HYDROCHLOROTHIAZIDE; TRIAMTERENE - Generic Drug Details

What are the generic sources for hydrochlorothiazide; triamterene and what is the scope of freedom to operate?

Hydrochlorothiazide; triamterene is the generic ingredient in four branded drugs marketed by Glaxosmithkline Llc, Ani Pharms, Cadila, Chartwell Rx, Duramed Pharms Barr, Lannett Co Inc, Macleods Pharms Ltd, Novartis, Pharmobedient, Sandoz, Vitarine, Aurobindo Pharma Usa, Am Therap, Apotex Inc, Pliva, Quantum Pharmics, Rubicon Research, Watson Labs, and Zydus Pharms, and is included in twenty-five NDAs. Additional information is available in the individual branded drug profile pages.

Twenty-four suppliers are listed for this compound.

Summary for HYDROCHLOROTHIAZIDE; TRIAMTERENE

US Patents:	0
Tradenames:	4
Applicants:	19
NDAs:	25
Finished Product Suppliers / Packagers:	24
Raw Ingredient (Bulk) Api Vendors:	6
Clinical Trials:	5
DailyMed Link:	HYDROCHLOROTHIAZIDE; TRIAMTERENE at DailyMed

Recent Clinical Trials for HYDROCHLOROTHIAZIDE; TRIAMTERENE

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

Sponsor	Phase
University of California, Irvine	Phase 4
West China Hospital	Phase 4
Vanderbilt University	N/A

See all HYDROCHLOROTHIAZIDE; TRIAMTERENE clinical trials

Pharmacology for HYDROCHLOROTHIAZIDE; TRIAMTERENE

Drug Class	Potassium-sparing Diuretic Thiazide Diuretic
Physiological Effect	Decreased Renal K+ Excretion Increased Diuresis

Anatomical Therapeutic Chemical (ATC) Classes for HYDROCHLOROTHIAZIDE; TRIAMTERENE

C03AA	Thiazides, plain
C03A	LOW-CEILING DIURETICS, THIAZIDES
C03	DIURETICS
C	Cardiovascular system

C03AA	Thiazides, plain
C03A	LOW-CEILING DIURETICS, THIAZIDES
C03	DIURETICS
C	Cardiovascular system

C03DB	Other potassium-sparing agents
C03D	ALDOSTERONE ANTAGONISTS AND OTHER POTASSIUM-SPARING AGENTS
C03	DIURETICS
C	Cardiovascular system

US Patents and Regulatory Information for HYDROCHLOROTHIAZIDE; TRIAMTERENE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Sandoz	TRIAMTERENE AND HYDROCHLOROTHIAZIDE	hydrochlorothiazide; triamterene	CAPSULE;ORAL	074821-001	Jun 5, 1997	AB	RX	No	Yes
Quantum Pharmics	TRIAMTERENE AND HYDROCHLOROTHIAZIDE	hydrochlorothiazide; triamterene	TABLET;ORAL	071980-001	Apr 17, 1988		DISCN	No	No
Rubicon Research	TRIAMTERENE AND HYDROCHLOROTHIAZIDE	hydrochlorothiazide; triamterene	TABLET;ORAL	216211-001	Feb 23, 2022	AB	RX	No	No
Watson Labs	TRIAMTERENE AND HYDROCHLOROTHIAZIDE	hydrochlorothiazide; triamterene	TABLET;ORAL	073449-001	Sep 23, 1993	AB	RX	No	No
Rubicon Research	TRIAMTERENE AND HYDROCHLOROTHIAZIDE	hydrochlorothiazide; triamterene	TABLET;ORAL	216211-002	Feb 23, 2022	AB	RX	No	No

Expired US Patents for HYDROCHLOROTHIAZIDE; TRIAMTERENE

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
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

Hydrochlorothiazide; Triamterene (Diuretic Combination) Market Dynamics and Financial Trajectory

Last updated: April 25, 2026

What is the product and how is it positioned in market supply?

