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Last Updated: December 23, 2024

Details for New Drug Application (NDA): 216196


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NDA 216196 describes PYRUKYND, which is a drug marketed by Agios Pharms Inc and is included in one NDA. It is available from one supplier. There are nine patents protecting this drug. Additional details are available on the PYRUKYND profile page.

The generic ingredient in PYRUKYND is mitapivat sulfate. One supplier is listed for this compound. Additional details are available on the mitapivat sulfate profile page.
Summary for 216196
Tradename:PYRUKYND
Applicant:Agios Pharms Inc
Ingredient:mitapivat sulfate
Patents:9
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 216196
Generic Entry Date for 216196*:
Constraining patent/regulatory exclusivity:
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.

Suppliers and Packaging for NDA: 216196
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
PYRUKYND mitapivat sulfate TABLET;ORAL 216196 NDA Agios Pharmaceuticals, Inc. 71334-205 71334-205-05 4 BLISTER PACK in 1 CARTON (71334-205-05) / 14 TABLET, FILM COATED in 1 BLISTER PACK (71334-205-14)
PYRUKYND mitapivat sulfate TABLET;ORAL 216196 NDA Agios Pharmaceuticals, Inc. 71334-210 71334-210-20 4 BLISTER PACK in 1 CARTON (71334-210-20) / 14 TABLET, FILM COATED in 1 BLISTER PACK (71334-210-14)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 5MG BASE
Approval Date:Feb 17, 2022TE:RLD:Yes
Regulatory Exclusivity Expiration:Feb 17, 2027
Regulatory Exclusivity Use:NEW CHEMICAL ENTITY
Regulatory Exclusivity Expiration:Feb 17, 2029
Regulatory Exclusivity Use:TREATMENT OF HEMOLYTIC ANEMIA IN ADULTS WITH PYRUVATE KINASE (PK) DEFICIENCY
Patent:⤷  SubscribePatent Expiration:May 3, 2032Product Flag?Substance Flag?Delist Request?
Patented Use:METHOD FOR INCREASING THE LIFETIME OF RED BLOOD CELLS (RBCS) FOR THE TREATMENT OF HEMOLYTIC ANEMIA IN ADULTS WITH PYRUVATE KINASE (PK) DEFICIENCY

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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.