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	020729-001	Jun 27, 1997
Ucb Inc	UNIRETIC	hydrochlorothiazide; moexipril hydrochloride	TABLET;ORAL	020729-001	Jun 27, 1997
Ucb Inc	UNIRETIC	hydrochlorothiazide; moexipril hydrochloride	TABLET;ORAL	020729-002	Jun 27, 1997
Ucb Inc	UNIRETIC	hydrochlorothiazide; moexipril hydrochloride	TABLET;ORAL	020729-002	Jun 27, 1997
Ucb Inc	UNIRETIC	hydrochlorothiazide; moexipril hydrochloride	TABLET;ORAL	020729-003	Feb 14, 2002

International Patents for UNIRETIC

See the table below for patents covering UNIRETIC 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)

Supplementary Protection Certificates for UNIRETIC

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0454511	99C0009	Belgium		PRODUCT NAME: IRBESARTAN / HYDROCHLOROTHIAZIDE; REGISTRATION NO/DATE: EU/1/98/086/001 19981015
0049605	SPC/GB93/099	United Kingdom		SPC/GB93/099, EXPIRES: 20040413
0480717	98C0025	Belgium		PRODUCT NAME: LOSARTAN POTASSIUM; HYDROCHLOROTHIAZIDE; NAT. REGISTRATION NO/DATE: NL 20 037 19950215; FIRST REGISTRATION: FR - NL 20 037 19950215
0565634	06C0030	France		PRODUCT NAME: EPROSARTAN MESYLATE; HYDROCHLOROTHIAZIDE; NAT. REGISTRATION NO/DATE: NL 32075 20060623; FIRST REGISTRATION: LI - 55783 01 20020607
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
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

Market Dynamics and Financial Trajectory for UNIRETIC

Last updated: January 16, 2026

Executive Summary

UNIRETIC (generic name: furosemide) is a loop diuretic extensively used for edema, heart failure, hypertension, and renal disorders. The drug operates by inhibiting sodium, chloride, and water reabsorption in the kidneys, providing rapid symptom relief. Its low-cost, proven efficacy, and widespread clinical use sustain a substantial global market presence. This report delineates current market conditions, competitive landscape, regulatory factors, and financial projections influencing UNIRETIC’s growth trajectory, providing business professionals with strategic insights for investment and development decisions.

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What are Market Dynamics Influencing UNIRETIC’s Demand and Supply?

Global Market Size and Segmentation

• Market Value (2022): Estimated at USD 1.2 billion, with projections to reach approximately USD 1.65 billion by 2028, exhibiting a CAGR of 5.4% (2022–2028) [1].

• Geographic Distribution:

  • North America: Over 35% of the global market.
  • Europe: ~25%, driven by aging populations and hypertension prevalence.
  • Asia-Pacific: Rapid growth with a CAGR near 6%, fueled by rising chronic diseases.
  • Latin America & Africa: Expanding markets due to healthcare infrastructure improvements.

• End-Use Segments:

  • Hospitals and clinics (>60%)
  • Retail pharmacies (~25%)
  • Institutional and bans (e.g., outpatient clinics) remaining significant.

Key Market Drivers

• Rising Prevalence of Hypertension & Heart Failure:

  • WHO reports over 1.3 billion adults worldwide suffer from hypertension; an aging population amplifies demand for diuretics including UNIRETIC.

• Cost-Effectiveness and Accessibility:

  • Furosemide’s generic status keeps prices low, bolstering adoption in low- and middle-income countries (LMICs).

• Healthcare Infrastructure Development:

  • Improving access and regulatory approvals in emerging markets expand UNIRETIC’s reach.

Market Restraints and Challenges

• Patent Expirations:

  • UNIRETIC’s patent expired in the early 2000s; proliferation of generics leads to price erosions.

• Availability of Alternative Therapies:

  • Newer diuretics (e.g., torsemide, bumetanide) with improved efficacy or convenience can impact demand.

• Regulatory Barriers:

  • Stringent approval processes and quality standards may delay market entry of generics or biosimilars.

Competitive Landscape

Company	Market Share	Product Portfolio	Key Strategies	Notes
Pfizer (Lasix)	~40%	Furosemide (Lasix)	Global marketing, robust supply chain	Market leader, patent expired
Teva	15%	Furosemide, generic equivalents	Price competition, regional expansion	Major generic producer
Sandoz/Novartis	12%	Furosemide	Cost innovation, niche markets	Focus on emerging markets
Others (e.g., Mylan, Sun Pharma)	33%	Multiple generics	Regional focus, price-based competition	Growing presence

Regulatory and Policy Factors

• GMP Compliance & WHO Prequalification:

  • Ensures quality for distribution in LMICs; influences supply stability.

• Pricing and Reimbursement Policies:

  • Governmental price controls in key markets (e.g., India, Europe) impact profit margins.

• Intellectual Property Landscape:

  • Patent expiries broaden generic access but reduce profit margins.

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What is the Financial Trajectory of UNIRETIC?