Hydrochlorothiazide; triamterene is an oral fixed-dose diuretic combination used primarily for hypertension and related fluid-management indications. The market is shaped by (1) long-standing generic availability, (2) payer preference for low-cost formularies, (3) limited new-entry differentiation, and (4) stable but mature demand tied to chronic cardiovascular therapy.

Market structure

• Originator-to-generic transition: The combination is widely available as generics in most major markets. The presence of multiple ANDA or equivalent filings typically compresses net pricing quickly after brand exclusivity ends.
• Formulary behavior: Diuretic combinations are treated as cost-advantaged “backbone” therapies within antihypertensive treatment pathways; payer step edits often direct patients to preferred low-cost options.
• Channel dynamics: Retail pharmacies and PBM-managed mail order dominate volume. Pharmacy reimbursement is primarily price-driven rather than innovation-driven.

How do pricing dynamics typically evolve for this combination?

Hydrochlorothiazide; triamterene pricing trajectories are structurally constrained by generic competition and substitution at the pharmacy counter.

Expected pricing pressure pattern (generic era)

• Initial decline post-exclusivity: Net price often drops sharply once multiple generic SKUs gain share.
• Ongoing downward drift: Continued competition between manufacturers tends to move net ASP down or flatten it near the level of the “cheapest adequate” SKU within each payer contract.
• Limited upside levers: New dosage strengths, packaging, or incremental label updates generally do not overcome generic price competition unless a manufacturer gains exclusivity over a specific strength, route, or regulated supply window.

Contracting and rebate mechanics (practical impact)

• PBM contracts: Net realization depends on PBM tier placement and bid competitiveness.
• Rebate competition: Multiple generic entrants increases pressure to discount for formulary access.
• NADAC/WAC spread: Like other mature generics, gross-to-net frequently widens as list prices stay high relative to net settlement terms.

What are the demand drivers in chronic therapy?

Demand is driven by chronic hypertension treatment persistence and switching patterns rather than episodic care.

Core demand drivers

• Long treatment horizon: Hypertension is chronic; diuretic combination use is steady once tolerated.
• Clinical substitution: Hydrochlorothiazide (HCTZ) and triamterene combinations are often switched within the diuretic class based on side-effect profile and electrolyte status.
• Safety monitoring patterns: Use requires electrolyte and renal monitoring, which affects adherence and persistence but not volume at population level.

How do patent and exclusivity factors shape the financial trajectory?

The combination has no meaningful long-duration blockbuster dynamic in the typical generic life cycle sense. Financial outcomes usually track genericization timing, supply stability, and any narrow exclusivity around specific formulations or regulatory status.

Financial implications of generic dominance

• Revenue ceiling: Sales remain constrained by generic price floors and pharmacy substitution.
• Market share dispersion: Multiple SKUs dilute the share concentration that would otherwise support premium pricing.
• Profit sensitivity: Margin is highly sensitive to raw materials, API cost, contract pricing, and manufacturing utilization.

What does the likely financial trajectory look like across time?

For a mature generic combination, the financial curve typically follows a “high-to-low” pattern after brand exclusivity ends, with periodic stability and short-lived volatility from supply and contracting.

Typical phases

1. Pre-generic era (brand or limited competition)
   • Higher ASP and gross margin
   • Fewer suppliers, less price pressure
2. Early generic penetration
   • Rapid ASP compression
   • Share shifts to lower-priced SKUs
3. Mature generic plateau
   • Stabilized unit volumes
   • Net price drifts downward or stabilizes near contract floors
4. Supply shocks / contracting resets
   • Temporary price spikes can occur when supply constraints hit
   • Short-lived recovery unless procurement restabilizes

What market risks and tailwinds affect unit sales and net revenue?

Risks that commonly impact mature diuretic generics

• Supply continuity: API or intermediate shortages can temporarily disrupt supply and shift pricing until normal supply resumes.
• Contract repricing: PBM and wholesaler repricing cycles can reset net revenue down even if unit volume holds.
• Regulatory actions: Recalls or quality actions can remove SKUs from shelves and reduce immediate volume.

Tailwinds

• Stable prescribing base: Hypertension prevalence sustains baseline demand.
• Formulary persistence: Once a low-cost SKU is placed, it often maintains share unless undercut.
• Multiple strength utilization: Availability across standard strengths supports continued patient matching.

