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 five branded drugs marketed by Ortho Mcneil Pharm, Rising, B Braun Medical Inc, Baxter Hlthcare Corp, Custopharm Inc, Eugia Pharma, Fresenius Kabi Usa, Hikma, Mylan, Sandoz Inc, Mallinckrodt Hosp, Cosette, Able, Acino Prods, Perrigo New York, Taro Pharm Inds Ltd, Polymedica, J And J Consumer Inc, Aurobindo Pharma Ltd, Granules, Heritage Pharma, Marksans Pharma, Ohm Labs, Perrigo, Sun Pharm Inds Ltd, Glaxosmithkline Cons, Mikart, Scherer Labs, Kvk Tech Inc, Forest Pharms, Mallinckrodt, Mayne Pharma Inc, Valeant, Dunhall, Larken Labs Inc, Alvogen, Halsey, Lgm Pharma, Senores Pharms, Watson Labs, Mayrand, Shire, Aurolife Pharma Llc, Gilbert Labs, Graham Dm, Lannett Co Inc, Nuvo Pharms Inc, Riconpharma Llc, Xspire Pharma, 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, ACI, Actavis Mid Atlantic, Akorn, Chartwell, Chartwell Molecular, Dava Pharms Inc, Pharm Assoc, Wockhardt Bio Ag, Valeant Pharms Llc, Am Therap, Amneal Pharms Ny, Duramed Pharms Barr, Elite Labs Inc, Everylife, Eywa, Fosun Pharma, Kv Pharm, Lederle, Mutual Pharm, Puracap Pharm, Purepac Pharm, Rhodes Pharms, Roxane, Sandoz, Superpharm, Usl Pharma, Valeant Pharm Intl, Vitarine, Warner Chilcott, Watson Labs Florida, Whiteworth Town Plsn, Carnrick, Glaxosmithkline, Vangard, Janssen Pharms, Schering Plough, Cent Pharms, Ivax Pharms, Genus, Mallinckrodt Inc, Tris Pharma Inc, Vistapharm, Wes Pharma Inc, Cypress Pharm Inc, Ucb Inc, Ascher, Actavis Labs Fl Inc, Amneal Pharms, Anda Repository, Apil, Ascent Pharms Inc, Barr, Caraco, Cerovene Inc, Epic Pharma Llc, Novel Labs Inc, Prinston Inc, Ranbaxy, Ranbaxy Labs Ltd, Sun Pharm Inds Inc, Upsher Smith Labs, Vintage Pharms Llc, Abana, Abbott, Abbvie, 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, Graviti Pharms, Macleods Pharms Ltd, Micro Labs Ltd India, and Zydus Pharms Usa Inc, and is included in five hundred and nine NDAs. There are twenty-two 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. Eighty-four suppliers are listed for this compound. There is one tentative approval for this compound.

Summary for acetaminophen

International Patents:	21
US Patents:	22
Tradenames:	105
Applicants:	151
NDAs:	509
Drug Master File Entries:	66
Finished Product Suppliers / Packagers:	84
Raw Ingredient (Bulk) Api Vendors:	160
Clinical Trials:	1,214
Patent Applications:	6,395
Formulation / Manufacturing:	see details
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 of Sao Paulo General Hospital	N/A
Gustavo Avila-Ortiz DDS, MS, PhD	Phase 4
Osteology Foundation	Phase 4

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	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
Hikma	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	acetaminophen; butalbital; caffeine	CAPSULE;ORAL	215135-002	Mar 25, 2022	AA	RX	No	No
Scherer Labs	CODEINE, ASPIRIN, APAP FORMULA NO. 2	acetaminophen; aspirin; codeine phosphate	CAPSULE;ORAL	085640-001	Approved Prior to Jan 1, 1982		DISCN	Yes	No
Vintage Pharms Llc	ZYDONE	acetaminophen; hydrocodone bitartrate	TABLET;ORAL	040288-001	Nov 27, 1998		DISCN	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
Mallinckrodt Hosp	OFIRMEV	acetaminophen	SOLUTION;INTRAVENOUS	022450-001	Nov 2, 2010
J And J Consumer Inc	TYLENOL	acetaminophen	TABLET, EXTENDED RELEASE;ORAL	019872-001	Jun 8, 1994

International Patents for acetaminophen

Country	Patent Number	Title	Estimated Expiration
Spain	2564547
Japan	5909750
Brazil	PI1011630	paracetamol para a administração parenteral