HYDROCHLOROTHIAZIDE - Generic Drug Details

What are the generic drug sources for hydrochlorothiazide and what is the scope of patent protection?

Hydrochlorothiazide is the generic ingredient in sixty-three branded drugs marketed by Alembic Pharms Ltd, Apotex, Aurobindo Pharma, Chartwell Molecular, Hikma Intl Pharms, Ipca Labs Ltd, Ivax Sub Teva Pharms, Jubilant Cadista, Prinston Inc, Quagen, Sciegen Pharms, Sun Pharm Inds Inc, Unichem, Teva Branded Pharm, Novitium Pharma, Morton Grove, Roxane, Novartis, Halsey, Abc Holding, Accord Hlthcare, Actavis Elizabeth, Alra, Ascot, Aurolife Pharma Llc, Barr, Chartwell Rx, Dava Pharms Inc, Elkins Sinn, Heather, Heritage, Impax Labs, Inwood Labs, Lannett Co Inc, Leading, Mast Mm, Mylan, Oxford Pharms, Pharmobedient, Pvt Form, Solvay, Sun Pharm Industries, Superpharm, Teva, Usl Pharma, Vangard, Warner Chilcott, Watson Labs, Watson Labs Teva, West Ward, Whiteworth Town Plsn, Merck, Abbvie, Sanofi Aventis Us, Alembic, Apotex Inc, Atlas Pharms Llc, Aurobindo Pharma Ltd, Dr Reddys Labs Ltd, Hikma, Hisun Pharm Hangzhou, Lupin Ltd, Macleods Pharms Ltd, Sandoz, Watson Labs Inc, Schering, Glaxosmithkline, Aiping Pharm Inc, Aurobindo, Corepharma, Epic Pharma Llc, Invagen Pharms, Lupin, Sun Pharm Inds Ltd, Almatica, Organon, Granules, Teva Pharms, Torrent Pharms, Zydus Pharms Usa Inc, Parke Davis, Purepac Pharm, Rising, Strides Pharma Intl, Concordia, Validus Pharms, Senores Pharms, Sun Pharm Inds, Glenmark Pharms, Ucb Inc, Cosette, Alkem Labs Ltd, Hangzhou Binjiang, Hetero Labs Ltd V, MSN, Natco Pharma Usa, Teva Pharms Usa, Torrent, Umedica, Zydus Pharms, Wyeth Ayerst, Wyeth Pharms Inc, Duramed Pharms Barr, Ani Pharms, Pfizer Pharms, Pharmeral, Pfizer, Mutual Pharm, Ivax Pharms, Lederle, Upsher Smith, Boehringer Ingelheim, Glenmark Pharms Ltd, Mankind Pharma, Natco, Glaxosmithkline Llc, Cadila, Vitarine, Aurobindo Pharma Usa, Am Therap, Pliva, Quantum Pharmics, Rubicon Research, Amneal Pharms, Mylan Pharms Inc, and Zydus Lifesciences, and is included in three hundred and thirty-seven NDAs. There is one patent protecting this compound. Additional information is available in the individual branded drug profile pages.

There are thirty-two drug master file entries for hydrochlorothiazide. Forty-two suppliers are listed for this compound. There are seven tentative approvals for this compound.

Summary for HYDROCHLOROTHIAZIDE

US Patents:	1
Tradenames:	63
Applicants:	126
NDAs:	337
Drug Master File Entries:	32
Finished Product Suppliers / Packagers:	42
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	394
Patent Applications:	7,195
Drug Prices:	Drug price trends for HYDROCHLOROTHIAZIDE
Drug Sales Revenues:	Drug sales revenues for HYDROCHLOROTHIAZIDE
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for HYDROCHLOROTHIAZIDE
What excipients (inactive ingredients) are in HYDROCHLOROTHIAZIDE?	HYDROCHLOROTHIAZIDE excipients list
DailyMed Link:	HYDROCHLOROTHIAZIDE at DailyMed

See drug prices for HYDROCHLOROTHIAZIDE

See drug sales revenues for HYDROCHLOROTHIAZIDE

Recent Clinical Trials for HYDROCHLOROTHIAZIDE

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

Sponsor	Phase
Eurofarma Laboratorios S.A.	PHASE3
Vital Strategies	NA
Shanghai Jiao Tong University School of Medicine	NA

See all HYDROCHLOROTHIAZIDE clinical trials

Generic filers with tentative approvals for HYDROCHLOROTHIAZIDE

Applicant	Application No.	Strength	Dosage Form
		12.5MG;300MG	TABLET;ORAL
		12.5MG;150MG	TABLET;ORAL
		25MG;300MG	TABLET; ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for HYDROCHLOROTHIAZIDE

Drug Class	Thiazide Diuretic
Physiological Effect	Increased Diuresis

Medical Subject Heading (MeSH) Categories for HYDROCHLOROTHIAZIDE

Antihypertensive Agents

Diuretics

Sodium Chloride Symporter Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for HYDROCHLOROTHIAZIDE

