➤ Get the DrugPatentWatch Daily Briefing

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

Serving leading biopharmaceutical companies globally:

Boehringer Ingelheim
McKesson
Baxter
Merck
Express Scripts
Mallinckrodt

Last Updated: May 18, 2021

DrugPatentWatch Database Preview

ACETAMINOPHEN - Generic Drug Details

➤ Get the DrugPatentWatch Daily Briefing
» See Plans and Pricing

« Back to Dashboard

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, 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, Xspire Pharma, 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, 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, Alvogen, 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-two 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
Western University, CanadaPhase 3

See all ACETAMINOPHEN clinical trials

Generic filers with tentative approvals for ACETAMINOPHEN
Applicant Application No. Strength Dosage Form
  Get Started Free  Get Started Free325MG; 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
Ivax Sub Teva Pharms PROPOXYPHENE NAPSYLATE AND ACETAMINOPHEN acetaminophen; propoxyphene napsylate TABLET;ORAL 070146-001 Aug 2, 1985 DISCN No No   Get Started Free   Get Started Free   Get Started Free
Amneal Pharms Ny OXYCODONE AND ACETAMINOPHEN acetaminophen; oxycodone hydrochloride TABLET;ORAL 040789-002 Nov 27, 2007 DISCN No No   Get Started Free   Get Started Free   Get Started Free
Mallinckrodt Hosp OFIRMEV acetaminophen SOLUTION;INTRAVENOUS 022450-001 Nov 2, 2010 AP RX Yes Yes   Get Started Free   Get Started Free Y   Get Started Free
Alvogen Pine Brook HYDROCODONE BITARTRATE AND ACETAMINOPHEN acetaminophen; hydrocodone bitartrate TABLET;ORAL 209958-003 Oct 24, 2018 DISCN No No   Get Started Free   Get Started Free   Get Started Free
>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   Get Started Free   Get Started Free
J And J Consumer Inc TYLENOL acetaminophen TABLET, EXTENDED RELEASE;ORAL 019872-001 Jun 8, 1994   Get Started Free   Get Started Free
Mallinckrodt Hosp OFIRMEV acetaminophen SOLUTION;INTRAVENOUS 022450-001 Nov 2, 2010   Get Started Free   Get Started Free
J And J Consumer Inc TYLENOL acetaminophen TABLET, EXTENDED RELEASE;ORAL 019872-001 Jun 8, 1994   Get Started Free   Get Started Free
>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:

Baxter
Merck
Boehringer Ingelheim
McKinsey
Moodys
AstraZeneca

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.