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Generated: October 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, Gilbert Labs, Shire, Graham Dm, Lannett Holdings Inc, Novast Labs Ltd, 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, Allied Pharma Inc, Anda Repository, 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, Apogee Pharma, Apotex Inc, and Macleods Pharms Ltd, and is included in four hundred and fifty-six 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 fifty patent family members in twenty-six countries.

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

Summary for Generic Name: acetaminophen

US Patents:18
Tradenames:104
Applicants:134
NDAs:456
Drug Master File Entries: see list66
Suppliers / Packagers: see list71
Bulk Api Vendors: see list114
Clinical Trials: see list724
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
Mutual Pharm
ACETAMINOPHEN AND CODEINE PHOSPHATE
acetaminophen; codeine phosphate
TABLET;ORAL087653-001Apr 13, 1982DISCNNoNo► Subscribe► Subscribe► Subscribe
Janssen Pharms
ULTRACET
acetaminophen; tramadol hydrochloride
TABLET;ORAL021123-001Aug 15, 2001ABRXYesYes► Subscribe► Subscribe► Subscribe
Am Therap
ACETAMINOPHEN AND CODEINE PHOSPHATE
acetaminophen; codeine phosphate
TABLET;ORAL089478-001Mar 3, 1987DISCNNoNo► Subscribe► Subscribe► Subscribe
Abhai Llc
HYDROCODONE BITARTRATE AND ACETAMINOPHEN
acetaminophen; hydrocodone bitartrate
TABLET;ORAL209037-003Jun 21, 2017AARXNoNo► Subscribe► Subscribe► Subscribe
Hikma Intl Pharms
BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE
acetaminophen; butalbital; caffeine; codeine phosphate
CAPSULE;ORAL075618-001Mar 23, 2001ABRXNoNo► Subscribe► Subscribe► Subscribe
Ucb Inc
HYDROCODONE BITARTRATE AND ACETAMINOPHEN
acetaminophen; hydrocodone bitartrate
TABLET;ORAL040134-001Nov 21, 1996DISCNNoNo► Subscribe► Subscribe► Subscribe
Am Therap
ACETAMINOPHEN AND CODEINE PHOSPHATE
acetaminophen; codeine phosphate
TABLET;ORAL089479-001Mar 3, 1987DISCNNoNo► Subscribe► Subscribe► Subscribe
Able
HYDROCODONE BITARTRATE AND ACETAMINOPHEN
acetaminophen; hydrocodone bitartrate
TABLET;ORAL040464-002Oct 23, 2002DISCNNoNo► Subscribe► Subscribe► Subscribe
Mallinckrodt
PROPOXYPHENE NAPSYLATE AND ACETAMINOPHEN
acetaminophen; propoxyphene napsylate
TABLET;ORAL075738-001Feb 2, 2001DISCNNoNo► Subscribe► Subscribe► Subscribe
Forest Pharms
BANCAP
acetaminophen; butalbital
CAPSULE;ORAL088889-001Jan 16, 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
Japan2010163462► Subscribe
Canada2233924► Subscribe
China1556694► Subscribe
Algeria3384► Subscribe
World Intellectual Property Organization (WIPO)0193830► Subscribe
European Patent Office0858329► Subscribe
Brazil9702362► Subscribe
Australia6612001► Subscribe
Hungary9901893► Subscribe
Australia742576► 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 leading biopharmaceutical companies globally:

Mallinckrodt
Baxter
Deloitte
Chinese Patent Office
UBS
QuintilesIMS
US Army
Johnson and Johnson
Chubb
Daiichi Sankyo

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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