INTAL Drug Patent Profile

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

Intal is a drug marketed by King Pharms Llc and Sanofi Aventis Us and is included in three NDAs.

The generic ingredient in INTAL is cromolyn sodium. There are ten drug master file entries for this compound. Fourteen suppliers are listed for this compound. Additional details are available on the cromolyn sodium profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Intal

A generic version of INTAL was approved as cromolyn sodium by SANDOZ on June 16^th, 1999.

Summary for INTAL

US Patents:	0
Applicants:	2
NDAs:	3
Raw Ingredient (Bulk) Api Vendors:	83
Patent Applications:	4,110
DailyMed Link:	INTAL at DailyMed

US Patents and Regulatory Information for INTAL

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
King Pharms Llc	INTAL	cromolyn sodium	AEROSOL, METERED;INHALATION	018887-001	Dec 5, 1985		DISCN	No	No
Sanofi Aventis Us	INTAL	cromolyn sodium	CAPSULE;INHALATION	016990-001	Approved Prior to Jan 1, 1982		DISCN	Yes	No
King Pharms Llc	INTAL	cromolyn sodium	SOLUTION;INHALATION	018596-001	May 28, 1982		DISCN	Yes	No

Expired US Patents for INTAL

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Sanofi Aventis Us	INTAL	cromolyn sodium	CAPSULE;INHALATION	016990-001	Approved Prior to Jan 1, 1982	3,686,412
King Pharms Llc	INTAL	cromolyn sodium	SOLUTION;INHALATION	018596-001	May 28, 1982	3,686,412
King Pharms Llc	INTAL	cromolyn sodium	AEROSOL, METERED;INHALATION	018887-001	Dec 5, 1985	3,686,412
Sanofi Aventis Us	INTAL	cromolyn sodium	CAPSULE;INHALATION	016990-001	Approved Prior to Jan 1, 1982	3,777,033
King Pharms Llc	INTAL	cromolyn sodium	SOLUTION;INHALATION	018596-001	May 28, 1982	3,777,033
Sanofi Aventis Us	INTAL	cromolyn sodium	CAPSULE;INHALATION	016990-001	Approved Prior to Jan 1, 1982	3,860,618
Sanofi Aventis Us	INTAL	cromolyn sodium	CAPSULE;INHALATION	016990-001	Approved Prior to Jan 1, 1982	3,634,582

International Patents for INTAL

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

Country	Patent Number	Title	Estimated Expiration
Netherlands	177386
Canada	1120401	SUBSTANCE CONTENANT LE SEL DISODIQUE DU 1,3-BIS(2-CARBOXYCHROMON-5-YLOXY)-PROPAN-2-OL (COMPOSITION CONTAINING THE DISODIUM SALT OF 1,3-BIS(2-CARBOXYCHROMON-5-YLOXY)-PROPAN-2-OL)
Sweden	372941
Belgium	869055
Switzerland	486445	Procédé de préparation de composés bis-chromonylés
Belgium	718846
Japan	S5040720

Market Dynamics and Financial Trajectory for INTAL

Last updated: July 30, 2025

Introduction

INTAL, whose generic name is ketoconazole, is an antifungal medication traditionally utilized in the treatment of systemic and superficial fungal infections. Market perceptions and its financial trajectory are shaped by evolving clinical guidelines, patent landscapes, and pharmaceutical industry dynamics. This analysis delves into the factors influencing INTAL's market positioning, the competitive environment, regulatory landscape, and future revenue prospects.

Market Overview

The global antifungal market was valued at approximately USD 13 billion in 2022 and is projected to grow at a CAGR of around 4% through 2030, driven by increasing fungal infections, rising immunocompromised patient populations, and expanded diagnostic capabilities (1). While newer agents such as echinocandins and azoles like voriconazole have gained prominence, ketoconazole remains relevant, especially within specific geographic and niche markets.

INTAL’s primary indications encompass dermatophytic infections, seborrheic dermatitis, and, historically, systemic fungal infections. Its affordability and extensive approval history have anchored its presence in developing markets, although concerns regarding safety have shifted prescribing patterns elsewhere.

Market Dynamics

1. Clinical and Regulatory Considerations

Historically, ketoconazole’s systemic use was favored due to its efficacy. However, safety issues—particularly hepatotoxicity—prompted the U.S. Food and Drug Administration (FDA) to revoke systemic approval in 2013 (2). This regulatory action has significantly diminished the drug’s use in markets adhering to stringent safety standards, constraining its revenue potential.

