➤ Get the DrugPatentWatch Daily Briefing

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

Serving leading biopharmaceutical companies globally:

Johnson and Johnson
Boehringer Ingelheim
McKesson
Mallinckrodt
Moodys
Baxter

Last Updated: July 6, 2020

DrugPatentWatch Database Preview

ACETAMINOPHEN Drug Profile


Email this page to a colleague

» See Plans and Pricing

« Back to Dashboard

Which patents cover Acetaminophen, and when can generic versions of Acetaminophen launch?

Acetaminophen is a drug marketed by Custopharm Inc, Fresenius Kabi Usa, Sandoz Inc, Able, Acino Prods, Perrigo New York, Taro Pharm Inds Ltd, Aurobindo Pharma Ltd, Granules India Ltd, Heritage Pharma, Ohm Labs, Perrigo, Sun Pharm Inds Ltd, Teva, Aci Healthcare Ltd, Actavis Mid Atlantic, Anda Repository, Dava Pharms Inc, Hi Tech Pharma, Lannett Co Inc, Pharm Assoc, Wockhardt Bio Ag, Am Therap, Amneal Pharms Ny, Aurolife Pharma Llc, Duramed Pharms Barr, Elite Labs Inc, Everylife, Eywa, Fosun Pharma, Halsey, Kv Pharm, Lederle, Mikart, Mutual Pharm, Puracap Pharm, Purepac Pharm, Rhodes Pharms, Roxane, Sandoz, Specgx Llc, Superpharm, Usl Pharma, Valeant Pharm Intl, Vintage, Vintage Pharms, Vitarine, Warner Chilcott, Watson Labs, Watson Labs Florida, Whiteworth Town Plsn, Cent Pharms, Gavis Pharms, Larken Labs Inc, Wraser Pharms Llc, Boca Pharma Llc, and West-ward Pharm Corp. and is included in one hundred and twenty-two NDAs. There is one patent protecting this drug.

This drug has seventeen patent family members in twelve countries.

The generic ingredient in ACETAMINOPHEN is acetaminophen; caffeine; dihydrocodeine bitartrate. There are sixty-six drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the acetaminophen; caffeine; dihydrocodeine bitartrate profile page.

US ANDA Litigation and Generic Entry Outlook for Acetaminophen

Annual sales in 2017 were $7mm indicating the motivation for generic entry (peak sales were $30mm in 2005).

There have been eleven patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

Indicators of Generic Entry

< Available with Subscription >

  Start Trial

Drug patent expirations by year for ACETAMINOPHEN
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
Scilex Pharmaceuticals, Inc.N/A
Washington D.C. Veterans Affairs Medical CenterN/A
Pain Management Institute Bethesda-Washington-MarylandN/A

See all ACETAMINOPHEN clinical trials

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
Mutual Pharm ACETAMINOPHEN AND CODEINE PHOSPHATE acetaminophen; codeine phosphate TABLET;ORAL 085794-001 Approved Prior to Jan 1, 1982 DISCN No No   Start Trial   Start Trial   Start Trial
Superpharm ACETAMINOPHEN AND CODEINE PHOSPHATE acetaminophen; codeine phosphate TABLET;ORAL 089254-001 May 19, 1986 DISCN No No   Start Trial   Start Trial   Start Trial
Aurolife Pharma Llc ACETAMINOPHEN AND CODEINE PHOSPHATE acetaminophen; codeine phosphate TABLET;ORAL 202800-001 Apr 15, 2013 AA RX No No   Start Trial   Start Trial   Start Trial
Able ACETAMINOPHEN AND CODEINE PHOSPHATE acetaminophen; codeine phosphate TABLET;ORAL 040452-001 Aug 1, 2002 DISCN No No   Start Trial   Start Trial   Start Trial
Roxane ACETAMINOPHEN AND CODEINE PHOSPHATE acetaminophen; codeine phosphate TABLET;ORAL 089513-001 Apr 25, 1989 DISCN 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

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

Serving leading biopharmaceutical companies globally:

Johnson and Johnson
Boehringer Ingelheim
McKesson
Mallinckrodt
Moodys
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.