Viewing data from:

AGAMREE

NDA

VAMOROLONE | N215239 | CATALYST PHARMACEUTICALS INC

1 strength7 unique patents2 unique exclusivities

Patent Timeline

7 unique patents, 2 exclusivities by expiration date

Active (7)TodayExclusivity

2026

2027

2028

2029

2030

2031

2032

2033

2034

2035

2036

2037

2038

2039

2040

2041

Today

May. 28, 2029

May. 28, 2029

Jul. 16, 2040

Mar. 17, 2040

Mar. 7, 2033

May. 28, 2029

Mar. 17, 2040

NCE

Oct. 26, 2028

ODE-450

Oct. 26, 2030

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

2 letters from Drugs@FDA

Date	Submission	Document
Jul 2, 2024	SUPPL -1	View Letter (PDF)
Oct 27, 2023	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 40MG/ML

RLD

7 patents2 exclusivities▴

SUSPENSION;ORAL | Approved: Oct 26, 2023

Patents (7)

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
8334279	May 28, 2029	—	—	—		—
10857161	May 28, 2029	—	—	Yes		—
11382922	Jul 16, 2040	—	Yes	Yes	—	—
11471471	Mar 17, 2040	—	—	—		—
11690853	Mar 7, 2033	—	—	—		—
11833159	May 28, 2029	—	—	Yes	—	—
12201639	Mar 17, 2040	—	Yes	Yes		—

Exclusivities (2)

Code	Date	Status
NCE	Oct 26, 2028	Active
ODE-450	Oct 26, 2030	Active