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 nine branded drugs marketed by Abbott, Ajanta Pharma Ltd, Alembic, Alkem Labs Ltd, Amneal Pharms Co, Ani Pharms, Appco, Ascot, Barr Labs Inc, Chartwell Rx, Cosette, Dava Pharms Inc, Inventia, 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, Sanofi Aventis Us, Casper Pharma Llc, Monarch Pharms, Par Pharm, Natco Pharma, Boehringer Ingelheim, and Novartis, and is included in sixty-eight NDAs. Additional information is available in the individual branded drug profile pages.

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

Summary for CHLORTHALIDONE

US Patents:	0
Tradenames:	9
Applicants:	40
NDAs:	68
Drug Master File Entries:	21
Finished Product Suppliers / Packagers:	36
Raw Ingredient (Bulk) Api Vendors:	106
Clinical Trials:	66
Patent Applications:	6,467
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
University of Bern	Phase 2
Insel Gruppe AG, University Hospital Bern	Phase 2
Jessa Hospital	Phase 4

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
Appco	CHLORTHALIDONE	chlorthalidone	TABLET;ORAL	210742-001	Oct 12, 2018	AB	RX	No	No
Sanofi Aventis Us	REGROTON	chlorthalidone; reserpine	TABLET;ORAL	015103-001	Approved Prior to Jan 1, 1982		DISCN	No	No
Watson Labs	CHLORTHALIDONE	chlorthalidone	TABLET;ORAL	087521-001	Approved Prior to Jan 1, 1982		DISCN	No	No
Warner Chilcott	CHLORTHALIDONE	chlorthalidone	TABLET;ORAL	087515-001	Jan 24, 1983		DISCN	No	No
Watson Labs	CHLORTHALIDONE	chlorthalidone	TABLET;ORAL	087029-001	Approved Prior to Jan 1, 1982		DISCN	No	No
Ani Pharms	CHLORTHALIDONE	chlorthalidone	TABLET;ORAL	087689-001	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

CHLORTHALIDONE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Chlorthalidone

Introduction

Chlorthalidone, a thiazide-like diuretic, has been a staple in the treatment of hypertension and edema since its FDA approval in 1960. This article delves into the market dynamics and financial trajectory of chlorthalidone, exploring its indications, market position, pricing, and the broader pharmaceutical market context.

Indications and Market Position

Chlorthalidone is primarily used to manage hypertension and edema associated with various conditions, including congestive heart failure, hepatic cirrhosis, and renal dysfunction[1][2][4].

• Hypertension: Chlorthalidone is considered a first-line agent for treating hypertension, especially in patients without contraindications or contributory comorbidities. The ALLHAT trial highlighted its efficacy in reducing the risk of stroke and heart failure compared to other antihypertensive agents[1][4].
• Edema: It is also used to treat fluid retention in several clinical settings, making it a versatile drug in the management of cardiovascular and renal diseases.

Market Competition

The antihypertensive market is highly competitive, with various classes of drugs available, including ACE inhibitors, calcium channel blockers, and beta-blockers.

• Thiazide Diuretics: Chlorthalidone competes within the thiazide diuretic class, which includes other drugs like hydrochlorothiazide. However, chlorthalidone's longer duration of action and specific pharmacokinetic profile set it apart[1][4].
• Combination Therapies: Often, chlorthalidone is used in combination with other antihypertensive drugs, which can affect its market share but also underscores its utility in complex hypertension management.

Pricing and Cost Considerations

The pricing of chlorthalidone is influenced by several factors, including its generic status, production costs, and market demand.

• Generic Status: Chlorthalidone is available as a generic drug, which generally reduces its cost compared to brand-name medications. This makes it more accessible to a wider patient population[2][4].
• Cost-Effectiveness: Studies have shown that thiazide diuretics like chlorthalidone are cost-effective in managing hypertension and reducing cardiovascular risks. This cost-effectiveness is a significant factor in their continued use and market presence[1][4].

Pharmaceutical Market Dynamics

The pharmaceutical market is subject to various dynamics that can impact the financial trajectory of drugs like chlorthalidone.

