Viewing data from:

RILUTEK

NDA

RILUZOLE | N020599 | AZURITY PHARMACEUTICALS SWITZERLAND GMBH

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

No clinical trials found on ClinicalTrials.gov for this drug

Medicare Part D Spending

CMS annual spending data for Tiglutik (2023)

Total Spending

$3.1M

Total Claims

764

Beneficiaries

181

Avg Cost/Unit

$6.46

Spending Trend

$722K(2019)→$2.3M(2020)→$2.6M(2021)→$3.4M(2022)→$3.1M(2023)

YoY Change:+6.1%

5yr CAGR:+4.5%

Source: CMS Medicare Part D Spending by Drug (2023). Shows gross drug cost under Part D.

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.