ACETAMINOPHEN - Generic Drug Details

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

Acetaminophen is the generic ingredient in one hundred and eight branded drugs marketed by Ortho Mcneil Pharm, Rising, Aspiro, B Braun Medical Inc, Baxter Hlthcare Corp, Eugia Pharma, Fresenius Kabi Usa, Hikma, Inforlife, Mylan, Sandoz, Wockhardt Bio Ag, Zydus Pharms, Mallinckrodt Hosp, Cosette, Able, Acino Prods, Perrigo New York, Taro, Polymedica, J And J Consumer Inc, Aurobindo Pharma, Granules, Heritage Pharma, Marksans Pharma, Ohm Labs, Perrigo, Sun Pharm Inds Ltd, Aurobindo Pharma Ltd, Haleon Us Holdings, Mikart, Scherer Labs, Zevra Therap, Forest Pharms, Mallinckrodt, Dr Reddys Labs Sa, Valeant, Dunhall, Larken Labs Inc, Alvogen, Halsey, Lgm Pharma, Ne Rx Pharma, Quagen, Senores Pharms, Watson Labs, Mayrand, Shire, Aurolife Pharma Llc, Gilbert Labs, Graham Dm, Key Therap, Lannett Co Inc, Novast Labs, Nuvo Pharms Inc, Us Chem, Abhai Llc, Actavis Labs Ut Inc, Hikma Pharms, Mirror Pharms Llc, Nesher Pharms, Specgx Llc, Strides Pharma, Sun Pharm Industries, Vintage Pharms, Hikma Intl Pharms, Nostrum Labs Inc, Wraser Pharms Llc, Pharm Res Assoc, Leitner Pharms, Boca Pharma Llc, West-ward Pharm Corp, Novartis, Teva, Robins Ah, Solvay, Actavis Mid Atlantic, Chartwell, Chartwell Molecular, Dava Pharms Inc, Genus Lifesciences, Pai Holdings, Valeant Pharms Llc, Am Therap, Amneal Pharms Ny, Duramed Pharms Barr, Elite Labs Inc, Everylife, Fosun Pharma, Kv Pharm, Lederle, Mutual Pharm, Puracap Pharm, Purepac Pharm, Rhodes Pharms, Roxane, Superpharm, Usl Pharma, Valeant Pharm Intl, Vitarine, Warner Chilcott, Watson Labs Florida, Wes Pharma Inc, Whiteworth Town Plsn, Carnrick, Glaxosmithkline, Vangard, Janssen Pharms, Schering Plough, Cent Pharms, Ivax Pharms, Genus, Mallinckrodt Inc, Pharm Assoc, Tris Pharma Inc, Cypress Pharm Inc, Ucb Inc, Ascher, Actavis Labs Fl Inc, Amneal Pharms, Apil, Ascent Pharms Inc, Barr, Caraco, Endo Operations, Epic Pharma Llc, Novel Labs Inc, Prinston Inc, Ranbaxy, Ranbaxy Labs Ltd, Sanaluz, Sun Pharm Inds Inc, Upsher Smith Labs, Vintage Pharms Llc, Abana, Abbott, Abbvie, Bionpharma, Dr Reddys, Glenmark Pharms Ltd, L Perrigo Co, Aft Pharms Us, Actavis Elizabeth, Bristol Myers Squibb, Gavis Pharms, Sanofi Aventis Us, Aaipharma Llc, Xanodyne Pharm, Cornerstone, Ivax Sub Teva Pharms, Mirror Pharms, Mylan Pharms Inc, Wockhardt Ltd, Alkem Labs Ltd, Chartwell Rx, Graviti Pharms, Macleods Pharms Ltd, Micro Labs Ltd India, and Zydus Pharms Usa Inc, and is included in five hundred and twenty-eight NDAs. There are thirty-one patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Acetaminophen has twenty-one patent family members in thirteen countries.

There are sixty-six drug master file entries for acetaminophen. Ninety-six suppliers are listed for this compound. There is one tentative approval for this compound.

Summary for ACETAMINOPHEN

International Patents:	21
US Patents:	31
Tradenames:	108
Applicants:	159
NDAs:	528
Drug Master File Entries:	66
Finished Product Suppliers / Packagers:	96
Raw Ingredient (Bulk) Api Vendors:	126
Clinical Trials:	1,308
Patent Applications:	7,116
Drug Prices:	Drug price trends for ACETAMINOPHEN
Drug Sales Revenues:	Drug sales revenues for ACETAMINOPHEN
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for ACETAMINOPHEN
What excipients (inactive ingredients) are in ACETAMINOPHEN?	ACETAMINOPHEN excipients list
DailyMed Link:	ACETAMINOPHEN at DailyMed

See drug prices for ACETAMINOPHEN

See drug sales revenues for ACETAMINOPHEN

Recent Clinical Trials for ACETAMINOPHEN

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

Sponsor	Phase
University Hospital "Sestre Milosrdnice"	N/A
Jessyka Lighthall	Phase 3
Jiangsu HengRui Medicine Co., Ltd.	Phase 1

See all ACETAMINOPHEN clinical trials

Generic filers with tentative approvals for ACETAMINOPHEN

Applicant	Application No.	Strength	Dosage Form
		325MG; 7.5MG	TABLET, EXTENDED RELEASE;ORAL

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

Medical Subject Heading (MeSH) Categories for ACETAMINOPHEN

Analgesics, Non-Narcotic

Antipyretics

Paragraph IV (Patent) Challenges for ACETAMINOPHEN

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
OFIRMEV	Injection	acetaminophen	650 mg/65 mL (10 mg/mL)	022450	1	2024-07-31
OFIRMEV	Injection	acetaminophen	1000 mg/100 mL (10 mg/mL)	022450	1	2011-04-07

US Patents and Regulatory Information for ACETAMINOPHEN

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Glaxosmithkline	EMPRACET W/ CODEINE PHOSPHATE #3	acetaminophen; codeine phosphate	TABLET;ORAL	083951-001	Approved Prior to Jan 1, 1982		DISCN	No	No
Alvogen	BUTALBITAL AND ACETAMINOPHEN	acetaminophen; butalbital	TABLET;ORAL	207635-001	Jun 5, 2017		DISCN	No	No
Chartwell	OXYCODONE AND ACETAMINOPHEN	acetaminophen; oxycodone hydrochloride	TABLET;ORAL	207834-001	Aug 15, 2019	AA	RX	No	No

Expired US Patents for ACETAMINOPHEN

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
J And J Consumer Inc	TYLENOL	acetaminophen	TABLET, EXTENDED RELEASE;ORAL	019872-001	Jun 8, 1994
J And J Consumer Inc	TYLENOL	acetaminophen	TABLET, EXTENDED RELEASE;ORAL	019872-001	Jun 8, 1994
Mallinckrodt Hosp	OFIRMEV	acetaminophen	SOLUTION;INTRAVENOUS	022450-001	Nov 2, 2010

International Patents for ACETAMINOPHEN

Country	Patent Number	Title	Estimated Expiration
China	102421426	Paracetamol for parenteral administration
World Intellectual Property Organization (WIPO)	2010121762
European Patent Office	2626068	Paracétamol destiné à l'administration parentérale (Paracetamol for parenteral administration)