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COMBOGESIC IV Drug Patent Profile

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Which patents cover Combogesic Iv, and when can generic versions of Combogesic Iv launch?

Combogesic Iv is a drug marketed by Hikma and is included in one NDA. There are five patents protecting this drug.

This drug has sixty-five patent family members in thirty countries.

The generic ingredient in COMBOGESIC IV is acetaminophen; ibuprofen sodium. There are sixty-six drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the acetaminophen; ibuprofen sodium profile page.

DrugPatentWatch^® Generic Entry Outlook for Combogesic Iv

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be October 17, 2026. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

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Summary for COMBOGESIC IV

International Patents:	65
US Patents:	5
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
What excipients (inactive ingredients) are in COMBOGESIC IV?	COMBOGESIC IV excipients list
DailyMed Link:	COMBOGESIC IV at DailyMed

Drug patent expirations by year for COMBOGESIC IV

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for COMBOGESIC IV

Generic Entry Date for COMBOGESIC IV^: ⤷ Sign Up* Constraining patent/regulatory exclusivity: NEW PRODUCT NDA: 215320 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.

Pharmacology for COMBOGESIC IV

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

US Patents and Regulatory Information for COMBOGESIC IV

COMBOGESIC IV is protected by eight US patents and one FDA Regulatory Exclusivity.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of COMBOGESIC IV is ⤷ Sign Up.

This potential generic entry date is based on NEW PRODUCT.
Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Patents protecting COMBOGESIC IV

Aqueous formulation comprising paracetamol and ibuprofen
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up

Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up

Combination composition
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: METHOD OF TREATING MILD TO MODERATE PAIN IN ADULTS

Combination composition
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: METHOD OF TREATING MODERATE TO SEVERE PAIN IN ADULTS AS AN ADJUNCT TO OPIOID ANALGESICS

Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: METHOD OF TREATING MILD TO MODERATE PAIN IN ADULTS

Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: METHOD OF TREATING MODERATE TO SEVERE PAIN IN ADULTS AS AN ADJUNCT TO OPIOID ANALGESICS

Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: METHOD OF TREATING MILD TO MODERATE PAIN IN ADULTS

Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: METHOD OF TREATING MODERATE TO SEVERE PAIN IN ADULTS AS AN ADJUNCT TO OPIOID ANALGESICS

FDA Regulatory Exclusivity protecting COMBOGESIC IV

NEW PRODUCT
Exclusivity Expiration: ⤷ Sign Up

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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	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
>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 COMBOGESIC IV

See the table below for patents covering COMBOGESIC IV around the world.

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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
>Country	>Patent Number	>Title	>Estimated Expiration