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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. 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 22^nd, 2024.

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

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			Y
Horizon	DUEXIS	famotidine; ibuprofen	TABLET;ORAL	022519-001	Apr 23, 2011		DISCN	Yes	No			Y
Horizon	DUEXIS	famotidine; ibuprofen	TABLET;ORAL	022519-001	Apr 23, 2011		DISCN	Yes	No
Horizon	DUEXIS	famotidine; ibuprofen	TABLET;ORAL	022519-001	Apr 23, 2011		DISCN	Yes	No			Y
Horizon	DUEXIS	famotidine; ibuprofen	TABLET;ORAL	022519-001	Apr 23, 2011		DISCN	Yes	No			Y

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
European Patent Office	1919288	MEDICAMENTS CONTENANT FAMOTIDINE ET IBUPROFENE, ET ADMINISTRATION DESDITS MEDICAMENTS (MEDICAMENTS CONTAINING FAMOTIDINE AND IBUPROFEN AND ADMINISTRATION OF SAME)
Denmark	2043637
European Patent Office	2438919	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)
Japan	2009543885
World Intellectual Property Organization (WIPO)	2007012019
Brazil	PI0714937	forma de dosagem unitÁria oral, e, uso de uma forma de dosagem unitÁria

DUEXIS Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for the Drug: Duexis

Introduction

Duexis, a combination drug consisting of 800 mg of ibuprofen and 26.6 mg of famotidine, has been a significant player in the pharmaceutical market, particularly for treating rheumatoid arthritis and other inflammatory conditions. Here, we delve into the market dynamics and financial trajectory of Duexis, including its recent developments, pricing, and impact on the healthcare industry.

Background of Duexis

Duexis is marketed as a convenient single-pill solution that combines the pain-relieving and anti-inflammatory properties of ibuprofen with the gastrointestinal protective effects of famotidine. This combination is designed to mitigate the gastrointestinal side effects associated with high doses of ibuprofen[1][4].

Brand Pricing and Market Impact

Historically, Duexis has been a high-cost medication. The wholesale acquisition cost (WAC) for a 30-day supply of Duexis was approximately $2,482, making it a costly option for patients and healthcare providers. Despite this, the drug has maintained a significant market presence, with thousands of member claims every year[1].

Generic Availability

A significant development in the market dynamics of Duexis is the recent introduction of a generic version. Approved by the FDA, the generic Duexis is manufactured by Alkem Labs and has a WAC of $404, representing an 84% drop from the brand product's price. This reduction is expected to impact the market significantly, although it is noteworthy that the active ingredients can still be obtained separately at a much lower cost[1].

Financial Performance of Duexis

Duexis has been a revenue-generating drug for its manufacturer, Horizon Therapeutics. In 2017, it was reported that Duexis had generated over $465 million in net sales since its introduction. However, the financial performance of Duexis has seen fluctuations. For instance, in the first quarter of 2017, net sales for Duexis and another similar drug, Vimovo, were significantly lower due to reduced insurance coverage and increased rebates demanded by insurers[4].

Impact of Generic Competition

The introduction of a generic version of Duexis is expected to alter the financial trajectory of the drug. While the generic will likely capture a significant portion of the market due to its lower price, it may not necessarily be the most cost-effective option. Patients can still achieve the same therapeutic benefits by taking the active ingredients separately at a lower cost. This dynamic highlights the complexity of drug pricing and the need for careful consideration of cost-effectiveness in healthcare decisions[1].

Marketing and Sales Strategies

Horizon Therapeutics, the original manufacturer of Duexis, has employed various strategies to maintain market share. These include promoting the convenience of a single-pill solution, covering patient out-of-pocket costs, and steering prescriptions to participating pharmacists. However, critics argue that such strategies can lead to unnecessary costs and waste in the healthcare system[4].

Acquisition and Integration

In a significant corporate development, Amgen acquired Horizon Therapeutics in October 2023 for approximately $27.8 billion. This acquisition includes the portfolio of Horizon's drugs, including Duexis. The integration of these drugs into Amgen's portfolio is expected to enhance Amgen's presence in the inflammation and rare disease markets[3].

Financial Results of Horizon Therapeutics

Before its acquisition, Horizon Therapeutics reported mixed financial results. In the fourth quarter of 2022, the company's net sales were $942 million, with a net income of $120.4 million. The full-year 2022 results showed net sales of $3.629 billion, with a net income of $521.5 million. These figures reflect the company's overall performance, including the contributions from Duexis and other drugs[5].

Market Trends and Future Outlook

The pharmaceutical market is highly competitive and subject to various regulatory and economic factors. The introduction of generics and biosimilars continues to shape the market dynamics. For Duexis, the future outlook will depend on how well the generic version is adopted and how effectively it competes with the brand product and separate active ingredients.

Convenience vs. Cost-Effectiveness

The convenience factor of Duexis, both the brand and generic versions, will continue to be a selling point. However, healthcare providers and payers are increasingly focusing on cost-effectiveness, which may lead to a shift towards prescribing the separate active ingredients rather than the combination drug[1].

Regulatory Environment

Regulatory changes and FDA approvals will continue to influence the market. The recent approval of the generic Duexis and the ongoing monitoring of prescribing trends will be crucial in determining the drug's future market share[1].

Patient and Payer Perspectives

Patients and payers are becoming more aware of the cost implications of their healthcare choices. As transparency in drug pricing increases, there may be greater scrutiny of high-cost medications like Duexis, even with the availability of a generic version[4].

Key Takeaways

• Generic Availability: A generic version of Duexis has been approved, significantly reducing the cost by 84%.
• Cost-Effectiveness: Despite the cost reduction, taking the active ingredients separately remains the most cost-effective option.
• Market Impact: The introduction of a generic is expected to alter the market dynamics, potentially reducing the brand product's market share.
• Financial Performance: Duexis has historically generated significant revenue but faces challenges from reduced insurance coverage and increased competition.
• Acquisition and Integration: The acquisition by Amgen integrates Duexis into a broader portfolio, potentially enhancing its market presence.

FAQs

What is Duexis used for?

Duexis is used to relieve pain and inflammation, particularly in conditions like rheumatoid arthritis, while also protecting against gastrointestinal damage associated with high doses of ibuprofen.

How much does Duexis cost?

The brand version of Duexis had a wholesale acquisition cost (WAC) of $2,482 for a 30-day supply. The generic version has a WAC of $404.

Why is the generic version of Duexis still expensive?

Although the generic version is significantly cheaper than the brand product, it is still more expensive than taking the active ingredients (ibuprofen and famotidine) separately.

Who manufactures the generic version of Duexis?

The generic version of Duexis is manufactured by Alkem Labs.

How does the acquisition by Amgen affect Duexis?

The acquisition by Amgen integrates Duexis into Amgen's portfolio, potentially enhancing its market presence and positioning within the inflammation and rare disease markets.

Sources

1. Infamous Combo-Drug Now Has a Generic Available - RXSS
2. Horizon Therapeutics plc Reports First-Quarter 2023 Financial Results - BioSpace
3. SHAREHOLDERS 2023 - Amgen Inc.
4. How Two Common Medications Became One $455 Million Specialty Pill - ProPublica
5. Horizon Therapeutics plc Reports Fourth-Quarter and Full-Year 2022 Financial Results - Business Wire