COMBOGESIC Drug Patent Profile

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When do Combogesic patents expire, and what generic alternatives are available?

Combogesic is a drug marketed by Aft Pharms Us and Hikma and is included in two NDAs. There are eight patents protecting this drug.

This drug has fifty-one patent family members in thirty-three countries.

The generic ingredient in COMBOGESIC 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.

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Summary for COMBOGESIC

International Patents:	51
US Patents:	3
Applicants:	2
NDAs:	2
Finished Product Suppliers / Packagers:	2
What excipients (inactive ingredients) are in COMBOGESIC?	COMBOGESIC excipients list
DailyMed Link:	COMBOGESIC at DailyMed

Drug patent expirations by year for COMBOGESIC

Pharmacology for COMBOGESIC

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

US Patents and Regulatory Information for COMBOGESIC

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

Patents protecting COMBOGESIC

Combination composition
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: A METHOD OF TREATING MILD TO MODERATE ACUTE PAIN IN ADULTS BY ADMINISTERING 975-1000 MG OF ACETAMINOPHEN AND 292.5-300 MG OF IBUPROFEN IN A SINGLE ADMINISTRATION

Pharmaceutical composition containing acetaminophen and ibuprofen
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: A METHOD OF TREATING MILD TO MODERATE ACUTE PAIN IN ADULTS BY ADMINISTERING 975-1000 MG OF ACETAMINOPHEN AND 292.5-300 MG OF IBUPROFEN IN A SINGLE ADMINISTRATION

Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: A METHOD OF TREATING MILD TO MODERATE ACUTE PAIN IN ADULTS BY ADMINISTERING 975-1000 MG OF ACETAMINOPHEN AND 292.5-300 MG OF IBUPROFEN IN A SINGLE ADMINISTRATION

FDA Regulatory Exclusivity protecting COMBOGESIC

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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
Aft Pharms Us	COMBOGESIC	acetaminophen; ibuprofen	TABLET;ORAL	209471-001	Mar 1, 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
Aft Pharms Us	COMBOGESIC	acetaminophen; ibuprofen	TABLET;ORAL	209471-001	Mar 1, 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
Aft Pharms Us	COMBOGESIC	acetaminophen; ibuprofen	TABLET;ORAL	209471-001	Mar 1, 2023		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
Aft Pharms Us	COMBOGESIC	acetaminophen; ibuprofen	TABLET;ORAL	209471-001	Mar 1, 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

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

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Country	Patent Number	Title	Estimated Expiration
Denmark	1781277		⤷ Sign Up
Costa Rica	20210451	COMPOSICIÓN FARMACÉUTICA QUE CONTIENE ACETAMINOFENO E IBUPROFENO (PHARMACEUTICAL COMPOSITION CONTAINING ACETOMINOPHEN AND IBUPROFEN)	⤷ Sign Up
Colombia	2021011525	Composición farmacéutica que contiene acetaminofeno e ibuprofeno	⤷ Sign Up
Cyprus	1112738		⤷ Sign Up
United Kingdom	202112205		⤷ Sign Up
Eurasian Patent Organization	202192118	ФАРМАЦЕВТИЧЕСКАЯ КОМПОЗИЦИЯ, СОДЕРЖАЩАЯ АЦЕТАМИНОФЕН И ИБУПРОФЕН	⤷ Sign Up
Canada	2570474	COMPOSITION COMBINEE (A COMBINATION COMPOSITION)	⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for COMBOGESIC

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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