UNIRETIC Drug Patent Profile

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

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

The generic ingredient in UNIRETIC is hydrochlorothiazide; moexipril hydrochloride. There are thirty-two drug master file entries for this compound. Additional details are available on the hydrochlorothiazide; moexipril hydrochloride profile page.

Summary for UNIRETIC

US Patents:	0
Applicants:	1
NDAs:	1

Paragraph IV (Patent) Challenges for UNIRETIC

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
UNIRETIC	Tablets	hydrochlorothiazide; moexipril hydrochloride	7.5mg/12.5mg, 15 mg/25 mg and 15 mg/12.5 mg	020729	1	2004-01-15

US Patents and Regulatory Information for UNIRETIC

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Ucb Inc	UNIRETIC	hydrochlorothiazide; moexipril hydrochloride	TABLET;ORAL	020729-001	Jun 27, 1997		DISCN	No	No
Ucb Inc	UNIRETIC	hydrochlorothiazide; moexipril hydrochloride	TABLET;ORAL	020729-003	Feb 14, 2002		DISCN	No	No
Ucb Inc	UNIRETIC	hydrochlorothiazide; moexipril hydrochloride	TABLET;ORAL	020729-002	Jun 27, 1997		DISCN	No	No

International Patents for UNIRETIC

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

Country	Patent Number	Title	Estimated Expiration
South Africa	8800382
Denmark	163120
Japan	2619904

Supplementary Protection Certificates for UNIRETIC

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0502314	SPC/GB02/037	United Kingdom		PRODUCT NAME: TELMISARTAN, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT, AND HYDROCHLOROTHIAZIDE; REGISTERED: UK EU/1/02/213/001 20020419; UK EU/1/02/213/002 20020419; UK EU/1/02/213/003 20020419; UK EU/1/02/214/004 20020419; UK EU/1/02/213/005 20020419; UK EU/1/02/213/006 20020419; UK EU/1/02/213/007 20020419; UK EU/1/02/213/008 20020419; UK EU/1/02/213/009 20020419; UK EU/1/02/213/010 20020419
0565634	06C0030	France		PRODUCT NAME: EPROSARTAN MESYLATE; HYDROCHLOROTHIAZIDE; NAT. REGISTRATION NO/DATE: NL 32075 20060623; FIRST REGISTRATION: LI - 55783 01 20020607
0454511	SPC/GB99/008	United Kingdom		PRODUCT NAME: 2-N-BUTYL-4-SPIROCYCLOPENTANE-1-((2'-(TETRAZOL-5-YL)BIPHENYL-4-YL)METHYL)-2-IMIDAZOLIN-5-ONE)(GENERIC NAME IRBESARTAN) OPTIONALLY IN THE FORM OF ONE OF ITS SALTS AND HYDROCHLOROTHIAZIDE; REGISTERED: UK EU/1/98/086/001 19981015; UK EU/1/98/086/002 19981015; UK EU/1/98/086/003 19981015; UK EU/1/98/086/004 19981015; UK EU/1/98/086/005 19981015; UK EU/1/98/086/006 19981015

Last updated: February 7, 2026

What is Uniretic and Its Market Position?

Uniretic (moexipril) is an ACE inhibitor used primarily for hypertension and heart failure. It originated from the broader class of ACE inhibitors, which target the renin-angiotensin system to lower blood pressure. Biosimilar versions of ACE inhibitors generally see market expansion as patents expire. Uniretic's patent protection in various markets has lapsed, opening opportunities for generic competition.

Patent Landscape and Regulatory Status

Uniretic was originally approved in 1994. Critical patents around its active ingredient or formulation are unlikely to be in force given the drug's age; however, exclusivity rules vary geographically. The U.S. Food and Drug Administration (FDA) approved uniretic in 1994, with generic versions approved subsequently, increasing price competition.

In Europe, Uniretic received approval from the European Medicines Agency (EMA) the same year. No recent patent litigations or exclusivity extensions appear active, indicating a generic-friendly environment.

Market Dynamics and Revenue Trajectory

Global Sales and Market Share

ACE inhibitors^1 dominate hypertension treatment, with key players including Pfizer (enalapril), Novartis (perindopril), and Merck (ramipril). Uniretic holds a minor segment mainly in niche markets or specific regions.

Analyst estimates suggest that ACE inhibitor sales in 2022 exceeded USD 15 billion globally. Uniretic's contribution remains small; approximate annual sales under USD 50 million in its prime regions through the mid-2000s. The market has shifted toward more selective or once-daily formulations, marginalizing older drugs like Uniretic.

Current Market Share and Competition

Uniretic's market presence declined after patent expiry, replaced by generics. Market leader enalapril (e.g., Vasotec) dominates, with generic versions accounting for over 80% of ACE inhibitor prescriptions in the U.S. As new drugs like sacubitril/valsartan (Entresto) enter the broader heart failure market, ACE inhibitors' share diminishes.

Regional and Demographic Factors

Developing markets still prescribe older ACE inhibitors due to cost advantages. Countries in Asia, Latin America, and Africa could sustain demand, especially where healthcare infrastructure favors older drugs with lower cost.

Investment Potentials of Uniretic

Opportunities

• Pending patent protections or regulatory exclusivity in emerging territories could create niche opportunities.
• Strategic partnerships with generic manufacturers could generate licensing revenue.

Risks

• Obsolescence due to newer antihypertensive medications offering better safety profiles.
• Price erosion from generics and biosimilars reducing profit margins.
• Limited pipeline innovations associated with Uniretic.

R&D and Patent Landscape

No active development programs or notable patents associated with Uniretic exist as of 2023. The focus has shifted to compounds with novel mechanisms, such as angiotensin receptor-neprilysin inhibitors (ARNIs). Patent protections for newer drugs threaten the long-term relevance of older ACE inhibitors like Uniretic.

Regulatory and Policy Factors

Regulatory environments favor generics; patent expiries have led to widespread availability of cheaper alternatives. Policies in the U.S., Europe, and other regions facilitate generic substitution, challenging Uniretic's market sustainability.

Investment Outlook

Prospects for Uniretic hinge on niche market access and regional regulatory decisions. Without new formulations, patents, or indications, its valuation remains limited. Peaks could occur in markets prioritizing cost-effective antihypertensive options, but the trend favors newer therapies.

Key Takeaways

• Uniretic's primary market role has diminished post-patent expiry.
• Competitive landscape favors generics, constraining pricing power.
• Market growth potential remains confined to developing regions and specific niche uses.
• Lack of innovation or pipeline activity limits future upside.
• Shipping and distribution agreements could provide incremental revenue streams.

FAQs

1. Is Uniretic still protected by patents?
Most patents for Uniretic expired by the late 2000s, leading to widespread generic availability.

2. What is Uniretic’s main competitive advantage today?
Limited; it is largely overshadowed by other ACE inhibitors with established market dominance and generic options.

3. Are there any ongoing clinical trials for Uniretic?
No current clinical trials or development programs for Uniretic are publicly known.

4. Which regions offer the best growth opportunities for older ACE inhibitors?
Developing markets in Asia, Latin America, and Africa, where healthcare budgets favor older, low-cost medications.

5. What factors could revive Uniretic's market relevance?
Introduction of new formulations, indications, or patents; strategic licensing; or niche market developments.

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Citations

[1] GlobalData, "ACE Inhibitors Market Report," 2023.