Viewing data from:

PALSONIFY

NDA

PALTUSOTINE HYDROCHLORIDE | N219070 | CRINETICS PHARMACEUTICALS INC

2 strengths9 unique patents2 unique exclusivities

Patent Timeline

9 unique patents, 2 exclusivities by expiration date

Active (9)TodayExclusivity

2026

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Today

Jul. 12, 2037

Jul. 12, 2037

Jan. 16, 2039

Jul. 12, 2037

Jul. 12, 2037

Sep. 7, 2041

Jul. 12, 2037

Sep. 7, 2041

Mar. 25, 2044

NCE

Sep. 25, 2030

ODE-537

Sep. 25, 2032

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

No ANDA patent litigation cases (NOS 835) matched from PACER

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Sep 26, 2025	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — EQ 20MG BASE

RLD

9 patents2 exclusivities▴

TABLET;ORAL | Approved: Sep 25, 2025

Patents (9)

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
9896432	Jul 12, 2037	—	Yes	Yes		—
10351547	Jul 12, 2037	—	Yes	Yes		—
10464918	Jan 16, 2039	—	Yes	—	—	—
10597377	Jul 12, 2037	—	Yes	Yes		—
10875839	Jul 12, 2037	—	—	—		—
11266641	Sep 7, 2041	—	—	Yes		—
11414397	Jul 12, 2037	—	Yes	Yes		—
11957674	Sep 7, 2041	—	—	—		—
12208092	Mar 25, 2044	—	—	—		—

Exclusivities (2)

Code	Date	Status
NCE	Sep 25, 2030	Active
ODE-537	Sep 25, 2032	Active

#002 — EQ 30MG BASE

RLD

9 patents2 exclusivities▾

TABLET;ORAL | Approved: Sep 25, 2025

Change History (2)

Recent changes detected for this application.

ADDED7/1/2026

Crinetics gained orphan drug exclusivity for Palsonify (paltusotine hydrochloride) upon approval of supplemental application 002 to NDA 219070.

New: New record

ADDED7/1/2026

New: New record