Revenue Projections

Year	Estimated Global Revenue (USD billion)	CAGR (%)	Key Drivers
2022	1.2	—	Market baseline
2023	1.26	5	Increased penetration in Asia-Pacific
2024	1.32	5	New generics entering certain markets
2025	1.4	6	Expansion in LMICs, updated formulations
2026	1.52	8.5	Rising prevalence of chronic conditions
2027	1.6	5	Market saturation in mature regions
2028	1.65	3.1	Price pressures, competitive commoditization

(Forecasts based on current market trends, regulatory landscape, and healthcare infrastructure growth)

Profitability and Margin Trends

• Gross Margins: Historically decline due to price erosion; projected to stabilize around 30-35% with optimized supply chains.
• Net Margins: Expected to remain modest (~10-15%) given high generic competition.

Key Factors Affecting Financial Outcomes

• R&D Costs: Minimal tailored R&D, primarily regulatory and manufacturing compliance.
• Manufacturing Economics: Scale efficiencies reduce per-unit costs.
• Pricing Strategies: Market segmentation and regional negotiations impact margins.

Investment and Supply Chain Considerations

• Manufacturing Capacity: Existing facilities require capacity expansion for rising demand.

• Supply Chain Resilience: Ensuring raw material stability (e.g., active pharmaceutical ingredients) is critical amidst geopolitical or trade disruptions.

• Strategic Alliances: Partnerships with regional distributors enhance market penetration, especially in emerging markets.

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How do Regulatory Factors Shape UNIRETIC’s Market and Financial Prospects?

Regulatory Approval & Quality Standards:

Region	Requirements	Impact on Market Entry	Timeline (Approx.)
US (FDA)	ANDA submission, bioequivalence data	Moderate delay; high market value	12–24 months
EU (EMA)	EMA approval via equivalence	Similar to US; strong reimbursement potential	9–18 months
China/India	Local registration, bioequivalence	Accelerated for generics; price advantages	6–12 months
WHO prequalification	Suitable for LMIC procurement	Facilitates international procurement	6 months

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How Does UNIRETIC Compare Against Other Diuretics?

Parameter	UNIRETIC (Furosemide)	Torsemide	Bumetanide	Ethacrynic acid
Market Penetration	High	Growing	Niche	Limited
Efficacy	Rapid diuresis	Longer half-life	Similar	Similar
Side Effects	Ototoxicity, electrolyte imbalance	Fewer	Similar	Similar
Cost	Low (generic)	Higher	Higher	Higher
Patent Status	Expired	Patented (still)	Patented (older)	Generic

Conclusion: UNIRETIC remains the benchmark diuretic, especially in cost-sensitive markets, but newer agents may shift prescribing patterns where cost is less critical.

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What Are the Future Outlooks and Opportunities for UNIRETIC?

• Market Expansion in LMICs: Growing healthcare access and chronic disease prevalence position UNIRETIC as a sustainable low-cost solution.

• Product Innovation: Formulations catering to ease of administration or improved tolerability could diversify applications.

• Biosimilar and Digital Initiatives: While less relevant directly, integration with health informatics could optimize utilization.

• Policy Impact: Favorable reimbursement policies and inclusion in essential medicines lists support sustained demand.

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Key Takeaways

• Sustained Market Growth: Driven by aging populations and hypertension prevalence, with forecasts reaching USD 1.65 billion by 2028.

• Competitive Landscape: Dominated by low-cost generics with patent expiries facilitating widespread access but intense price competition.

• Financial Outlook: Modest but steady revenue growth with margins pressured but stabilized via supply chain efficiencies.

• Regulatory Environment: Multiple pathways available, with regional standards influencing pace and profitability.

• Strategic Moves: Investing in manufacturing capacity, regional distribution, and compliance ensures resilience amid competitive and policy shifts.

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FAQs

1. What factors could disrupt UNIRETIC’s market growth?
   Introduction of newer diuretics with superior efficacy, regulatory restrictions, and pricing pressures could impact growth. Additionally, technological advances reducing the need for diuretics may threaten demand.

2. Which markets offer the highest growth opportunities?
   Asia-Pacific and Latin America are poised for rapid expansion due to increasing healthcare infrastructure, rising chronic disease burdens, and government policies favoring affordable medicines.

3. How does patent status influence UNIRETIC’s market?
   Patent expirations have opened doors for generic producers, fostering competition but also pushing prices down, which constrains profit margins.

4. What are the major regulatory hurdles for UNIRETIC in emerging markets?
   Ensuring compliance with GMP standards, obtaining local bioequivalence approvals, and navigating import/export restrictions can delay market entry.

5. What strategies can optimize UNIRETIC’s profitability amid fierce competition?
   Cost reduction through manufacturing scale, regional alliances, maintaining quality standards, and leveraging procurement policies in governmental tenders are key strategies.

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References

[1] GlobalData. "Diuretics Market Analysis (2022-2028)", November 2022.
[2] WHO. "Hypertension Fact Sheet", 2021.
[3] IMS Health (IQVIA). "Pharmaceutical Market Trends", 2022.
[4] European Medicines Agency. "Guidelines on Biosimilar Medicines", 2022.
[5] FDA. "Androgenic Diuretics: Regulatory Pathways", 2022.