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Generated: August 17, 2017

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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 acetaminophen patent protection?

Acetaminophen
is the generic ingredient in one hundred and four branded drugs marketed by Ohm Labs, Polymedica, Custopharm Inc, 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, Tedor Pharma Inc, Mayrand, Watson Labs, Nexgen Pharma, Dunhall, Halsey, Larken Labs Inc, Mikart Inc, Forest Pharms, Sun Pharm Inds, Mallinckrodt Inc, 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, 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, Abhai Llc, Amneal Pharms, Novel Labs Inc, Vistapharm, Apil, Cent Pharms, Caraco, Nesher Pharms, Abbott, Cypress Pharm Inc, Actavis Labs Fl Inc, Abana, Ascher, Vintage Pharms Llc, Upsher-smith Labs, Rhodes Pharms, Actavis Elizabeth, West-ward Pharms Int, Bristol Myers Squibb, Ascent Pharms Inc, Cerovene Inc, 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 Macleods Pharms Ltd, and is included in four hundred and fifty-four NDAs. There are eighteen patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Acetaminophen has forty-nine patent family members in twenty-six countries.

There are sixty-six drug master file entries for acetaminophen. Sixty-nine suppliers are listed for this compound.

Summary for Generic Name: acetaminophen

Tradenames:104
Patents:18
Applicants:133
NDAs:454
Drug Master File Entries: see list66
Suppliers / Packagers: see list69
Bulk Api Vendors: see list108
Clinical Trials: see list713
Patent Applications: see list9,787
Formulation / Manufacturing:see details
Drug Prices:see low prices
DailyMed Link:acetaminophen at DailyMed
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Vintage Pharms
HYDROCODONE BITARTRATE AND ACETAMINOPHEN
acetaminophen; hydrocodone bitartrate
TABLET;ORAL040144-002Apr 25, 1997DISCNNoNo► Subscribe► Subscribe► Subscribe
Halsey
PROPOXYPHENE NAPSYLATE AND ACETAMINOPHEN
acetaminophen; propoxyphene napsylate
TABLET;ORAL072106-001May 13, 1988DISCNNoNo► Subscribe► Subscribe► Subscribe
Mallinckrodt Inc
XARTEMIS XR
acetaminophen; oxycodone hydrochloride
TABLET, EXTENDED RELEASE;ORAL204031-001Mar 11, 2014RXYesYes► Subscribe► SubscribeY ► Subscribe
Aurolife Pharma Llc
ACETAMINOPHEN AND CODEINE PHOSPHATE
acetaminophen; codeine phosphate
TABLET;ORAL202800-002Apr 15, 2013AARXNoNo► Subscribe► Subscribe► Subscribe
Purepac Pharm
ACETAMINOPHEN AND CODEINE PHOSPHATE
acetaminophen; codeine phosphate
TABLET;ORAL089080-001Jul 17, 1986DISCNNoNo► Subscribe► 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, 1994► Subscribe► Subscribe
J And J Consumer Inc
TYLENOL
acetaminophen
TABLET, EXTENDED RELEASE;ORAL019872-001Jun 8, 1994► Subscribe► Subscribe
J And J Consumer Inc
TYLENOL
acetaminophen
TABLET, EXTENDED RELEASE;ORAL019872-001Jun 8, 1994► Subscribe► Subscribe
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International Patent Family for Ingredient: acetaminophen

Country Document Number Estimated Expiration
Hungary226117► Subscribe
Canada2233924► Subscribe
Czech Republic9801048► Subscribe
Peru05082003► Subscribe
African Regional IP Organization (ARIPO)9801223► 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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Serving 500+ biopharmaceutical companies globally:

Boehringer Ingelheim
Cantor Fitzgerald
US Department of Justice
Accenture
Fuji
Baxter
Argus Health
UBS
Medtronic
US Army

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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