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 five 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:	5
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
University of Central Florida	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				⤷ Sign Up
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	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
>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
China	113018258	包含对乙酰氨基酚和布洛芬的水性制剂 (Aqueous formulation comprising paracetamol and ibuprofen)	⤷ Sign Up
European Patent Office	2635269	COMPOSITION COMBINÉE (A COMBINATION COMPOSITION)	⤷ Sign Up
South Korea	101900520		⤷ Sign Up
Portugal	2635269		⤷ Sign Up
Canada	2955557	FORMULATION AQUEUSE COMPRENANT DU PARACETAMOL ET DE L'IBUPROFENE (AQUEOUS FORMULATION COMPRISING PARACETAMOL AND IBUPROFEN)	⤷ Sign Up
China	106794163	包含对乙酰氨基酚和布洛芬的水性制剂 (Aqueous formulation comprising paracetamol and ibuprofen)	⤷ Sign Up
Australia	2015289035	Aqueous formulation comprising paracetamol and ibuprofen	⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

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