MAXZIDE Drug Patent Profile

Which patents cover Maxzide, and what generic alternatives are available?

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

The generic ingredient in MAXZIDE 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

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	134
Clinical Trials:	1
Drug Prices:	Drug price information for MAXZIDE
DailyMed Link:	MAXZIDE at DailyMed

See drug prices for MAXZIDE

See drug sales revenues for MAXZIDE

Recent Clinical Trials for MAXZIDE

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

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

See all MAXZIDE clinical trials

US Patents and Regulatory Information for MAXZIDE

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	hydrochlorothiazide; triamterene	TABLET;ORAL	019129-001	Oct 22, 1984	AB	RX	Yes	Yes
Aurobindo Pharma Usa	MAXZIDE-25	hydrochlorothiazide; triamterene	TABLET;ORAL	019129-003	May 13, 1988	AB	RX	Yes	No

Expired US Patents for MAXZIDE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Aurobindo Pharma Usa	MAXZIDE	hydrochlorothiazide; triamterene	TABLET;ORAL	019129-001	Oct 22, 1984
Aurobindo Pharma Usa	MAXZIDE	hydrochlorothiazide; triamterene	TABLET;ORAL	019129-001	Oct 22, 1984

International Patents for MAXZIDE

See the table below for patents covering MAXZIDE 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

Supplementary Protection Certificates for MAXZIDE

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

Market Dynamics and Financial Trajectory for MAXZIDE

Last updated: July 27, 2025

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Introduction

MAXZIDE, a combination antihypertensive medication composed of triamterene and hydrochlorothiazide, commands significant interest within the cardiology and hypertension treatment sectors. Its unique mechanism, combining a potassium-sparing diuretic and a thiazide diuretic, positions it as an effective choice for managing resistant hypertension. This analysis focuses on the current market environment, competitive landscape, regulatory factors, and financial prospects shaping MAXZIDE’s trajectory.

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Market Overview and Key Drivers

The global antihypertensive drugs market, valued at approximately USD 25 billion in 2022, exemplifies robust growth driven by increasing hypertension prevalence, aging populations, and rising awareness of cardiovascular health. The segment's compound annual growth rate (CAGR) is estimated at around 3.5% through 2027.

MAXZIDE's primary demand stems from hypertensive patients requiring combination therapy to improve blood pressure control and reduce cardiovascular risk. Factors propelling demand include:

• Growing prevalence of hypertension: The World Health Organization estimates over 1.2 billion adults globally suffer from hypertension, with projections indicating escalation in developing nations (WHO, 2022)[1].

• Guideline shifts favoring combination therapy: Leading guidelines increasingly endorse fixed-dose combinations like MAXZIDE for better adherence and efficacy.

• Concomitant comorbidity management: Patients with comorbid conditions such as heart failure benefit from MAXZIDE’s outcomes, reinforcing its market utility.

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Competitive Landscape

MAXZIDE faces competition from other combination antihypertensives, notably:

• Single-agent monotherapies: ACE inhibitors, ARBs—a less preferred choice for resistant cases but still dominant.

• Other fixed-dose combinations: Such as losartan/hydrochlorothiazide, amlodipine/benazepril, which hold significant market share.

• Emerging therapies: Novel agents and device-based interventions pose future competitive threats, though their adoption remains gradual.

Major pharmaceutical players, including GSK (the original manufacturer), Teva Pharmaceuticals, and other generics companies, dominate distribution channels, affecting pricing and market penetration.

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Regulatory and Patent Landscape

MAXZIDE primarily benefits from a well-established regulatory environment owing to its long-standing approval profile. Patent protection for its active ingredients has largely expired, leading to a surge in generic formulations. This substantially enhances accessibility but exerts downward pressure on price points.

The expiration of exclusivity in key markets like the US (post-2010s) results in increased generic competition, influencing margins and sales volume. However, branded formulations maintain a niche through physician preference, formulary inclusion, and patient adherence benefits.