• Patent and Generic Competition: The expiration of patents allows generic versions of drugs to enter the market, which can significantly reduce prices and alter market dynamics. Chlorthalidone, being a long-standing generic drug, benefits from this scenario[3].
• Regulatory Frameworks: Government policies and regulatory measures can influence drug prices. For example, initiatives to control drug prices and promote generic use can affect the market share and revenue of drugs like chlorthalidone[3].

Financial Trajectory

The financial trajectory of chlorthalidone is stable due to its established position in the market and its generic status.

• Revenue Stability: As a generic drug, chlorthalidone's revenue is less volatile compared to newer, patented drugs. Its widespread use and low production costs contribute to stable revenue streams[2][4].
• Cost Savings: The use of chlorthalidone can lead to significant cost savings for healthcare systems. For instance, the ALLHAT trial demonstrated that thiazide diuretics are as effective as, or sometimes better than, other antihypertensive agents, which can reduce overall healthcare costs[1][4].

Off-Label Uses and Market Expansion

Chlorthalidone has several off-label uses that can expand its market presence.

• Calcium Nephrolithiasis: It is used to treat calcium nephrolithiasis, which can attract a niche market and increase its revenue potential[1][4].
• Ménière Disease and Diabetes Insipidus: Although not FDA-approved for these conditions, chlorthalidone's efficacy in treating them can further diversify its market[1][4].

Challenges and Future Outlook

Despite its stable market position, chlorthalidone faces challenges and opportunities in the evolving pharmaceutical landscape.

• Compliance and Adherence: Ensuring patient compliance and adherence to chlorthalidone therapy is crucial for its continued effectiveness and market success[2].
• Innovative Formulations: Developing innovative formulations or combination therapies could enhance chlorthalidone's market appeal and extend its patent life, although this is less likely given its generic status[3].

Regulatory and Policy Influences

Government policies and regulatory changes can significantly impact the market dynamics of chlorthalidone.

• Price Control Measures: Initiatives to control drug prices can affect the profitability of chlorthalidone, although its generic status generally keeps prices low[3].
• Healthcare Reforms: Changes in healthcare policies, such as those promoting the use of generic drugs, can favor the continued use and financial stability of chlorthalidone[3].

Conclusion

Chlorthalidone's market dynamics are characterized by its established position as a first-line treatment for hypertension and edema, its cost-effectiveness, and its generic status. While it faces competition from other antihypertensive agents, its long duration of action and specific pharmacokinetic profile maintain its relevance in the market.

Key Takeaways

• Chlorthalidone is a thiazide-like diuretic used primarily for hypertension and edema.
• It is considered a first-line agent for uncomplicated hypertension.
• Its generic status contributes to its cost-effectiveness and stable revenue.
• Off-label uses expand its market potential.
• Regulatory policies and healthcare reforms can influence its market dynamics.

FAQs

Q: What are the primary indications for chlorthalidone? A: Chlorthalidone is primarily used to treat hypertension and edema associated with conditions such as congestive heart failure, hepatic cirrhosis, and renal dysfunction.

Q: Why is chlorthalidone considered a first-line agent for hypertension? A: Chlorthalidone is considered a first-line agent due to its efficacy in reducing the risk of stroke and heart failure, as demonstrated by the ALLHAT trial.

Q: How does the generic status of chlorthalidone affect its market? A: The generic status of chlorthalidone reduces its cost, making it more accessible and contributing to its stable revenue streams.

Q: What are some off-label uses of chlorthalidone? A: Chlorthalidone is used off-label to treat conditions such as calcium nephrolithiasis, Ménière disease, and diabetes insipidus.

Q: How do regulatory policies impact the market dynamics of chlorthalidone? A: Regulatory policies aimed at controlling drug prices and promoting generic use can favor the continued use and financial stability of chlorthalidone.

Sources

1. StatPearls - NCBI Bookshelf: Chlorthalidone - StatPearls - NCBI Bookshelf.
2. Mayo Clinic: Chlorthalidone (oral route) - Mayo Clinic.
3. PLOS ONE: Addressing the challenge of high-priced prescription drugs in the era of precision medicine: A systematic review of drug life cycles, therapeutic drug markets and regulatory frameworks.
4. DrugBank: Chlorthalidone: Uses, Interactions, Mechanism of Action - DrugBank.