ACETADOTE Drug Patent Profile

Which patents cover Acetadote, and what generic alternatives are available?

Acetadote is a drug marketed by Cumberland Pharms and is included in one NDA. There are five patents protecting this drug and one Paragraph IV challenge.

This drug has eighteen patent family members in eleven countries.

The generic ingredient in ACETADOTE is acetylcysteine. There are three drug master file entries for this compound. Sixteen suppliers are listed for this compound. Additional details are available on the acetylcysteine profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Acetadote

A generic version of ACETADOTE was approved as acetylcysteine by HOSPIRA on August 30^th, 1994.

Summary for ACETADOTE

International Patents:	18
US Patents:	5
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	158
Clinical Trials:	14
Patent Applications:	3,686
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for ACETADOTE
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for ACETADOTE
What excipients (inactive ingredients) are in ACETADOTE?	ACETADOTE excipients list
DailyMed Link:	ACETADOTE at DailyMed

See drug prices for ACETADOTE

Recent Clinical Trials for ACETADOTE

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Central South University	Phase 1
University of Missouri-Columbia	Phase 1
Shandong Provincial Hospital	Phase 1

See all ACETADOTE clinical trials

Pharmacology for ACETADOTE

Drug Class	Antidote Antidote for Acetaminophen Overdose Mucolytic
Mechanism of Action	Reduction Activity
Physiological Effect	Decreased Respiratory Secretion Viscosity Increased Glutathione Concentration

Anatomical Therapeutic Chemical (ATC) Classes for ACETADOTE

R05CB	Mucolytics
R05C	EXPECTORANTS, EXCL. COMBINATIONS WITH COUGH SUPPRESSANTS
R05	COUGH AND COLD PREPARATIONS
R	Respiratory system

S01XA	Other ophthalmologicals
S01X	OTHER OPHTHALMOLOGICALS
S01	OPHTHALMOLOGICALS
S	Sensory organs

V03AB	Antidotes
V03A	ALL OTHER THERAPEUTIC PRODUCTS
V03	ALL OTHER THERAPEUTIC PRODUCTS
V	Various

Paragraph IV (Patent) Challenges for ACETADOTE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
ACETADOTE	Injection	acetylcysteine	200 mg/mL, 30 mL vials	021539	3	2012-04-04

US Patents and Regulatory Information for ACETADOTE

ACETADOTE is protected by five US patents.

Patents protecting ACETADOTE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Cumberland Pharms	ACETADOTE	acetylcysteine	INJECTABLE;INTRAVENOUS	021539-001	Jan 23, 2004	AP	RX	Yes	Yes
Cumberland Pharms	ACETADOTE	acetylcysteine	INJECTABLE;INTRAVENOUS	021539-001	Jan 23, 2004	AP	RX	Yes	Yes
Cumberland Pharms	ACETADOTE	acetylcysteine	INJECTABLE;INTRAVENOUS	021539-001	Jan 23, 2004	AP	RX	Yes	Yes
Cumberland Pharms	ACETADOTE	acetylcysteine	INJECTABLE;INTRAVENOUS	021539-001	Jan 23, 2004	AP	RX	Yes	Yes
Cumberland Pharms	ACETADOTE	acetylcysteine	INJECTABLE;INTRAVENOUS	021539-001	Jan 23, 2004	AP	RX	Yes	Yes			Y

International Patents for ACETADOTE

See the table below for patents covering ACETADOTE around the world.

Country	Patent Number	Title	Estimated Expiration
Australia	2011281035	Acetycysteine compositions and methods of use thereof
Hong Kong	1123972	乙酰半胱氨酸組合物及其用途 (ACETYLCYSTEINE COMPOSITION AND USES THEREFOR)
Japan	2009506030
South Korea	20080047398	ACETYLCYSTEINE COMPOSITION AND USES THEREFOR
European Patent Office	2596112	COMPOSITIONS D'ACÉTYLCYSTÉINE ET MÉTHODES D'UTILISATION CORRESPONDANTES (ACETYCYSTEINE COMPOSITIONS AND METHODS OF USE THEREOF)