VIMOVO Drug Patent Profile

Which patents cover Vimovo, and what generic alternatives are available?

Vimovo is a drug marketed by Horizon and is included in one NDA.

The generic ingredient in VIMOVO is esomeprazole magnesium; naproxen. There are seventy-four drug master file entries for this compound. Eight suppliers are listed for this compound. Additional details are available on the esomeprazole magnesium; naproxen profile page.

Summary for VIMOVO

US Patents:	0
Applicants:	1
NDAs:	1
Clinical Trials:	11
Drug Prices:	Drug price information for VIMOVO
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for VIMOVO
What excipients (inactive ingredients) are in VIMOVO?	VIMOVO excipients list
DailyMed Link:	VIMOVO at DailyMed

See drug prices for VIMOVO

See drug sales revenues for VIMOVO

Recent Clinical Trials for VIMOVO

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

Sponsor	Phase
EMS	Phase 3
Hanyang University Seoul Hospital	Phase 2
Horizon Pharma Ireland, Ltd., Dublin Ireland	Phase 4

See all VIMOVO clinical trials

Paragraph IV (Patent) Challenges for VIMOVO

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
VIMOVO	Delayed-release Tablets	esomeprazole magnesium; naproxen	375 mg/20 mg and 500 mg/20 mg	022511	1	2010-11-05

US Patents and Regulatory Information for VIMOVO

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Horizon	VIMOVO	esomeprazole magnesium; naproxen	TABLET, DELAYED RELEASE;ORAL	022511-002	Apr 30, 2010		DISCN	Yes	No
Horizon	VIMOVO	esomeprazole magnesium; naproxen	TABLET, DELAYED RELEASE;ORAL	022511-001	Apr 30, 2010		DISCN	Yes	No

Expired US Patents for VIMOVO

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Horizon	VIMOVO	esomeprazole magnesium; naproxen	TABLET, DELAYED RELEASE;ORAL	022511-001	Apr 30, 2010	8,858,996
Horizon	VIMOVO	esomeprazole magnesium; naproxen	TABLET, DELAYED RELEASE;ORAL	022511-002	Apr 30, 2010	8,858,996
Horizon	VIMOVO	esomeprazole magnesium; naproxen	TABLET, DELAYED RELEASE;ORAL	022511-001	Apr 30, 2010	6,369,085*PED

International Patents for VIMOVO

When does loss-of-exclusivity occur for VIMOVO?

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

Argentina

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 VIMOVO around the world.

Country	Patent Number	Title	Estimated Expiration
Denmark	1411900
Canada	2290963	TRIHYDRATE DE MAGNESIUM S-OMEPRAZOLE (S-OMEPRAZOLE MAGNESIUM TRIHYDRATE)
Denmark	0984957

Supplementary Protection Certificates for VIMOVO

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1411900	132012902015795	Italy		PRODUCT NAME: NAPROSSENE E ESOMEPRAZOLO SALE DI MAGNESIO TRIIDRATO(VIMOVO); AUTHORISATION NUMBER(S) AND DATE(S): PL 17901/0263-0001, 20101105;DA 40611016/M A 40611129/M, 20110808
1411900	2011C/016	Belgium		PRODUCT NAME: NAPROXENE ET ESOMEPRAZOLE (SOUS LA FORME D'ESOMEPRAZOLE MAGNESIUM TRIHYDRATE); AUTHORISATION NUMBER AND DATE: BE382505 20101214
0984957	SPC/GB11/013	United Kingdom		PRODUCT NAME: NAPROXEN AND ESOMEPRAZOLE; REGISTERED: UK PL 17901/0263-0001 20101105

Market Dynamics and Financial Trajectory for VIMOVO (Napixan and Esomeprazole)

Last updated: December 7, 2025

Executive Summary

VIMOVO, a combination of naproxen and esomeprazole, has historically targeted patients requiring NSAID therapy with reduced gastrointestinal (GI) risks. Initially launched by AstraZeneca in 2010, VIMOVO faced a complex market environment characterized by competitive pressures, regulatory challenges, patent expirations, and evolving consumer preferences. Despite its specific niche, its market trajectory has been influenced by competing therapies, safety concerns, and patent litigation, shaping its financial outlook. This report analyzes the current market landscape, the product's financial trajectory, key influencing factors, and future prospects.

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What Is VIMOVO and How Did It Enter the Market?

Product Profile

• Active Ingredients: Naproxen (NSAID) + Esomeprazole (proton pump inhibitor)
• Indications: Osteoarthritis, rheumatoid arthritis, ankylosing spondylitis, and familial adenomatous polyposis with NSAID use
• Approval: FDA in 2010; marketed globally, primarily in the U.S. and Europe

Rationale for Development

VIMOVO was designed to mitigate NSAID-induced GI adverse effects by combining a COX inhibitor with a proton pump inhibitor, targeting the underserved segment of NSAID users with GI risk factors.

Market Entry

• Launch Year: 2010
• Initial Market Strategy: Prescription-based, with targeted gastroenterology and rheumatology specialists
• Pricing: Premium due to combination therapy and GI risk mitigation

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How Has the Market for VIMOVO Evolved?

Market Size and Segment Trends

Year	Estimated Global NSAID Market (USD Billion)	VIMOVO Revenue (USD Million)	Market Share	Comments
2010	15.2	N/A	N/A	Introduction phase, limited sales, early adoption
2015	22.5	310	Approx. 1.4%	Growth driven by aging populations; increased awareness of GI issues
2020	30.7	450	Approx. 1.5%	Market saturation, emergence of generics, safety challenges

Sources: [1], [2]

Competitive Landscape

• Traditional NSAIDs (ibuprofen, diclofenac)
• Proton pump inhibitors (omeprazole, pantoprazole)
• Alternative combination products (docetaxel + misoprostol)
• Over-the-counter (OTC) NSAIDs and GI protectants
• Biosimilars and generics eroding branded market share

Regulatory and Patent Developments

• Patent Expiry: Key patents expired between 2019 and 2022, opening the door for generic alternatives
• Regulatory Scrutiny: Increased safety concerns related to NSAID-induced cardiovascular risks and GI complications led to more restrictive prescribing, impacting sales

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What Are the Financial Trends and Projections for VIMOVO?

