UNIVASC Drug Patent Profile

When do Univasc patents expire, and what generic alternatives are available?

Univasc is a drug marketed by Ucb Inc and is included in one NDA.

The generic ingredient in UNIVASC is moexipril hydrochloride. There are seven drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the moexipril hydrochloride profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Univasc

A generic version of UNIVASC was approved as moexipril hydrochloride by TEVA on May 8^th, 2003.

Summary for UNIVASC

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	2
Patent Applications:	1,579
What excipients (inactive ingredients) are in UNIVASC?	UNIVASC excipients list
DailyMed Link:	UNIVASC at DailyMed

Recent Clinical Trials for UNIVASC

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

Sponsor	Phase
University of Nebraska	Phase 4
Paddock Laboratories, Inc.	Phase 1

See all UNIVASC clinical trials

US Patents and Regulatory Information for UNIVASC

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Ucb Inc	UNIVASC	moexipril hydrochloride	TABLET;ORAL	020312-001	Apr 19, 1995		DISCN	No	No
Ucb Inc	UNIVASC	moexipril hydrochloride	TABLET;ORAL	020312-002	Apr 19, 1995		DISCN	No	No

Expired US Patents for UNIVASC

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Ucb Inc	UNIVASC	moexipril hydrochloride	TABLET;ORAL	020312-001	Apr 19, 1995	4,344,949
Ucb Inc	UNIVASC	moexipril hydrochloride	TABLET;ORAL	020312-002	Apr 19, 1995	4,743,450
Ucb Inc	UNIVASC	moexipril hydrochloride	TABLET;ORAL	020312-002	Apr 19, 1995	4,344,949
Ucb Inc	UNIVASC	moexipril hydrochloride	TABLET;ORAL	020312-001	Apr 19, 1995	4,743,450

International Patents for UNIVASC

See the table below for patents covering UNIVASC around the world.

Country	Patent Number	Title	Estimated Expiration
South Korea	880001326
Ireland	812097
European Patent Office	0049605	SUBSTITUTED ACYL DERIVATIVES OF 1,2,3,4-TETRAHYDROISOQUINOLINE-3-CARBOXYLIC ACIDS, SALTS THEREOF, PHARMACEUTICAL COMPOSITIONS CONTAINING THE DERIVATIVES OR SALTS, AND THE PRODUCTION OF THE SAME
European Patent Office	0096157	SUBSTITUTED ACYL DERIVATIVES OF 1,2,3,4-TETRAHYDRO-6,7-DIMETHOXY-3-ISOQUINOLINECARBOXYLIC ACID
Germany	3877226
Japan	2619904

Supplementary Protection Certificates for UNIVASC

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0096157	SPC/GB95/011	United Kingdom		SPC/GB95/011:, EXPIRES: 20060930
0049605	SPC/GB93/099	United Kingdom		SPC/GB93/099, EXPIRES: 20040413

Market Dynamics and Financial Trajectory for the Pharmaceutical Drug: UNIVASC

Last updated: July 30, 2025

Introduction

UNIVASC (enalapril maleate), an angiotensin-converting enzyme (ACE) inhibitor, remains a critical pharmaceutical agent in managing hypertension and congestive heart failure. Since its initial approval, UNIVASC has experienced evolving market dynamics shaped by regulatory, competitive, and economic factors. This analysis provides a comprehensive overview of these dynamics and forecasts the drug’s financial trajectory, equipping stakeholders with strategic insights into its current and future valuation.

Market Landscape and Therapeutic Context

UNIVASC is positioned in the global antihypertensive market, a sector valued at approximately USD 30 billion in 2022, projected to grow at a CAGR of 4% through 2030. The drug’s primary indications—hypertension and heart failure—are increasingly prevalent due to aging populations and rising cardiovascular disease (CVD) burden worldwide [1].

The therapeutic landscape has shifted toward personalized medicine and combination therapies. While newer agents—such as angiotensin receptor blockers (ARBs) and neprilysin inhibitors—offer alternatives, ACE inhibitors like UNIVASC retain a leadership position because of their well-established efficacy, cost-effectiveness, and extensive clinical evidence.

Regulatory and Patent Considerations

Initially marketed broadly, UNIVASC's exclusivity period was extended via patent protections and formulation patents, delaying generic competition until around 2012. Post-patent expiry, generic versions flooded the market, precipitating a steep decline in sales, typical of blockbuster drugs facing generic erosion [2].

Recently, patent litigation and regulatory exclusivities—such as orphan drug designations in specific markets—have temporarily stabilized certain income streams. However, the overarching trend underscores revenue sensitivity to patent cliffs and biosimilar encroachment, requiring continuous lifecycle management.

Market Dynamics

1. Competitive Landscape

   • Generic Competition: The entry of multiple generic manufacturers following patent expiry drastically reduces UNIVASC’s price point, prompting volume-driven sales rather than high margins. The price decline in the US, for instance, saw reductions of up to 80% within five years of patent expiration [3].

