Trial #	Patent	Type	Petitioner	Status	Filed	Decision
PGR2020-00064	10478453	PGR	Eton Pharmaceuticals, Inc.	Institution Denied	2020-05-19	—
PGR2020-00068	10583155	PGR	Eton Pharmaceuticals Inc.	Institution Denied	2020-06-08	—
PGR2020-00086	10653719	PGR	Eton Pharmaceuticals, Inc.	Institution Denied	2020-09-21	—
PGR2024-00016	11642370	PGR	Nexus Pharmaceuticals LLC	Institution Denied	2024-02-08	2024-08-08

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

API Supply Chain0 active DMFs1 inactive

0 active API suppliers hold Drug Master Files for this ingredient. Limited supplier base — potential supply chain risk.

NIPPON RIKAGAKUYAKUHIN CO LTDInactiveCYSTEINE HYDROCHLORIDE

DMF 107411994

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

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Dec 17, 2019	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 500MG/10ML (50MG/ML)

RLD

19 patents0 exclusivities▴

SOLUTION;INTRAVENOUS | Approved: Dec 13, 2019

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
10478453	Jan 15, 2039	—	—	Yes		—
10493051	Mar 15, 2039	—	—	Yes	—	—
10543186	Mar 15, 2039	—	—	—		—
10583155	Jan 15, 2039	—	—	Yes		—
10653719	Jan 15, 2039	—	—	Yes	—	—
10702490	Mar 15, 2039	—	—	Yes	—	—
10905713	Jan 15, 2039	—	—	Yes	—	—
10905714	Jan 15, 2039	—	—	Yes	—	—
10912795	Jan 15, 2039	—	—	Yes	—	—
10918662	Jan 15, 2039	—	—	Yes	—	—
10933089	Jan 15, 2039	—	—	Yes	—	—
11045438	Mar 15, 2039	—	—	Yes	—	—
11510941	Mar 2, 2039	—	—	Yes	—	—
11510942	Jan 15, 2039	—	—	Yes		—
11642370	Jan 15, 2039	—	—	Yes	—	—
11648262	Jan 15, 2039	—	—	Yes	—	—
11679125	Jan 15, 2039	—	—	Yes	—	—
11684636	Jan 15, 2039	—	—	Yes	—	—
11826383	Jan 15, 2039	—	—	Yes	—	—