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Acetaminophen - Generic Drug Details

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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, Aurobindo Pharma Ltd, Custopharm Inc, Fresenius Kabi Usa, Mylan, Sandoz Inc, Mallinckrodt Hosp, Cosette, Able, Acino Prods, Perrigo New York, Taro Pharm Inds Ltd, Polymedica, J And J Consumer Inc, Granules, Heritage Pharma, Ohm Labs, Perrigo, Sun Pharm Inds Ltd, Glaxosmithkline Cons, Mikart, Scherer Labs, Kvk Tech Inc, Forest Pharms, Mallinckrodt, Granules Pharms, Mayne Pharma Inc, Valeant, Dunhall, Larken Labs Inc, Cnty Line Pharms, Halsey, Lgm Pharma, Watson Labs, Mayrand, Shire, Aurolife Pharma Llc, Gilbert Labs, Graham Dm, Hikma, Lannett Co Inc, Nuvo Pharms Inc, Wraser Pharms Llc, Us Chem, Abhai Llc, Actavis Labs Ut Inc, Hikma Pharms, Mirror Pharms Llc, Nesher Pharms, Novast Labs, Specgx Llc, Strides Pharma, Sun Pharm Industries, Vintage Pharms, Hikma Intl Pharms, Pharm Res Assoc, Leitner Pharms, Boca Pharma Llc, West-ward Pharm Corp, Novartis, Teva, Robins Ah, Solvay, Aci Healthcare Ltd, Actavis Mid Atlantic, Akorn, Anda Repository, 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, Nostrum Labs Inc, Puracap Pharm, Purepac Pharm, Rhodes Pharms, Roxane, Sandoz, Superpharm, Usl Pharma, Valeant Pharm Intl, Vintage, Vitarine, Warner Chilcott, Watson Labs Florida, Whiteworth Town Plsn, Carnrick, Glaxosmithkline, Vangard, Janssen Pharms, Schering Plough, Cent Pharms, Ivax Pharms, Genus, Mallinckrodt Inc, Vistapharm, Wes Pharma Inc, Cypress Pharm Inc, Ucb Inc, Ascher, Actavis Labs Fl Inc, Alvogen Pine Brook, Amneal Pharms, Apil, Ascent Pharms Inc, Barr, Caraco, Cerovene Inc, Epic Pharma Llc, Novel Labs Inc, Par Pharm, Ranbaxy, Ranbaxy Labs Ltd, Sun Pharm Inds Inc, Tris Pharma Inc, Upsher Smith Labs, Vintage Pharms Llc, Abana, Abbott, Abbvie, Actavis Elizabeth, Mikart Inc, Bristol Myers Squibb, Alvogen, Gavis Pharms, Sanofi Aventis Us, Aaipharma Llc, Xanodyne Pharm, Cornerstone, Ivax Sub Teva Pharms, Mirror Pharms, Mylan Pharms Inc, Wockhardt Ltd, Alkem Labs Ltd, Macleods Pharms Ltd, Micro Labs Ltd India, Rising, and Zydus Pharms Usa Inc, and is included in four hundred and ninety-six NDAs. There are twenty-four patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Acetaminophen has thirty-six patent family members in twenty-four countries.

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

Summary for acetaminophen

International Patents:	36
US Patents:	24
Tradenames:	105
Applicants:	147
NDAs:	496
Drug Master File Entries:	66
Suppliers / Packagers:	68
Bulk Api Vendors:	146
Clinical Trials:	1,031
Patent Applications:	6,564
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
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
New York City Health and Hospitals Corporation	Phase 4
Northwell Health	N/A
Alberta Children's Hospital	Phase 2

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	NDA	Submissiondate
OFIRMEV	SOLUTION;INTRAVENOUS	acetaminophen	022450	2011-04-07
TYLENOL	TABLET, EXTENDED RELEASE;ORAL	acetaminophen	019872

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
Novel Labs Inc	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	acetaminophen; hydrocodone bitartrate	TABLET;ORAL	206245-003	Dec 1, 2016	AA	RX	No	No
Par Pharm	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	acetaminophen; hydrocodone bitartrate	TABLET;ORAL	202935-002	Jun 15, 2016	AA	RX	No	No
Mirror Pharms Llc	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	acetaminophen; butalbital; caffeine	TABLET;ORAL	040883-001	Dec 23, 2008		DISCN	No	No
Mallinckrodt	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	acetaminophen; hydrocodone bitartrate	TABLET;ORAL	040084-001	Jun 1, 1995		DISCN	No	No
Dunhall	TRIAPRIN	acetaminophen; butalbital	CAPSULE;ORAL	089268-001	Jul 2, 1987		DISCN	No	No
Nesher Pharms	OXYCODONE AND ACETAMINOPHEN	acetaminophen; oxycodone hydrochloride	TABLET;ORAL	210079-003	Dec 28, 2017	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
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
J And J Consumer Inc	TYLENOL	acetaminophen	TABLET, EXTENDED RELEASE;ORAL	019872-001	Jun 8, 1994

International Patents for acetaminophen

Country	Patent Number	Estimated Expiration
China	102421426
World Intellectual Property Organization (WIPO)	2010121762
Brazil	PI1011630
France	2809619
Russian Federation	2003100090
Japan	2011503198