~ Buy the COMBOGESIC IV (acetaminophen; ibuprofen sodium) Drug Profile, 2024 PDF Report in the Report Store ~

COMBOGESIC IV Drug Patent Profile

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 three 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

Summary for COMBOGESIC IV

International Patents:	65
US Patents:	3
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Formulation / Manufacturing:	see details
What excipients (inactive ingredients) are in COMBOGESIC IV?	COMBOGESIC IV excipients list
DailyMed Link:	COMBOGESIC IV at DailyMed

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

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

Anatomical Therapeutic Chemical (ATC) Classes for COMBOGESIC IV

C01EB	Other cardiac preparations
C01E	OTHER CARDIAC PREPARATIONS
C01	CARDIAC THERAPY
C	Cardiovascular system

G02CC	Antiinflammatory products for vaginal administration
G02C	OTHER GYNECOLOGICALS
G02	OTHER GYNECOLOGICALS
G	Genito-urinary system and sex hormones

M01AE	Propionic acid derivatives
M01A	ANTIINFLAMMATORY AND ANTIRHEUMATIC PRODUCTS, NON-STEROIDS
M01	ANTIINFLAMMATORY AND ANTIRHEUMATIC PRODUCTS
M	Musculo-skeletal system

M02AA	Antiinflammatory preparations, non-steroids for topical use
M02A	TOPICAL PRODUCTS FOR JOINT AND MUSCULAR PAIN
M02	TOPICAL PRODUCTS FOR JOINT AND MUSCULAR PAIN
M	Musculo-skeletal system

R02AX	Other throat preparations
R02A	THROAT PREPARATIONS
R02	THROAT PREPARATIONS
R	Respiratory system

US Patents and Regulatory Information for COMBOGESIC IV

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

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

FDA Regulatory Exclusivity protecting COMBOGESIC IV

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

International Patents for COMBOGESIC IV

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

Country	Patent Number	Title	Estimated Expiration
Spain	2742373
Lithuania	3169307
Russian Federation	2013123646	КОМБИНИРОВАННАЯ КОМПОЗИЦИЯ
Poland	3169307
South Korea	101900520