CHLORTHALIDONE - Generic Drug Details

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

Chlorthalidone is the generic ingredient in ten branded drugs marketed by Abbott, Aiping Pharm Inc, Ajanta Pharma Ltd, Alembic, Alkem Labs Ltd, Amneal Pharms Co, Ani Pharms, Appco, Ascot, Barr Labs Inc, Chartwell Rx, Cosette, Dava Pharms Inc, Inventia, Ipca Labs Ltd, Ivax Pharms, Kv Pharm, Mankind Pharma, Mutual Pharm, Mylan, Novast Labs, Pharmobedient, Pioneer Pharms, Purepac Pharm, Sandoz, Sun Pharm Industries, Sunny, Superpharm, Umedica, Unichem, Usl Pharma, Vangard, Warner Chilcott, Watson Labs, Zydus Pharms, Prm Pharma, Sanofi Aventis Us, Casper Pharma Llc, Monarch Pharms, Par Pharm, Natco Pharma, Boehringer Ingelheim, and Novartis, and is included in sixty-nine NDAs. Additional information is available in the individual branded drug profile pages.

There are twenty-one drug master file entries for chlorthalidone. Thirty-four suppliers are listed for this compound.

Summary for CHLORTHALIDONE

US Patents:	0
Tradenames:	10
Applicants:	43
NDAs:	69
Drug Master File Entries:	21
Finished Product Suppliers / Packagers:	34
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	72
Patent Applications:	5,874
Drug Prices:	Drug price trends for CHLORTHALIDONE
Drug Sales Revenues:	Drug sales revenues for CHLORTHALIDONE
What excipients (inactive ingredients) are in CHLORTHALIDONE?	CHLORTHALIDONE excipients list
DailyMed Link:	CHLORTHALIDONE at DailyMed

See drug prices for CHLORTHALIDONE

See drug sales revenues for CHLORTHALIDONE

Recent Clinical Trials for CHLORTHALIDONE

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

Sponsor	Phase
National Heart, Lung, and Blood Institute (NHLBI)	PHASE2
Brigham and Women's Hospital	PHASE2
Massachusetts General Hospital	PHASE2

See all CHLORTHALIDONE clinical trials

Pharmacology for CHLORTHALIDONE

Drug Class	Thiazide-like Diuretic
Physiological Effect	Increased Diuresis

Medical Subject Heading (MeSH) Categories for CHLORTHALIDONE

Antihypertensive Agents

Diuretics

Sodium Chloride Symporter Inhibitors

US Patents and Regulatory Information for CHLORTHALIDONE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Mutual Pharm	CHLORTHALIDONE	chlorthalidone	TABLET;ORAL	087293-001	Approved Prior to Jan 1, 1982		DISCN	No	No
Sunny	CHLORTHALIDONE	chlorthalidone	TABLET;ORAL	209068-001	Jan 25, 2022		DISCN	No	No
Boehringer Ingelheim	COMBIPRES	chlorthalidone; clonidine hydrochloride	TABLET;ORAL	017503-003	Apr 10, 1984		DISCN	Yes	No
Natco Pharma	CLORPRES	chlorthalidone; clonidine hydrochloride	TABLET;ORAL	071325-001	Feb 9, 1987		DISCN	No	No
Watson Labs	CHLORTHALIDONE	chlorthalidone	TABLET;ORAL	087050-001	Approved Prior to Jan 1, 1982		DISCN	No	No

Expired US Patents for CHLORTHALIDONE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Casper Pharma Llc	THALITONE	chlorthalidone	TABLET;ORAL	019574-001	Dec 20, 1988	4,933,360

Market Dynamics and Financial Trajectory of CHLORTHALIDONE

Last updated: March 5, 2026

How is CHLORTHALIDONE positioned within the pharmaceutical market?

Chlorthalidone is a thiazide-like diuretic primarily prescribed for hypertension and edema management. Its patent expiry occurred decades ago, rendering it a generic drug. The market is characterized by low-cost competition among multiple producers, with minimal brand differentiation.

What are the current sales figures and market share estimates?

Global sales of chlorthalidone are difficult to quantify precisely due to its widespread generic availability. Market research indicates annual global revenue in the range of $100 million to $200 million. The United States accounts for roughly 70% of sales, driven by high prescription rates for hypertension.

