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SPRYCEL Drug Profile
» See Plans and Pricing
When do Sprycel patents expire, 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.
This drug has one hundred and twenty-eight patent family members in thirty-nine countries.
The generic ingredient in SPRYCEL is dasatinib. There are fourteen drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the dasatinib profile page.
US ANDA Litigation and Generic Entry Outlook for Sprycel
Sprycel was eligible for patent challenges on June 28, 2010.
There have been five patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.
Indicators of Generic Entry
Summary for SPRYCEL
| International Patents: | 128 |
| US Patents: | 5 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 1 |
| Bulk Api Vendors: | 117 |
| Clinical Trials: | 59 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for SPRYCEL |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for SPRYCEL |
| DailyMed Link: | SPRYCEL at DailyMed |
Recent Clinical Trials for SPRYCEL
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Baylor College of Medicine | Phase 2 |
| National Cancer Institute (NCI) | Phase 3 |
| Sundeep Khosla, M.D. | Phase 2 |
Pharmacology for SPRYCEL
| Drug Class | Kinase Inhibitor |
| Mechanism of Action | Protein Kinase Inhibitors Cytochrome P450 3A4 Inhibitors |
US Patents and Regulatory Information for SPRYCEL
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Bristol Myers Squibb | SPRYCEL | dasatinib | TABLET;ORAL | 021986-006 | Oct 28, 2010 | RX | Yes | No | Start Trial | Start Trial | Start Trial | ||||
| Bristol Myers Squibb | SPRYCEL | dasatinib | TABLET;ORAL | 021986-005 | Oct 28, 2010 | RX | Yes | No | Start Trial | Start Trial | Y | Start Trial | |||
| Bristol Myers Squibb | SPRYCEL | dasatinib | TABLET;ORAL | 021986-003 | Jun 28, 2006 | RX | Yes | No | Start Trial | Start Trial | Start Trial | ||||
| Bristol Myers Squibb | SPRYCEL | dasatinib | TABLET;ORAL | 021986-005 | Oct 28, 2010 | RX | Yes | No | Start Trial | Start Trial | Start Trial | ||||
| Bristol Myers Squibb | SPRYCEL | dasatinib | TABLET;ORAL | 021986-004 | May 30, 2008 | 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 SPRYCEL
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Bristol Myers Squibb | SPRYCEL | dasatinib | TABLET;ORAL | 021986-005 | Oct 28, 2010 | Start Trial | Start Trial |
| Bristol Myers Squibb | SPRYCEL | dasatinib | TABLET;ORAL | 021986-003 | Jun 28, 2006 | Start Trial | Start Trial |
| Bristol Myers Squibb | SPRYCEL | dasatinib | TABLET;ORAL | 021986-006 | Oct 28, 2010 | Start Trial | Start Trial |
| Bristol Myers Squibb | SPRYCEL | dasatinib | TABLET;ORAL | 021986-001 | Jun 28, 2006 | Start Trial | Start Trial |
| Bristol Myers Squibb | SPRYCEL | dasatinib | TABLET;ORAL | 021986-006 | Oct 28, 2010 | Start Trial | Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for SPRYCEL
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| New Zealand | 542171 | Start Trial |
| Brazil | PI0009721 | Start Trial |
| Russian Federation | 2005132408 | Start Trial |
| South Africa | 200606242 | Start Trial |
| Denmark | 1169038 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for SPRYCEL
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1169038 | 6/2013 | Austria | Start Trial | PRODUCT NAME: DASATINIB UND PHARMAZEUTISCH VERTRAEGLICHE SALZE DAVON; REGISTRATION NO/DATE: EU/1/06/363/001-015 20061120 |
| 1169038 | 122013000012 | Germany | Start Trial | 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 | 132013902119320 | Italy | Start Trial | PRODUCT NAME: DASATINIB E I SUOI SALI FARMACEUTICAMENTE ACCETTABILI(SPRYCEL); AUTHORISATION NUMBER(S) AND DATE(S): DA EU/1/06/363/001 A EU/I/06/363/015, 20061120 |
| 1169038 | 1390004-8 | Sweden | Start Trial | PRODUCT NAME: DASATINIB OCH FARMACEUTISKT GODTAGBARA SALTER DAERAV; REG. NO/DATE: EU/1/06/363/001 20061120 |
| 1169038 | C01169038/01 | Switzerland | Start Trial | FORMER OWNER: BRISTOL-MYERS SQUIBB HOLDINGS IRELAND, CH |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
