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
Raw Ingredient (Bulk) Api Vendors:	6
Clinical Trials:	1
Patent Applications:	172
What excipients (inactive ingredients) are in MAXZIDE-25?	MAXZIDE-25 excipients list
DailyMed Link:	MAXZIDE-25 at DailyMed

Recent Clinical Trials for MAXZIDE-25

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

Sponsor	Phase
VA Office of Research and Development
US Department of Veterans Affairs

See all MAXZIDE-25 clinical trials

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

Expired US Patents for MAXZIDE-25

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Aurobindo Pharma Usa	MAXZIDE-25	hydrochlorothiazide; triamterene	TABLET;ORAL	019129-003	May 13, 1988

International Patents for MAXZIDE-25

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

Country	Patent Number	Title	Estimated Expiration
Hong Kong	46285	COSMETIC COMPOSITIONS FOR THE TREATMENT OF DRY SKIN
Japan	S5933213	MEDICINAL COMPOSITION AND MANUFACTURE
France	2363326
Austria	51147
Malaysia	8500566	COSMETIC COMPOSITIONS FOR THE TREATMENT OF DRY SKIN
Belgium	858404
South Africa	7705363

Supplementary Protection Certificates for MAXZIDE-25

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
0502314	C300095	Netherlands		PRODCUT NAME: TELMISARTAN, DESGEWENST IN DE VORM VAN EEN FYSIOLOGISCH VERDRAAGBAAR ZOUT, EN HYDROCHLOROTHIAZIDE; REGISTRATION NO/DATE: EU/1/02/213/001-010 20020419
0480717	98C0025	Belgium		PRODUCT NAME: LOSARTAN POTASSIUM; HYDROCHLOROTHIAZIDE; NAT. REGISTRATION NO/DATE: NL 20 037 19950215; FIRST REGISTRATION: FR - NL 20 037 19950215
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
0454511	99C0009	Belgium		PRODUCT NAME: IRBESARTAN / HYDROCHLOROTHIAZIDE; REGISTRATION NO/DATE: EU/1/98/086/001 19981015
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
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 MAXZIDE-25

Last updated: August 6, 2025

Introduction

MAXZIDE-25, a combination antihypertensive medication, consists of 25 mg of hydrochlorothiazide and 37.5 mg of triamterene. It primarily targets hypertension management by utilizing the synergistic effects of a thiazide diuretic and a potassium-sparing agent. Its unique pharmacological profile positions MAXZIDE-25 within a competitive landscape characterized by evolving market dynamics and shifting regulatory, economic, and clinical factors. This analysis explores these elements and forecasts MAXZIDE-25’s financial trajectory within the global pharmaceutical ecosystem.

Market Landscape and Epidemiological Drivers

Global Hypertension Burden

Hypertension affects over 1.3 billion adults worldwide, representing a significant market for antihypertensive therapies [1]. As prevalence escalates due to lifestyle factors, aging populations, and urbanization, the demand for effective, tolerable combination therapies like MAXZIDE-25 increases. In particular, North America and Europe—regions with robust healthcare infrastructures—drive a substantial portion of the global market, supported by high awareness, screening programs, and physician adherence to guideline-recommended combination treatments.

Treatment Paradigm Shifts

Clinicians increasingly favor fixed-dose combination (FDC) medications like MAXZIDE-25, which enhance patient compliance through simplified regimens. The synergy between hydrochlorothiazide and triamterene allows for effective blood pressure control while minimizing side effects such as hypokalemia, supporting its role in personalized hypertension management.

Market Competition and Product Landscape

MAXZIDE-25 faces competition from other established combination therapies, including ACE inhibitors with diuretics, calcium channel blockers, and ARB-based combinations. The market entry of newer agents, such as SGLT2 inhibitors for hypertensive diabetic patients, also influences market share distribution. Nevertheless, MAXZIDE-25’s proven efficacy, tolerability, and cost-effectiveness sustain its relevance in primary care settings.

Regulatory Landscape and Patent Outlook

Regulatory Approvals and Market Access

MAXZIDE-25 has received regulatory approval across major markets, notably the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA). Institutional guidelines, such as those from the American College of Cardiology and the European Society of Hypertension, endorse its use for stage 1 hypertension, reinforcing demand.

Patent and Patent Expiry Considerations

While specific patents on MAXZIDE-25 have expired or are nearing expiration in several jurisdictions, formulation patents and manufacturing exclusivities delay generic entry. The expiration timeline influences market competitiveness and pricing strategies, with generic introductions potentially eroding margins but increasing volume-based revenues.

Economic and Pricing Dynamics

Pricing Strategies and Reimbursement

As a mid-priced generic FDC, MAXZIDE-25 benefits from broad insurance coverage and reimbursement in developed markets, supporting sustained sales. Pricing strategies focus on balancing profitability with market penetration, especially as biosimilar and generic competitors emerge.