How does this combination compare with single-agent diuretics?

From a payer and prescriber standpoint, fixed-dose combinations are often used to improve adherence and simplify titration when clinically appropriate.

Competitive positioning

• Against HCTZ monotherapy: Combination use can improve electrolyte management strategy versus escalating monotherapy.
• Against triamterene monotherapy: Combination is often preferred for cost and therapeutic balance.
• Within combination cohorts: The product competes with other antihypertensive combinations where formularies emphasize low-cost generics.

Practical financial effect

• Combination products may hold share better than some single agents if formularies treat them as preferred “simple regimens,” but pricing still converges toward generic low-cost benchmarks.

What is the cost structure and margin sensitivity profile?

For mature generics, margins are typically thin relative to branded drugs. Profitability depends on operational efficiency and procurement terms.

Margin drivers

• API and intermediate costs: Direct material swings can move gross margin quickly.
• Manufacturing utilization: Underutilization can raise per-unit fixed costs.
• Packaging and regulatory compliance: Compliance costs increase per SKU and per changeover.
• Freight and working capital: Wholesale distribution requires efficient cash conversion.

What procurement, reimbursement, and inventory factors influence near-term performance?

Near-term performance is often driven by supply and contracting rather than demand shocks.

Near-term performance levers

• Wholesaler inventory strategy: Wholesalers reorder based on projected demand and supply risk.
• PBM tier changes: A one-tier movement can change net realization quickly.
• Retail migration: Patients and prescribers may stay with a tolerated generic; pharmacy substitution rules can still shift the exact SKU.

What are investment or R&D implications implied by the market mechanics?

Financial thesis for incumbents

• Scale matters more than differentiation: Margin is supported by manufacturing scale, contract terms, and supply reliability.
• Portfolio strategy: Companies often maintain positions by offering multiple strengths and controlling production runs.

Financial thesis for new entrants

• Limited upside from standard formulations: Entry economics are challenged by price competition unless entrants secure a narrow advantage (supply reliability, strength coverage, or manufacturing cost advantage).
• More viable paths: A focus on reformulation, regulatory strategy, or supply chain resilience tends to be more realistic than clinical differentiation.

Key Takeaways

• Hydrochlorothiazide; triamterene is a mature, generic-dominated diuretic combination where financial performance is driven primarily by payer contracting, pharmacy substitution, and supply stability rather than innovation.
• Pricing trajectories typically follow rapid ASP compression post-exclusivity, followed by a mature plateau with downward drift or stabilization near contract floors.
• Demand is stable due to chronic hypertension treatment persistence, while near-term revenue is highly sensitive to PBM tier placement and supply availability.
• Margin sensitivity is high: unit economics depend on API costs, manufacturing utilization, and discounting under PBM and wholesaler terms.
• Competitive advantage is usually operational (cost, scale, uninterrupted supply) rather than product differentiation.

FAQs

1. Why does net revenue for hydrochlorothiazide; triamterene tend to track pricing more than volume?
   Generic substitution and PBM contracting shift the market toward low-cost SKUs, so small pricing and tier changes often outweigh volume fluctuations.

2. What typically creates short-term revenue volatility for mature diuretic generics?
   Supply disruptions, recall/quality events, and contract repricing cycles can change net realization quickly even when underlying demand remains steady.

3. Does clinical monitoring meaningfully affect long-term unit sales for this combination?
   Monitoring affects adherence and persistence in specific patient subgroups but generally does not materially reduce population-level chronic use.

4. How does the fixed-dose combination format influence payer behavior?
   It can be viewed as a cost-effective regimen simplification option, but formulary placement still hinges on the lowest-cost preferred SKU among alternatives.

5. What is the most credible driver of profitability in this market?
   Manufacturing cost position and supply reliability that enable competitive contracting and reduce lost sales from stockouts.

---

References (APA)

[1] U.S. Food and Drug Administration. (n.d.). Drug Approval Reports and databases. https://www.fda.gov/drugs/drug-approvals-and-databases