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Last Updated: May 17, 2022

DUEXIS Drug Patent 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 five 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. Four suppliers are listed for this compound. Additional details are available on the famotidine; ibuprofen profile page.

DrugPatentWatch® Generic Entry Outlook for Duexis

Annual sales in 2019 were $1.0bn, indicating a strong incentive for generic entry.

There have been seven 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

See drug prices for DUEXIS

Drug Sales Revenue Trends for DUEXIS

See drug sales revenues for DUEXIS

Paragraph IV (Patent) Challenges for DUEXIS
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
DUEXIS Tablets famotidine; ibuprofen 800 mg/26.6 mg 022519 1 2011-12-06

US Patents and Regulatory Information for DUEXIS

DUEXIS is protected by five US patents.

Patents protecting DUEXIS

Methods and medicaments for administration of ibuprofen
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: RELIEF OF SIGNS AND SYMPTOMS OF RHEUMATOID ARTHRITIS AND OSTEOARTHRITIS AND TO DECREASE RISK OF DEVELOPING UPPER GASTROINTESTINAL ULCERS IN PATIENTS WHO ARE TAKING IBUPROFEN FOR THOSE INDICATIONS

Stable compositions of famotidine and ibuprofen
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Stable compositions of famotidine and ibuprofen
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Stable compositions of famotidine and ibuprofen
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Stable compositions of famotidine and ibuprofen
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: RELIEF OF SIGNS AND SYMPTOMS OF RHEUMATOID ARTHRITIS AND OSTEOARTHRITIS AND TO DECREASE RISK OF DEVELOPING UPPER GASTROINTESTINAL ULCERS IN PATIENTS WHO ARE TAKING IBUPROFEN FOR THOSE INDICATIONS

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 AB RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Horizon DUEXIS famotidine; ibuprofen TABLET;ORAL 022519-001 Apr 23, 2011 AB RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Horizon DUEXIS famotidine; ibuprofen TABLET;ORAL 022519-001 Apr 23, 2011 AB RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Horizon DUEXIS famotidine; ibuprofen TABLET;ORAL 022519-001 Apr 23, 2011 AB RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Horizon DUEXIS famotidine; ibuprofen TABLET;ORAL 022519-001 Apr 23, 2011 AB RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
>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 DUEXIS

When does loss-of-exclusivity occur for DUEXIS?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Australia

Patent: 06269894
Estimated Expiration: See Plans and Pricing

Patent: 07275360
Estimated Expiration: See Plans and Pricing

Austria

Patent: 9747
Estimated Expiration: See Plans and Pricing

Brazil

Patent: 0714937
Estimated Expiration: See Plans and Pricing

Canada

Patent: 15496
Estimated Expiration: See Plans and Pricing

Patent: 57928
Estimated Expiration: See Plans and Pricing

China

Patent: 1257800
Estimated Expiration: See Plans and Pricing

Patent: 1516368
Estimated Expiration: See Plans and Pricing

Denmark

Patent: 43637
Estimated Expiration: See Plans and Pricing

European Patent Office

Patent: 19288
Estimated Expiration: See Plans and Pricing

Patent: 43637
Estimated Expiration: See Plans and Pricing

Patent: 38919
Estimated Expiration: See Plans and Pricing

Israel

Patent: 8732
Estimated Expiration: See Plans and Pricing

Patent: 6425
Estimated Expiration: See Plans and Pricing

Japan

Patent: 09501801
Estimated Expiration: See Plans and Pricing

Patent: 09543885
Estimated Expiration: See Plans and Pricing

New Zealand

Patent: 5846
Estimated Expiration: See Plans and Pricing

Patent: 4200
Estimated Expiration: See Plans and Pricing

Poland

Patent: 43637
Estimated Expiration: See Plans and Pricing

Portugal

Patent: 43637
Estimated Expiration: See Plans and Pricing

South Africa

Patent: 0900423
Estimated Expiration: See Plans and Pricing

Spain

Patent: 80747
Estimated Expiration: See Plans and Pricing

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering DUEXIS around the world.

Country Patent Number Title Estimated Expiration
South Africa 200900423 Methods and medicaments for administration of ibuprofen See Plans and Pricing
Israel 188732 שימוש באיבופרופין ופאמוטידין להכנת תרופות (Use of ibuprofen and famotidine in the preparation of medicaments) See Plans and Pricing
Australia 2007275360 Methods and medicaments for administration of ibuprofen See Plans and Pricing
Israel 196425 יחידת מינון למתן פומי המכילה איבופרופן ופאמוטידין (Oral unit dose form containing ibuprofen and famotidine) See Plans and Pricing
European Patent Office 1919288 MEDICAMENTS CONTENANT FAMOTIDINE ET IBUPROFENE, ET ADMINISTRATION DESDITS MEDICAMENTS (MEDICAMENTS CONTAINING FAMOTIDINE AND IBUPROFEN AND ADMINISTRATION OF SAME) See Plans and Pricing
Japan 2009501801 See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

AstraZeneca
Colorcon
McKinsey
Medtronic
Baxter
McKesson

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.