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Last Updated: October 4, 2024

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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. Eleven suppliers are listed for this compound. Additional details are available on the famotidine; ibuprofen profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Duexis

A generic version of DUEXIS was approved as famotidine; ibuprofen by ENDO OPERATIONS on March 22nd, 2024.

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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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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 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: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
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: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Stable compositions of famotidine and ibuprofen
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Stable compositions of famotidine and ibuprofen
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Stable compositions of famotidine and ibuprofen
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
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 DISCN Yes No ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Horizon DUEXIS famotidine; ibuprofen TABLET;ORAL 022519-001 Apr 23, 2011 DISCN Yes No ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Horizon DUEXIS famotidine; ibuprofen TABLET;ORAL 022519-001 Apr 23, 2011 DISCN Yes No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Horizon DUEXIS famotidine; ibuprofen TABLET;ORAL 022519-001 Apr 23, 2011 DISCN Yes No ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Horizon DUEXIS famotidine; ibuprofen TABLET;ORAL 022519-001 Apr 23, 2011 DISCN Yes No ⤷  Sign Up ⤷  Sign Up Y ⤷  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 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
Patent: Medicaments containing famotidine and ibuprofen and administration of same
Estimated Expiration: ⤷  Sign Up

Patent: 07275360
Patent: Methods and medicaments for administration of ibuprofen
Estimated Expiration: ⤷  Sign Up

Austria

Patent: 39747
Estimated Expiration: ⤷  Sign Up

Brazil

Patent: 0714937
Patent: forma de dosagem unitÁria oral, e, uso de uma forma de dosagem unitÁria
Estimated Expiration: ⤷  Sign Up

Canada

Patent: 15496
Patent: MEDICAMENTS CONTENANT FAMOTIDINE ET IBUPROFENE, ET ADMINISTRATION DESDITS MEDICAMENTS (MEDICAMENTS CONTAINING FAMOTIDINE AND IBUPROFEN AND ADMINISTRATION OF SAME)
Estimated Expiration: ⤷  Sign Up

Patent: 57928
Patent: PROCEDES ET MEDICAMENTS DESTINES A L'ADMINISTRATION D'IBUPROFENE (METHODS AND MEDICAMENTS FOR ADMINISTRATION OF IBUPROFEN)
Estimated Expiration: ⤷  Sign Up

China

Patent: 1257800
Patent: Medicaments containing famotidine and ibuprofen and administration of same
Estimated Expiration: ⤷  Sign Up

Patent: 1516368
Patent: Methods and medicaments for administration of ibuprofen
Estimated Expiration: ⤷  Sign Up

Denmark

Patent: 43637
Estimated Expiration: ⤷  Sign Up

European Patent Office

Patent: 19288
Patent: MEDICAMENTS CONTENANT FAMOTIDINE ET IBUPROFENE, ET ADMINISTRATION DESDITS MEDICAMENTS (MEDICAMENTS CONTAINING FAMOTIDINE AND IBUPROFEN AND ADMINISTRATION OF SAME)
Estimated Expiration: ⤷  Sign Up

Patent: 43637
Patent: PROCÉDÉS ET MÉDICAMENTS DESTINÉS À L'ADMINISTRATION D'IBUPROFÈNE (METHODS AND MEDICAMENTS FOR ADMINISTRATION OF IBUPROFEN)
Estimated Expiration: ⤷  Sign Up

Patent: 38919
Patent: Compositions contenant de l'ibuprofene et de la famotidine ainsi que des compositions contenant de 25 mg a 28 mg de la famotidine (Compositions comprising famotidine and ibuprofen as well as compositions comprising 25 mg to 28 mg famotidine)
Estimated Expiration: ⤷  Sign Up

Israel

Patent: 8732
Patent: שימוש באיבופרופין ופאמוטידין להכנת תרופות (Use of ibuprofen and famotidine in the preparation of medicaments)
Estimated Expiration: ⤷  Sign Up

Patent: 6425
Patent: יחידת מינון למתן פומי המכילה איבופרופן ופאמוטידין (Oral unit dose form containing ibuprofen and famotidine)
Estimated Expiration: ⤷  Sign Up

Japan

Patent: 09501801
Estimated Expiration: ⤷  Sign Up

Patent: 09543885
Estimated Expiration: ⤷  Sign Up

New Zealand

Patent: 5846
Patent: Medicaments containing famotidine and ibuprofen and administration of same
Estimated Expiration: ⤷  Sign Up

Patent: 4200
Patent: METHODS AND MEDICAMENTS FOR ADMINISTRATION OF IBUPROFEN AND FAMOTIDINE
Estimated Expiration: ⤷  Sign Up

Poland

Patent: 43637
Estimated Expiration: ⤷  Sign Up

Portugal

Patent: 43637
Estimated Expiration: ⤷  Sign Up

South Africa

Patent: 0900423
Patent: Methods and medicaments for administration of ibuprofen
Estimated Expiration: ⤷  Sign Up

Spain

Patent: 80747
Estimated Expiration: ⤷  Sign Up

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
Australia 2007275360 Methods and medicaments for administration of ibuprofen ⤷  Sign Up
Israel 196425 יחידת מינון למתן פומי המכילה איבופרופן ופאמוטידין (Oral unit dose form containing ibuprofen and famotidine) ⤷  Sign Up
World Intellectual Property Organization (WIPO) 2007012022 ⤷  Sign Up
Australia 2006269894 Medicaments containing famotidine and ibuprofen and administration of same ⤷  Sign Up
Japan 2009501801 ⤷  Sign Up
European Patent Office 1919288 MEDICAMENTS CONTENANT FAMOTIDINE ET IBUPROFENE, ET ADMINISTRATION DESDITS MEDICAMENTS (MEDICAMENTS CONTAINING FAMOTIDINE AND IBUPROFEN AND ADMINISTRATION OF SAME) ⤷  Sign Up
Canada 2615496 MEDICAMENTS CONTENANT FAMOTIDINE ET IBUPROFENE, ET ADMINISTRATION DESDITS MEDICAMENTS (MEDICAMENTS CONTAINING FAMOTIDINE AND IBUPROFEN AND ADMINISTRATION OF SAME) ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

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