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Last Updated: August 7, 2020

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DUEXIS Drug Profile

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

Duexis is a drug marketed by Horizon and is included in one NDA. There are six patents protecting this drug and one Paragraph IV challenge.

This drug has twenty-five patent family members in fifteen countries.

The generic ingredient in DUEXIS is famotidine; ibuprofen. There are eighteen drug master file entries for this compound. Additional details are available on the famotidine; ibuprofen profile page.

US ANDA Litigation and Generic Entry Outlook for Duexis

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be July 18, 2026. This may change due to patent challenges or generic licensing.

Annual sales in 2018 were $45mm indicating the motivation for generic entry (peak sales were $524mm in 2016).

There have been two patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

Indicators of Generic Entry

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Drug patent expirations by year for DUEXIS
Drug Prices for DUEXIS

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Drug Sales Revenue Trends for DUEXIS

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Generic Entry Opportunity Date for DUEXIS
Generic Entry Date for DUEXIS*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
TABLET;ORAL

*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 DUEXIS

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Horizon Pharma Ireland, Ltd., Dublin IrelandPhase 4
Pediatric Rheumatology Collaborative Study GroupPhase 4

See all DUEXIS clinical trials

Paragraph IV (Patent) Challenges for DUEXIS
Tradename Dosage Ingredient NDA Submissiondate
DUEXIS TABLET;ORAL famotidine; ibuprofen 022519 2011-12-06

US Patents and Regulatory Information for DUEXIS

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Horizon DUEXIS famotidine; ibuprofen TABLET;ORAL 022519-001 Apr 23, 2011 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Horizon DUEXIS famotidine; ibuprofen TABLET;ORAL 022519-001 Apr 23, 2011 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Horizon DUEXIS famotidine; ibuprofen TABLET;ORAL 022519-001 Apr 23, 2011 RX Yes Yes   Start Trial   Start Trial   Start Trial
Horizon DUEXIS famotidine; ibuprofen TABLET;ORAL 022519-001 Apr 23, 2011 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Horizon DUEXIS famotidine; ibuprofen TABLET;ORAL 022519-001 Apr 23, 2011 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Horizon DUEXIS famotidine; ibuprofen TABLET;ORAL 022519-001 Apr 23, 2011 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

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Serving leading biopharmaceutical companies globally:

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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.