THALITONE Drug Patent Profile

When do Thalitone patents expire, and what generic alternatives are available?

Thalitone is a drug marketed by Casper Pharma Llc and Monarch Pharms and is included in two NDAs.

The generic ingredient in THALITONE 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 Thalitone

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

Summary for THALITONE

US Patents:	0
Applicants:	2
NDAs:	2
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	105
Clinical Trials:	4
Patent Applications:	4,049
Drug Prices:	Drug price information for THALITONE
What excipients (inactive ingredients) are in THALITONE?	THALITONE excipients list
DailyMed Link:	THALITONE at DailyMed

See drug prices for THALITONE

Recent Clinical Trials for THALITONE

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

Sponsor	Phase
Anthony J Viera, MD, MPH	N/A
North Carolina Translational and Clinical Sciences Institute	N/A
Virginia Commonwealth University	Phase 4

See all THALITONE clinical trials

Pharmacology for THALITONE

Drug Class	Thiazide-like Diuretic
Physiological Effect	Increased Diuresis

US Patents and Regulatory Information for THALITONE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Casper Pharma Llc	THALITONE	chlorthalidone	TABLET;ORAL	019574-001	Dec 20, 1988		RX	Yes	No
Casper Pharma Llc	THALITONE	chlorthalidone	TABLET;ORAL	019574-002	Feb 12, 1992	BX	RX	Yes	Yes
Monarch Pharms	THALITONE	chlorthalidone	TABLET;ORAL	088051-001	Nov 12, 1982		DISCN	No	No

Expired US Patents for THALITONE

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

International Patents for THALITONE

See the table below for patents covering THALITONE around the world.

Country	Patent Number	Title	Estimated Expiration
Spain	8602633
Spain	530628
Canada	1212329	DISPERSIONS DE CHLORTHALIDONE (CHLORTHALIDONE DISPERSIONS)
Hungary	191596	PROCESS FOR PRODUCING PHARMACEUTICAL COMPOSITION
Finland	841019
Norway	164956

THALITONE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Chlorthalidone (THALITONE)

Introduction

Chlorthalidone, marketed under the brand name THALITONE among others, is a thiazide-like diuretic used to treat hypertension and edema associated with various conditions. Understanding the market dynamics and financial trajectory of this drug is crucial for pharmaceutical companies, investors, and healthcare professionals.

Historical Context and Market Entry

THALITONE was originally manufactured by Pfizer, but the company discontinued its production. However, the FDA determined that the discontinuation was not due to safety or efficacy concerns[1].

Generic Approval and Market Impact

In 2019, Zydus Cadila received FDA approval to market chlorthalidone tablets, the generic equivalent of THALITONE. This approval marked a significant milestone, as it reintroduced the drug into the market, providing patients with an alternative treatment option for hypertension and edema[1].

Indications and Usage

Chlorthalidone is indicated for the treatment of hypertension to lower blood pressure and reduce the risk of cardiovascular events such as strokes and myocardial infarctions. It is also used as adjunctive therapy in edema associated with heart failure, cirrhosis of the liver, and renal disease[2].

Dosage and Administration

The recommended initial dose for hypertension is 15 mg daily, which can be increased to 25 mg if necessary. For edema, the initial dose is typically 50 mg to 100 mg daily, with the option to adjust up to a maximum of 200 mg daily[2].

Market Size and Growth

The global antihypertensive drugs market, which includes chlorthalidone, is projected to grow significantly from 2021 to 2031. This growth is driven by increasing prevalence of hypertension, an aging population, and advancements in healthcare infrastructure. The market is segmented by drug type, including diuretics like chlorthalidone, and by geography[4].

Competitive Landscape

The antihypertensive drugs market is highly competitive, with various classes of drugs such as ACE inhibitors, beta-blockers, and calcium channel blockers. Chlorthalidone competes with other diuretics like hydrochlorothiazide. The market also includes fixed-dose combinations, which can offer convenience and improved compliance for patients[4].

