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Last Updated: August 14, 2022

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, 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.

Drug Prices for acetaminophen

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Drug Sales Revenue Trends for acetaminophen

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Recent Clinical Trials for acetaminophen

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
University of Sao Paulo General HospitalN/A
Gustavo Avila-Ortiz DDS, MS, PhDPhase 4
Osteology FoundationPhase 4

See all acetaminophen clinical trials

Generic filers with tentative approvals for ACETAMINOPHEN
Applicant Application No. Strength Dosage Form
See Plans and PricingSee Plans and Pricing325MG; 7.5MGTABLET, 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
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 See Plans and Pricing See Plans and Pricing See Plans and Pricing
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 See Plans and Pricing See Plans and Pricing See Plans and Pricing
Vintage Pharms Llc ZYDONE acetaminophen; hydrocodone bitartrate TABLET;ORAL 040288-001 Nov 27, 1998 DISCN No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

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 See Plans and Pricing See Plans and Pricing
Mallinckrodt Hosp OFIRMEV acetaminophen SOLUTION;INTRAVENOUS 022450-001 Nov 2, 2010 See Plans and Pricing See Plans and Pricing
J And J Consumer Inc TYLENOL acetaminophen TABLET, EXTENDED RELEASE;ORAL 019872-001 Jun 8, 1994 See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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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 verification 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.