MITAPIVAT SULFATE - Generic Drug Details

What are the generic sources for mitapivat sulfate and what is the scope of freedom to operate?

Mitapivat sulfate is the generic ingredient in one branded drug marketed by Agios Pharms Inc and is included in one NDA. There are nine patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Mitapivat sulfate has one hundred and seventy-four patent family members in forty-five countries.

One supplier is listed for this compound.

Summary for MITAPIVAT SULFATE

International Patents:	174
US Patents:	9
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Clinical Trials:	12
DailyMed Link:	MITAPIVAT SULFATE at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for MITAPIVAT SULFATE

Dosage:

TABLET;ORAL

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for MITAPIVAT SULFATE

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

Sponsor	Phase
Agios Pharmaceuticals, Inc.	Phase 4
Agios Pharmaceuticals, Inc.	Phase 2/Phase 3
Agios Pharmaceuticals, Inc.	Phase 3

See all MITAPIVAT SULFATE clinical trials

Pharmacology for MITAPIVAT SULFATE

Drug Class	Pyruvate Kinase Activator
Mechanism of Action	Cytochrome P450 2B6 Inducers Cytochrome P450 2C19 Inducers Cytochrome P450 2C8 Inducers Cytochrome P450 2C9 Inducers Cytochrome P450 3A Inducers P-Glycoprotein Inhibitors Pyruvate Kinase Activators UGT1A1 Inducers

US Patents and Regulatory Information for MITAPIVAT SULFATE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Agios Pharms Inc	PYRUKYND	mitapivat sulfate	TABLET;ORAL	216196-001	Feb 17, 2022		RX	Yes	No
Agios Pharms Inc	PYRUKYND	mitapivat sulfate	TABLET;ORAL	216196-001	Feb 17, 2022		RX	Yes	No
Agios Pharms Inc	PYRUKYND	mitapivat sulfate	TABLET;ORAL	216196-003	Feb 17, 2022		RX	Yes	Yes
Agios Pharms Inc	PYRUKYND	mitapivat sulfate	TABLET;ORAL	216196-002	Feb 17, 2022		RX	Yes	No			Y	Y

International Patents for MITAPIVAT SULFATE

Country	Patent Number	Title	Estimated Expiration
Taiwan	I649313
Philippines	12020550644	CRYSTALLINE FORMS OF N-(4-(4-(CYCLOPROPYLMETHYL)PIPERAZINE-1-CARBONYL)PHENYL)QUINOLINE-8-SULFONAMIDE
South Korea	101712035
Japan	2018027985	ピルビン酸キナーゼ活性化剤の使用方法 (METHOD FOR USING PYRUVATE KINASE ACTIVATOR FOR USE)

Supplementary Protection Certificates for MITAPIVAT SULFATE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2448582	23C1017	France		PRODUCT NAME: MITAPIVAT OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE MITAPIVAT, EN PARTICULIER SULFATE DE MITAPIVAT.; REGISTRATION NO/DATE: EU/1/22/1662 20221110
2448582	2023C/517	Belgium		PRODUCT NAME: MITAPIVAT OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI, EN PARTICULIER LE SULFATE DE MITAPIVAT; AUTHORISATION NUMBER AND DATE: EU/1/22/1662 20221110
2448582	301230	Netherlands		PRODUCT NAME: MITAPIVAT, DAN WEL EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN, IN HET BIJZONDER MITAPIVATSULFAAT; REGISTRATION NO/DATE: EU/1/22/1662 20221110
2448582	19/2023	Austria		PRODUCT NAME: MITAPIVAT ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON, INSBESONDERE MITAPIVAT-SULFAT; REGISTRATION NO/DATE: EU/1/22/1662 (MITTEILUNG) 20221110