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Last Updated: April 20, 2024

Acetaminophen; ibuprofen - Generic Drug Details


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What are the generic drug sources for acetaminophen; ibuprofen and what is the scope of freedom to operate?

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

Acetaminophen; ibuprofen has forty-eight patent family members in thirty-two countries.

Thirty-five suppliers are listed for this compound.

Summary for acetaminophen; ibuprofen
International Patents:48
US Patents:6
Tradenames:4
Applicants:7
NDAs:7
Finished Product Suppliers / Packagers: 35
Clinical Trials: 235
DailyMed Link:acetaminophen; ibuprofen at DailyMed
Recent Clinical Trials for acetaminophen; ibuprofen

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

SponsorPhase
Korea University Guro HospitalPhase 4
Kyongbo Pharmaceutical Co.,LtdPhase 4
Novo Nordisk A/SPhase 1

See all acetaminophen; ibuprofen clinical trials

Pharmacology for acetaminophen; ibuprofen

US Patents and Regulatory Information for acetaminophen; ibuprofen

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Hikma COMBOGESIC IV acetaminophen; ibuprofen sodium SOLUTION;INTRAVENOUS 215320-001 Oct 17, 2023 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Granules ACETAMINOPHEN AND IBUPROFEN acetaminophen; ibuprofen TABLET;ORAL 216592-001 Jul 13, 2023 OTC No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Marksans Pharma ACETAMINOPHEN AND IBUPROFEN acetaminophen; ibuprofen TABLET;ORAL 216994-001 Jul 10, 2023 OTC No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Hikma COMBOGESIC IV acetaminophen; ibuprofen sodium SOLUTION;INTRAVENOUS 215320-001 Oct 17, 2023 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Haleon Us Holdings ADVIL DUAL ACTION WITH ACETAMINOPHEN acetaminophen; ibuprofen TABLET;ORAL 211733-001 Feb 28, 2020 OTC Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Aft Pharms Ltd COMBOGESIC acetaminophen; ibuprofen TABLET;ORAL 209471-001 Mar 1, 2023 DISCN Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Bionpharma ACETAMINOPHEN AND IBUPROFEN acetaminophen; ibuprofen TABLET;ORAL 216999-001 Aug 1, 2023 OTC 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

International Patents for acetaminophen; ibuprofen

Country Patent Number Title Estimated Expiration
Australia 2019268077 Pharmaceutical Composition Containing Acetaminophen ⤷  Try a Trial
Portugal 1781277 ⤷  Try a Trial
Chile 2021002252 Composición farmacéutica que comprende paracetamol e ibuprofeno ⤷  Try a Trial
United Kingdom 0700027 ⤷  Try a Trial
Ecuador SP21072036 COMPOSICIÓN FARMACÉUTICA QUE CONTIENE ACETAMINOFENO E IBUPROFENO ⤷  Try a Trial
European Patent Office 1781277 COMPOSITION COMBINEE COMPRENANT IBUPROFEN ET PARACETAMOL (A COMBINATION COMPOSITION COMPRISING IBUPROFEN AND PARACETAMOL) ⤷  Try a Trial
China 113795243 含有对乙酰氨基酚和布洛芬的药物组合物 (PHARMACEUTICAL COMPOSITION CONTAINING ACETOMINOPHEN AND IBUPROFEN) ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for acetaminophen; ibuprofen

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1781277 PA2024501 Lithuania ⤷  Try a Trial 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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