Pyrukynd is a drug owned by Agios Pharmaceuticals Inc. It is protected by 10 US drug patents filed from 2022 to 2024 out of which none have expired yet. Pyrukynd's patents will be open to challenges from 17 February, 2026. Based on its patents and exclusivities, its generic launch date is estimated to be Jul 31, 2041. Details of Pyrukynd'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
(13 years from now) | Active |
| US8785450 | Therapeutic compounds and compositions |
Feb, 2031
(5 years from now) | Active |
| USRE49582 | Therapeutic compounds and compositions |
Feb, 2031
(5 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 |
| US11234976 | Methods of using pyruvate kinase activators |
Oct, 2038
(12 years from now) | Active |
| US11793806 | Pyruvate kinase activators for use in therapy |
Apr, 2033
(7 years from now) | Active |
| US9193701 | Pyruvate kinase activators for use in therapy |
Oct, 2032
(6 years from now) | Active |
| US9682080 | Pyruvate kinase activators for use in therapy |
May, 2032
(6 years from now) | Active |
| US9980961 | Pyruvate kinase activators for use in therapy |
May, 2032
(6 years from now) | Active |
| US10632114 | 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 Pyrukynd's patents.
Latest Legal Activities on Pyrukynd's Patents
Given below is the list of recent legal activities going on the following patents of Pyrukynd.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| transaction for FDA Determination of Regulatory Review Period | 14 Mar, 2024 | US9193701 |
| transaction for FDA Determination of Regulatory Review Period | 28 Feb, 2024 | US9193701 |
| Mail Patent eCofC Notification | 27 Feb, 2024 | US11878049 |
| Recordation of Patent eCertificate of Correction | 27 Feb, 2024 | US11878049 |
| Patent eCofC Notification | 27 Feb, 2024 | US11878049 |
| Email Notification
Critical | 27 Feb, 2024 | US11878049 |
| Post Issue Communication - Certificate of Correction | 05 Feb, 2024 | US11878049 |
| Mail Patent eGrant Notification | 23 Jan, 2024 | US11878049 |
| Email Notification
Critical | 23 Jan, 2024 | US11878049 |
| Patent eGrant Notification | 23 Jan, 2024 | US11878049 |
FDA has granted several exclusivities to Pyrukynd. Till the time
these exclusivities
are active, no other company can market a generic or bioequivalent version of Pyrukynd, 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
Pyrukynd.
Exclusivity Information
Pyrukynd holds 2 exclusivities out of which none have expired. Its last outstanding exclusivity is set to expire in 2029. Details of Pyrukynd's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Chemical Entity Exclusivity(NCE) | Feb 17, 2027 |
| Orphan Drug Exclusivity(ODE-392) | Feb 17, 2029 |
US patents provide insights into the exclusivity only within the United States, but
Pyrukynd 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 Pyrukynd's family patents as well as insights into
ongoing legal events
on those patents.
Pyrukynd's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Pyrukynd'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)
Pyrukynd Generics:
There are no approved generic versions for Pyrukynd as of now.
About Pyrukynd
Pyrukynd is a drug owned by Agios Pharmaceuticals Inc. It is used for treating hemolytic anemia in adults with pyruvate kinase (PK) deficiency. Pyrukynd uses Mitapivat Sulfate as an active ingredient. Pyrukynd was launched by Agios Pharms Inc in 2022.
Approval Date:
Pyrukynd was approved by FDA for market use on 17 February, 2022.
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 Pyrukynd is 17 February, 2022, its NCE-1 date is estimated to be 17 February, 2026.
Active Ingredient:
Pyrukynd uses Mitapivat Sulfate as the active ingredient. Check out other Drugs and Companies using Mitapivat Sulfate ingredient
Treatment:
Pyrukynd is used for treating hemolytic anemia in adults with pyruvate kinase (PK) deficiency.
Dosage:
Pyrukynd is available in tablet form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| EQ 5MG BASE | TABLET | Prescription | ORAL |
| EQ 20MG BASE | TABLET | Prescription | ORAL |
| EQ 50MG BASE | TABLET | Prescription | ORAL |