➤ Get the DrugPatentWatch Daily Briefing

Get Daily Updates on Generic Entry, Litigation, Biosimilars, and more …

Serving leading biopharmaceutical companies globally:

McKinsey
Boehringer Ingelheim
Express Scripts
Merck
McKesson
Dow

Last Updated: March 4, 2021

DrugPatentWatch Database Preview

Acetaminophen - Generic Drug Details

➤ Get the DrugPatentWatch Daily Briefing
» See Plans and Pricing

« Back to Dashboard

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

Acetaminophen is the generic ingredient in one hundred and five branded drugs marketed by Ortho Mcneil Pharm, Aurobindo Pharma Ltd, 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, Granules Pharms, Mayne Pharma Inc, Valeant, Dunhall, Larken Labs Inc, Cnty Line Pharms, Halsey, Lgm Pharma, Watson Labs, Mayrand, Shire, Aurolife Pharma Llc, Gilbert Labs, Graham Dm, Hikma, Lannett Co Inc, Nuvo Pharms Inc, Wraser Pharms Llc, Us Chem, Abhai Llc, Actavis Labs Ut Inc, Hikma Pharms, Mirror Pharms Llc, Nesher Pharms, Novast Labs, Specgx Llc, Strides Pharma, Sun Pharm Industries, Vintage Pharms, Hikma Intl Pharms, 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, Nostrum Labs Inc, 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, Alvogen, 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-six NDAs. There are twenty-four 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. Sixty-nine suppliers are listed for this compound. There is one tentative approval for this compound.

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
Laval UniversityPhase 3
CHU de Quebec-Universite LavalPhase 3
Fraser HealthN/A

See all acetaminophen clinical trials

Generic filers with tentative approvals for ACETAMINOPHEN
Applicant Application No. Strength Dosage Form
  Start Trial  Start Trial325MG; 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 NDA Submissiondate
OFIRMEV SOLUTION;INTRAVENOUS acetaminophen 022450 2011-04-07
TYLENOL TABLET, EXTENDED RELEASE;ORAL acetaminophen 019872

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
Cerovene Inc HYDROCODONE BITARTRATE AND ACETAMINOPHEN acetaminophen; hydrocodone bitartrate TABLET;ORAL 211690-001 Feb 7, 2020 DISCN No No   Start Trial   Start Trial   Start Trial
Vintage Pharms HYDROCODONE BITARTRATE AND ACETAMINOPHEN acetaminophen; hydrocodone bitartrate TABLET;ORAL 040656-001 Jan 19, 2006 AA RX No No   Start Trial   Start Trial   Start Trial
Nesher Pharms OXYCODONE AND ACETAMINOPHEN acetaminophen; oxycodone hydrochloride TABLET;ORAL 210079-003 Dec 28, 2017 AA RX No No   Start Trial   Start Trial   Start Trial
>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
Mallinckrodt Hosp OFIRMEV acetaminophen SOLUTION;INTRAVENOUS 022450-001 Nov 2, 2010   Start Trial   Start Trial
J And J Consumer Inc TYLENOL acetaminophen TABLET, EXTENDED RELEASE;ORAL 019872-001 Jun 8, 1994   Start Trial   Start Trial
J And J Consumer Inc TYLENOL acetaminophen TABLET, EXTENDED RELEASE;ORAL 019872-001 Jun 8, 1994   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

McKinsey
Colorcon
Mallinckrodt
Medtronic
Express Scripts
Baxter

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.