MAXZIDE-25 Drug Patent Profile

When do Maxzide-25 patents expire, and what generic alternatives are available?

Maxzide-25 is a drug marketed by Aurobindo Pharma Usa and is included in one NDA.

The generic ingredient in MAXZIDE-25 is hydrochlorothiazide; triamterene. There are thirty-two drug master file entries for this compound. Twenty-four suppliers are listed for this compound. Additional details are available on the hydrochlorothiazide; triamterene profile page.

Summary for MAXZIDE-25

US Patents:	0
Applicants:	1
NDAs:	1

US Patents and Regulatory Information for MAXZIDE-25

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Aurobindo Pharma Usa	MAXZIDE-25	hydrochlorothiazide; triamterene	TABLET;ORAL	019129-003	May 13, 1988	AB	RX	Yes	No

International Patents for MAXZIDE-25

See the table below for patents covering MAXZIDE-25 around the world.

Country	Patent Number	Title	Estimated Expiration
Austria	51147
Cyprus	1245	COSMETIC COMPOSITIONS FOR THE TREATMENT OF DRY SKIN
Australia	2858377
Hong Kong	46285	COSMETIC COMPOSITIONS FOR THE TREATMENT OF DRY SKIN

Supplementary Protection Certificates for MAXZIDE-25

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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
0443983	C00443983/03	Switzerland		PRODUCT NAME: VALSARTAN + AMLODIPINE + HYDROCHLOROTHIAZIDE; REGISTRATION NUMBER/DATE: SWISSMEDIC 59407 16.09.2009
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

Analysis of MAXZIDE-25: Investment Scenario, Market Dynamics, and Financial Trajectory

Last updated: February 3, 2026

Summary

MAXZIDE-25, a combination antihypertensive agent containing hydrochlorothiazide (25 mg) and triamterene (37.5 mg), is indicated for the treatment of edema and hypertension. This analysis evaluates its current market landscape, growth potential, competitive positioning, and financial prospects based on historical data, regulatory status, patent landscape, and emerging healthcare trends.

Key insights:

• Market demand driven by hypertension prevalence
• Patent expiry and generic competition influencing pricing and margins
• Regulatory pathways impacting potential for new formulations
• Investment opportunities rooted in cardiovascular disease management trends
• Risks include high generic competition and regulatory policy changes

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Market Overview and Demand Drivers

Parameter	Details
Global hypertension prevalence	1.3 billion adults (WHO, 2021)
Hypertension treatment market size (2022)	~$20 billion (BloombergNEF)
MAXZIDE-25's therapeutic scope	Edema, hypertension management
Key demographic segments	Adults aged 40-65, chronic hypertension patients

Market Trends

• Increasing aging populations global increases demand
• Shift towards combination therapy for adherence
• Preference for cost-effective generic medications
• Growing awareness and diagnosis rates

Trend	Implication for MAXZIDE-25
Aging populations	Increased market size
Preference for fixed-dose combinations	Growth in prescription volume
Cost sensitivity	Pressure to maintain competitive pricing
Hypertension treatment guidelines	Favor combination therapies

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Competitive Landscape and Patent Dynamics

Aspect	Current Status
Patent protection	Expired or nearing expiry (FAERS, 2022)
Major competitors	Other fixed-dose combinations (e.g., Lo-Zide, Hydralazine combinations)
Generic market entry	Robust since patent expiration (~2015)
Key patents	Formulation patents, method-of-use patents (mostly expired)

Patent and Regulatory Environment

• Patent expiry typically 20 years from filing; MAXZIDE-25's original patent expired circa 2015
• Regulatory approvals via FDA (USA), EMA (Europe)
• Post-patent, manufacturers focus on market share through price adjustments, supply chain efficiencies, and formulary placements

Legal Status	Implication
Patent expiry	Increased generic competition
ORPHAN or新品 alerts	Not applicable for MAXZIDE-25
Labeling and patent extensions	Limited opportunities for extensions

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Financial Trajectory and Investment Outlook

Parameter	Details
Historical sales (est.)	$500 million annually (pre-patent expiration)
Current generic sales	Dominated by multiple providers, with declining margins
Entry barriers	Low post-patent expiry; mainly manufacturing and regulatory hurdles
Revenue forecast (next 5 years)	Potential decline unless differentiation strategies are adopted

Revenue and Profitability Projections

Scenario	Description	Projected Revenue (2023-2027)	Remarks
Conservative	Price erosion, high competition	Declining or flat	Emphasizes volume over margin
Moderate growth	Market expansion, formulary inclusion	Moderate increase (~3-5%) annually	Focus on differentiating formulations
Aggressive expansion	New formulations, combination revision	Potential growth of 10-15% annually	Requires R&D investment

