UNIVASC Drug Patent Profile

Which patents cover Univasc, and when can generic versions of Univasc launch?

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

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

International Patents for UNIVASC

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

Country	Patent Number	Title	Estimated Expiration
U.S.S.R.	1148560	METHOD OF OBTAINING SUBSTITUTED ACUL DERIVATIVE OF 1,2,3,4-TETRAHYDROISOQUINOLINE--3-CARBOXYLIC ACID OR PHARMACEUTICALLY ACCEPTED SALTS
Australia	563683
Australia	597471
South Korea	830007567

Supplementary Protection Certificates for UNIVASC

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

UNIVASC (moexipril): Investment Scenario and Fundamentals Analysis

Last updated: February 7, 2026

Overview of UNIVASC

UNIVASC contains moexipril, an ACE inhibitor approved for hypertension treatment. It is marketed primarily in the United States and select international markets. Moexipril's patent expired in the early 2000s, leading to increased generic competition. The drug's sales are primarily driven by its positioning as a first-line therapy for hypertension, with a well-established safety profile.

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Market Landscape and Competitive Position

Aspect	Details
Patent Status	Expired since early 2000s; generic versions available
Market Size of ACE inhibitors	Estimated at $12 billion globally in 2022; expected CAGR of 2-3% through 2028
Key Competitors	Lisinopril, Enalapril, Ramipril, Benazepril
Market Share	UNIVASC's parent company, out of market share for moexipril itself, focuses on branded niche markets and combination drugs

The widespread availability of generics has reduced price premiums, pressuring profit margins for UNIVASC. The drug's exclusive rights ended nearly two decades ago, limiting growth prospects directly attributable to UNIVASC.

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Financial and R&D Fundamentals

Aspect	Data
Current Sales	Estimated below $20 million annually (public data, circa 2022)
R&D Investment	No recent dedicated R&D; focused on new formulations and combination therapies within proprietary pipelines
Pricing Strategy	Competitive generics pricing, no significant brand premiums
Regulatory Status	Fully approved in US (FDA), EMA, and other jurisdictions; no pending label changes

The product's sales since patent expiration rely on existing contracts and legacy markets. Recent restructuring indicates minimal pipeline investment specifically for moexipril.

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Regulatory and Patent Considerations

Aspect	Details
Patent Expiry	Moexipril patent expired circa 2004
Exclusivity	Limited; no pediatric or orphan exclusivities granted
Regulatory Hurdles	Minimal, as the generic versions have been on the market for years
Potential for New Indications	Low, due to longstanding generics and lack of novel formulations

No regulatory barriers hinder generic competition, and no recent extensions or exclusivities protect the drug, limiting revenue growth and strategic positioning.

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Investment Outlook

• Market Saturation: The ACE inhibitor market is mature with declining growth—market expansion driven by new combination therapies, rather than UNIVASC alone.
• Revenue Stability: Limited, given generic competition, low brand loyalty, and modest sales levels.
• Growth Opportunities: Nonexistent within the current product scope; future growth depends on pipeline success or new indications.
• Risk Profile: High competition, low differentiation, minimal pipeline activity specific to UNIVASC.

Conclusion:

UNIVASC’s current investment profile reflects a mature, low-growth asset dominated by generic competition. Limited upside exists unless the parent company advances new formulations or combination products leveraging existing patents or technological advantages.

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Key Takeaways

1. UNIVASC’s moexipril lost patent protection nearly two decades ago, leading to intense generic competition.
2. The drug generates modest sales estimates below $20 million annually, with no significant growth trajectory.
3. The market for ACE inhibitors is mature, with limited scope for expansion outside of combination therapies.
4. R&D investment specific to UNIVASC declined post-patent expiry, focusing instead on new products within the parent company's pipeline.
5. Investment risk remains high due to commoditization, competitive pricing, and lack of regulatory or patent barriers to market entry.

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FAQs

1. Why is UNIVASC considered a low-growth asset?
Because its patent expired in 2004, resulting in generic competition that suppresses pricing and sales, with no recent product innovations or new indications.

2. Are there regulatory hurdles for UNIVASC?
No. The drug is fully approved in major markets with no pending label changes or regulatory actions that could impact sales.

3. What are the revenue prospects for UNIVASC?
Limited. Projected sales remain below $20 million annually, with most revenues dictated by generic market dynamics.

4. How does the generic competition affect UNIVASC’s profitability?
It exerts downward pressure on prices, margins, and overall profitability, making it unattractive for investment purely based on the drug.

5. What strategic options exist for stakeholders interested in UNIVASC?
Options include developing combination therapies, repurposing for new indications, or leveraging proprietary formulations, though none are currently active.

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References

[1] EvaluatePharma, 2022. Global ACE inhibitor Market Data.
[2] FDA Drug Approvals and Patent Records, 2023.
[3] Market Research Future, 2022. Hypertension Drug Market Analysis.