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
VA Office of Research and Development
US Department of Veterans Affairs

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	4,105,783
Aurobindo Pharma Usa	MAXZIDE	hydrochlorothiazide; triamterene	TABLET;ORAL	019129-001	Oct 22, 1984	4,444,769

International Patents for MAXZIDE

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

Country	Patent Number	Title	Estimated Expiration
United Kingdom	1589224
South Africa	7705363
Austria	29663
Germany	3373623
Austria	51147

Supplementary Protection Certificates for MAXZIDE

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
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
0454511	99C0009	Belgium		PRODUCT NAME: IRBESARTAN / HYDROCHLOROTHIAZIDE; REGISTRATION NO/DATE: EU/1/98/086/001 19981015

Market Dynamics and Financial Trajectory of MAXZIDE

Last updated: March 6, 2026

What is MAXZIDE and its Approved Uses?

MAXZIDE is a combination drug containing 25 mg of hydrochlorothiazide and 37.5 mg of triamterene. It is prescribed primarily for hypertension management and edema associated with congestive heart failure, hepatic cirrhosis, or renal disease. The drug has been marketed under various brand names since its approval.

Patent and Regulatory Status

MAXZIDE’s patent expired in the United States in September 1994, opening the market to generic competitors. It is regulated by the Food and Drug Administration (FDA), with the most recent approval for its generic versions obtained in 2012. Post-patent expiry, the drug has experienced increased competition, particularly from generics.

Market Size and Revenue Sources

The global antihypertensive market was valued at approximately $41 billion in 2022, with diuretics comprising a significant segment. MAXZIDE remains a prescribed option, especially in the US, where diuretics account for about 5% of antihypertensive prescriptions. Its revenues are primarily derived from the US market, where it commands a list price of roughly $50–$70 per month for branded formulations.

Competition and Market Share

Generic versions captured an estimated 80% of MAXZIDE’s US market share by 2022. Major generic manufacturers include Teva, Mylan, and Sun Pharma. The consolidated market share of generics in this segment exceeds 90%, driven by affordability and expanded prescribing.

Price Trends and Reimbursement Policies

Pricing has declined sharply since patent expiration. The average wholesale price (AWP) for MAXZIDE has decreased from approximately $70 monthly to about $20–$40 for generics. Insurance reimbursement policies favor generics, further suppressing branded drug revenues. Medicaid and Medicare Part D plans predominantly cover generics, with copayments often under $10.

Revenue Projections and Financial Trajectory

Forecasting suggests:

• In the next 5 years, revenues will predominantly come from generic sales, with total US sales estimated at $500–$700 million annually.
• Market penetration for generics will reach near saturation, with minimal room for pricing increases.
• Potential expansion relies on new formulations or combination therapies with improved dosing or reduced side effects, which are currently under development.

Strategic Factors Influencing Market Dynamics

• Pricing pressure from generics drives margins downward.
• Regulatory changes favoring biosimilars and generics could further erode revenues.
• Patent litigation is minimal due to patent expiration, reducing legal risks.
• Emerging markets present growth opportunities, but price sensitivity limits profit margins.

Investment Outlook

The current market landscape for MAXZIDE indicates a declining revenue trajectory for branded versions, with a shift toward low-margin generic sales. Companies involved in manufacturing or distributing MAXZIDE generics will see stable but low-growth revenues. There is limited potential for premium pricing, and innovation in this segment is constrained by patent expiry and existing generic saturation.

Key Factors for Stakeholders

• Pharmaceutical companies: Focus on cost-effective manufacturing, portfolio diversification, or development of next-generation antihypertensives.
• Investors: Monitor generic market share trends and regulatory shifts affecting small-molecule diuretics.
• Healthcare providers: Consider affordability and insurance coverage in prescription decisions.

Key Takeaways

• MAXZIDE’s patent expiry led to rapid generic market penetration.
• Revenues have declined for branded formulations, stabilized at low levels.
• The US market dominates, with emerging markets providing incremental growth.
• Price erosion is ongoing, driven by competition and reimbursement policies.
• Future growth opportunities are limited without new formulations or combinations.

FAQs

1. How does patent expiration affect MAXZIDE’s market?
Patent expiration allowed generic manufacturers to enter, significantly reducing prices and market share for the branded version.

2. Are new formulations or combinations expected for MAXZIDE?
No current development programs are publicly reported for MAXZIDE-specific formulations; innovation mainly focuses on newer antihypertensive classes.

3. What is the outlook for generic manufacturers of MAXZIDE?
Generic manufacturers will see stable revenues with thin margins, concentrated on cost-efficient production and market share maintenance.

4. How do reimbursement policies influence MAXZIDE’s sales?
Reimbursement favors generics, leading to lower out-of-pocket costs for patients and reduced revenues for branded drugs.

5. Are there regulatory risks affecting MAXZIDE’s market?
Regulatory risks are minimal due to patent expiration and stable approval status; however, policy changes promoting biosimilars and generics could impact future sales.

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References

[1] IMS Health. (2023). Global antihypertensive drug market report.
[2] U.S. Food and Drug Administration. (2012). New drug approvals.
[3] SSR Health. (2022). US prescription drug pricing analysis.
[4] IQVIA. (2022). Market share and sales trends for antihypertensive drugs.
[5] Wall Street Journal. (2022). Generic drug market dynamics.