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Last Updated: November 20, 2024

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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*:
Constraining patent/regulatory exclusivity:
NEW PRODUCT
NDA:
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

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

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
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.

Country Patent Number Title Estimated Expiration
Hungary E048881 ⤷  Sign Up
Russian Federation 2013123646 КОМБИНИРОВАННАЯ КОМПОЗИЦИЯ ⤷  Sign Up
Colombia 6771406 Una composición combinada ⤷  Sign Up
South Korea 101900520 ⤷  Sign Up
New Zealand 728796 Aqueous formulation comprising paracetamol and ibuprofen ⤷  Sign Up
Serbia 59258 KOMBINOVANA KOMPOZICIJA (A COMBINATION COMPOSITION) ⤷  Sign Up
Serbia 60289 VODENA FORMULACIJA KOJA SADRŽI PARACETAMOL I IBUPROFEN (AQUEOUS FORMULATION COMPRISING PARACETAMOL AND IBUPROFEN) ⤷  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.