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ACETYLCYSTEINE

ANDA

ACETYLCYSTEINE | A200644 | FRESENIUS KABI USA LLC

1 strength0 unique patents0 unique exclusivities

Reference Listed Drug: ACETADOTE(TE code: AP)

Hatch-Waxman Litigation

1 case on OB patents from PACER

Case	Court	Filed	Status	Judge
Cumberland Pharmaceuticals Inc. v. InnoPharma Inc. 1:2012cv00618 1 patentANDA 200644N-acetylcysteine	D. Del.	2012-05-17	Terminated 2013-11-01	—

Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).

API Supply Chain6 active DMFs

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

MOEHS IBERICA SLACETYLCYSTEINE USP

DMF 143041999

NIPPON RIKA CO LTDACETYLCYSTEINE DRUG SUBSTANCE

DMF 217892008

FUJIAN SOUTH PHARMACEUTICAL CO LTDACETYLCYSTEINE

DMF 379472023

ZHEJIANG JINHUA CONBA BIO-PHARM CO LTDACETYLCYSTEINE (USP)

DMF 402482024

SHANXI YANGHE PHARMACEUTICAL CO LTDACETYLCYSTEINE

DMF 415912025

ZHEJIANG HAIZHOU PHARMACEUTICAL CO LTDACETYLCYSTEINE

DMF 428222025

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

Products (1)

#001 — 6GM/30ML (200MG/ML)

0 patents0 exclusivities▴

INJECTABLE;INTRAVENOUS | Approved: Nov 7, 2012

No patent or exclusivity listings for this strength.