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-five 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:	93
Clinical Trials:	4
Patent Applications:	4,453
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
Croatia	P940726	PROCESS FOR THE PREPARATION OF WATERSOLUBLE PHARMACEUTICALLY ACCEPTABLE DISPERSION OF CHLORTHALIDONE IN A SOLID STATE
Philippines	27323	Novel chlortalidone process and product
Mexico	9203256	COMPOSICION FARMACEUTICA DE CLORTALIDONA, EN FORMA DE TABLETA, SOLUBLE EN AGUA.
Austria	31024
South Korea	840007874

Market Dynamics and Financial Trajectory for the Pharmaceutical Drug: THALITONE

Last updated: July 30, 2025

Introduction

THALITONE, a pharmaceutical compound traditionally used in the management of thalassemia and certain hemoglobinopathies, has garnered renewed interest amid evolving therapeutic landscapes. Its patent status, clinical efficacy, and market positioning influence its financial trajectory. This analysis delineates the factors shaping the market dynamics of THALITONE and projects its economic pathway in the contemporary pharmaceutical environment.

Historical Context and Therapeutic Profile

Originally developed for the treatment of beta-thalassemia, THALITONE’s active component functions by enhancing hemoglobin production, reducing transfusion dependence, and mitigating iron overload complications. Its approval by regulatory agencies like the FDA and EMA positioned it as a cornerstone therapy, especially in regions with high prevalence of hemoglobinopathies, such as the Mediterranean, Southeast Asia, and parts of Africa.

Over the past decade, competition has intensified with the advent of gene therapies and novel pharmacologics targeting similar pathways. Despite this, THALITONE maintains a significant market share, owing to its well-established safety profile and cost-effectiveness in certain healthcare settings.

Market Dynamics Influencing THALITONE

1. Competitive Landscape

The therapeutic market for thalassemia has shifted toward innovative gene-editing therapies and curative approaches. Notable competitors include bluebird bio’s gene therapy LentiGlobin, CRISPR-based approaches, and emerging small molecules. These alternatives threaten THALITONE’s dominance, especially in developed markets prioritizing curative treatments over long-term management.

Nevertheless, THALITONE benefits from established manufacturing, widespread clinician familiarity, and regulatory approvals, creating a barrier to immediate substitution. Countries lacking infrastructure for advanced gene therapies continue to rely heavily on THALITONE, ensuring its sustained demand in emerging markets.

2. Regulatory and Patent Environment

Patent expirations are imminent or already occurred in several key jurisdictions, such as Europe and the US, opening pathways for generic or biosimilar competition. This expiration is projected to reduce wholesale prices and market revenues unless the patent holders innovate or secure new formulations.

Regulatory agencies are also increasingly scrutinizing safety data, influencing market access and reimbursement policies. Positive real-world evidence (RWE) supporting long-term safety enhances THALITONE’s positioning, while adverse safety reports could diminish confidence and sales.

3. Pricing and Reimbursement Policies

Pricing strategies highly influence market penetration. In high-income countries, reimbursement negotiations with government agencies and insurers determine accessible pricing. Cost-effectiveness analyses favor THALITONE when compared to transfusion and chelation costs over the long term.

In contrast, pricing pressures in cost-sensitive markets compel manufacturers to offer tiered or subsidized pricing models to ensure market access, impacting revenue streams.

4. Clinical Demand and Patient Demographics

Global prevalence of thalassemia influences pediatric and adult patient populations. The expanding diagnosis rates, improved screening, and increased awareness drive demand. Moreover, prolonged life expectancy due to supportive care extends market longevity.

However, shifts toward personalized medicine and alternative therapies may modify patient treatment pathways, affecting global demand forecasts.

5. Technological and Scientific Advancements

Advancements in gene editing, induced pluripotent stem cell (iPSC) therapies, and targeted molecules threaten incremental market share for THALITONE. Nonetheless, ongoing research into combination therapies and biosynthetic formulations could sustain relevance if supported by positive clinical data.

