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. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the mitapivat sulfate profile page.
The generic ingredient in PYRUKYND is mitapivat sulfate. There is one drug master file entry for this compound. 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.
Pharmacology for NDA: 216196
Suppliers and Packaging for NDA: 216196
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| AQVESME | 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. | 71334-205 | 71334-205-05 | 4 BLISTER PACK in 1 CARTON (71334-205-05) / 14 TABLET, FILM COATED in 1 BLISTER PACK (71334-205-14) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 5MG BASE | ||||
| Approval Date: | Feb 17, 2022 | TE: | 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: | 10,632,114 | Patent Expiration: | May 3, 2032 | Product 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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