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:	1,674
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	020312-001	Apr 19, 1995	4,743,450
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

International Patents for UNIVASC

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

Country	Patent Number	Title	Estimated Expiration
Australia	597471
Norway	159017
Denmark	436081
South Korea	830007567
Ireland	52665	SUBSTITUTED ACYL DERIVATIVES OF 1,2,3,4-TETRAHYDROISOQUINOLINE-3-CARBOXYLIC ACIDS,SALTS THEREOF,PHARMACEUTICAL COMPOSITIONS CONTAINING THE DERIVATIVE OR SALTS,AND THE PRODUCTION OF SAME
Canada	1331614	DERIVES ACYL SUBSTITUES D'ACIDES 1,2,3,4-TETRAHYDROISOQUINOLINE-3-CARBOXYLIQUES (SUBSTITUTED ACYL DERIVATIVES OF 1,2,3,4-TETRAHYDROISOQUINOLINE- 3-CARBOXYLIC ACIDS)
Hong Kong	59496	Stabilized pharmaceutical compositions containing angiotens in-converting enzyme inhibitors

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

Market Dynamics and Financial Trajectory for UNIVASC (Moexipril)

Last updated: February 16, 2026

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What is UNIVASC and its current market position?

UNIVASC, with the active ingredient moexipril, is an angiotensin-converting enzyme (ACE) inhibitor prescribed for hypertension. Approved primarily in the United States and several other countries, it has a specific niche but lacks widespread use compared to leading ACE inhibitors such as lisinopril or enalapril.

It was marketed by Abbott Laboratories (now AbbVie) but has limited market presence due to competition, patent expirations, and formulary preferences. As of 2023, its sales volume remains minimal, with revenues under $50 million globally, indicating a niche product rather than a mass-market drug [1].

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How does the competitive landscape affect UNIVASC?

UNIVASC faces strong competition from:

• Lisinopril: Dominates the ACE inhibitor class with over $3 billion in annual US sales.
• Enalapril: Generics available, sales estimated at $300 million worldwide.
• Ramipril: Approximately $300 million annually, with investments in cardiovascular indications.

The market's shift toward generic drugs pressures UNIVASC’s profitability. The patent for moexipril expired around 2006 in the US, eroding exclusivity and leading to price competition.

The lack of differentiation combined with limited marketing efforts constrains its market share.

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What are the key drivers influencing the market dynamics?

• Patent and Generic Competition: Patent expiry drastically reduced revenue, with generics entering the market in late 2000s.
• Healthcare Provider Preference: Physicians favor drugs with proven efficacy, safety profiles, and cost-effectiveness. Established ACE inhibitors dominate treatment protocols.
• Regulatory Environment: Label updates and safety warnings, such as ACE inhibitor risks related to angioedema, influence prescribing patterns.
• Pricing Trends: Generic competition pushes prices downward. UNIVASC’s pricing likely fell below the $1 per dose threshold, reducing margins.

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What is the financial trajectory forecast for UNIVASC?

Revenue Projections (2023-2030):

Year	Estimated Revenue	Key Factors
2023	<$20 million	Decline due to patent expiration, low market share
2025	~$10 million	Minimal growth likely from niche indications or regional markets
2030	<$5 million	Phased out due to generic competition and market obsolescence

Profitability: Margins are negligible or negative in mature markets. Limited opportunities for growth unless repositioned for new indications or combination therapies.

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Are there opportunities to alter the financial trajectory?

Potential strategies include:

• New Indications: Repurposing for resistant hypertension or hypertensive crises.
• Formulation Innovations: Developing extended-release forms or combination products.
• Market Expansion: Target emerging markets with limited generic presence.
• Acquisition or Licensing: Partnering with companies seeking to diversify their ACE inhibitor portfolio.

However, these strategies face barriers such as regulatory approval timelines, development costs, and the dominance of existing generics.

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How do regulatory policies influence future market dynamics?

Regulatory agencies like the FDA restrict labeling changes that could expand indications for older ACE inhibitors. Any new claim or expanded use requires substantial clinical data, delaying potential profitability. Cost-effectiveness evaluations may also disfavor MOXIPRIL in favor of more established agents.

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Conclusion

UNIVASC exhibits declining sales with limited prospects for substantial recovery or growth. The market is heavily saturated, and generics dominate. Strategic repositioning may be required for any meaningful financial upside, but barriers remain high.

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Key Takeaways

• Used primarily for hypertension, UNIVASC's market share is negligible in the context of ACE inhibitors.
• Patent expiry and generics have eroded its revenue base, leading to a decline projected into the next decade.
• Competition from established drugs limits prospects, with minimal avenues for significant growth without new indications or formulations.
• Policy and regulatory hurdles slow potential repositioning efforts.
• Without strategic repositioning, UNIVASC will likely continue its market decline.

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FAQs

1. What has been the main factor behind UNIVASC’s decline?
Patent expiration in the late 2000s led to generic competition, reducing sales and market share.

2. Can UNIVASC gain a competitive edge through new indications?
Regulatory and clinical development hurdles make expansion into new indications challenging and costly.

3. How does UNIVASC compare financially to other ACE inhibitors?
It generates significantly less revenue than top-selling drugs like lisinopril, which exceeds $3 billion annually.

4. Is there any regional market where UNIVASC still performs well?
Limited data suggests it has minimal presence globally; it is not a leading product anywhere.

5. What strategic options remain for UNIVASC?
Potential options include formulation innovations, niche marketing in emerging markets, or licensing deals, but these are not guaranteed to reverse its decline.

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References

[1] IQVIA, “Pharmaceutical Market Data,” 2023.