Mitapivat sulfate - Generic Drug Details

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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-nine patent family members in forty-five countries.

One supplier is listed for this compound.

Summary for mitapivat sulfate

International Patents:	179
US Patents:	9
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Clinical Trials:	13
DailyMed Link:	mitapivat sulfate at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for mitapivat sulfate

Generic Entry Date for mitapivat sulfate^: ⤷ Subscribe* Constraining patent/regulatory exclusivity: ⤷ Subscribe 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
EuroBloodNet Association	Phase 2
Agios Pharmaceuticals, Inc.	Phase 4
Agios Pharmaceuticals, Inc.	Phase 2/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

Anatomical Therapeutic Chemical (ATC) Classes for mitapivat sulfate

B06AX	Other hematological agents
B06A	OTHER HEMATOLOGICAL AGENTS
B06	OTHER HEMATOLOGICAL AGENTS
B	Blood and blood forming organs

US Patents and Regulatory Information for mitapivat sulfate

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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
Agios Pharms Inc	PYRUKYND	mitapivat sulfate	TABLET;ORAL	216196-001	Feb 17, 2022		RX	Yes	No	⤷ Subscribe	⤷ Subscribe	Y	Y		⤷ Subscribe
Agios Pharms Inc	PYRUKYND	mitapivat sulfate	TABLET;ORAL	216196-001	Feb 17, 2022		RX	Yes	No	⤷ Subscribe	⤷ Subscribe	Y	Y		⤷ Subscribe
Agios Pharms Inc	PYRUKYND	mitapivat sulfate	TABLET;ORAL	216196-001	Feb 17, 2022		RX	Yes	No	⤷ Subscribe	⤷ Subscribe				⤷ Subscribe
Agios Pharms Inc	PYRUKYND	mitapivat sulfate	TABLET;ORAL	216196-001	Feb 17, 2022		RX	Yes	No	⤷ Subscribe	⤷ Subscribe				⤷ Subscribe
Agios Pharms Inc	PYRUKYND	mitapivat sulfate	TABLET;ORAL	216196-001	Feb 17, 2022		RX	Yes	No	⤷ Subscribe	⤷ Subscribe				⤷ Subscribe
Agios Pharms Inc	PYRUKYND	mitapivat sulfate	TABLET;ORAL	216196-001	Feb 17, 2022		RX	Yes	No	⤷ Subscribe	⤷ Subscribe				⤷ Subscribe
>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 mitapivat sulfate

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Country	Patent Number	Title	Estimated Expiration
Slovenia	2448582		⤷ Subscribe
Morocco	50805	FORMES CRISTALLINES DE N-(4-(4-(CYCLOPROPYLMÉTHYL) PIPÉRAZINE-1-CARBONYL)PHÉNYL)QUINOLÉINE-8-SULFONAMIDE	⤷ Subscribe
Australia	2018373122	Crystalline forms of N-(4-(4-(cyclopropylmethyl) piperazine-1-carbonyl)phenyl)quinoline-8-sulfonamide	⤷ Subscribe
Brazil	112013028422		⤷ Subscribe
Canada	2944788	COMPOSES, ET COMPOSITIONS ASSOCIEES, QUI MODULENT LA PYRUVATE KINASE M2, ET METHODES DE FABRICATION ASSOCIEES (COMPOUNDS, AND COMPOSITIONS THEREOF, WHICH MODULATE PYRUVATE KINASE M2, AND METHODS OF MAKING SAME)	⤷ Subscribe
Philippines	12017501176	PYRUVATE KINASE ACTIVATORS FOR USE THERAPY	⤷ Subscribe
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for mitapivat sulfate

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2448582	122023000025	Germany	⤷ Subscribe	PRODUCT NAME: MITAPIVAT ODER EIN PHARMAZEUTISCH AKZEPTABLES SALZ DAVON, INSBESONDERE MITAPIVATSULFAT; REGISTRATION NO/DATE: EU/1/22/1662 20221109
2448582	2390014-5	Sweden	⤷ Subscribe	PRODUCT NAME: MITAPIVAT OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, IN PARTICULAR MITAPIVAT SULFATE; REG. NO/DATE: EU/1/22/1662 20221110
2448582	19/2023	Austria	⤷ Subscribe	PRODUCT NAME: MITAPIVAT ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON, INSBESONDERE MITAPIVAT-SULFAT; REGISTRATION NO/DATE: EU/1/22/1662 (MITTEILUNG) 20221110
2448582	CR 2023 00014	Denmark	⤷ Subscribe	PRODUCT NAME: MITAPIVAT ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF, ISAER MITAPIVATSULFAT; REG. NO/DATE: EU/1/22/1662 20221110
2448582	23C1017	France	⤷ Subscribe	PRODUCT NAME: MITAPIVAT OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE MITAPIVAT, EN PARTICULIER SULFATE DE MITAPIVAT.; REGISTRATION NO/DATE: EU/1/22/1662 20221110
2448582	PA2023513	Lithuania	⤷ Subscribe	PRODUCT NAME: MITAPIVATAS ARBA JO FARMACINIU POZIURIU PRIIMTINA DRUSKA, YPAC MITAPIVATO SULFATAS; REGISTRATION NO/DATE: EU/1/22/1662 20221109
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.