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Last Updated: September 27, 2021

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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 freedom to operate?

Acetaminophen is the generic ingredient in one hundred and five branded drugs marketed by Ortho Mcneil Pharm, Mylan Labs Ltd, Aurobindo Pharma Ltd, B Braun Medical Inc, Custopharm Inc, Fresenius Kabi Usa, Mylan, Sandoz Inc, Mallinckrodt Hosp, Cosette, Able, Acino Prods, Perrigo New York, Taro Pharm Inds Ltd, Polymedica, J And J Consumer Inc, Granules, Heritage 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, Watson Labs, Mayrand, Shire, Aurolife Pharma Llc, Gilbert Labs, Graham Dm, Hikma, Lannett Co Inc, Nuvo Pharms Inc, 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 Healthcare Ltd, Actavis Mid Atlantic, Akorn, Anda Repository, 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, Vintage, Vitarine, Warner Chilcott, Watson Labs Florida, Whiteworth Town Plsn, Carnrick, Glaxosmithkline, Vangard, Janssen Pharms, Schering Plough, Cent Pharms, Ivax Pharms, Genus, Mallinckrodt Inc, Vistapharm, Wes Pharma Inc, Cypress Pharm Inc, Ucb Inc, Ascher, Actavis Labs Fl Inc, Alvogen Pine Brook, Amneal Pharms, Apil, Ascent Pharms Inc, Barr, Caraco, Cerovene Inc, Epic Pharma Llc, Novel Labs Inc, Par Pharm, Ranbaxy, Ranbaxy Labs Ltd, Sun Pharm Inds Inc, Tris Pharma Inc, Upsher Smith Labs, Vintage Pharms Llc, Abana, Abbott, Abbvie, Actavis Elizabeth, Mikart Inc, Bristol Myers Squibb, Chartwell, Gavis Pharms, Sanofi Aventis Us, Aaipharma Llc, Xanodyne Pharm, Cornerstone, Ivax Sub Teva Pharms, Mirror Pharms, Mylan Pharms Inc, Wockhardt Ltd, Alkem Labs Ltd, Macleods Pharms Ltd, Micro Labs Ltd India, Rising, and Zydus Pharms Usa Inc, and is included in four hundred and ninety-nine NDAs. There are twenty-three patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Acetaminophen has thirty-six patent family members in twenty-four countries.

There are sixty-six drug master file entries for acetaminophen. Seventy-four suppliers are listed for this compound. There are two tentative approvals for this compound.

Summary for acetaminophen
International Patents:36
US Patents:23
Tradenames:105
Applicants:148
NDAs:499
Drug Master File Entries: 66
Finished Product Suppliers / Packagers: 74
Raw Ingredient (Bulk) Api Vendors: 154
Clinical Trials: 1,081
Patent Applications: 4,871
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
Uniformed Services University of the Health SciencesPhase 2
Laboratorios Silanes S.A. de C.V.Phase 3
Lisa Dean Moseley FoundationPhase 3

See all acetaminophen clinical trials

Generic filers with tentative approvals for ACETAMINOPHEN
Applicant Application No. Strength Dosage Form
⤷  Try it Free⤷  Try it Free325MG; 7.5MGTABLET, EXTENDED RELEASE;ORAL
⤷  Try it Free⤷  Try it Free1GM/100ML (10MG/ML)SOLUTION;INTRAVENOUS

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 NDA Submissiondate
OFIRMEV SOLUTION;INTRAVENOUS acetaminophen 022450 2011-04-07
TYLENOL TABLET, EXTENDED RELEASE;ORAL acetaminophen 019872

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
Ortho Mcneil Pharm TYLENOL W/ CODEINE NO. 4 acetaminophen; codeine phosphate CAPSULE;ORAL 087421-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Mallinckrodt Inc XARTEMIS XR acetaminophen; oxycodone hydrochloride TABLET, EXTENDED RELEASE;ORAL 204031-001 Mar 11, 2014 DISCN Yes No ⤷  Try it Free ⤷  Try it Free Y ⤷  Try it Free
Aurolife Pharma Llc ACETAMINOPHEN AND CODEINE PHOSPHATE acetaminophen; codeine phosphate TABLET;ORAL 202800-001 Apr 15, 2013 AA RX No No ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Wes Pharma Inc HYDROCODONE BITARTRATE AND ACETAMINOPHEN acetaminophen; hydrocodone bitartrate TABLET;ORAL 210211-003 Oct 30, 2017 AA RX No No ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Mayne Pharma Inc OXYCODONE AND ACETAMINOPHEN acetaminophen; oxycodone hydrochloride TABLET;ORAL 090177-006 Oct 20, 2008 DISCN No No ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Hikma ROXICET acetaminophen; oxycodone hydrochloride SOLUTION;ORAL 089351-001 Dec 3, 1986 DISCN No No ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Vintage Pharms Llc OXYCODONE AND ACETAMINOPHEN acetaminophen; oxycodone hydrochloride CAPSULE;ORAL 040303-001 Dec 30, 1999 DISCN No No ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
>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
Mallinckrodt Hosp OFIRMEV acetaminophen SOLUTION;INTRAVENOUS 022450-001 Nov 2, 2010 ⤷  Try it Free ⤷  Try it Free
J And J Consumer Inc TYLENOL acetaminophen TABLET, EXTENDED RELEASE;ORAL 019872-001 Jun 8, 1994 ⤷  Try it Free ⤷  Try it Free
J And J Consumer Inc TYLENOL acetaminophen TABLET, EXTENDED RELEASE;ORAL 019872-001 Jun 8, 1994 ⤷  Try it Free ⤷  Try it Free
J And J Consumer Inc TYLENOL acetaminophen TABLET, EXTENDED RELEASE;ORAL 019872-001 Jun 8, 1994 ⤷  Try it Free ⤷  Try it Free
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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Serving leading biopharmaceutical companies globally:

McKinsey
Moodys
Baxter
Colorcon
Boehringer Ingelheim
Johnson and Johnson

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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Preferred Citation:

Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2021, www.DrugPatentWatch.com.

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