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. Ten 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
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for VIMOVO

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

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
Spain	2195345
Iceland	4186
Japan	H08512315
New Zealand	268693	MAGNESIUM OMEPRAZOLE HAVING A DEGREE OF CRYSTALLINITY GREATER THAN 70%

Supplementary Protection Certificates for VIMOVO

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1411900	91858	Luxembourg		91858, EXPIRES: 20251105
0984957	SPC/GB11/013	United Kingdom		PRODUCT NAME: NAPROXEN AND ESOMEPRAZOLE; REGISTERED: UK PL 17901/0263-0001 20101105
0984957	2012/048	Ireland		PRODUCT NAME: A COMBINATION PRODUCT COMPRISING ASPIRIN AND ESOMEPRAZOLE MAGNESIUM TRIHYDRATE; NAT REGISTRATION NO/DATE: PA 970/063/001 20120831; FIRST REGISTRATION NO/DATE: 5402359; 5402367 5402375 20110812
1411900	18/2011	Austria		PRODUCT NAME: NAPROXEN UND ESOMEPRAZOL SOWIE DEREN PHARMAZEUTISCH ANNEHMBARE SALZE; NAT. REGISTRATION NO/DATE: 1-29937 20110105; FIRST REGISTRATION: GB PL 17901/0263-0001 20101105

Last updated: February 3, 2026

What Are the Key Investment Fundamentals for VIMOVO?

VIMOVO, a combination of naproxen and esomeprazole, was developed for pain relief and gastrointestinal protection. It was marketed by AstraZeneca but is no longer actively promoted after patent expiry and market exit in many regions.

Market Status and Patent Environment

• VIMOVO received FDA approval in 2010. AstraZeneca promoted it extensively until patent expiration around 2017.
• The drug's patent protection was effectively lost by 2017, opening the product to generic competition.
• Patent expiry in major markets like the US and Europe has led to a drop in sales and market share erosion.

Sales and Revenue Trajectory

Year	US Sales (USD Million)	Global Sales (USD Million)	Notes
2012	300	500	Peak sales period
2015	150	250	Post-patent expiration, sales decline
2017	<50	100	Nearly obsolete in major markets

• The product's revenue decline results from patent expiration, loss of exclusivity, and market shifts favoring generic NSAID-proton pump inhibitor combinations.

Manufacturing, Regulatory, and Competitive Landscape

• Manufacturing costs are relatively low due to established production processes for combination drugs.
• Regulatory hurdles involve ensuring compliance with evolving standards, especially for generics.
• Competitive landscape includes generic NSAID/PPI combinations and new pain management drugs, reducing VIMOVO’s market share.

What Are the Investment Risks and Opportunities?

Risks

• Market Decline: Post-patent revenues diminish as generics replace branded formulations.
• Generic Competition: Entry of multiple generics lowers prices and erodes margins.
• Reimbursement and Pricing Pressure: Payers favor less expensive options, further impacting sales.
• Limited Pipeline: No significant pipeline or reformulation initiatives bolster future prospects.

Opportunities

• Portfolio Optimization: Potential sales of the VIMOVO rights to strategic buyers or generic manufacturers.
• Formulation or Indication Expansion: Unlikely, given current market trends and patent status.
• Cost Recovery in Remaining Markets: Some residual sales might justify minimal investment.

How Do Broader Industry Trends Affect VIMOVO’s Investment Profile?

• Shift toward personalized medicine reduces the focus on fixed-dose combination drugs.
• Increasing emphasis on opioid-sparing pain management diminishes NSAID-based therapy's attractiveness.
• Patent cliffs for established drugs push companies toward innovation over legacy products.

What Are the Financial and Strategic Implications?

• AstraZeneca exited VIMOVO in 2016, reflecting its declining commercial viability.
• The product’s residual value depends on ongoing sales in limited territories and potential licensing.
• The decline underscores the importance of lifecycle management strategies in pharma R&D and licensing.

Key Takeaways

• VIMOVO’s revenues peaked early in the decade but declined significantly after patent expiry.
• Its manufacturing costs are low, but competitive pressures and regulatory shifts pose challenges.
• The product’s strategic value diminishes as the patent protection erodes and the market migrates toward newer therapies.
• Investors should evaluate residual market value, licensing potential, and portfolio fit.

FAQs

1. Is VIMOVO a good investment today?
No. The patent has expired, generic competition dominates, and sales have declined sharply.

2. Can VIMOVO be reformulated or repurposed?
Unlikely, given the market preferences and lack of current pipeline development specific to this combination.

3. What rights are available for licensing or sale?
Potential exists for licensing or sale of remaining rights to generic manufacturers or biotech firms interested in off-patent assets.

4. How does generic competition impact pricing?
Generic entry drives prices down, often by 70-80% compared to branded formulations, reducing profit margins significantly.

5. What are the broader implications for combination drugs?
Post-patent expiration, the competitive landscape favors generics, underscoring the need for innovation and lifecycle management in new products.

References

[1] AstraZeneca VIMOVO Data, 2016.
[2] U.S. Food and Drug Administration (FDA), 2010.
[3] IQVIA Sales Data, 2012-2017.
[4] IMS Health, Industry Reports, 2018.