DUEXIS Drug Patent Profile

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. Six 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 six 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

Summary for DUEXIS

International Patents:	25
US Patents:	5
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	1
Patent Applications:	75
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

See drug prices for DUEXIS

See drug sales revenues 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

Anatomical Therapeutic Chemical (ATC) Classes for DUEXIS

A02BA	H2-receptor antagonists
A02B	DRUGS FOR PEPTIC ULCER AND GASTRO-OESOPHAGEAL REFLUX DISEASE (GORD)
A02	DRUGS FOR ACID RELATED DISORDERS
A	Alimentary tract and metabolism

C01EB	Other cardiac preparations
C01E	OTHER CARDIAC PREPARATIONS
C01	CARDIAC THERAPY
C	Cardiovascular system

G02CC	Antiinflammatory products for vaginal administration
G02C	OTHER GYNECOLOGICALS
G02	OTHER GYNECOLOGICALS
G	Genito-urinary system and sex hormones

M01AE	Propionic acid derivatives
M01A	ANTIINFLAMMATORY AND ANTIRHEUMATIC PRODUCTS, NON-STEROIDS
M01	ANTIINFLAMMATORY AND ANTIRHEUMATIC PRODUCTS
M	Musculo-skeletal system

M02AA	Antiinflammatory preparations, non-steroids for topical use
M02A	TOPICAL PRODUCTS FOR JOINT AND MUSCULAR PAIN
M02	TOPICAL PRODUCTS FOR JOINT AND MUSCULAR PAIN
M	Musculo-skeletal system

R02AX	Other throat preparations
R02A	THROAT PREPARATIONS
R02	THROAT PREPARATIONS
R	Respiratory system

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

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			Y
Horizon	DUEXIS	famotidine; ibuprofen	TABLET;ORAL	022519-001	Apr 23, 2011	AB	RX	Yes	Yes			Y
Horizon	DUEXIS	famotidine; ibuprofen	TABLET;ORAL	022519-001	Apr 23, 2011	AB	RX	Yes	Yes

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

Austria

Brazil

Canada

China

Denmark

European Patent Office

Israel

Japan

New Zealand

Poland

Portugal

South Africa

Spain

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
Japan	2009501801
New Zealand	565846	Medicaments containing famotidine and ibuprofen and administration of same
Australia	2007275360	Methods and medicaments for administration of ibuprofen