Is Aqvesme still available?

Yes. Aqvesme (NDA 216196) is listed with marketing status Prescription in the FDA Orange Book.

Does Aqvesme have a generic?

The FDA Orange Book does not currently list an approved generic (ANDA) sharing Aqvesme's active ingredient (Mitapivat Sulfate).

When do Aqvesme's patents expire?

The FDA Orange Book lists 6 patents against Aqvesme, with the last listed patent expiring Jul 31, 2041. A generic launching before a listed patent expires generally must file a Paragraph IV certification.

Does Aqvesme have FDA marketing exclusivity?

Yes. The Orange Book records 3 marketing-exclusivity periods for Aqvesme. Exclusivity can delay generic approval independently of any listed patents.

What is Aqvesme's FDA application number?

Aqvesme is approved under NDA 216196, held by Agios Pharms Inc.

Orange Book product · Brand (NDA)

Aqvesme

Mitapivat Sulfate

Brand (NDA)NDA 216196RLD Agios Pharms Inc

Approved

Dec 23, 2025

Application

Brand (NDA)

TE code

Not listed

Listed patents

Aqvesme (Mitapivat Sulfate) is Agios Pharms Inc's brand-name drug, approved by the FDA under NDA 216196 in 2025. It is a reference-listed drug (RLD) — the approved product that generic ANDA applicants must show their version is equivalent to. The FDA Orange Book lists 6 patents against it, the last expiring 2041. 3 marketing-exclusivity periods are recorded.

Sourced from the FDA Orange Book

Approval, patents, exclusivity

Key dates

Approval
FDA approval date of this drug product.
Dec 23, 2025
7 mo ago
Today
Exclusivity ends · NCE
New chemical entity exclusivity (5 years)
Feb 17, 2027
in 7 mo
Exclusivity ends · NP
New product exclusivity (3 years)
Dec 23, 2028
in 2 yr 6 mo
Patent 10632114 expires
Listed method-of-use patent (U-4391) expiration.
May 03, 2032
in 5 yr 11 mo
Patent 9682080 expires
Listed method-of-use patent (U-4392) expiration.
May 03, 2032
in 5 yr 11 mo
Patent 9193701 expires
Listed method-of-use patent (U-4393) expiration.
Oct 26, 2032
in 6 yr 5 mo
Exclusivity ends · ODE-522
Orphan-drug exclusivity (7 years)
Dec 23, 2032
in 6 yr 7 mo
Patent RE49582 expires
Listed drug substance patent expiration.
Apr 11, 2035
in 8 yr 10 mo
Patent 11254652 expires
Listed drug substance patent expiration.
Nov 21, 2038
in 12 yr 6 mo
Patent 11878049 expires
Listed method-of-use patent (U-4390) expiration.
Jul 31, 2041
in 15 yr 3 mo

Protection horizon

Patent & exclusivity timeline

Patent expiryExclusivity endToday

FDA product record

Pharmaceutical detail

Active ingredient

MITAPIVAT SULFATE

Strength

EQ 100MG BASE

Dosage form

TABLET

Route

ORAL

TE code

Not listed

Application

NDA 216196

Product number

004

Marketing status

Prescription

Reference listed drug (RLD)

Yes

Reference standard (RS)

Yes

Same application

Other strengths in NDA 216196

Brand + generics

Active-ingredient family

This is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.

No other applications share this active ingredient.

View full Mitapivat Sulfate family

Hatch-Waxman

Marketing exclusivity

Marketing exclusivity (3)

NCENew chemical entity exclusivity (5 years)
Feb 17, 2027
in 7 mo
NPNew product exclusivity (3 years)
Dec 23, 2028
in 2 yr 6 mo
ODE-522Orphan-drug exclusivity (7 years)
Dec 23, 2032
in 6 yr 7 mo

Orange Book patent file

Listed patents

Listed patents (6)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
Patent	Expires	In	Type
10632114	May 03, 2032	in 5 yr 11 mo	U-4391
9682080	May 03, 2032	in 5 yr 11 mo	U-4392
9193701	Oct 26, 2032	in 6 yr 5 mo	U-4393
RE49582	Apr 11, 2035	in 8 yr 10 mo	SubstanceProduct
11254652	Nov 21, 2038	in 12 yr 6 mo	SubstanceProduct
11878049	Jul 31, 2041	in 15 yr 3 mo	U-4390

Aqvesme — frequently asked questions

Approval, therapeutic equivalence, patents, and exclusivity for this product, from the FDA Orange Book.

Built directly from the FDA Orange Book data file. This product page links back to the Mitapivat Sulfate active-ingredient family, which is the canonical reference for generics, patents, and exclusivity across all strengths.

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