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PYRUKYND

mitapivat · Kit

Prescription NDA RLD
Informational index, not medical advice. Content is reproduced from public FDA and NLM data. Always confirm against the manufacturer's current prescribing information.

Overview

Brand name
PYRUKYND
Generic name
mitapivat
Dosage form
Kit
Route
—
Marketing category
NDA · NDA
Labeler
Agios Pharmaceuticals, Inc.
Product type
Human Prescription Drug
DEA schedule
Not scheduled
Active ingredients
0
NDC product codes
2
Packages
2
Data completeness
54% of corroborating sources present

Forms, strengths and routes

Source: NDC Directory
Dosage form
Kit
Route of administration
—
Presentations
4

Regulatory status

Source: Drugs@FDANDC Directory
Application number
216196
Application type
NDA · New Drug Application
Approval date
February 17, 2022
Sponsor
AGIOS PHARMS INC
Products on application
4
Submissions recorded
4
Products approved under application 216196.
Product Trade name Form Strength Ingredient Status TE Flags
216196-001 PYRUKYND TABLET MITAPIVAT SULFATE Prescription — RLD
216196-002 PYRUKYND TABLET MITAPIVAT SULFATE Prescription — RLD
216196-003 PYRUKYND TABLET MITAPIVAT SULFATE Prescription — RLD RS
216196-004 AQVESME TABLET MITAPIVAT SULFATE Prescription — RLD RS

Therapeutic equivalence

Source: Orange Book
TE code
—
Reference Listed Drug
Yes
Reference Standard
Yes

Codes beginning with “A” indicate products the FDA considers therapeutically equivalent. Codes beginning with “B” indicate bioequivalence has not been established. See methodology.

Patents and exclusivity

Source: Orange Book
Patent listings submitted under 21 U.S.C. 355(b)(1) and (c)(2).
Patent Expires Product Substance Use code Submitted
9682080 May 3, 2032 001 No U-3319 March 8, 2022
9980961 May 3, 2032 001 No U-3319 March 8, 2022
10632114 May 3, 2032 001 No U-3320 March 8, 2022
9682080 May 3, 2032 002 No U-3319 March 8, 2022
9980961 May 3, 2032 002 No U-3319 March 8, 2022
10632114 May 3, 2032 002 No U-3320 March 8, 2022
9682080 May 3, 2032 003 No U-3319 March 8, 2022
9980961 May 3, 2032 003 No U-3319 March 8, 2022
10632114 May 3, 2032 003 No U-3320 March 8, 2022
10632114 May 3, 2032 004 No U-4391 January 20, 2026
9682080 May 3, 2032 004 No U-4392 January 20, 2026
9193701 October 26, 2032 001 No U-3319 March 8, 2022
9193701 October 26, 2032 002 No U-3319 March 8, 2022
9193701 October 26, 2032 003 No U-3319 March 8, 2022
9193701 October 26, 2032 004 No U-4393 January 20, 2026
11793806 April 12, 2033 001 No U-3320 October 31, 2023
11793806 April 12, 2033 002 No U-3320 October 31, 2023
11793806 April 12, 2033 003 No U-3320 October 31, 2023
RE49582 April 11, 2035 001 Yes July 27, 2023
RE49582 April 11, 2035 002 Yes July 27, 2023
RE49582 April 11, 2035 003 Yes July 27, 2023
RE49582 April 11, 2035 004 Yes January 20, 2026
11234976 October 11, 2038 001 No U-3321 March 8, 2022
11234976 October 11, 2038 002 No U-3321 March 8, 2022
11234976 October 11, 2038 003 No U-3321 March 8, 2022
11254652 November 21, 2038 001 Yes March 8, 2022
11254652 November 21, 2038 002 Yes March 8, 2022
11254652 November 21, 2038 003 Yes March 8, 2022
11254652 November 21, 2038 004 Yes January 20, 2026
11878049 July 31, 2041 001 No U-3782 January 26, 2024
11878049 July 31, 2041 002 No U-3782 January 26, 2024
11878049 July 31, 2041 003 No U-3782 January 26, 2024
11878049 July 31, 2041 004 No U-4390 January 20, 2026
Regulatory exclusivity periods.
Code Expires Product
NCE February 17, 2027 001
NCE February 17, 2027 002
NCE February 17, 2027 003
NCE February 17, 2027 004
NP December 23, 2028 004
ODE-392 February 17, 2029 001
ODE-392 February 17, 2029 002
ODE-392 February 17, 2029 003
ODE-522 December 23, 2032 004

Approval history

Source: Drugs@FDA
Most recent submissions on application 216196.
Type No. Action Status Date Review
Supplement 6 Manufacturing (CMC) Approved April 8, 2026 N/A
Supplement 3 Efficacy Approved December 23, 2025 Standard
Supplement 4 Labeling Approved January 3, 2025 Standard
Original application 1 Type 1 - New Molecular Entity Approved February 17, 2022 Priority

Review documents

  • 0 · Supplement · August 11, 2026
  • 0 · Supplement · August 7, 2026
  • 0 · Supplement · June 23, 2026
  • 0 · Supplement · June 23, 2026
  • 0 · Supplement · January 2, 2026
  • 0 · Supplement · January 7, 2025
  • 0 · Supplement · January 6, 2025
  • 0 · Original application · March 17, 2022
  • 0 · Original application · February 18, 2022
  • 0 · Original application · February 17, 2022

Packaging and NDCs

Source: NDC Directory
Every National Drug Code package associated with this medication. The NDC is the identifier used for dispensing, billing and pharmacovigilance in the United States.
Package NDC Product NDC Labeler Description Marketing start
71334-225-12 71334-225 Agios Pharmaceuticals, Inc. 1 KIT in 1 CARTON (71334-225-12) * 7 TABLET, FILM COATED in 1 BLISTER PACK (71334-210-07) * 7 TABLET, FILM COATED in 1 BLISTER PACK (71334-205-07) February 18, 2022
71334-230-13 71334-230 Agios Pharmaceuticals, Inc. 1 KIT in 1 CARTON (71334-230-13) * 7 TABLET, FILM COATED in 1 BLISTER PACK (71334-215-07) * 7 TABLET, FILM COATED in 1 BLISTER PACK (71334-210-07) February 18, 2022
71334-225 71334-225 Agios Pharmaceuticals, Inc. — February 18, 2022
71334-230 71334-230 Agios Pharmaceuticals, Inc. — February 18, 2022

Sources for this page

Every dataset that contributed a fact to this page.
Dataset Agency Used for
NDC Directory FDA Identity, ingredients, strengths, forms, routes, labelers, packages
Drugs@FDA FDA Application, sponsor, submissions, review documents, marketing status
Orange Book FDA Therapeutic equivalence codes, reference drug flags, patents, exclusivity

Generated September 25, 2026 · 9 sections on this page.