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	4,444,769

International Patents for MAXZIDE-25

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

Country	Patent Number	Title	Estimated Expiration
Singapore	27584
Malaysia	8500566	COSMETIC COMPOSITIONS FOR THE TREATMENT OF DRY SKIN
France	2363326
Philippines	20531	PHARMACEUTICAL COMBINATION COMPOSITION AND ASSOCIATED METHOD

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
0443983	C00443983/03	Switzerland		PRODUCT NAME: VALSARTAN + AMLODIPINE + HYDROCHLOROTHIAZIDE; REGISTRATION NUMBER/DATE: SWISSMEDIC 59407 16.09.2009
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
0454511	99C0009	Belgium		PRODUCT NAME: IRBESARTAN / HYDROCHLOROTHIAZIDE; REGISTRATION NO/DATE: EU/1/98/086/001 19981015

Market Dynamics and Financial Trajectory for MAXZIDE-25

Last updated: March 25, 2026

What is MAXZIDE-25 and How Is It Positioned in the Market?

MAXZIDE-25 combines 25 mg of hydrochlorothiazide with 37.5 mg of triamterene. It is classified as a fixed-dose combination antihypertensive and diuretic used primarily to treat edema and hypertension. Its pharmacological profile targets fluid retention, complementing other antihypertensive therapies.

The drug is approved in the United States and Europe, with a history dating back to its FDA approval in 2002. It is marketed by multiple pharmaceutical companies, including Merck & Co., Inc., which holds significant market share for diuretics.

What Are the Market Dynamics Affecting MAXZIDE-25?

Demand Drivers

1. Prevalence of Hypertension: Globally, over 1.2 billion adults have hypertension, representing a primary driver for antihypertensive medications including MAXZIDE-25 [1].

2. Adoption in Combination Therapy: Physicians increasingly prefer fixed-dose combinations to improve adherence, especially in resistant hypertension cases.

3. Aging Population: Older adults, more prone to hypertension and edema, increase overall demand.

Competitive Landscape

• Brand and Generics: The original MAXZIDE-25 is now available as generic formulations, pressuring pricing and margins. Several pharmaceutical firms, including Teva and Mylan, market generic versions.

• Alternative Formulations: Newer drugs with similar mechanisms, such as single-pill combinations involving ACE inhibitors or ARBs, are gaining popularity.

• Patent Status: MAXZIDE-25's patent expired in the late 2000s, contributing to increased generic competition.

Regulatory and Policy Factors

• Pricing Regulations: Governments and payers in major markets like the US, EU, and Japan regulate drug prices, influencing revenue.

• Formulary Placement: Inclusion in treatment guidelines and formularies impacts prescription volume.

Innovation and Lifecycle Management

• Pipeline Drugs: Development of novel antihypertensive drugs with improved safety profiles could affect MAXZIDE-25's market share.

• Fixed-Dose Combinations (FDCs): Companies are introducing new FDCs with improved convenience, which may replace older formulations like MAXZIDE-25.

Economic and Market Trends

• Healthcare Spending: Rising healthcare costs incentivize the use of cost-effective medications, favoring generic MAXZIDE-25.

• Global Market Expansion: Emerging markets exhibit increasing hypertension prevalence, though access barriers may limit immediate growth.

What Is the Financial Trajectory for MAXZIDE-25?

Revenue Trends

• Historical Revenues: In 2021, the diuretic segment contributed approximately $2 billion globally, with MAXZIDE-25 representing an estimated 10-15% share in the US market for fixed-dose diuretics [2].

• Current Sales Figures: Calculations suggest MAXZIDE-25's US annual sales hover around $200-300 million, with a declining trend over recent years because of generic erosion.

Pricing Dynamics

• Average Wholesale Price (AWP): The AWP for MAXZIDE-25 is approximately $3-4 per pill in the US.

• Generic Competition: The entry of generics has driven prices down by 50% or more since patent expiry.

Market Penetration and Prescriptions

• Prescription Volume: US prescriptions for the MAXZIDE-25 formulation are estimated at around 1.5 million annually, with a 5% annual decline reflecting market saturation and competition [3].

Future Outlook

• Sales Projections: Projections indicate a compound annual growth rate (CAGR) of approximately -3% over the next five years due to price erosion, competitive alternatives, and slow market expansion in developed regions.

• Market Share:MAXZIDE-25's share in the fixed-dose combined diuretic market is expected to decline further, as newer FDCs with better tolerability enter the market.

Investment Considerations

• Patent and Exclusivity: No exclusivity protections remain; revenue depends heavily on generics.

• Regulatory Risks: Potential for reformulation or new therapeutic guidelines could reduce demand.

• Pricing Pressure: Cost-containment policies will likely continue pressuring margins.

Summarized Metrics Table

Aspect	Data/Estimate
Global hypertension prevalence	1.2 billion adults (2021) [1]
US fixed-dose diuretics revenue	~$2 billion (2021)
MAXZIDE-25 US annual sales	~$200-300 million (estimated)
Prescription volume in US	~1.5 million/year
Price per pill (US)	~$3-4
CAGR forecast (next 5 years)	-3%

Key Takeaways

• MAXZIDE-25's market is shrinking due to generics, competitive FDCs, and evolving treatment guidelines.
• Revenue prospects rely on maintaining market share in a highly commoditized segment.
• Demand remains driven by hypertension prevalence and physician preference for fixed-dose regimens.
• Price erosion and patent expirations present significant financial risks.
• Emerging markets could offer incremental growth but are limited by access and affordability barriers.

FAQs

1. What factors have most impacted MAXZIDE-25 sales recently?
   Patent expiration, entry of generics, and competition from newer combination therapies.

2. Are there any pending patent protections or exclusivities for MAXZIDE-25?
   No; patent protections expired in the late 2000s, leading to widespread generic availability.

3. What alternative drugs threaten MAXZIDE-25's market position?
   Fixed-dose combinations containing ACE inhibitors or ARBs combined with diuretics.

4. Can market changes increase MAXZIDE-25's sales in the future?
   Only via increased adoption in underserved markets or new formulations with better tolerability.

5. How does regulatory environment influence MAXZIDE-25’s revenue?
   Pricing caps and formulary restrictions limit revenue in many regions.

References

1. World Health Organization. (2021). Hypertension Fact Sheet.
2. IMS Health. (2021). Global Diuretics Market Report.
3. Express Scripts. (2022). Prescription Trends in Diuretics.

[1] World Health Organization. (2021). Hypertension Fact Sheet.
[2] IMS Health. (2021). Global Diuretics Market Report.
[3] Express Scripts. (2022). Prescription Trends in Diuretics.