Dasatinib - Generic Drug Details

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What are the generic drug sources for dasatinib and what is the scope of freedom to operate?

Dasatinib is the generic ingredient in three branded drugs marketed by Apotex, Nanocopoeia, and Bristol Myers Squibb, and is included in four NDAs. There are five patents protecting this compound and three Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Dasatinib has fifty-three patent family members in twenty-nine countries.

There are fourteen drug master file entries for dasatinib. Four suppliers are listed for this compound. There are four tentative approvals for this compound.

Summary for dasatinib

International Patents:	53
US Patents:	5
Tradenames:	3
Applicants:	3
NDAs:	4
Drug Master File Entries:	14
Finished Product Suppliers / Packagers:	4
Raw Ingredient (Bulk) Api Vendors:	139
Clinical Trials:	361
Patent Applications:	6,922
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for dasatinib
What excipients (inactive ingredients) are in dasatinib?	dasatinib excipients list
DailyMed Link:	dasatinib at DailyMed

Recent Clinical Trials for dasatinib

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Hospital Universitario Dr. Jose E. Gonzalez	Phase 2
Fernando De la Garza Salazar	Phase 2
Institut Paoli-Calmettes	Phase 2

See all dasatinib clinical trials

Generic filers with tentative approvals for DASATINIB

Applicant	Application No.	Strength	Dosage Form
⤷ Sign Up	⤷ Sign Up	140MG	TABLET;ORAL
⤷ Sign Up	⤷ Sign Up	100MG	TABLET;ORAL
⤷ Sign Up	⤷ Sign Up	80MG	TABLET;ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for dasatinib

Drug Class	Kinase Inhibitor
Mechanism of Action	Cytochrome P450 3A4 Inhibitors Protein Kinase Inhibitors

Medical Subject Heading (MeSH) Categories for dasatinib

Antineoplastic Agents
Protein Kinase Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for dasatinib

L01EA	BCR-ABL tyrosine kinase inhibitors
L01E	PROTEIN KINASE INHIBITORS
L01	ANTINEOPLASTIC AGENTS
L	Antineoplastic and immunomodulating agents

Paragraph IV (Patent) Challenges for DASATINIB

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
SPRYCEL	Tablets	dasatinib	80 mg and 140 mg	021986	1	2011-06-17
SPRYCEL	Tablets	dasatinib	20 mg, 50 mg, 70 mg and 100 mg	021986	1	2010-06-28

US Patents and Regulatory Information for dasatinib

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Glossary

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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	021986-002	Jun 28, 2006	AB	RX	Yes	No	⤷ Sign Up	⤷ Sign Up			Y	⤷ Sign Up
Bristol Myers Squibb	SPRYCEL	dasatinib	TABLET;ORAL	021986-001	Jun 28, 2006	AB	RX	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Nanocopoeia	PHYRAGO	dasatinib	TABLET;ORAL	216099-001	Dec 5, 2023		RX	Yes	No	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
>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 dasatinib

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Bristol Myers Squibb	SPRYCEL	dasatinib	TABLET;ORAL	021986-002	Jun 28, 2006	⤷ Sign Up	⤷ Sign Up
Bristol Myers Squibb	SPRYCEL	dasatinib	TABLET;ORAL	021986-004	May 30, 2008	⤷ Sign Up	⤷ Sign Up
Bristol Myers Squibb	SPRYCEL	dasatinib	TABLET;ORAL	021986-002	Jun 28, 2006	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

International Patents for dasatinib

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Country	Patent Number	Title	Estimated Expiration
Norway	338049		⤷ Sign Up
Mexico	2007005115	COMBINACION DE UN INHIBIDOR DE PROTEINA CINASA SRC Y UN INHIBIDOR DE PROTEINA CINASA BCR-ABL PARA EL TRATAMIENTO DE ENFERMEDADES PROLIFERATIVAS. (COMBINATION OF A SRC KINASE INHIBITOR AND A BCR-ABL INHIBITOR FOR THE TREATMENT OF PROLIFERATIVE DISEASES.)	⤷ Sign Up
South Korea	20060124692	PROCESS FOR PREPARING 2-AMINOTHIAZOLE-5-AROMATIC CARBOXAMIDES AS KINASE INHIBITORS	⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for dasatinib

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1169038	132013902119320	Italy	⤷ Sign Up	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	2013/003	Ireland	⤷ Sign Up	PRODUCT NAME: DASATINIB AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF.; REGISTRATION NO/DATE: EU/1/06/363/001-015 20061120
1169038	13C0003	France	⤷ Sign Up	PRODUCT NAME: DASATINIB ET SES SELS PHARMACEUTIQUEMENT ACCEPTABLES; REGISTRATION NO/DATE: EU/1/06/363/001 20061122
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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