ACETADOTE Drug Patent Profile

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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. Fifteen 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.

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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:	3,590
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

Drug patent expirations by year for ACETADOTE

Recent Clinical Trials for ACETADOTE

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

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

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

Acetylcysteine composition and uses therefor
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up

Acetylcysteine composition and uses thereof
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: METHOD OF TREATING ACETAMINOPHEN OVERDOSE WITH ACETYLCYSTEINE SOLUTIONS

Acetycysteine compositions and methods of use thereof
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: METHOD OF TREATING ACETAMINOPHEN OVERDOSE WITH ACETYLCYSTEINE SOLUTIONS

Acetylcysteine compositions and methods of use thereof
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: COMPOSITION AND METHOD FOR PROVIDING A REDUCTION IN SIDE EFFECTS FOR HUMAN PATIENTS IN NEED OF ACETYLCYSTEINE THERAPY

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Glossary

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

International Patents for ACETADOTE

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

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Country	Patent Number	Title	Estimated Expiration
Malaysia	173215	ACETYLCYSTEINE COMPOSITIONS AND METHODS OF USE THEREOF	⤷ Sign Up
Japan	2009506030		⤷ Sign Up
World Intellectual Property Organization (WIPO)	2007024311		⤷ Sign Up
China	102266316		⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration