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 |
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
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.