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PYRUKYND

NDA

MITAPIVAT SULFATE | N216196 | AGIOS PHARMACEUTICALS INC

4 strengths9 unique patents4 unique exclusivities

Patent Timeline

9 unique patents, 4 exclusivities by expiration date

Active (9)TodayExclusivityIPRPTAB Challenge

2027

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2032

2033

2034

2035

2036

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2042

Today

Apr. 11, 2035

Oct. 26, 2032

May. 3, 2032

May. 3, 2032

May. 3, 2032

Oct. 11, 2038

Nov. 21, 2038

Apr. 12, 2033

Jul. 31, 2041IPR

NCE

Feb. 17, 2027

Dec. 23, 2028

ODE-392

Feb. 17, 2029

ODE-522

Dec. 23, 2032

PTAB Proceedings

1 challenge on OB patents at the Patent Trial and Appeal Board

Trial #	Patent	Type	Petitioner	Status	Filed	Decision
IPR2026-00351	11878049	IPR	Apotex Inc et al.	Discretionary Denial	2026-05-18	2026-09-23

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

1 case on OB patents (1 active) from PACER

Case	Court	Filed	Status	Judge
Agios Pharmaceuticals, Inc. v. Annora Pharma Private Limited et al 1:2026cv00603 3 patentsANDA 221270mitapivat	D. Del.	2026-05-26	Active	—

Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

11 trials from ClinicalTrials.gov — 4 recruiting, 6 active, 1 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
A Study Evaluating the Efficacy and Safety of Mitapivat (AG-348) in Participants With Sickle Cell Disease (RISE UP)NCT05031780	Phase 2/3	Active	Agios Pharmaceuticals, Inc.	286	2022-02-11 → 2030-02
To Assess Safety of Mitapivat and Provide Proof of Concept of the Efficacy of the Drug in Patients With RBC Membranopathies or CDAII.NCT07055243	Phase 2	Active	University Health Network, Toronto	9	2025-10-20 → 2029-10
A Study to Evaluate the Efficacy and Safety of Mitapivat in Pediatric Participants With Pyruvate Kinase Deficiency (PKD) Who Are Not Regularly Transfused, Followed by a 5-Year Extension Period NCT05175105	Phase 3	Active	Agios Pharmaceuticals, Inc.	30	2022-06-06 → 2030-01
A Study Evaluating the Efficacy and Safety of Mitapivat in Participants With Transfusion-Dependent Alpha- or Beta-Thalassemia (α- or β-TDT)NCT04770779	Phase 3	Active	Agios Pharmaceuticals, Inc.	258	2021-11-30 → 2029-06
A Study Evaluating the Efficacy and Safety of Mitapivat in Participants With Non-Transfusion-Dependent Alpha- or Beta-Thalassemia (α- or β-NTDT)NCT04770753	Phase 3	Active	Agios Pharmaceuticals, Inc.	194	2021-12-20 → 2028-12
A Study to Evaluate the Efficacy and Safety of Mitapivat in Pediatric Participants With Pyruvate Kinase Deficiency (PKD) Who Are Regularly Transfused, Followed by a 5-Year Extension Period NCT05144256	Phase 3	Active	Agios Pharmaceuticals, Inc.	49	2022-06-08 → 2029-06
A Study to Provide Access to Mitapivat for Participants Who Previously Participated in an Agios-Sponsored Mitapivat Study NCT05777993	Phase 4	By Invitation	Agios Pharmaceuticals, Inc.	59	2023-07-06 → 2029-08
A Study to Investigate the Efficacy, Pharmacokinetics, and Safety of Mitapivat in Pediatric Participants With Transfusion-Dependent Alpha- or Beta-Thalassemia (α- or β-TDT)NCT07506863	Phase 3	Recruiting	Agios Pharmaceuticals, Inc.	54	2026-09 → 2032-06
A Study to Investigate the Effect of Mitapivat on Transfusion Burden in Subjects With Sickle Cell Disease (SCD)NCT07656415	Phase 3	Recruiting	Agios Pharmaceuticals, Inc.	159	2026-07-21 → 2030-08
A Study to Investigate the Efficacy, Pharmacokinetics, and Safety of Mitapivat in Pediatric Participants With α- or β-Non-Transfusion-Dependent Thalassemia NCT07517133	Phase 3	Recruiting	Agios Pharmaceuticals, Inc.	45	2026-09 → 2032-03

Source: ClinicalTrials.gov. Trials matched by ingredient name.