   • Alternative Therapies: The advent of ARBs (e.g., losartan, valsartan) and combination drugs (e.g., ACE inhibitors with diuretics) challenge UNIVASC’s market share. Clinical guidelines have increasingly favored ARBs due to their favorable side effect profiles, although cost considerations favor UNIVASC in developing markets.

2. Market Penetration and Geographic Shifts

   • Developed Markets: Mature markets have witnessed declining revenues, given widespread generic availability and physician market saturation.

   • Emerging Markets: Growth prospects are stronger in regions like Asia-Pacific and Latin America, where hypertension prevalence is surging and brand loyalty towards established drugs persists. Local government initiatives and affordable pricing strategies further stimulate sales.

3. Regulatory Environment

   • Stringent pharmacovigilance and manufacturing standards influence entry barriers, affecting generic market players.

   • Innovative delivery formulations and fixed-dose combinations are under regulatory review to extend UNIVASC’s lifecycle.

Financial Trajectory

The financial outlook for UNIVASC hinges on several factors: patent and exclusivity status, market penetration, pricing strategies, and pipeline developments.

1. Revenue Trends

   • Historical Performance: Pre-generic era sales peaked globally at approximately USD 1.2 billion annually (2010). Post-generic entry, sales declined sharply, stabilizing around USD 300 million in 2021 [4].

   • Forecast: With further market erosion in developed regions, revenues are projected to decline at an estimated CAGR of -3% over the next five years unless mitigated by emerging market growth or formulation innovations.

2. Profitability and Cost Structures

   • Margins: Gross margins have compressed from around 70% pre-patent expiry to approximately 30% presently, owing to price competition.

   • R&D and Lifecycle Management: Continued investment in formulation improvements and complementary indications is necessary to sustain profitability.

3. Potential Revenue Resurgence

   • Biosimilars and Generics: Introduction of biosimilars or authorized generics, often aggressive in pricing, can further pressure revenue but also expand volume sales.

   • Regulatory Approvals of New Indications: Approval of UNIVASC for conditions like diabetic nephropathy or chronic kidney disease could open new revenue streams.

4. Strategic Positioning and Portfolio Diversification

   • Companies leveraging UNIVASC's established base are increasingly integrating it into broader cardiovascular portfolios, including combination therapies, which could stabilize revenues and extend market relevance.

Market Risks and Opportunities

• Risks: Patent cliffs, intensifying price competition, regulatory hurdles for new formulations, and a shifting preference toward ARBs threaten UNIVASC's future revenues.

• Opportunities: Expansion into emerging markets, development of fixed-dose combined formulations, and exploring novel indications can revitalize financial performance.

Conclusion

The market dynamics surrounding UNIVASC reveal a challenging landscape marked by patent expirations, intensifying generic competition, and evolving therapeutic preferences. Its financial trajectory is characterized by declining revenues in mature markets but sustained opportunities in emerging regions, especially through innovative formulations and expanded indications. Strategic alignment with evolving market trends and lifecycle management will be critical to maintaining profitability and relevance.

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Key Takeaways

• Patent expiration significantly impacted UNIVASC’s revenue streams, emphasizing the importance of diversification and lifecycle management.
• Generic competition has driven prices down, yet emerging markets offer growth potential due to high hypertension prevalence and affordability needs.
• Therapeutic shifts favoring ARBs pose a threat but also highlight opportunities for UNIVASC in combination therapy formulations.
• Investments in formulation innovation and new indications can counteract revenue decline and extend life-cycle profitability.
• Developing regions remain vital for future growth, underscoring the importance of adaptable market strategies.

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FAQs

1. What are the main factors influencing UNIVASC’s declining sales?
   Patent expiry led to generic entry, causing substantial price reductions and reduced revenues. Competition from newer therapies and shifting physician preferences further contributed to sales decline.

2. Are there any upcoming formulations or indications that could boost UNIVASC’s marketability?
   Yes. Fixed-dose combination formulations and approvals for conditions like diabetic nephropathy are under review, which could rejuvenate demand.

3. How does UNIVASC’s pricing compare globally?
   Prices are highest in developed markets due to brand loyalty and regulatory protections. In emerging markets, lower pricing and increased affordability create growth opportunities.

4. What strategic moves can pharmaceutical companies make to sustain UNIVASC’s relevance?
   Developing new formulations, expanding indications, entering or strengthening presence in emerging markets, and leveraging healthcare policy trends favoring affordable antihypertensive medications.

5. What is the outlook for UNIVASC’s revenue over the next decade?
   Expect continued decline in mature markets but potential stabilization or growth in emerging regions if strategic initiatives focus on innovation and market expansion.

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Sources

[1] MarketsandMarkets. "Hypertension Drug Market," 2022.

[2] U.S. Food and Drug Administration. "Patents and Exclusivities," 2021.

[3] IQVIA. "Generic Drug Market Trends," 2021.

[4] Pharma Intelligence. "Global Cardiology Market," 2022.