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

US Patents and Regulatory Information for HYDROCHLOROTHIAZIDE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Purepac Pharm	METHYLDOPA AND HYDROCHLOROTHIAZIDE	hydrochlorothiazide; methyldopa	TABLET;ORAL	070688-001	Apr 24, 1986		DISCN	No	No
Prinston Inc	TELMISARTAN AND HYDROCHLOROTHIAZIDE	hydrochlorothiazide; telmisartan	TABLET;ORAL	209028-001	Nov 6, 2017	AB	RX	No	No
Macleods Pharms Ltd	VALSARTAN AND HYDROCHLOROTHIAZIDE	hydrochlorothiazide; valsartan	TABLET;ORAL	203145-005	Apr 19, 2013	AB	RX	No	No
Alembic	OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE	hydrochlorothiazide; olmesartan medoxomil	TABLET;ORAL	204233-003	Apr 24, 2017	AB	RX	No	No
Ivax Sub Teva Pharms	METHYLDOPA AND HYDROCHLOROTHIAZIDE	hydrochlorothiazide; methyldopa	TABLET;ORAL	071460-001	Mar 8, 1988		DISCN	No	No
Zydus Lifesciences	VALSARTAN AND HYDROCHLOROTHIAZIDE	hydrochlorothiazide; valsartan	TABLET;ORAL	203000-003	Mar 15, 2019		DISCN	No	No

Market Dynamics and Financial Trajectory for Hydrochlorothiazide

Last updated: February 19, 2026

Hydrochlorothiazide (HCTZ) is a thiazide diuretic prescribed for hypertension and edema. Its market landscape has experienced significant shifts, influenced by regulatory changes, patent status, and emerging therapies.

Market Overview and Key Drivers

Hydrochlorothiazide remains one of the most prescribed antihypertensive agents worldwide. Its low cost, established efficacy, and safety profile sustain its market presence.

Production and Patent Status

• Patent Expiry: Hydrochlorothiazide's original patents expired around the early 2000s, leading to a proliferation of generics.
• Manufacturers: Numerous generic manufacturers hold market shares, resulting in high competition and low prices.
• Market Entry Barriers: Minimal, due to the availability of APIs and established manufacturing processes.

Regulatory & Reimbursement Impacts

• Several health authorities, including the U.S. Food and Drug Administration (FDA), have issued updates affecting HCTZ. For example, the FDA issuing guidance in 2017 regarding the risk of skin cancer associated with its use has influenced prescriber behavior.
• Reimbursement policies favor generics, further pressuring branded versions.

Market Size and Trends

• Estimated global sales amount to approximately $500 million annually, with the U.S. accounting for about 70% of revenue.
• The market has shown a declining trend of about 2% annually since 2015, attributed to shifts towards newer antihypertensive classes and regulatory advisories.

Competitive Landscape

Market Share Distribution

Company / Brand	Estimated Market Share	Notes
Teva Pharmaceuticals	35%	Dominates generic segment
Mylan (now part of Viatris)	20%	Significant player with multiple formulations
Others	45%	Includes multiple small and mid-size manufacturers

Pricing Dynamics

• Average wholesale price has decreased by approximately 30% over the past five years.
• Price erosion primarily results from intensified generic competition and prior authorization requirements from payers.

Emerging Trends and Regulatory Environment

• The trend toward fixed-dose combinations (FDCs) reduces HCTZ monotherapy sales but integrates hydrochlorothiazide as an adjunct.
• The 2017 FDA warning slowed the growth of HCTZ prescriptions but did not eliminate demand, given its cost-effectiveness.
• Increased use of novel antihypertensive agents like angiotensin receptor blockers (ARBs) and calcium channel blockers (CCBs) has marginally displaced HCTZ prescribing.

Revenue Projections and Market Outlook

Year	Estimated Global Sales (USD million)	Growth Rate	Key Factors
2022	500	-2%	Saturation, generics, regulatory factors
2023	490	-2%	Continued competition, slow growth in new indications
2024	480	-2%	Market maturity persists
2025	470	-2%	Slight decline continues

The pipeline for innovative diuretics remains limited; thus, HCTZ's revenue trajectory is characterized by gradual decline rather than resurgence.

R&D and Patent Strategy

• No current patents protect hydrochlorothiazide manufacturing processes or formulations.
• R&D efforts focus on combination therapies, where HCTZ acts as a component, particularly in fixed-dose antihypertensive combinations.

Investment and Business Implications

• Companies holding large generics portfolios benefit from stable manufacturing and distribution channels but face declining profitability margins.
• Vertical integration into formulation and delivery systems offers potential cost reductions.
• Opportunities exist in developing new delivery formats or combination therapies to extend product lifecycle.

Conclusion

Hydrochlorothiazide's market remains relevant due to its low cost and persistent clinical demand but faces a declining trajectory driven by regulatory pressures, generic competition, and emerging therapies. Its future depends on strategic positioning within combination regimens and shifts in prescribing practices.

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Key Takeaways

• Hydrochlorothiazide's global sales are approximately USD 500 million, decreasing annually by roughly 2%.
• The patent expiration and participation of multiple generics result in intense price competition.
• Regulatory advisories, including skin cancer risks, have modestly impacted prescriber behavior.
• Growth prospects depend on its integration into combination therapies rather than monotherapy.
• The market is mature, with limited innovations in direct drug formulations.

FAQs

1. What factors are driving the decline in hydrochlorothiazide sales?
The decline stems from increased use of newer antihypertensive agents, regulatory advisories, and persistent generic price competition.

2. Are there any recent patent protections for hydrochlorothiazide?
No. The original patents expired around the early 2000s, leading to widespread generic manufacturing.

3. How does regulatory guidance impact hydrochlorothiazide market dynamics?
Regulatory advisories, such as the 2017 FDA warning on skin cancer risk, influence prescribing patterns and can lead to reduced use.

4. What are the main competitive advantages of hydrochlorothiazide?
Its low manufacturing cost and established clinical efficacy sustain its use despite declining sales.

5. What future strategies could prolong hydrochlorothiazide's market relevance?
Integration into fixed-dose combinations and exploring new delivery mechanisms offer potential pathways for revenue stabilization.