ACETAMINOPHEN; IBUPROFEN - Generic Drug Details

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What are the generic 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, Dr Reddys, Glenmark Pharms Ltd, Granules, L Perrigo Co, Marksans Pharma, Haleon Us Holdings, Aft Pharms Us, and Hikma, and is included in ten NDAs. There are nine 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-nine suppliers are listed for this compound.

Summary for ACETAMINOPHEN; IBUPROFEN

International Patents:	63
US Patents:	9
Tradenames:	4
Applicants:	10
NDAs:	10
Finished Product Suppliers / Packagers:	39
Clinical Trials:	243
DailyMed Link:	ACETAMINOPHEN; IBUPROFEN at DailyMed

Recent Clinical Trials for ACETAMINOPHEN; IBUPROFEN

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

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
Marksans Pharma	ACETAMINOPHEN AND IBUPROFEN	acetaminophen; ibuprofen	TABLET;ORAL	216994-001	Jul 10, 2023		OTC	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Aft Pharms Us	COMBOGESIC	acetaminophen; ibuprofen	TABLET;ORAL	209471-001	Mar 1, 2023		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
Aft Pharms Us	COMBOGESIC	acetaminophen; ibuprofen	TABLET;ORAL	209471-001	Mar 1, 2023		RX	Yes	Yes	⤷ 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
>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
Mexico	2021016089	COMPOSICIÓN NOVEDOSA DE IBUPROFENO Y ACETAMINOFENO. (NOVEL IBUPROFEN AND ACETAMINOPHEN COMPOSITION.)	⤷ Sign Up
Israel	285866	תכשיר רוקחות המכיל אצטומינופן ואיבופרופן (Pharmaceutical composition containing acetominophen and ibuprofen)	⤷ Sign Up
Poland	1781277		⤷ Sign Up
Russian Federation	2455983	КОМБИНИРОВАННАЯ КОМПОЗИЦИЯ (COMBINED COMPOSITION)	⤷ 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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