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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. Ten 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 22^nd, 2024.

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Summary for DUEXIS

International Patents:	25
US Patents:	5
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	2
Clinical Trials:	1
Patent Applications:	42
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for DUEXIS
Drug Sales Revenues:	Drug sales revenues for DUEXIS
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for DUEXIS
What excipients (inactive ingredients) are in DUEXIS?	DUEXIS excipients list
DailyMed Link:	DUEXIS at DailyMed

Drug patent expirations by year for DUEXIS

Recent Clinical Trials for DUEXIS

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

Sponsor	Phase
Horizon Pharma Ireland, Ltd., Dublin Ireland	Phase 4
Pediatric Rheumatology Collaborative Study Group	Phase 4

See all DUEXIS clinical trials

Pharmacology for DUEXIS

Drug Class	Histamine-2 Receptor Antagonist Nonsteroidal Anti-inflammatory Drug
Mechanism of Action	Cyclooxygenase Inhibitors Histamine H2 Receptor Antagonists

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
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

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Glossary

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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
>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.

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Country	Patent Number	Title	Estimated Expiration
Australia	2006269894	Medicaments containing famotidine and ibuprofen and administration of same	⤷ Sign Up
World Intellectual Property Organization (WIPO)	2007012022		⤷ Sign Up
Brazil	PI0714937	forma de dosagem unitÁria oral, e, uso de uma forma de dosagem unitÁria	⤷ Sign Up
Japan	2009501801		⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

AI Research Assistant

Questions you can ask:

Summary for DUEXIS

Recent Clinical Trials for DUEXIS

Pharmacology for DUEXIS

Paragraph IV (Patent) Challenges for DUEXIS

Patents protecting DUEXIS

When does loss-of-exclusivity occur for DUEXIS?

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