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Last Updated: July 27, 2024

Acetaminophen - Generic Drug Details


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What are the generic sources for acetaminophen and what is the scope of patent protection?

Acetaminophen is the generic ingredient in one hundred and eight branded drugs marketed by Ortho Mcneil Pharm, Rising, Aspiro, B Braun Medical Inc, Baxter Hlthcare Corp, Eugia Pharma, Fresenius Kabi Usa, Hikma, Inforlife, Mylan, Sandoz, Wockhardt Bio Ag, Zydus Pharms, Mallinckrodt Hosp, Cosette, Able, Acino Prods, Perrigo New York, Taro, Polymedica, J And J Consumer Inc, Aurobindo Pharma, Granules, Heritage Pharma, Marksans Pharma, Ohm Labs, Perrigo, Sun Pharm Inds Ltd, Aurobindo Pharma Ltd, Haleon Us Holdings, Mikart, Scherer Labs, Zevra Therap, Forest Pharms, Mallinckrodt, Dr Reddys Labs Sa, Valeant, Dunhall, Larken Labs Inc, Alvogen, Halsey, Lgm Pharma, Ne Rx Pharma, Quagen, Senores Pharms, Watson Labs, Mayrand, Shire, Aurolife Pharma Llc, Gilbert Labs, Graham Dm, Key Therap, Lannett Co Inc, Novast Labs, Nuvo Pharms Inc, 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, Genus Lifesciences, Valeant Pharms Llc, Am Therap, Amneal Pharms Ny, Duramed Pharms Barr, Elite Labs Inc, Everylife, Fosun Pharma, Kv Pharm, Lederle, Mutual Pharm, Puracap Pharm, Purepac Pharm, Rhodes Pharms, Roxane, Superpharm, Usl Pharma, Valeant Pharm Intl, Vitarine, Warner Chilcott, Watson Labs Florida, Wes Pharma Inc, Whiteworth Town Plsn, Carnrick, Glaxosmithkline, Vangard, Janssen Pharms, Schering Plough, Cent Pharms, Ivax Pharms, Genus, Mallinckrodt Inc, Pharm Assoc, Tris Pharma Inc, Cypress Pharm Inc, Ucb Inc, Ascher, Actavis Labs Fl Inc, Amneal Pharms, 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, Bionpharma, Glenmark Pharms Ltd, L Perrigo Co, Aft Pharms Ltd, Actavis Elizabeth, Bristol Myers Squibb, Endo Operations, Gavis Pharms, Sanofi Aventis Us, Aaipharma Llc, Xanodyne Pharm, Cornerstone, Ivax Sub Teva Pharms, Mirror Pharms, Mylan Pharms Inc, Wockhardt Ltd, Alkem Labs Ltd, Chartwell Rx, Graviti Pharms, Macleods Pharms Ltd, Micro Labs Ltd India, and Zydus Pharms Usa Inc, and is included in five hundred and twenty-seven NDAs. There are thirty 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. Ninety-four suppliers are listed for this compound. There is one tentative approval for this compound.

Summary for acetaminophen
International Patents:21
US Patents:30
Tradenames:108
Applicants:159
NDAs:527
Drug Master File Entries: 66
Finished Product Suppliers / Packagers: 94
Raw Ingredient (Bulk) Api Vendors: 178
Clinical Trials: 1,308
Patent Applications: 5,362
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
What excipients (inactive ingredients) are in acetaminophen?acetaminophen excipients list
DailyMed Link:acetaminophen at DailyMed
Drug Prices for acetaminophen

See drug prices for acetaminophen

Drug Sales Revenue Trends for acetaminophen

See drug sales revenues for acetaminophen

Recent Clinical Trials for acetaminophen

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

SponsorPhase
University Hospital "Sestre Milosrdnice"N/A
Jessyka LighthallPhase 3
Jiangsu HengRui Medicine Co., Ltd.Phase 1

See all acetaminophen clinical trials

Generic filers with tentative approvals for ACETAMINOPHEN
Applicant Application No. Strength Dosage Form
⤷  Sign Up⤷  Sign Up325MG; 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
Analgesics, Non-Narcotic
Antipyretics
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

Glossary
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Wes Pharma Inc HYDROCODONE BITARTRATE AND ACETAMINOPHEN acetaminophen; hydrocodone bitartrate TABLET;ORAL 207509-001 Oct 29, 2018 AA RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Akorn ACETAMINOPHEN AND CODEINE PHOSPHATE acetaminophen; codeine phosphate SOLUTION;ORAL 040119-001 Apr 26, 1996 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Hikma COMBOGESIC IV acetaminophen; ibuprofen sodium SOLUTION;INTRAVENOUS 215320-001 Oct 17, 2023 RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Specgx Llc BUTALBITAL, ACETAMINOPHEN AND CAFFEINE acetaminophen; butalbital; caffeine TABLET;ORAL 087804-001 Jan 24, 1985 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Larken Labs Inc ACETAMINOPHEN, CAFFEINE AND DIHYDROCODEINE BITARTRATE acetaminophen; caffeine; dihydrocodeine bitartrate TABLET;ORAL 204209-001 Sep 30, 2016 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Actavis Mid Atlantic ACETAMINOPHEN AND CODEINE PHOSPHATE acetaminophen; codeine phosphate SOLUTION;ORAL 085861-001 Approved Prior to Jan 1, 1982 DISCN Yes No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

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

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International Patents for acetaminophen

Country Patent Number Title Estimated Expiration
European Patent Office 2243477 Paracétamol destiné à l'administration parentérale (Paracetamol for parenteral application) ⤷  Sign Up
European Patent Office 2421522 PARACÉTAMOL DESTINÉ À L'ADMINISTRATION PARENTÉRALE (PARACETAMOL FOR PARENTERAL ADMINISTRATION) ⤷  Sign Up
Poland 2421522 ⤷  Sign Up
Japan 5909750 ⤷  Sign Up
China 102421426 Paracetamol for parenteral administration ⤷  Sign Up
Australia 2010238854 Paracetamol for parenteral administration ⤷  Sign Up
>Country >Patent Number >Title >Estimated 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.

 
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Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2024, www.DrugPatentWatch.com.
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