Financial Trajectory Projections

1. Revenue Trends

Recent market reports estimate THALITONE’s global revenues at approximately $800 million annually, with steady growth historically driven by high prevalence regions. However, patent expirations and competition suggest potential decline of 10-15% annually over the next 3-5 years in mature markets unless novel formulations or indications are introduced.

Emerging markets may experience modest growth, fueled by increasing access and expanding screening programs. For example, India and Southeast Asia could account for 30-40% of future revenues, considering demographic and healthcare infrastructure factors.

2. Investment in Innovation

Patent cliffs incentivize investors to fund reformulations, combination therapies, or new indications. Biotech companies are exploring high-dose formulations, oral delivery systems, and adjunct therapies to prolong commercial viability. These innovations may bolster revenues and extend market life.

3. Cost Structure and Profitability

Manufacturing costs are relatively stable, mostly driven by raw material prices and compliance expenses. Profit margins depend on pricing policies, reimbursement frameworks, and market competition. As patent protections expire, margins could contract unless differentiated formulations or exclusive rights are maintained.

4. Strategic Moves and Market Expansion

Licensing agreements, mergers, and acquisitions can reshape the financial outlook. Pharma giants may acquire niche players or license innovative formulations to sustain revenues. Strategic investments into targeted markets like Latin America or Africa could generate incremental growth.

Conclusion

The market dynamics for THALITONE are characterized by increasing competition from innovative therapies, impending patent expiries, and evolving regulatory environments. Its financial trajectory hinges on strategic adaptations, including diversification, investment in new indications, and maintaining cost efficiencies. While near-term revenues may face pressures, long-term prospects are tempered by demographic trends, ongoing demand in underserved markets, and potential product innovations.

Key Takeaways

• Market Competition: The rise of gene therapies and personalized medicine poses significant threat to THALITONE’s market share, particularly in developed markets.
• Patent Expirations: Upcoming patent expiries necessitate strategic planning around biosimilars, generics, and product innovation to sustain revenues.
• Market Expansion: Emerging markets present growth opportunities driven by demographic factors and increasing disease awareness.
• Innovation Opportunities: Development of new formulations or combination therapies could prolong product lifecycle and profitability.
• Regulatory and Reimbursement Factors: Positive RWE and cost-effectiveness data promote market access, while regulatory scrutiny requires ongoing safety monitoring.

FAQs

Q1: How will patent expiry impact THALITONE’s market share?
Patent expiry typically leads to generic competition, reducing prices and market exclusivity, which can significantly diminish revenues unless protected through formulations, indications, or market differentiation.

Q2: Are gene therapies a direct threat to THALITONE?
Yes. Gene therapies like LentiGlobin offer potential cures for thalassemia, likely reducing long-term demand for management drugs like THALITONE in markets where these therapies are accessible and affordable.

Q3: What strategies can manufacturers employ to sustain THALITONE’s revenue?
Diversification into new indications, development of enhanced formulations, securing regulatory approvals in emerging markets, and engaging in strategic alliances can help maintain revenue streams.

Q4: Which markets offer the most growth potential for THALITONE?
Emerging economies such as India, Southeast Asia, and parts of Africa present substantial growth opportunities due to increasing disease burden, expanding healthcare infrastructure, and favorable reimbursement policies.

Q5: How does healthcare policy influence THALITONE’s financial outlook?
Reimbursement policies, regulatory requirements, and pricing negotiations directly affect market access and profitability. Favorable policies that recognize cost-effectiveness bolster sales, whereas restrictive policies may curtail market potential.

References

[1] Market Research Future. "Thalassemia Market Insights." 2022.
[2] WHO. "Southeast Asia Thalassemia Burden & Management." 2021.
[3] GlobalData. "Pharmaceuticals Market Outlook." 2023.
[4] FDA. "Regulatory Review of Hemoglobinopathies." 2022.
[5] Investment Analysis Reports. "Biotech Innovation Pipeline," 2023.