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Last Updated: November 4, 2024

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

SponsorPhase
Cairo UniversityPhase 4
Jessyka LighthallPhase 3
Rutgers, The State University of New JerseyPhase 4

See all ACETAMINOPHEN; IBUPROFEN clinical trials

Pharmacology 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

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 ⤷  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
Hikma COMBOGESIC IV acetaminophen; ibuprofen sodium SOLUTION;INTRAVENOUS 215320-001 Oct 17, 2023 RX Yes Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Aurobindo Pharma Ltd ACETAMINOPHEN AND IBUPROFEN acetaminophen; ibuprofen TABLET;ORAL 218359-001 Mar 26, 2024 DISCN No 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
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

Country Patent Number Title Estimated Expiration
Australia 2022201196 Pharmaceutical composition comprising acetaminophen and ibuprofen ⤷  Sign Up
Peru 20220591 COMPOSICION FARMACEUTICA QUE CONTIENE ACETAMINOFENO E IBUPROFENO ⤷  Sign Up
United Kingdom 202112205 ⤷  Sign Up
Poland 1781277 ⤷  Sign Up
World Intellectual Property Organization (WIPO) 2020176736 ⤷  Sign Up
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) ⤷  Sign Up
>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 ⤷  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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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.