
| dasatinib | Tablets | 20 mg, 50 mg, 70 mg and 100 mg | Sprycel | 6/28/2010 |
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 | |||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 6,979,694 | Cyclic protein tyrosine kinase inhibitors | ► Subscribe | |||||||||||||
| 8,716,323 | Cyclic protein tyrosine kinase inhibitors | ► Subscribe | |||||||||||||
| 8,242,270 | Process for preparing 2-aminothiazole-5-aromatic carboxamides as kinase inhibitors | ► Subscribe | |||||||||||||
| 7,189,854 | Cyclic protein tyrosine kinase inhibitors | ► Subscribe | |||||||||||||
| 8,993,567 | Cyclic protein tyrosine kinase inhibitors | ► Subscribe | |||||||||||||
| 7,091,223 | Cyclic protein tyrosine kinase inhibitors | ► Subscribe | |||||||||||||
| 9,382,219 | Cyclic protein tyrosine kinase inhibitors | ► Subscribe | |||||||||||||
| This preview shows a limited data set Subscribe for full access, or try a Trial | |||||||||||||||
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 | |||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Norway | 322470 | ► Subscribe | |||||||||||||
| Russian Federation | 2365372 | ► Subscribe | |||||||||||||
| Slovenia | 1711481 | ► Subscribe | |||||||||||||
| Serbia | 52291 | ► Subscribe | |||||||||||||
| Israel | 177280 | ► Subscribe | |||||||||||||
| Brazil | PI0515721 | ► Subscribe | |||||||||||||
| Canada | 2555291 | ► Subscribe | |||||||||||||
| Brazil | PI0507476 | ► Subscribe | |||||||||||||
| Denmark | 1610780 | ► Subscribe | |||||||||||||
| Denmark | 1711481 | ► Subscribe | |||||||||||||
| This preview shows a limited data set Subscribe for full access, or try a Trial | |||||||||||||||
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 | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 13/003 | Ireland | ► Subscribe | PRODUCT NAME: DASATINIB AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF.; REGISTRATION NO/DATE: EU/1/06/363/001-015 20061120 | ||||||||||||
| 2013 00006 | Denmark | ► Subscribe | |||||||||||||
| 0567 | Netherlands | ► Subscribe | PRODUCT NAME: DASATINIB, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT; REGISTRATION NO/DATE: EU/1/06/363/001 - 009 20061120 | ||||||||||||
| 00567 | Netherlands | ► Subscribe | PRODUCT NAME: DASATINIB, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT; REGISTRATION NO/DATE: EU/1/06/363/001 .... 009 20061120 | ||||||||||||
| 90004-8 | Sweden | ► Subscribe | PRODUCT NAME: DASATINIB OCH FARMACEUTISKT GODTAGBARA SALTER DAERAV; REG. NO/DATE: EU/1/06/363/001 20061120 | ||||||||||||
| 146 | Luxembourg | ► Subscribe | PRODUCT NAME: DASATINIB ET SES SELS PHARMACEUTIQUEMENT ACCEPTABLES | ||||||||||||
| C0003 | France | ► Subscribe | PRODUCT NAME: DASATINIB ET SES SELS PHARMACEUTIQUEMENT ACCEPTABLES; REGISTRATION NO/DATE: EU/1/06/363/001 20061122 | ||||||||||||
| 2013000012 | Germany | ► Subscribe | PRODUCT NAME: DASATINIB UND PHARMAZEUTISCH GEEIGNETE SALZE DAVON; REGISTRATION NO/DATE: EU/1/06/363/001-009 EU/1/06/363/010-011 EU/1/06/363/012-015 20061120 | ||||||||||||
| 1169038/01 | Switzerland | ► Subscribe | FORMER OWNER: BRISTOL-MYERS SQUIBB HOLDINGS IRELAND, CH | ||||||||||||
| This preview shows a limited data set Subscribe for full access, or try a Trial | |||||||||||||||
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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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