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Acetaminophen - Generic Drug Details

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Acetaminophen is the generic ingredient in one hundred and five branded drugs marketed by Ohm Labs, Polymedica, Paddock Llc, Sun Pharm Inds Ltd, Able, Perrigo New York, Roxane, G And W Labs, Aurobindo Pharma Ltd, Taro Pharms North, Mallinckrodt Ip, Sandoz Inc, J And J Consumer Inc, Fresenius Kabi Usa, Perrigo, Ortho Mcneil Pharm, Glaxosmithkline Cons, Scherer Labs, Mikart, Mallinckrodt, Valeant, Cnty Line Pharms, Mayrand, Watson Labs, Nexgen Pharma, Dunhall, Halsey, Larken Labs Inc, Mikart Inc, Forest Pharms, Sun Pharm Inds, Mayne Pharma Inc, Vintage Pharms, Us Chem, Actavis Labs Ut Inc, Nuvo Pharm Inc, Hikma Pharms Llc, Gilbert Labs, Shire, Graham Dm, Lannett Holdings Inc, Ingenus Pharms Nj, Mirror Pharms Llc, Hikma Intl Pharms, Nexgen Pharma Inc, Boca Pharma Llc, West-ward Pharm Corp, Leitner Pharms, Pharm Res Assoc, Wraser Pharms Llc, Novartis, Aurolife Pharma Llc, Vintage, Wockhardt, Warner Chilcott, Whiteworth Town Plsn, Pharm Assoc, Vangard, Everylife, Sandoz, Hi Tech Pharma, Mallinckrodt Inc, Usl Pharma, Duramed Pharms Barr, Teva, Valeant Pharms Llc, Lederle, Watson Labs Florida, Carnrick, Robins Ah, Glaxosmithkline, Mutual Pharm, Superpharm, Janssen Pharms, Actavis Mid Atlantic, Puracap Pharm, Kv Pharm, Frontida Biopharm, Vitarine, Am Therap, Amneal Pharms Ny, Purepac Pharm, Solvay, Valeant Pharm Intl, Dava Pharms Inc, Schering Plough, Ucb Inc, Par Pharm, Ivax Pharms, Barr, Tris Pharma Inc, Abbvie, Sun Pharm Inds Inc, Ranbaxy Labs Ltd, Ranbaxy, Vistapharm, Allergan Sales Llc, Cent Pharms, Caraco, Nesher Pharms, Abbott, Cypress Pharm Inc, Actavis Labs Fl Inc, Abana, Ascher, Vintage Pharms Llc, Rhodes Pharms, Actavis Elizabeth, Bristol Myers Squibb, Alvogen Malta, Gavis Pharms, Sanofi Aventis Us, Aaipharma Llc, Mylan, Mirror Pharms, Xanodyne Pharm, Cornerstone, Mylan Pharms Inc, Ivax Sub Teva Pharms, Wockhardt Ltd, Micro Labs Ltd India, Zydus Pharms Usa Inc, Atlas Pharms Llc, Apotex Inc, and Amneal Pharms, and is included in four hundred and thirty-nine NDAs. There are sixteen patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

This ingredient has forty-eight patent family members in twenty-five countries.

There are sixty-five drug master file entries for acetaminophen. Seventy suppliers are listed for this compound.

Summary for Generic Name: acetaminophen

Tradenames:105
Patents:16
Applicants:125
NDAs:439
Drug Master File Entries: see list65
Suppliers / Packaging: see list70
Formulation / Manufacturing:see details
Drug Prices:see low prices
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Am Therap
ACETAMINOPHEN AND CODEINE PHOSPHATE
acetaminophen; codeine phosphate
TABLET;ORAL089482-001Mar 3, 1987DISCNNo► subscribe► subscribe
Janssen Pharms
ULTRACET
acetaminophen; tramadol hydrochloride
TABLET;ORAL021123-001Aug 15, 2001RXYes► subscribe► subscribe
Aurolife Pharma Llc
OXYCODONE AND ACETAMINOPHEN
acetaminophen; oxycodone hydrochloride
TABLET;ORAL201972-003Jul 15, 2013RXNo► subscribe► subscribe
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Expired Orange Book Patents for Generic Ingredient: acetaminophen

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
J And J Consumer Inc
TYLENOL
acetaminophen
TABLET, EXTENDED RELEASE;ORAL019872-001Jun 8, 19944,820,522► subscribe
J And J Consumer Inc
TYLENOL
acetaminophen
TABLET, EXTENDED RELEASE;ORAL019872-001Jun 8, 19945,004,613► subscribe
J And J Consumer Inc
TYLENOL
acetaminophen
TABLET, EXTENDED RELEASE;ORAL019872-001Jun 8, 19944,968,509► subscribe
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International Patent Family for Ingredient: acetaminophen

Country Document Number Estimated Expiration
Yugoslavia103► subscribe
Canada2705733► subscribe
World Intellectual Property Organization (WIPO)0193830► subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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