PHYRAGO Drug Patent Profile

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When do Phyrago patents expire, and what generic alternatives are available?

Phyrago is a drug marketed by Nanocopoeia and is included in one NDA. There are three patents protecting this drug.

This drug has six patent family members in six countries.

The generic ingredient in PHYRAGO is dasatinib. There are fourteen drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the dasatinib profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Phyrago

A generic version of PHYRAGO was approved as dasatinib by APOTEX on June 10^th, 2016.

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Summary for PHYRAGO

International Patents:	6
US Patents:	3
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
What excipients (inactive ingredients) are in PHYRAGO?	PHYRAGO excipients list
DailyMed Link:	PHYRAGO at DailyMed

Drug patent expirations by year for PHYRAGO

Pharmacology for PHYRAGO

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

US Patents and Regulatory Information for PHYRAGO

PHYRAGO is protected by seven US patents and one FDA Regulatory Exclusivity.

Patents protecting PHYRAGO

Amorphous solid dispersions of dasatinib and uses thereof
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: USE OF DASATINIB FOR TREATMENT OF ADULTS WITH CHRONIC, ACCELERATED, OR MYELOID OR LYMPHOID BLAST PHASE PH+ CML WITH RESISTANCE OR INTOLERANCE TO PRIOR THERAPY INCLUDING IMATINIB, WHEN COADMINISTERED WITH A GASTRIC ACID REDUCING AGENT

Amorphous solid dispersions of dasatinib and uses thereof
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Patent Expiration: ⤷ Sign Up
Patented Use: USE OF DASATINIB FOR TREATMENT OF ADULTS WITH PH+ ALL WITH RESISTANCE OR INTOLERANCE TO PRIOR THERAPY, WHEN COADMINISTERED WITH A GASTRIC ACID REDUCING AGENT

Amorphous solid dispersions of dasatinib and uses thereof
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Patent Expiration: ⤷ Sign Up
Patented Use: USE OF DASATINIB FOR TREATMENT OF NEWLY DIAGNOSED ADULTS WITH PH+ CML IN CHRONIC PHASE, WHEN COADMINISTERED WITH A GASTRIC ACID REDUCING AGENT

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Patent Expiration: ⤷ Sign Up

Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: USE OF DASATINIB FOR TREATMENT OF ADULTS WITH CHRONIC, ACCELERATED, OR MYELOID OR LYMPHOID BLAST PHASE PH+ CML WITH RESISTANCE OR INTOLERANCE TO PRIOR THERAPY INCLUDING IMATINIB, WHEN ADMINISTERED AT ELEVATED GASTRIC PH

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Patent Expiration: ⤷ Sign Up
Patented Use: USE OF DASATINIB FOR TREATMENT OF NEWLY DIAGNOSED ADULTS WITH PH+ CML IN CHRONIC PHASE, WHEN ADMINISTERED AT ELEVATED GASTRIC PH

Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: USE OF DASATINIB FOR TREATMENT OF ADULTS WITH PH+ ALL WITH RESISTANCE OR INTOLERANCE TO PRIOR THERAPY, WHEN ADMINISTERED AT ELEVATED GASTRIC PH

FDA Regulatory Exclusivity protecting PHYRAGO

INFORMATION ADDED TO THE CLINICAL PHARMACOLOGY SECTION TO INCLUDE RESULTS FROM A DRUG INTERACTION STUDY WITH GASTRIC ACID REDUCING AGENTS
Exclusivity Expiration: ⤷ Sign Up

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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
Nanocopoeia	PHYRAGO	dasatinib	TABLET;ORAL	216099-006	Dec 5, 2023		RX	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Nanocopoeia	PHYRAGO	dasatinib	TABLET;ORAL	216099-004	Dec 5, 2023		RX	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Nanocopoeia	PHYRAGO	dasatinib	TABLET;ORAL	216099-004	Dec 5, 2023		RX	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Nanocopoeia	PHYRAGO	dasatinib	TABLET;ORAL	216099-005	Dec 5, 2023		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Nanocopoeia	PHYRAGO	dasatinib	TABLET;ORAL	216099-001	Dec 5, 2023		RX	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Nanocopoeia	PHYRAGO	dasatinib	TABLET;ORAL	216099-003	Dec 5, 2023		RX	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Nanocopoeia	PHYRAGO	dasatinib	TABLET;ORAL	216099-005	Dec 5, 2023		RX	Yes	Yes	⤷ 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

International Patents for PHYRAGO

See the table below for patents covering PHYRAGO around the world.

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Country	Patent Number	Title	Estimated Expiration
World Intellectual Property Organization (WIPO)	2021150981		⤷ Sign Up
Canada	3168667	DISPERSIONS SOLIDES AMORPHES DE DASATINIB ET LEURS UTILISATIONS (AMORPHOUS SOLID DISPERSIONS OF DASATINIB AND USES THEREOF)	⤷ Sign Up
European Patent Office	4093379	DISPERSIONS SOLIDES AMORPHES DE DASATINIB ET LEURS UTILISATIONS (AMORPHOUS SOLID DISPERSIONS OF DASATINIB AND USES THEREOF)	⤷ Sign Up
Israel	294928	פיזורים מוצקים אמורפיים של dasatinib ושימושים בהם (Amorphous solid dispersions of dasatinib and uses thereof)	⤷ Sign Up
Australia	2021210974	Amorphous solid dispersions of dasatinib and uses thereof	⤷ Sign Up
Japan	2023513444	ダサチニブの非晶質固体分散体及びその使用	⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for PHYRAGO

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1169038	6/2013	Austria	⤷ Sign Up	PRODUCT NAME: DASATINIB UND PHARMAZEUTISCH VERTRAEGLICHE SALZE DAVON; REGISTRATION NO/DATE: EU/1/06/363/001-015 20061120
1169038	2013C/005	Belgium	⤷ Sign Up	PRODUCT NAME: DASATINIB SOUS TOUTES FORMES COUVERTES PAR LA PROTECTION DU BREVET DE BASE INCLUANT LES SOLVATES, LES HYDRATES, TEL QUE LA FORME MONOHYDRATEE, ET LES SELS PHARMACEUTIQUEMENT ACCEPTABLES; AUTHORISATION NUMBER AND DATE: EU/1/06/363/001 20061122
1169038	300567	Netherlands	⤷ Sign Up	PRODUCT NAME: DASATINIB, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT; REGISTRATION NO/DATE: EU/1/06/363/001 - 009 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	C300567	Netherlands	⤷ Sign Up	PRODUCT NAME: DASATINIB, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT; REGISTRATION NO/DATE: EU/1/06/363/001 .... 009 20061120
1169038	CA 2013 00006	Denmark	⤷ Sign Up	PRODUCT NAME: DASATINIB OG FARMACEUTISK ACCEPTABLE SALTE DERAF, HERUNDER MONOHYDRATET; REG. NO/DATE: EU/1/06/363/001-015 20061122
1169038	92146	Luxembourg	⤷ Sign Up	PRODUCT NAME: DASATINIB ET SES SELS PHARMACEUTIQUEMENT ACCEPTABLES
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description