Acetaminophen; ibuprofen - Generic Drug Details

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

Acetaminophen; ibuprofen is the generic ingredient in four branded drugs marketed by Aurobindo Pharma Ltd, Bionpharma, Glenmark Pharms Ltd, Granules, L Perrigo Co, Marksans Pharma, Haleon Us Holdings, Aft Pharms Ltd, and Hikma, and is included in nine NDAs. There are eight patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Acetaminophen; ibuprofen has sixty-three patent family members in thirty-three countries.

Thirty-seven suppliers are listed for this compound.

Summary for acetaminophen; ibuprofen

International Patents:	63
US Patents:	8
Tradenames:	4
Applicants:	9
NDAs:	9
Finished Product Suppliers / Packagers:	37
Clinical Trials:	243
DailyMed Link:	acetaminophen; ibuprofen at DailyMed

Recent Clinical Trials for acetaminophen; ibuprofen

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Sponsor	Phase
Cairo University	Phase 4
Jessyka Lighthall	Phase 3
Rutgers, The State University of New Jersey	Phase 4

See all acetaminophen; ibuprofen clinical trials

Pharmacology for acetaminophen; ibuprofen

Drug Class	Nonsteroidal Anti-inflammatory Drug
Mechanism of Action	Cyclooxygenase Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for acetaminophen; ibuprofen

Paragraph IV (Patent) Challenges for ACETAMINOPHEN; IBUPROFEN

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
ADVIL DUAL ACTION WITH ACETAMINOPHEN	Tablets	acetaminophen; ibuprofen	125 mg/250 mg	211733	2	2024-03-28

US Patents and Regulatory Information for acetaminophen; ibuprofen

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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
Bionpharma	ACETAMINOPHEN AND IBUPROFEN	acetaminophen; ibuprofen	TABLET;ORAL	216999-001	Aug 1, 2023		OTC	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Aft Pharms Ltd	COMBOGESIC	acetaminophen; ibuprofen	TABLET;ORAL	209471-001	Mar 1, 2023		DISCN	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Hikma	COMBOGESIC IV	acetaminophen; ibuprofen sodium	SOLUTION;INTRAVENOUS	215320-001	Oct 17, 2023		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Haleon Us Holdings	ADVIL DUAL ACTION WITH ACETAMINOPHEN	acetaminophen; ibuprofen	TABLET;ORAL	211733-001	Feb 28, 2020		OTC	Yes	Yes	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
L Perrigo Co	ACETAMINOPHEN AND IBUPROFEN	acetaminophen; ibuprofen	TABLET;ORAL	214836-001	Feb 28, 2023		OTC	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Marksans Pharma	ACETAMINOPHEN AND IBUPROFEN	acetaminophen; ibuprofen	TABLET;ORAL	216994-001	Jul 10, 2023		OTC	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Aurobindo Pharma Ltd	ACETAMINOPHEN AND IBUPROFEN	acetaminophen; ibuprofen	TABLET;ORAL	218359-001	Mar 26, 2024		OTC	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; ibuprofen

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Country	Patent Number	Title	Estimated Expiration
Jordan	P20210235	تركيبة صيدلانية تحتوي على أسيتامينوفين وإيبوبروفين (PHARMACEUTICAL COMPOSITION CONTAINING ACETOMINOPHEN AND IBUPROFEN)	⤷ Sign Up
Australia	2005260243	A combination composition	⤷ Sign Up
Australia	2019268077	Pharmaceutical Composition Containing Acetaminophen	⤷ Sign Up
South Africa	200700896	Atkinson, Hartley Campbell	⤷ Sign Up
Mexico	2021016089	COMPOSICIÓN NOVEDOSA DE IBUPROFENO Y ACETAMINOFENO. (NOVEL IBUPROFEN AND ACETAMINOPHEN COMPOSITION.)	⤷ Sign Up
Tunisia	2021000176	PHARMACEUTICAL COMPOSITION CONTAINING ACETOMINOPHEN AND IBUPROFEN	⤷ Sign Up
China	114173767	布洛芬和对乙酰氨基酚的新型组合物 (Novel composition of ibuprofen and acetaminophen)	⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for acetaminophen; ibuprofen

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1781277	PA2024501	Lithuania	⤷ Sign Up	PRODUCT NAME: IBUPROFENO IR PARACETAMOLIO DERINYS; REGISTRATION NO/DATE: LT/1/23/5212/001-002 20230726
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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