Regulatory agencies, including the FDA and EMA, continue to emphasize combination therapies for hypertension, fostering an environment conducive to MAXZIDE’s sustained utilization.

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Market Entry and Distribution Strategy

Successful growth hinges on strategic alliances with payers, integration into treatment guidelines, and access expansion through formulary placements. Growing awareness campaigns emphasizing the medication’s efficacy and safety profile augment its market acceptance.

Distribution channels include hospital pharmacies, retail outlets, and online platforms. The increasing shift toward outpatient management favors outpatient prescription uptakes, optimizing reach.

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Financial Trajectory and Forecasts

Revenue Projections

Given the hybrid environment of mature patent expiry and broad generic availability, revenue forecasts demonstrate moderate growth, with notable regional variability:

• United States: The largest contributor, with an estimated USD 500 million in annual sales pre-2021, is expected to decline slightly due to generics but stabilize as formulary preferences favor MAXZIDE in resistant hypertension protocols.

• Europe: Markets benefit from similar generic competition, yet adoption remains steady with adherence benefits observed in clinical settings.

• Emerging Markets: Rapid growth potential, especially in Asia-Pacific, owing to increasing hypertension prevalence and expanding healthcare infrastructure.

Margins and Profitability

The introduction of generics suppresses margins; however, branding efforts and physician loyalty sustain profitability for established manufacturers. Margins across developed markets average 15-25%, with economies of scale enhancing profitability for large generic manufacturers.

Innovative Formulations and Differentiation

Future financial growth may stem from the development of extended-release formulations, combination pills with other antihypertensives, or innovative delivery methods, potentially commanding premium pricing.

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Risks and Challenges

• Intense price erosion: Due to generic entry, risking revenue decline.

• Regulatory hurdles: Future reformulations or new indications require data submissions and approvals.

• Market saturation: Particularly in developed markets, leading to plateaued sales.

• Emerging therapies: New pharmacological agents or device-based interventions could affect MAXZIDE’s market share.

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Conclusion

MAXZIDE operates within a dynamic, highly competitive hypertension management landscape characterized by a growing global patient base, expanding treatment guidelines embracing combination therapies, and escalating generic competition. While revenues are challenged by patent expiries, strategic positioning, optimized formulary access, and potential innovation could sustain its financial trajectory.

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Key Takeaways

• The global hypertension market’s growth underpins MAXZIDE’s demand but faces pricing pressures from widespread generic availability.

• Strategic alliances with payers and inclusion in clinical guidelines can sustain sales amid competitive pressures.

• Diversification through innovative formulations and expanding to emerging markets offers avenues for revenue enhancement.

• Regulatory considerations remain favorable, with a well-understood safety profile facilitating ongoing use.

• Long-term growth hinges on balancing generic competition with brand loyalty and differentiated offerings.

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FAQs

1. What factors influence MAXZIDE’s market share in hypertension therapy?
Market share depends on guideline endorsements, physician prescribing habits, formulary placements, and patient adherence, with brand loyalty and perceived efficacy playing critical roles.

2. How does patent expiration affect MAXZIDE’s financial outlook?
Patent expiries lead to increased generic competition, reducing prices and profit margins but also expanding accessibility and potential volume of prescriptions.

3. What are the growth prospects for MAXZIDE in emerging markets?
Rapid urbanization, rising hypertension prevalence, and expanding healthcare infrastructure position emerging markets as significant growth opportunities, contingent upon effective distribution and affordability strategies.

4. How are regulatory agencies influencing MAXZIDE’s market?
Regulatory frameworks favor the continued use and approval of combination antihypertensives. Future approvals of new formulations could enhance its market positioning.

5. What strategic initiatives could maximize MAXZIDE’s revenue?
Innovating with extended-release formulations, integrating additional active ingredients, and reinforcing clinical evidence to influence treatment guidelines can extend its market viability.

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References

[1] World Health Organization. (2022). Hypertension. https://www.who.int/news-room/fact-sheets/detail/hypertension