Viewing data from:

CETYLEV

NDA

ACETYLCYSTEINE | N207916 | ARBOR PHARMACEUTICALS LLC

2 strengths3 unique patents0 unique exclusivities

Patent Timeline

3 unique patents by expiration date

Active (3)Today

2027

2028

2029

2030

2031

2032

Today

8747894

May. 8, 2032

9427421

May. 8, 2032

9561204

May. 8, 2032

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

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.

Approval Letters

2 letters from Drugs@FDA

Date	Submission	Document
Apr 19, 2017	SUPPL -3	View Letter (PDF)
Feb 2, 2016	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — 500MG

RLD

3 patents0 exclusivities▴

TABLET, EFFERVESCENT;ORAL | Approved: Jan 29, 2016

Patents (3)

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
8747894	May 8, 2032	—	—	Yes		—
9427421	May 8, 2032	—	—	Yes	—	—
9561204	May 8, 2032	—	—	—		—

#002 — 2.5GM

RLD

3 patents0 exclusivities▾

TABLET, EFFERVESCENT;ORAL | Approved: Jan 29, 2016