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Last Updated: March 28, 2024

ACETAMINOPHEN Drug Patent Profile


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When do Acetaminophen patents expire, and what generic alternatives are available?

Acetaminophen is a drug marketed by Rising, Aspiro, B Braun Medical Inc, Baxter Hlthcare Corp, Eugia Pharma, Fresenius Kabi Usa, Hikma, Inforlife, Mylan, Sandoz, Wockhardt Bio Ag, Zydus Pharms, Able, Acino Prods, Perrigo New York, Taro, Aurobindo Pharma, Granules, Heritage Pharma, Marksans Pharma, Ohm Labs, Perrigo, Sun Pharm Inds Ltd, Teva, ACI, Actavis Mid Atlantic, Akorn, Chartwell, Chartwell Molecular, Dava Pharms Inc, Genus Lifesciences, Am Therap, Amneal Pharms Ny, Aurolife Pharma Llc, Duramed Pharms Barr, Elite Labs Inc, Everylife, Fosun Pharma, Halsey, Kv Pharm, Lederle, Mikart, Mutual Pharm, Nostrum Labs Inc, Puracap Pharm, Purepac Pharm, Rhodes Pharms, Roxane, Specgx Llc, Strides Pharma, Superpharm, Usl Pharma, Valeant Pharm Intl, Vitarine, Warner Chilcott, Watson Labs, Watson Labs Florida, Wes Pharma Inc, Whiteworth Town Plsn, Cent Pharms, Bionpharma, L Perrigo Co, Gavis Pharms, Aurobindo Pharma Ltd, Larken Labs Inc, Wraser Pharms Llc, Boca Pharma Llc, and West-ward Pharm Corp. and is included in one hundred and thirty-seven 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. One supplier is listed for this compound. Additional details are available on the acetaminophen; caffeine; dihydrocodeine bitartrate profile page.

DrugPatentWatch® Generic Entry Outlook for Acetaminophen

There have been fourteen 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

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Drug patent expirations by year for ACETAMINOPHEN
Drug Prices for ACETAMINOPHEN

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Drug Sales Revenue Trends for ACETAMINOPHEN

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Recent Clinical Trials for ACETAMINOPHEN

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

SponsorPhase
University Hospital "Sestre Milosrdnice"N/A
University of Sao Paulo General HospitalN/A
Johnson & Johnson Consumer Inc. (J&JCI)Phase 1

See all ACETAMINOPHEN clinical trials

Medical Subject Heading (MeSH) Categories for ACETAMINOPHEN
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

ACETAMINOPHEN is protected by one US patents.

Patents protecting ACETAMINOPHEN

Paracetamol for parenteral administration
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Patent Expiration: ⤷  Try a Trial

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Halsey ACETAMINOPHEN AND CODEINE PHOSPHATE acetaminophen; codeine phosphate TABLET;ORAL 083872-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Roxane ACETAMINOPHEN AND CODEINE PHOSPHATE acetaminophen; codeine phosphate TABLET;ORAL 089513-001 Apr 25, 1989 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Dava Pharms Inc ACETAMINOPHEN AND CODEINE PHOSPHATE acetaminophen; codeine phosphate SOLUTION;ORAL 040098-001 Sep 20, 1996 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
>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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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.