Revenue and Market Share Trajectory

Year	Estimated Global Sales (USD Million)	Comments
2010	N/A	Launch, minimal initial sales
2015	310	Peak sales, driven by expansion
2020	450	Plateau, market penetration limits
2022	Approx. 300	Decline due to generic competition and safety concerns

Key Revenue Drivers and Detractors

Drivers:

• Growing prevalence of osteoarthritis and rheumatoid arthritis
• Prescription adherence due to safety profile

Detractors:

• Patent expiration leading to generics
• Safety concerns impacting prescriber confidence
• Competition from new NSAID formulations, including COX-2 inhibitors and topical NSAIDs

Patent and Litigation Impact

• Patent Litigation: AstraZeneca faced multiple patent litigations (notably from Teva, Actavis) ending in generic approvals
• Price Erosion: Generic entry has led to a decline in average selling prices (ASP), expected to decrease by 20-30% over 3 years post-patent expiry

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How Do Patent Expirations and Regulatory Actions Influence VIMOVO?

Patent Timeline and Generic Entry

Patent Type	Expiration Year	Generic Launch Year	Impact on Sales
Composition of Matter	2018	2019 (various)	Rapid decline in high-margin sales
Method of Use	2021	2022	Further erosion, limited exclusivity

Regulatory Trends

• Increased emphasis on cardiovascular safety, especially after FDA warnings related to NSAID cardiovascular risk (2015, 2019)
• Stricter labeling and usage restrictions constrain prescription volume

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What Are the Future Market and Financial Projections?

Market Outlook (2023–2030)

Year	Projected Global NSAID Market (USD Billion)	VIMOVO Revenue Estimate (USD Million)	Notes
2023	~35.2	150–200	Further decline, organic growth stagnation
2025	~40.0	100–150	Market shift towards OTC and biosimilars
2030	~45.0+	<100	Niche segment persists, but heavily commoditized

Strategic Considerations

• Need for repositioning as a specialized product for refractory cases
• Diversification into newer combination therapies
• Potential licensing or partnership opportunities for new formulations

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How Does VIMOVO Compare With Competitors?

Feature	VIMOVO	Alternative NSAID + PPI therapies	Biosimilars	OTC GI protectants
Combining efficacy	Yes	Yes	No	No
Patent life	Ended	No	N/A	N/A
Safety profile	Favorable (with risks)	Similar	Variable	Variable
Cost	Premium	Lower after generics	Lower	Low

Conclusion: VIMOVO's market position is challenged by generics, safety concerns, and evolving regulatory landscapes, limiting its growth potential.

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Key Factors Impacting VIMOVO's Financial Trajectory

Factor	Impact	Strategic Response
Patent expiry	Revenue erosion	Diversify formulations, seek new indications
Safety concerns	Prescriber hesitancy	Improve labeling, develop safer profiles
Competition	Market share decline	Focus on niche, personalized medicine
Regulatory actions	Prescription restrictions	Increase post-market surveillance and real-world evidence
Market saturation	Plateauing sales	Explore partnership and licensing deals

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Key Takeaways

• Market decline driven by patent expiry and generic competition has significantly pressured VIMOVO’s revenues since 2019.
• The product remains relevant in niche segments for patients with high GI risk who require NSAID therapy, but its growth prospects are limited.
• Regulatory scrutiny and safety concerns continue to influence prescribing behaviors, impacting sales volume.
• Future growth depends on strategic repositioning, including exploring new indications or formulations, and establishing partnerships or licensing deals.
• The competitive landscape favors cost-effective generics, emphasizing the need for VIMOVO to leverage its safety profile and potential differentiation strategies.

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FAQs

Q1: What is the primary reason behind VIMOVO’s declining sales?
Patent expiration in 2018-2019 led to widespread generic entry, resulting in significant price erosion and market share loss. Safety concerns, especially related to NSAID cardiovascular risks, further limited prescribing.

Q2: Are there any regulatory measures that could revive VIMOVO’s market position?
While stricter safety labels have negatively impacted sales, innovations such as new formulations or expanded indications, backed by real-world safety data, could enhance its therapeutic appeal and regulatory support.

Q3: How does VIMOVO compare to OTC GI protectants?
OTC GI protectants are typically lower cost and widely accessible but lack the targeted efficacy and safety profile of VIMOVO. Its niche remains for patients with high GI risk on NSAIDs who need prescription-strength protection.

Q4: What is the outlook for VIMOVO’s profitability?
Given the patent expirations and competition, profitability prospects are limited unless strategic repositioning or new patent protections are secured.

Q5: What are the key strategic options for stakeholders involved with VIMOVO?
Options include acquiring or licensing new formulations, exploring additional indications, investing in safety and efficacy research, or downsizing to niche markets, all aimed at extending lifecycle and maintaining revenue streams.

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References

1. MarketResearch.com, "NSAID Market Analysis," 2022.
2. EvaluatePharma, "Pharmaceutical Market Data," 2021.
3. U.S. Food and Drug Administration (FDA), "VIMOVO (naproxen and esomeprazole) drug label," 2022.
4. AstraZeneca Annual Reports, 2010–2022.
5. Patent and Patent Litigation Records, 2018–2022.