Pricing and Generic Competition

The introduction of generic chlorthalidone by Zydus Cadila has likely reduced the cost of treatment for patients, making it more accessible. Generic competition generally drives prices down, benefiting consumers but potentially impacting the revenue of the original brand manufacturer. However, the economics of drug development suggest that patented products eventually face competition from generics, which can lower prices and increase market penetration[3].

Economic Implications

The development and pricing of pharmaceuticals, including chlorthalidone, are influenced by a combination of policies and market forces. The shift towards precision medicines and the targeting of small patient populations can affect pricing strategies and the likelihood of generic entry. For drugs like chlorthalidone, which have a broader patient base, generic competition is more likely to emerge, driving prices down and increasing affordability[3].

Financial Trajectory

The financial trajectory of chlorthalidone is expected to be positive due to the growing demand for antihypertensive drugs. With the generic version available, the drug is likely to see increased prescriptions and sales. Zydus Cadila's approval to manufacture chlorthalidone has added to their portfolio of 266 federal approvals and 350 abbreviated new drug applications, indicating a strong financial position in the generic drug market[1].

Regulatory Environment

The FDA's approval process and regulatory environment play a crucial role in the market dynamics of chlorthalidone. The agency's determination that Pfizer's discontinuation of THALITONE was not due to safety or efficacy concerns paved the way for generic approval. Regulatory compliance and ongoing monitoring are essential for maintaining market presence and ensuring patient safety[1].

Patient Impact

For patients, the availability of generic chlorthalidone means access to a cost-effective treatment option for hypertension and edema. This can lead to better adherence to treatment plans and improved health outcomes. The drug's efficacy in reducing blood pressure and managing edema makes it a valuable addition to comprehensive cardiovascular risk management strategies[2].

Future Outlook

The future outlook for chlorthalidone is promising, driven by the growing need for antihypertensive treatments and the cost-effectiveness of generic options. As the global antihypertensive drugs market continues to grow, chlorthalidone is likely to remain a significant player, particularly in regions with high prevalence of hypertension and limited access to more expensive branded medications.

Key Takeaways

• Generic Approval: Zydus Cadila's FDA approval for generic chlorthalidone has reintroduced the drug into the market.
• Market Growth: The global antihypertensive drugs market is projected to grow significantly from 2021 to 2031.
• Competitive Landscape: Chlorthalidone competes with other diuretics and fixed-dose combinations in a highly competitive market.
• Pricing and Affordability: Generic competition has made chlorthalidone more affordable for patients.
• Regulatory Compliance: FDA approval and ongoing regulatory compliance are crucial for market presence.
• Patient Impact: The drug provides a cost-effective treatment option for hypertension and edema, improving patient adherence and health outcomes.

FAQs

What is chlorthalidone used for?

Chlorthalidone is used to treat hypertension and edema associated with heart failure, cirrhosis of the liver, and renal disease[2].

Why was THALITONE discontinued by Pfizer?

THALITONE was discontinued by Pfizer, but the FDA determined that the discontinuation was not due to safety or efficacy concerns[1].

Who manufactures the generic version of chlorthalidone?

Zydus Cadila manufactures the generic version of chlorthalidone, which was approved by the FDA in 2019[1].

How does chlorthalidone compare to other antihypertensive drugs?

Chlorthalidone is a thiazide-like diuretic that competes with other diuretics and fixed-dose combinations in the antihypertensive drugs market[4].

What is the expected market growth for antihypertensive drugs?

The global antihypertensive drugs market is projected to grow significantly from 2021 to 2031, driven by increasing prevalence of hypertension and advancements in healthcare[4].

Sources

1. Cardiovascular Business: "Generic equivalent of Pfizer hypertension drug approved"[1].
2. DailyMed: "chlorthalidone tablet THALITONE"[2].
3. National Bureau of Economic Research: "The Economics of Drug Development: Pricing and Innovation in a Changing Market"[3].
4. iHealthcareAnalyst: "Antihypertensive Drugs Market and Forecast 2024-2031"[4].