Aqvesme is a drug owned by Agios Pharmaceuticals Inc. It is protected by 6 US drug patents filed in 2026 out of which none have expired yet. Aqvesme's patents have been open to challenges since 17 February, 2026. Based on its patents and exclusivities, its generic launch date is estimated to be Jul 31, 2041. Details of Aqvesme's patents and their expiration are given in the table below.
| Drug Patent Number | Drug Patent Title | Drug Patent Expiry | Status |
|---|---|---|---|
| These drug patents protect the active ingredient(API) of the drug. Only drug patent owner can launch products that use this active ingredient until these patents expire. | |||
| US11254652 | Crystalline forms of N-(4-(4-(cyclopropymethyl)piperazine-1-carbonyl)phenyl)quinoline-8-sulfonamide |
Nov, 2038
(12 years from now) | Active |
| USRE49582 | Therapeutic compounds and compositions |
Feb, 2031
(4 years from now) | Active |
| These drug patents focus on the other aspects of the drug like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
| US11878049 | Mitapivat therapy and modulators of cytochrome P450 |
Jul, 2041
(15 years from now) | Active |
| US9193701 | Pyruvate kinase activators for use in therapy |
Oct, 2032
(6 years from now) | Active |
| US10632114 | Pyruvate kinase activators for use in therapy |
May, 2032
(6 years from now) | Active |
| US9682080 | Pyruvate kinase activators for use in therapy |
May, 2032
(6 years from now) | Active |
A patent's expiry date may change depending upon legal activities going on that patent. Critical
activities like
abandoning of a patent, term extension of a patent or amendment of its claims can increase or decrease
the life of a
patent hence affecting its expiry date and in turn affecting the generic launch date of that drug.
Tracking these
ongoing activities on a patent application helps to keep an eye on the latest developments in the
patent process of
the drug which can give an idea of how early a drug's generic could be available. The next section
provides a list of
recent legal activities on Aqvesme's patents.
Latest Legal Activities on Aqvesme's Patents
Given below is the list of recent legal activities going on the following patents of Aqvesme.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 4th Year, Large Entity | 22 Aug, 2025 | US11254652 |
| Mail Patent eCofC Notification | 01 Jul, 2025 | US11254652 |
| Recordation of Patent eCertificate of Correction | 01 Jul, 2025 | US11254652 |
| Patent eCofC Notification | 01 Jul, 2025 | US11254652 |
| Email Notification | 01 Jul, 2025 | US11254652 |
| Withdrawal of Application for PTE | 25 Jun, 2025 | US9193701 |
| Post Issue Communication - Certificate of Correction | 13 Jun, 2025 | US11254652 |
| Notice of Final Determination -Election Required | 06 Jun, 2025 | US9193701 |
| Notice of Final Determination -Election Required | 06 Jun, 2025 | USRE49582 |
| FDA Final Eligibility Letter | 20 May, 2025 | US9193701 |
FDA has granted several exclusivities to Aqvesme. Till the time
these exclusivities
are active, no other company can market a generic or bioequivalent version of Aqvesme, regardless of the status of it's patents. These exclusivities hence play a crucial role in
delaying the generic
launch. Given below are details of the exclusivities granted to
Aqvesme.
Exclusivity Information
Aqvesme holds 2 exclusivities out of which none have expired. Its last outstanding exclusivity is set to expire in 2028. Details of Aqvesme's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Chemical Entity Exclusivity(NCE) | Feb 17, 2027 |
| New Product(NP) | Dec 23, 2028 |
US patents provide insights into the exclusivity only within the United States, but
Aqvesme is protected by patents in multiple countries.
Understanding
the full scope
of patent protection is crucial in strategizing market entry. By looking at the broader patent
landscape, you can
identify markets with weaker patent protection which could be ideal generic entry points. The
following section offers
details on Aqvesme's family patents as well as insights into
ongoing legal events
on those patents.
Aqvesme's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Aqvesme's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Jul 31, 2041 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Aqvesme Generics:
There are no approved generic versions for Aqvesme as of now.
Alternative Brands for Aqvesme
There are several other brand drugs using the same active ingredient (Mitapivat Sulfate) as Aqvesme. Given below is the list of those companies and their brand drugs, to help you identify new opportunities, assess competitors, and plan your market strategies more effectively.
| Drug Owner | Drug Name | |
|---|---|---|
| Agios Pharms Inc |
|
About Aqvesme
Aqvesme is a drug owned by Agios Pharmaceuticals Inc. Aqvesme uses Mitapivat Sulfate as an active ingredient. Aqvesme was launched by Agios in 2025.
Approval Date:
Aqvesme was approved by FDA for market use on 23 December, 2025.
NCE-1 date:
NCE-1 date also known as the four year date occurs four years after the original drug approval and marks the first opportunity for a generic manufacturer to file an ANDA with a Paragraph IV certification. This is the earliest point when generic competition might begin, provided the challenge is successful. Since the approval date for Aqvesme is 23 December, 2025, its NCE-1 date is estimated to be 17 February, 2026.
Active Ingredient:
Aqvesme uses Mitapivat Sulfate as the active ingredient. Check out other Drugs and Companies using Mitapivat Sulfate ingredient
Dosage:
Aqvesme is available in tablet form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| EQ 100MG BASE | TABLET | Prescription | ORAL |