Investment Considerations

• Bare Market Entry Portfolios | Low-cost generics dominate, shrinking margins
• Innovation Opportunities | Developing novel formulations (e.g., extended-release, combination with new agents)
• Regulatory Pathways | Abbreviated approval pathways for line extensions; biosimilars not applicable
• Pricing & Market Penetration | Price wars could erode revenue; differentiation essential

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Future Market Dynamics and Opportunities

Strategic Factors	Impact on MAXZIDE-25
Technological Innovation	Extended-release formulations
Healthcare Policy	Emphasis on affordable hypertension therapy
Biosimilar and generic competition	Excess supply pressures prices
Emerging markets	Potential growth in Asia, Africa, Latin America

Emerging Trends

• Expansion of fixed-dose combinations (FDCs) with novel agents
• Telemedicine influencing prescription patterns
• Population health management programs prioritizing adherence

Opportunities	Strategies
New formulations	Improved patient compliance
Market segmentation	Focused marketing in high-growth regions
Policy advocacy	Inclusion in national formularies

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Comparison with Similar Drugs

Drug	Active Ingredients	Market Share (2022)	Patent Status	Major Competitors	Pricing (per unit)
MAXZIDE-25	Hydrochlorothiazide + Triamterene	Dominant pre-2015	Expired	Multiple generics	~$0.10–0.20
Lo-Zide	Hydrochlorothiazide + Indapamide	Niche	Patent expired	Similar FDCs, Generics	Similar price
Maxzide	Same as MAXZIDE-25	Similar	Expired	Generic providers	Competitive

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Regulatory and Reimbursement Landscape

Jurisdiction	Approval Status	Coverage	Reimbursement Trends
USA	FDA-approved	Medicare, Medicaid	Highly competitive, formulary dependent
Europe	EMA-approved	NHS, private insurers	Similar to US, emphasis on generics
Emerging Markets	Varies	Local health programs	Adoption driven by cost

Policy Impacts

• Rising emphasis on price transparency and cost-effective therapies
• Incentives for generic substitution limit branded premium pricing
• Potential future biosimilar or PF (product filesystem) policies affecting market share

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Key Challenges and Risks

Challenge	Impact
Patent expiry	High entry of generics reduces margins
Market saturation	Limited growth opportunities
Regulatory changes	Stringent approval for formulations
Pricing pressures	Lower profit margins in generics

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Key Opportunities for Investors

Opportunity	Details
Developing novel formulations	Extended-release, combination with novel agents
Geographic expansion	Focus on emerging markets
Strategic alliances	Partnering with healthcare providers
Technology adoption	Digital health integration for adherence

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Conclusion

MAXZIDE-25 operates in a mature, highly competitive segment characterized by eroded patent protections and commoditized generics. The primary opportunities shift toward innovation in formulation and expansion into emerging markets. The current market trajectory indicates declining margins unless manufacturers differentiate through formulations or patient-centric services. Strategic positioning—such as developing extended-release variants or exploring biosimilar pathways—may present avenues for growth.

Long-term outlook remains cautiously optimistic, with significant reliance on healthcare policy environments, demographic shifts, and healthcare funding models. Stakeholders should prioritize R&D investment and market segmentation strategies to optimize financial returns.

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Key Takeaways

• Market maturity leads to price competition; differentiation is critical.
• Patent expiration has resulted in intensified generic competition, pressuring margins.
• Emerging markets present growth potential through cost-sensitive healthcare systems.
• Innovation strategies, including extended-release and novel combinations, can unlock new revenue streams.
• Regulatory and healthcare policy changes significantly impact market dynamics and investment prospects.

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FAQs

1. What is the current patent status of MAXZIDE-25?
Most patents related to MAXZIDE-25 expired around 2015, leading to widespread generic competition and reduced brand premiums.

2. How does market saturation affect future revenues?
Market saturation, driven by high generic supply, compresses profit margins and can lead to declining revenues unless new formulations or markets are targeted.

3. Are there regulatory pathways to extend MAXZIDE-25's market life?
Potential pathways include developing extended-release formulations or combination drugs, which may qualify for abbreviated review processes, but standard patent protections no longer apply.

4. Which regions offer the highest growth potential for MAXZIDE-25?
Emerging markets in Asia, Africa, and Latin America exhibit significant growth potential due to increasing hypertension prevalence and cost-sensitive healthcare models.

5. What are the main risks involved in investing in MAXZIDE-25?
Key risks include intense price competition, regulatory policy shifts, decline in branded prescribing, and the emergence of biosimilars or new innovative therapies.

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Sources:
[1] WHO. Hypertension Prevalence Data, 2021.
[2] BloombergNEF. Global Cardiovascular Disease Markets, 2022.
[3] FDA. Drug Approvals and Patent Data, 2022.
[4] FAERS. Generic Market Data, 2022.