ACETAMINOPHEN Drug Patent Profile

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

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, Actavis Mid Atlantic, Chartwell, Chartwell Molecular, Dava Pharms Inc, Genus Lifesciences, Pai Holdings, Strides Pharma, 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, Superpharm, Usl Pharma, Valeant Pharm Intl, Vitarine, Warner Chilcott, Watson Labs, Watson Labs Florida, Wes Pharma Inc, Whiteworth Town Plsn, Cent Pharms, Aurobindo Pharma Ltd, Bionpharma, Dr Reddys, Glenmark Pharms Ltd, L Perrigo Co, Gavis Pharms, Larken Labs Inc, Wraser Pharms Llc, Boca Pharma Llc, and West-ward Pharm Corp. and is included in one hundred and forty 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

Annual sales in 2021 were $4mm indicating the motivation for generic entry (peak sales were $30mm in 2005).

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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Summary for ACETAMINOPHEN

International Patents:	17
US Patents:	1
Applicants:	69
NDAs:	140
Finished Product Suppliers / Packagers:	96
Raw Ingredient (Bulk) Api Vendors:	126
Clinical Trials:	1,308
Patent Applications:	4,207
Drug Prices:	Drug price information 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 patent expirations by year for ACETAMINOPHEN

Recent Clinical Trials for ACETAMINOPHEN

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

Sponsor	Phase
University Hospital "Sestre Milosrdnice"	N/A
Jessyka Lighthall	Phase 3
Jiangsu HengRui Medicine Co., Ltd.	Phase 1

See all ACETAMINOPHEN clinical trials

Medical Subject Heading (MeSH) Categories for ACETAMINOPHEN

Analgesics, Non-Narcotic
Antipyretics

Paragraph IV (Patent) Challenges for ACETAMINOPHEN

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
OFIRMEV	Injection	acetaminophen	650 mg/65 mL (10 mg/mL)	022450	1	2024-07-31
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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Glossary

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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	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Roxane	ACETAMINOPHEN AND CODEINE PHOSPHATE	acetaminophen; codeine phosphate	TABLET;ORAL	089513-001	Apr 25, 1989		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Pai Holdings	ACETAMINOPHEN AND CODEINE PHOSPHATE	acetaminophen; codeine phosphate	SOLUTION;ORAL	040119-001	Apr 26, 1996		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Sun Pharm Inds Ltd	ACETAMINOPHEN	acetaminophen	TABLET, EXTENDED RELEASE;ORAL	090205-001	Nov 18, 2009		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

International Patents for ACETAMINOPHEN

See the table below for patents covering ACETAMINOPHEN around the world.

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Country	Patent Number	Title	Estimated Expiration
European Patent Office	2421522	PARACÉTAMOL DESTINÉ À L'ADMINISTRATION PARENTÉRALE (PARACETAMOL FOR PARENTERAL ADMINISTRATION)	⤷ Sign Up
European Patent Office	2243477	Paracétamol destiné à l'administration parentérale (Paracetamol for parenteral application)	⤷ Sign Up
China	102421426	Paracetamol for parenteral administration	⤷ Sign Up
Denmark	2626068		⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration