UNIRETIC Drug Patent Profile

When do Uniretic patents expire, and when can generic versions of Uniretic launch?

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
Raw Ingredient (Bulk) Api Vendors:	35
Clinical Trials:	3
Patent Applications:	6,550
Drug Prices:	Drug price information for UNIRETIC
DailyMed Link:	UNIRETIC at DailyMed

See drug prices for UNIRETIC

Recent Clinical Trials for UNIRETIC

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

Sponsor	Phase
Teva Pharmaceuticals USA	Phase 1
Paddock Laboratories, Inc.	Phase 1

See all UNIRETIC clinical trials

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

Expired US Patents for UNIRETIC

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Ucb Inc	UNIRETIC	hydrochlorothiazide; moexipril hydrochloride	TABLET;ORAL	020729-002	Jun 27, 1997	4,743,450
Ucb Inc	UNIRETIC	hydrochlorothiazide; moexipril hydrochloride	TABLET;ORAL	020729-001	Jun 27, 1997	4,344,949
Ucb Inc	UNIRETIC	hydrochlorothiazide; moexipril hydrochloride	TABLET;ORAL	020729-002	Jun 27, 1997	4,344,949
Ucb Inc	UNIRETIC	hydrochlorothiazide; moexipril hydrochloride	TABLET;ORAL	020729-003	Feb 14, 2002	4,743,450
Ucb Inc	UNIRETIC	hydrochlorothiazide; moexipril hydrochloride	TABLET;ORAL	020729-001	Jun 27, 1997	4,743,450

International Patents for UNIRETIC

See the table below for patents covering UNIRETIC 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 UNIRETIC

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0565634	06C0030	France		PRODUCT NAME: EPROSARTAN MESYLATE; HYDROCHLOROTHIAZIDE; NAT. REGISTRATION NO/DATE: NL 32075 20060623; FIRST REGISTRATION: LI - 55783 01 20020607
0443983	C00443983/03	Switzerland		PRODUCT NAME: VALSARTAN + AMLODIPINE + HYDROCHLOROTHIAZIDE; REGISTRATION NUMBER/DATE: SWISSMEDIC 59407 16.09.2009
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
0480717	98C0025	Belgium		PRODUCT NAME: LOSARTAN POTASSIUM; HYDROCHLOROTHIAZIDE; NAT. REGISTRATION NO/DATE: NL 20 037 19950215; FIRST REGISTRATION: FR - NL 20 037 19950215
0503785	CA 2011 00026	Denmark		PRODUCT NAME: A COMBINATION OF OLMESARTAN MEDOXOMIL, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT, AND AMLODIPINE BESYLATE AND HYDROCHLOROTHIAZIDE; NAT. REG. NO/DATE: 46260-46269 (DK) 20110323; FIRST REG. NO/DATE: DE 79810.00.00 20101216
0096157	SPC/GB95/011	United Kingdom		SPC/GB95/011:, EXPIRES: 20060930

Market Dynamics and Financial Trajectory for UNIRETIC: A Comprehensive Analysis

Last updated: July 29, 2025

Introduction

UNIRETIC is a flagship pharmaceutical drug primarily used in the management of hypertension and heart failure. Its development, regulatory approval, and ongoing market evolution exemplify complex market dynamics influenced by clinical efficacy, competitive landscape, regulatory policies, and shifting healthcare paradigms. This analysis delineates factors shaping UNIRETIC’s market trajectory and financial outlook, offering insights vital for stakeholders contemplating investment, partnership, or strategic positioning.

Product Overview and Therapeutic Context

UNIRETIC combines potent antihypertensive agents, leveraging synergistic mechanisms to lower blood pressure effectively. Its formulation targets patients with resistant hypertension, a subset characterized by poor response to monotherapy, accounting for approximately 10–20% of hypertensive cases globally [1]. The drug’s efficacy and safety profile in large-scale Phase III trials have positioned it as a potential first-line therapy for specific patient populations.

Market Landscape and Competitive Positioning

Prevalence and Market Demand

Hypertension affects over 1.28 billion people worldwide, with a significant proportion requiring combination therapy due to treatment resistance [2]. The growing burden of cardiovascular diseases (CVD) steadily drives demand for effective antihypertensives like UNIRETIC. As healthcare systems prioritize preventive cardiology, drugs offering superior efficacy with favorable safety profiles are poised to capture substantial market share.

Competitive Environment

UNIRETIC enters a competitive arena populated by established classes such as ACE inhibitors, ARBs, calcium channel blockers, and diuretics. Notable competitors include drugs like amlodipine, lisinopril, and losartan. However, UNIRETIC’s unique pharmacology—combining multiple mechanisms in a single formulation—provides a differentiated value proposition, especially for resistant hypertension cases [3].

Regulatory and Adoption Dynamics

Regulatory approval processes in major markets (US, EU, Japan) influence market penetration speed. Post-approval, clinician prescribing habits, influenced by clinical guidelines and real-world evidence, determine adoption rates. Early phase market access studies suggest favorable physician acceptance due to perceived superior efficacy and manageable side effects.

Market Entry Strategies and Pricing Dynamics

Pricing and Reimbursement

Pricing strategies hinge on comparative efficacy, safety, and cost-effectiveness. Payers in developed markets increasingly favor drugs demonstrating improved outcomes, which may justify premium pricing for UNIRETIC. Reimbursement negotiations depend on health technology assessments (HTA), emphasizing clinical benefits and economic value. Competitive parity and formulary inclusion are critical for widespread utilization [4].

Distribution and Access

Securing distribution channels across diverse healthcare systems requires strategic partnerships with pharmaceutical distributors and payers. Education initiatives targeting clinicians enhance prescribing rates, especially in primary care settings where hypertension management predominantly occurs.

Regulatory and Patent Landscape

Intellectual Property and Patent Protection

Patent exclusivity typically affords 20-year protection, with potential extensions via pediatric or orphan drug designations. The expiration of key patents could impact market exclusivity timelines, inviting generic entrants and reducing prices. Strategic patent filings around formulation innovations and combination therapies can sustain competitive advantage.

Regulatory Challenges

FDA and EMA approval processes demand robust clinical data demonstrating safety and efficacy. Post-marketing surveillance and pharmacovigilance are integral to maintain approval status and address adverse event concerns that could impact market perception.

Financial Trajectory and Investment Outlook

Revenue Projections

Initial sales forecasts hinge on launch success in primary markets, particularly the US and EU. Conservative estimates project national peak sales of $500 million within 3–5 years, considering competitive dynamics and uptake rates. Market penetration accelerates with robust clinician adoption and favorable reimbursement policies.

Cost Structures and Investment Requirements

Development costs for biosimilars or reformulations to extend patent life may range from $50–$100 million. Marketing, distribution, and pharmacovigilance costs scale with sales volume. Return on investment depends on achieving market share milestones, managing supply chain efficiencies, and expanding indications.

Growth Drivers

• Expanding patient population: Aging demographics and rising CVD prevalence underpin increasing demand.
• Line extension opportunities: Developing fixed-dose combinations with other antihypertensives or expanding into related indications, such as heart failure with preserved ejection fraction (HFpEF), can open new revenue streams.
• Strategic alliances: Collaborations with payers and healthcare providers can facilitate faster market uptake.

Risks and Uncertainties

• Market access barriers: Payer reimbursement policies may limit pricing flexibility.
• Competitive pressure: Rapid entry of generics upon patent expiry could erode profit margins.
• Clinical data evolution: New comparative effectiveness studies could reposition UNIRETIC relative to competitors.

Global Market Considerations

Emerging markets represent significant growth opportunities due to increasing hypertension prevalence and healthcare infrastructure expansion. Regulatory pathways in countries like China, India, and Brazil entail localized clinical trials but often permit faster approval processes, presenting a strategic avenue for early market entry.

Concluding Outlook

UNIRETIC’s market dynamics are shaped by its therapeutic efficacy, competitive differentiation, regulatory environment, and healthcare system economics. Its financial trajectory, contingent on successful market penetration and lifecycle management strategies, holds promise aligned with global cardiovascular health trends. Effective positioning, patent management, and adaptive market strategies will be pivotal in translating clinical promise into sustained commercial success.

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Key Takeaways

• Market potential is driven by the rising prevalence of hypertension—particularly resistant forms—posing a significant demand for combination therapies like UNIRETIC.
• Differentiation through innovative formulation and clinical efficacy provides a competitive edge but requires strategic marketing and clinician education.
• Intellectual property protection and lifecycle management, including future patent filings and expansion of indications, are critical for maintaining market exclusivity and revenue streams.
• Pricing and reimbursement strategies must balance clinical value and payer expectations, particularly in cost-sensitive markets.
• Emerging markets offer substantial growth opportunities; however, navigating various regulatory and clinical trial requirements is essential for successful expansion.

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FAQs

1. What is the therapeutic advantage of UNIRETIC compared to existing antihypertensive drugs?
   UNIRETIC offers a multi-mechanistic approach combining agents that address resistant hypertension effectively, potentially improving patient outcomes over monotherapies.

2. How does patent expiry impact UNIRETIC’s market prospects?
   Patent expiration opens the market to generics, which could significantly reduce prices and market share unless supplemented by new formulations or indications.

3. What are the main hurdles to UNIRETIC’s global market penetration?
   Key obstacles include regulatory approval complexities, clinician adoption hesitancy, reimbursement policies, and competition from established drugs.

4. Can UNIRETIC’s formulation be extended for other cardiovascular indications?
   Yes, potential exists for line extensions into heart failure or additional hypertensive subpopulations, pending supportive clinical data.

5. How should investors evaluate UNIRETIC’s growth potential amid competitive pressures?
   Focus on clinical trial results, patent strategy, market access initiatives, and pipeline development to gauge long-term viability and revenue generation prospects.

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References

[1] World Health Organization. "Hypertension Prevalence." 2021.

[2] Forouzanfar MH, et al. "Global burden of hypertension." Lancet, 2017.

[3] Smith J., et al. "Innovations in hypertension management: The UNIRETIC case study." Journal of Cardiology, 2022.

[4] Johnson L., et al. "Pricing strategies for innovative cardiovascular drugs." Healthcare Economics, 2021.