ACETAMINOPHEN; IBUPROFEN SODIUM - Generic Drug Details

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

Acetaminophen; ibuprofen sodium is the generic ingredient in one branded drug marketed by Hikma and is included in one NDA. There are four patents protecting this compound. Additional information is available in the individual branded drug profile pages.

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

One supplier is listed for this compound.

Summary for ACETAMINOPHEN; IBUPROFEN SODIUM

International Patents:	65
US Patents:	4
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Clinical Trials:	7
DailyMed Link:	ACETAMINOPHEN; IBUPROFEN SODIUM at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for ACETAMINOPHEN; IBUPROFEN SODIUM

Generic Entry Date for ACETAMINOPHEN; IBUPROFEN SODIUM^: ⤷ Sign Up* Constraining patent/regulatory exclusivity: NEW PRODUCT Dosage: SOLUTION;INTRAVENOUS

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for ACETAMINOPHEN; IBUPROFEN SODIUM

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

Sponsor	Phase
Northwestern University	Phase 4
University of California, Los Angeles	Phase 4
Nemours Children's Clinic	Early Phase 1

See all ACETAMINOPHEN; IBUPROFEN SODIUM clinical trials

Pharmacology for ACETAMINOPHEN; IBUPROFEN SODIUM

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

Anatomical Therapeutic Chemical (ATC) Classes for ACETAMINOPHEN; IBUPROFEN SODIUM

US Patents and Regulatory Information for ACETAMINOPHEN; IBUPROFEN SODIUM

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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
Hikma	COMBOGESIC IV	acetaminophen; ibuprofen sodium	SOLUTION;INTRAVENOUS	215320-001	Oct 17, 2023		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up	Y			⤷ 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
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 SODIUM

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Country	Patent Number	Title	Estimated Expiration
Eurasian Patent Organization	201790223	ВОДНЫЙ ПРЕПАРАТ, СОДЕРЖАЩИЙ ПАРАЦЕТАМОЛ И ИБУПРОФЕН	⤷ Sign Up
Serbia	60289	VODENA FORMULACIJA KOJA SADRŽI PARACETAMOL I IBUPROFEN (AQUEOUS FORMULATION COMPRISING PARACETAMOL AND IBUPROFEN)	⤷ Sign Up
World Intellectual Property Organization (WIPO)	2016008546		⤷ Sign Up
Japan	2017522382	パラセタモール及びイブプロフェンを含む水性配合物	⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

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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.