You're using a free limited version of DrugPatentWatch: Upgrade for Complete Access

Last Updated: December 22, 2024

CHLORTHALIDONE Drug Patent Profile


✉ Email this page to a colleague

« Back to Dashboard


Which patents cover Chlorthalidone, and when can generic versions of Chlorthalidone launch?

Chlorthalidone is a drug 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, and Zydus Pharms. and is included in fifty-eight NDAs.

The generic ingredient in CHLORTHALIDONE is chlorthalidone. There are twenty-one drug master file entries for this compound. Thirty-six suppliers are listed for this compound. Additional details are available on the chlorthalidone profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Chlorthalidone

A generic version of CHLORTHALIDONE was approved as chlorthalidone by SUN PHARM INDUSTRIES on July 21st, 1986.

  Subscribe

AI Research Assistant
Questions you can ask:
  • What is the 5 year forecast for CHLORTHALIDONE?
  • What are the global sales for CHLORTHALIDONE?
  • What is Average Wholesale Price for CHLORTHALIDONE?
Drug patent expirations by year for CHLORTHALIDONE
Drug Prices for CHLORTHALIDONE

See drug prices for CHLORTHALIDONE

Drug Sales Revenue Trends for CHLORTHALIDONE

See drug sales revenues for CHLORTHALIDONE

Recent Clinical Trials for CHLORTHALIDONE

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

SponsorPhase
Insel Gruppe AG, University Hospital BernPhase 2
University of BernPhase 2
Vrije Universiteit BrusselPhase 4

See all CHLORTHALIDONE clinical trials

Pharmacology for CHLORTHALIDONE
Drug ClassThiazide-like Diuretic
Physiological EffectIncreased Diuresis
Medical Subject Heading (MeSH) Categories for CHLORTHALIDONE

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
Zydus Pharms CHLORTHALIDONE chlorthalidone TABLET;ORAL 207813-001 May 10, 2019 AB RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Novast Labs CHLORTHALIDONE chlorthalidone TABLET;ORAL 206904-001 Mar 30, 2017 AB RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Kv Pharm CHLORTHALIDONE chlorthalidone TABLET;ORAL 087312-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

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.

More… ↓

⤷  Subscribe

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.