VA Federal Supply Schedule

Government-negotiated contract prices | 12 NDCs (6 FSS, 6 Big4)

Lowest Price

$2410.31

Highest Price

$25889.45

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
71334-0205-05PYRUKYND 5MG TAB,28 DAY PACK	$19282.46	Big4	Agios Pharmaceuticals, Inc.	09/28/2030
71334-0205-05PYRUKYND 5MG TAB,28 DAY PACK	$25889.45	FSS	Agios Pharmaceuticals, Inc.	09/28/2030
71334-0210-20PYRUKYND 20MG TAB,28 DAY PACK	$19282.46	Big4	Agios Pharmaceuticals, Inc.	09/28/2030
71334-0210-20PYRUKYND 20MG TAB,28 DAY PACK	$25889.45	FSS	Agios Pharmaceuticals, Inc.	09/28/2030
71334-0215-50PYRUKYND 50MG TAB,28 DAY PACK	$19278.60	Big4	Agios Pharmaceuticals, Inc.	09/28/2030
71334-0215-50PYRUKYND 50MG TAB,28 DAY PACK	$25889.45	FSS	Agios Pharmaceuticals, Inc.	09/28/2030

Showing 6 of 12 NDCs.

Source: VA Federal Supply Schedule (va.gov). Prices are government-negotiated contract prices.

Medicare Part D Spending

CMS annual spending data for Pyrukynd (2024)

Total Spending

$6.0M

Total Claims

226

Beneficiaries

Avg Cost/Unit

$467.38

Spending Trend

$1.6M(2022)→$4.5M(2023)→$6.0M(2024)

YoY Change:-2.1%

5yr CAGR:-0.9%

Source: CMS Medicare Part D Spending by Drug (2024). Shows gross drug cost under Part D.

API Supply Chain3 active DMFs

3 active API suppliers hold Drug Master Files for this ingredient.

HETERO DRUGS LTDMITAPIVAT SULFATE

DMF 426462025

BIOPHORE INDIA PHARMACEUTICALS PVT LTDMITAPIVAT SULFATE

DMF 428872025

MAITHRI DRUGS PRIVATE LTDMITAPIVAT SULFATE

DMF 397742024

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

5 letters from Drugs@FDA

Date	Submission	Document
Sep 28, 2026	SUPPL -7	View Letter (PDF)
Aug 11, 2026	SUPPL -6	View Letter (PDF)
Jun 23, 2026	SUPPL -3	View Letter (PDF)
Jan 6, 2025	SUPPL -4	View Letter (PDF)
Feb 18, 2022	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (4)

Sort:

#004 — EQ 100MG BASE

RLD

6 patents3 exclusivities▾

TABLET;ORAL | Approved: Dec 23, 2025

#001 — EQ 5MG BASE

RLD

9 patents2 exclusivities▴

TABLET;ORAL | Approved: Feb 17, 2022

Patents (9)

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
RE49582	Apr 11, 2035	—	Yes	Yes	—	—
9193701	Oct 26, 2032	—	—	—		—
9682080	May 3, 2032	—	—	—		—
9980961	May 3, 2032	—	—	—		—
10632114	May 3, 2032	—	—	—		—
11234976	Oct 11, 2038	—	—	—		—
11254652	Nov 21, 2038	—	Yes	Yes	—	—
11793806	Apr 12, 2033	—	—	—		—
11878049	Jul 31, 2041	—	—	—		—

Exclusivities (2)

Code	Date	Status
NCE	Feb 17, 2027	< 1 year
ODE-392	Feb 17, 2029	Active

#002 — EQ 20MG BASE

RLD

9 patents2 exclusivities▾

TABLET;ORAL | Approved: Feb 17, 2022

#003 — EQ 50MG BASE

RLD

9 patents2 exclusivities▾

TABLET;ORAL | Approved: Feb 17, 2022