Viewing data from:

RILUTEK

NDA

RILUZOLE | N020599 | AZURITY PHARMACEUTICALS INC

1 strength0 unique patents0 unique exclusivities

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

53 trials from ClinicalTrials.gov — 3 recruiting, 1 active, 34 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Riluzole and Sorafenib Tosylate in Treating Patients With Advanced Solid Tumors or Melanoma NCT01303341	Phase 1	Active	National Cancer Institute (NCI)	35	2011-02-18 → 2027-09-11
Repurposing Riluzole for Cancer-Related Cognitive Impairment: A Pilot Trial NCT06580002	Phase 2	Recruiting	University of California, Irvine	75	2024-12-02 → 2027-12
Efficacy and Safety of Masitinib Versus Placebo in the Treatment of ALS Patients NCT03127267	Phase 3	Recruiting	AB Science	495	2021-02-02 → 2027-12
Riluzole in Patients With Spinocerebellar Ataxia Type 7 NCT03660917	Phase 2/3	Recruiting	S. Andrea Hospital	34	2021-06-01 → 2026-09-01
A Double-Blind Placebo Controlled Trial of Riluzole in Bipolar Depression NCT00376220	Phase 2	Completed	Johns Hopkins University	94	2004-05 → 2010-05
Acetylcholine Receptors From Human Muscles as Pharmacological Target for ALS NCT02645461	N/A	Completed	University of Roma La Sapienza	50	2014-01 → 2015-12
Effect of Riluzole as a Symptomatic Approach in Patients With Chronic Cerebellar Ataxia NCT00202397	Phase 2	Completed	S. Andrea Hospital	40	2005-06 → 2008-08
Developing New Treatments for Tourette Syndrome: Therapeutic Trials With Modulators of Glutamatergic Neurotransmission NCT01018056	Phase 4	Completed	Johns Hopkins University	39	2009-11 → 2013-09
Riluzole to Treat Child and Adolescent Obsessive-Compulsive Disorder With or Without Autism Spectrum Disorders NCT00251303	Phase 2	Completed	National Institute of Mental Health (NIMH)	78	2005-08 → 2012-02
Pilot Study of Riluzole for Drug-Refractory Irritability in Autism Spectrum Disorders NCT02081027	Early Phase 1	Completed	Children's Hospital Medical Center, Cincinnati	8	2013-09-19 → 2015-05

Source: ClinicalTrials.gov. Trials matched by ingredient name.

API Supply Chain6 active DMFs3 inactive

6 active API suppliers hold Drug Master Files for this ingredient.

SCINOPHARM TAIWAN LTDRILUZOLE USP

DMF 152522001

ALIVUS LIFE SCIENCES LTDRILUZOLE USP

DMF 221072008

SUN PHARMACEUTICAL INDUSTRIES LTDRILUZOLE USP

DMF 224382009

HETERO DRUGS LTDRILUZOLE

DMF 232152009

ALKEM LABORATORIES LTDRILUZOLE USP

DMF 252602011

SYN TECH CHEM AND PHARM CO LTDRILUZOLE

DMF 261472012

APOTEX PHARMACHEM INDIA PVT LTDInactiveRILUZOLE USP

DMF 225962009

DR REDDYS LABORATORIES LTDInactiveRILUZOLE

DMF 235692010

ESTEVE QUIMICA SAInactiveRILUZOLE

DMF 246932011

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

11 letters from Drugs@FDA

Date	Submission	Document
Sep 12, 2025	SUPPL -21	View Letter (PDF)
Sep 12, 2025	SUPPL -21	View Letter (PDF)
May 13, 2020	SUPPL -19	View Letter (PDF)
Apr 11, 2016	SUPPL -17	View Letter (PDF)
Jan 20, 2010	SUPPL -13	View Letter (PDF)
Jul 17, 2009	SUPPL -11	View Letter (PDF)
Jul 17, 2009	SUPPL -12	View Letter (PDF)
Sep 24, 2004	SUPPL -8	View Letter (PDF)
Jun 8, 2003	SUPPL -3	View Letter (PDF)
Jun 8, 2003	SUPPL -5	View Letter (PDF)
Jun 8, 2003	SUPPL -2	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 50MG

RLD

0 patents0 exclusivities▴

TABLET;ORAL | Approved: Dec 12, 1995

No patent or exclusivity listings for this strength.