Cost of Goods and Manufacturing

Manufacturing costs are stabilized through scale efficiencies, with the commoditization of key active pharmaceutical ingredients (APIs). Contract manufacturing organizations (CMOs) facilitate cost-effective production, which is critical in maintaining competitive pricing while securing margins.

Market Penetration and Patient Adoption

Physician prescribing patterns and patient adherence levels directly impact revenue growth. Market penetration is influenced by clinical guideline updates, physician education, and patient preferences for combination therapies with favorable side-effect profiles.

Technological and Innovation Challenges

Formulation and Delivery

Advances in drug delivery, such as extended-release formulations or fixed-dose combination tablets with improved dosing flexibility, could enhance MAXZIDE-25’s market position. However, innovation costs and regulatory hurdles pose challenges to timely product differentiation.

Digital Health and Data Integration

Incorporating digital adherence tools and telemedicine support into hypertension management strategies can enhance treatment outcomes and patient engagement, indirectly boosting MAXZIDE-25’s use.

Future Financial Trajectory

Growth Drivers

• Aging Population and Epidemiology: Increasing hypertensive populations sustain demand.
• Guideline Endorsements: Ongoing inclusion in clinical practice guidelines promotes prescriber confidence.
• Market Expansion: Emerging markets’ healthcare investments amplify sales opportunities.
• Partnerships and Licensing: Strategic alliances facilitate broader distribution, especially in regions with emerging healthcare infrastructure.

Market Risks and Challenges

• Generic Competition: Patent expirations could lead to commoditization, impacting pricing.
• Regulatory Changes: Stringent regulatory environments and reimbursement reforms may influence profitability.
• Emerging Therapies: Novel antihypertensive agents with superior efficacy could threaten market share.

Projected Financial Outcomes

Based on current market size—estimated at several billion USD globally—and steady penetration in developed markets, MAXZIDE-25’s revenue trajectory is expected to be stable over the next five years. A conservative CAGR of 3-5% is plausible, driven by increased adoption, expansion into emerging markets, and potential formulary inclusions. The pharmaceutical manufacturer’s ability to innovate, maintain competitive pricing, and navigate patent landscapes will be pivotal in sustaining growth.

Strategic Recommendations

• Focus on Market Expansion: Invest in regulatory approvals in high-growth emerging markets.
• Enhance Formulation: Develop new formulations to improve adherence and address unmet needs.
• Patent Strategy and Lifecycle Management: Maximize exclusivity through patent extensions and new formulation patents.
• Engage in Clinical Research: Generate post-marketing data to reinforce guideline recommendations and prescriber confidence.
• Leverage Digital Tools: Incorporate digital health solutions to improve adherence and gather real-world evidence.

Key Takeaways

• Growing Hypertension Burden: The escalating global prevalence of hypertension sustains demand for combination therapies like MAXZIDE-25.
• Competitive Market Landscape: Though challenged by generics and new therapies, MAXZIDE-25’s efficacy and cost-effectiveness maintain its market position.
• Regulatory and Patent Dynamics: Patent expirations necessitate strategic innovation and lifecycle management to preserve profitability.
• Pricing and Reimbursement: Broad coverage and favorable pricing models support consistent revenue streams.
• Future Outlook: Moderate, steady growth is anticipated, contingent on market expansion, innovation, and strategic positioning amidst evolving competition.

FAQs

1. What are the primary indications for MAXZIDE-25?
MAXZIDE-25 is indicated for the treatment of hypertension, particularly in patients requiring combination therapy to achieve blood pressure control effectively. Its components reduce systemic vascular resistance and minimize side effects associated with monotherapy.

2. How does MAXZIDE-25 compare to other antihypertensive combinations?
MAXZIDE-25 offers a balanced profile with proven efficacy, favorable tolerability, and cost benefits. Its potassium-sparing effect distinguishes it from thiazide-only combinations, reducing the risk of hypokalemia—a common concern with diuretic therapy.

3. What factors influence the market share of MAXZIDE-25?
Market share hinges on clinical guideline endorsements, physician prescribing habits, patent status, price competitiveness, and patient adherence. Competition from newer agents and emerging drug classes also influences its positioning.

4. How do patent expirations impact the financial outlook of MAXZIDE-25?
Patent expirations typically lead to increased generic competition, reducing prices and profit margins. They also create opportunities for biosimilar entrants. Strategic patent management and new formulation development are essential to mitigate these impacts.

5. What are the potential growth areas for MAXZIDE-25?
Emerging markets present significant growth opportunities due to increasing hypertension prevalence and expanding healthcare access. Additionally, integrating digital health initiatives and developing improved formulations can enhance market share and patient adherence.

References

[1] World Health Organization. (2021). Hypertension. Available at: https://www.who.int/news-room/fact-sheets/detail/hypertension