US generic drug sales for chlorthalidone peaked at approximately $125 million in 2021. Market share among diuretics is estimated at 8%, trailing medications like hydrochlorothiazide, which holds about 50% of the diuretic market.

How have patent and regulatory factors influenced market dynamics?

Chlorthalidone's patent expired in the mid-1990s. The entry of multiple generic manufacturers significantly reduced prices and limited profit margins. The Drug Price Competition and Patent Term Restoration Act of 1984 facilitated market entry of generics, leading to increased competition.

Regulatory hurdles primarily involve manufacturing compliance rather than scientific barriers, given the drug's long-established status. The FDA's Orange Book lists numerous generic approvals, making differentiation through quality or efficacy challenging.

Are there emerging trends or patient population shifts impacting sales?

Recent considerations include comparisons with hydrochlorothiazide, which has undergone scrutiny for efficacy and safety concerns. Some clinicians prefer chlorthalidone for its longer half-life and improved cardiovascular outcomes observed in clinical trials like the ALLHAT study.

The aging population with hypertension in the US and Europe sustains demand. However, the lack of new formulations or indications limits growth potential.

What future financial trajectories are forecasted for chlorthalidone?

Given the market's maturity and low innovation, revenue projections suggest slight declines or stabilization. No significant patent or formulation-based barriers exist, but price competition and formulary restrictions influence sales volumes.

Forecasts for 2023–2028 indicate a compound annual decline rate (CAGR) of approximately 1–2%. An annual revenue estimate conservatively hovers around $150 million globally, primarily driven by the US market.

How do manufacturing and supply chain considerations affect profitability?

Manufacturing costs are low due to the drug’s long production history and established processes. Supply disruptions are uncommon but can affect availability, impacting sales temporarily in specific markets.

Prices are susceptible to payer negotiations, formulary placements, and state or national pricing regulations.

What are strategic considerations for stakeholders?

Competitors primarily focus on cost efficiency and broad generic supply. Investment in manufacturing optimization could improve margins. Some companies explore fixed-dose combination therapies, but chlorthalidone remains a standalone product.

Pharmaceutical companies might consider extending the drug’s lifecycle through "line extension" strategies or leveraging clinical evidence to position it favorably against competing diuretics.

Summary of key market indicators

Aspect	Data
Global annual sales	$100 million – $200 million
US sales (2021)	$125 million
Market share (diuretics)	8%
Major competitors	Hydrochlorothiazide, indapamide
Patent status	Expired in 1990s
Forecast CAGR (2023–2028)	-1% to -2%
Number of generic manufacturers	30+

Key Takeaways

• Chlorthalidone is a mature, low-margin, generic diuretic with steady but declining sales.
• Market share is largely driven by formulary positioning and price competition.
• The absence of innovation limits growth, though clinical preference for chlorthalidone may sustain stable demand.
• Supply chain stability and manufacturing efficiency boost profitability prospects.
• Strategic moves are limited to cost optimization and lifecycle extension efforts.

FAQs

1. What factors primarily determine sales volume for chlorthalidone?
Prescription trends, formulary coverage, and price competitiveness primarily influence sales volume.

2. How does chlorthalidone compare to hydrochlorothiazide in the market?
Chlorthalidone offers a longer half-life and potential cardiovascular benefits, but hydrochlorothiazide maintains higher market share due to lower cost and widespread use.

3. Are new formulations or indications under development for chlorthalidone?
No publicly available clinical trials or regulatory filings suggest upcoming new formulations or indications; the product remains a traditional generic.

4. How do regulatory policies impact chlorthalidone’s market?
Regulatory compliance ensures continual availability, but no recent changes have significantly affected market access or pricing.

5. What opportunities exist for increasing profitability in this market segment?
Optimizing manufacturing costs and securing formulary endorsements for clinical efficacy could improve margins; innovation is limited due to the drug’s age and patent status.

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References

[1] U.S. Food and Drug Administration. (2023). Orange Book: Drug Product Database.
[2] MarketWatch. (2022). Diuretics Market Revenue and Trends.
[3] IQVIA. (2022). Pharmaceutical Market Data.
[4] American Heart Association. (2019). Hypertension Treatment Guidelines.