Palsonify is a drug owned by Crinetics Pharmaceuticals Inc. It is protected by 9 US drug patents filed in 2025 out of which none have expired yet. Palsonify's patents will be open to challenges from 25 September, 2029. Based on its patents and exclusivities, its generic launch date is estimated to be Mar 25, 2044. Details of Palsonify'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. | |||
| US10464918 | Process Of Making Somatostatin Modulators |
Jan, 2039
(12 years from now) | Active |
| US11414397 | Somatostatin Modulators And Uses Thereof |
Jul, 2037
(11 years from now) | Active |
| US10597377 | Somatostatin Modulators And Uses Thereof |
Jul, 2037
(11 years from now) | Active |
| US9896432 | Somatostatin Modulators And Uses Thereof |
Jul, 2037
(11 years from now) | Active |
| US10351547 | Somatostatin Modulators And Uses Thereof |
Jul, 2037
(11 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). | |||
| US12208092 | Compositions And Methods For Administering Paltusotine To Patients With Hepatic Impairment |
Mar, 2044
(18 years from now) | Active |
| US11957674 | Formulations Of A Somatostatin Modulator |
Sep, 2041
(15 years from now) | Active |
| US11266641 | NA |
Sep, 2041
(15 years from now) | Active |
| US10875839 | Somatostatin Modulators And Uses Thereof |
Jul, 2037
(11 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 Palsonify's patents.
Latest Legal Activities on Palsonify's Patents
Given below is the list of recent legal activities going on the following patents of Palsonify.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 4th Year, Large Entity | 18 Aug, 2025 | US11414397 |
| Patent eCofC Notification | 22 Apr, 2025 | US10464918 |
| Email Notification | 22 Apr, 2025 | US10351547 |
| Recordation of Patent eCertificate of Correction | 22 Apr, 2025 | US10464918 |
| Recordation of Patent eCertificate of Correction | 22 Apr, 2025 | US10351547 |
| Patent eCofC Notification | 22 Apr, 2025 | US10351547 |
| Mail Patent eCofC Notification | 22 Apr, 2025 | US10464918 |
| Mail Patent eCofC Notification | 22 Apr, 2025 | US10351547 |
| Email Notification | 22 Apr, 2025 | US10464918 |
| Email Notification | 22 Apr, 2025 | US11414397 |
FDA has granted several exclusivities to Palsonify. Till the time
these exclusivities
are active, no other company can market a generic or bioequivalent version of Palsonify, 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
Palsonify.
Exclusivity Information
Palsonify holds 1 exclusivities out of which none have expired. Its last outstanding exclusivity is set to expire in 2030. Details of Palsonify's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Chemical Entity Exclusivity(NCE) | Sep 25, 2030 |
US patents provide insights into the exclusivity only within the United States, but
Palsonify 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 Palsonify's family patents as well as insights into
ongoing legal events
on those patents.
Palsonify's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Palsonify's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Mar 25, 2044 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Palsonify Generics:
There are no approved generic versions for Palsonify as of now.
About Palsonify
Palsonify is a drug owned by Crinetics Pharmaceuticals Inc. Palsonify uses Paltusotine Hydrochloride as an active ingredient. Palsonify was launched by Crinetics in 2025.
Approval Date:
Palsonify was approved by FDA for market use on 25 September, 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 Palsonify is 25 September, 2025, its NCE-1 date is estimated to be 25 September, 2029.
Active Ingredient:
Palsonify uses Paltusotine Hydrochloride as the active ingredient. Check out other Drugs and Companies using Paltusotine Hydrochloride ingredient
Dosage:
Palsonify is available in tablet form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| EQ 20MG BASE | TABLET | Prescription | ORAL |
| EQ 30MG BASE | TABLET | Prescription | ORAL |