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	216196-003	Feb 17, 2022		RX	Yes	Yes			Y	Y
Agios Pharms Inc	PYRUKYND	mitapivat sulfate	TABLET;ORAL	216196-001	Feb 17, 2022		RX	Yes	No
Agios Pharms Inc	PYRUKYND	mitapivat sulfate	TABLET;ORAL	216196-002	Feb 17, 2022		RX	Yes	No
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
Israel	276414	אקטיבטור לקינאז של פירובאט לשימוש בטיפול (Pyruvate kinase activators for use in therapy)
Japan	6272754
South Korea	20180079451	치료에 사용하기 위한 피루베이트 키나아제 활성제 (PYRUVATE KINASE ACTIVATORS FOR USE IN THERAPY)
Lithuania	3713919

Supplementary Protection Certificates for MITAPIVAT SULFATE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2448582	C202330019	Spain		PRODUCT NAME: MITAPIVAT O UNA SAL FARMACEUTICAMENTE ACEPTABLE DEL MISMO, EN PARTICULAR SULFATO DE MITAPIVAT; NATIONAL AUTHORISATION NUMBER: EU/1/22/1662; DATE OF AUTHORISATION: 20221109; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/22/1662; DATE OF FIRST AUTHORISATION IN EEA: 20221109
2448582	LUC00306	Luxembourg		PRODUCT NAME: MITAPIVAT OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, IN PARTICULAR MITAPIVAT SULFATE; AUTHORISATION NUMBER AND DATE: EU/1/22/1662 20221110
2448582	122023000025	Germany		PRODUCT NAME: MITAPIVAT ODER EIN PHARMAZEUTISCH AKZEPTABLES SALZ DAVON, INSBESONDERE MITAPIVATSULFAT; REGISTRATION NO/DATE: EU/1/22/1662 20221109
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