Acetylcysteine - Generic Drug Details

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What are the generic sources for acetylcysteine and what is the scope of freedom to operate?

Acetylcysteine is the generic ingredient in eight branded drugs marketed by Cumberland Pharms, Eugia Pharma, Exela Pharma, Fresenius Kabi Usa, Glenmark Pharms Inc, Indoco, Rising, Sagent Pharms Inc, Somerset Theraps Llc, Steriscience Speclts, Zydus Pharms, Alvogen, Am Regent, Hospira, Roxane, Apothecon, DEY, Arbor Pharms Llc, Galephar, and Mead Johnson, and is included in thirty NDAs. There are eight patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Acetylcysteine has nineteen patent family members in eleven countries.

There are three drug master file entries for acetylcysteine. Sixteen suppliers are listed for this compound. There is one tentative approval for this compound.

Summary for acetylcysteine

International Patents:	19
US Patents:	8
Tradenames:	8
Applicants:	20
NDAs:	30
Drug Master File Entries:	3
Finished Product Suppliers / Packagers:	16
Raw Ingredient (Bulk) Api Vendors:	158
Clinical Trials:	400
Patent Applications:	6,888
Drug Prices:	Drug price trends for acetylcysteine
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for acetylcysteine
What excipients (inactive ingredients) are in acetylcysteine?	acetylcysteine excipients list
DailyMed Link:	acetylcysteine at DailyMed

See drug prices for acetylcysteine

Recent Clinical Trials for acetylcysteine

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

Sponsor	Phase
Navamindradhiraj University	Phase 3
Air Force 986 Hospital	N/A
The First Affiliated Hospital of ShiheziI University	N/A

See all acetylcysteine clinical trials

Generic filers with tentative approvals for ACETYLCYSTEINE

Applicant	Application No.	Strength	Dosage Form
⤷ Sign Up	⤷ Sign Up	6GM/30ML (200MG/ML)	INJECTABLE;INTRAVENOUS

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for acetylcysteine

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

Medical Subject Heading (MeSH) Categories for acetylcysteine

Antiviral Agents
Expectorants
Free Radical Scavengers

Anatomical Therapeutic Chemical (ATC) Classes for acetylcysteine

Paragraph IV (Patent) Challenges for ACETYLCYSTEINE

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 acetylcysteine

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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
Arbor Pharms Llc	CETYLEV	acetylcysteine	TABLET, EFFERVESCENT;ORAL	207916-002	Jan 29, 2016		DISCN	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Somerset Theraps Llc	ACETYLCYSTEINE	acetylcysteine	INJECTABLE;INTRAVENOUS	218397-001	Jun 7, 2024	AP	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Hospira	ACETYLCYSTEINE	acetylcysteine	SOLUTION;INHALATION, ORAL	071365-001	May 1, 1989		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Galephar	LEGUBETI	acetylcysteine lysine	FOR SOLUTION;ORAL	215040-001	Feb 13, 2024		DISCN	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Sagent Pharms Inc	ACETYLCYSTEINE	acetylcysteine	INJECTABLE;INTRAVENOUS	091684-001	Oct 31, 2017	AP	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Zydus Pharms	ACETYLCYSTEINE	acetylcysteine	INJECTABLE;INTRAVENOUS	208166-001	Jul 20, 2018	AP	RX	No	No	⤷ 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 acetylcysteine

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Country	Patent Number	Title	Estimated Expiration
China	103038356	Acetycysteine compositions and methods of use thereof	⤷ Sign Up
South Korea	101408336		⤷ Sign Up
Japan	5303272		⤷ Sign Up
New Zealand	566100	Acetylcysteine composition and uses therefor	⤷ Sign Up
Philippines	12012501687	ACETYLCYSTEINE COMPOSITION AND USES THEREFOR	⤷ Sign Up
Australia	2006282030	Acetylcysteine composition and uses therefor	⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

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