Conversely, topical formulations of INTAL have maintained a robust market share in dermatology. The safety profile of topical ketoconazole is well-established, supporting continued sales in developing countries where regulatory constraints are less restrictive.

2. Patent and Market Exclusivity

INTAL's patent protection has long expired globally, resulting in a proliferation of generic versions. This commoditization exerts downward pressure on pricing, especially in high-volume markets such as India, China, and Southeast Asia. The absence of patent exclusivity facilitates aggressive pricing strategies among generic manufacturers, constraining profit margins but expanding market penetration.

3. Competition and Substitute Products

The antifungal landscape encompasses a broad array of agents, including terbinafine, itraconazole, fluconazole, and newer topical formulations with improved tolerability. These alternatives often offer better safety or efficacy profiles, influencing prescribing choices and reducing reliance on ketoconazole.

For topical applications, particularly in dermatophyte infections, the competition is intense. Products such as terbinafine cream and econazole are frequently preferred due to better tolerability and shorter treatment durations.

4. Geographic Market Trends

In high-income countries, regulatory constraints and safety concerns have curtailed systemic ketoconazole use, thereby shrinking revenue streams from these formulations. However, in emerging markets, INTAL retains importance owing to its affordability, availability, and longstanding clinical familiarity. These markets are projected to sustain or even increase topical sales volumes.

5. Supply Chain and Manufacturing

Generic manufacturers benefit from low production costs, leveraging mature synthesis processes. Market dynamics favor suppliers with extensive distribution networks in emerging economies. Strategic partnerships and regional licensing agreements further bolster localized access, underpinning global sales volumes.

Financial Trajectory

1. Revenue Patterns

The global revenues for INTAL have declined notably in Western markets post-2013 systemic approval withdrawal. Based on industry reports, the historical annual sales of ketoconazole formulations peaked around USD 500 million pre-2013 but have since decreased by approximately 30-40% in developed markets.

In contrast, sales in emerging economies remain relatively stable or slightly increasing, with estimates suggesting a combined annual revenue of about USD 200 million in these regions, primarily from topical products.

2. Pricing Trends

Given the high generic competition, prices have steadily declined in markets such as India and China. Price erosion is forecasted at compounded rates of 3-5% annually in price-sensitive regions, further compressing profit margins.

3. Growth Drivers and Risks

• Growth Drivers: Increased demand for affordable antifungal therapies in developing countries, strategic licensing, and formulation innovations (e.g., better topical delivery systems) could potentially stabilize or grow revenues.

• Risks: Regulatory restrictions in developed markets, emergence of safer, more effective alternatives, and possible safety concerns with topical formulations.

4. R&D and Portfolio Diversification

Manufacturers exploring reformulations, combination therapies, or novel delivery mechanisms might rejuvenate the product’s financial outlook. However, given ketoconazole’s older classification, investments in R&D are limited, constraining potential growth avenues.

Strategic Outlook

The future of INTAL hinges primarily on geographic market strategies. Key opportunities include:

• Expanding in emerging markets via strategic partnerships with local distributors.
• Innovating topical formulations to enhance safety and compliance.
• Leveraging regulatory filings to solidify market presence in jurisdictions with less restrictive oversight.

Nonetheless, a declining global systemic indication and competitive pressure will continue to negatively impact revenue trajectory in traditional markets.

Key Takeaways

• Market landscape of INTAL has shifted significantly following safety concerns and regulatory restrictions, notably in developed jurisdictions.
• Pricing pressures from generic competition and eroding margins necessitate strategic diversification.
• Emerging markets remain vital, with topical formulations serving as primary revenue drivers.
• Innovation and regional partnerships are critical to reversing revenue declines.
• Regulatory and safety issues will continue to influence the drug’s future applications and market success.

FAQs

Q1. What caused the decline in INTAL’s systemic market in high-income countries?
A1. The FDA revoked systemic ketoconazole approval in 2013 due to safety concerns, particularly hepatotoxicity, leading to reduced prescriptions and market availability.

Q2. Are there ongoing efforts to develop new formulations of INTAL?
A2. Currently, reformulation efforts are limited, with most focus on topical products, although some companies explore improved delivery systems to enhance safety and efficacy.

Q3. How does INTAL compete against newer antifungals?
A3. In topical markets, INTAL remains price-competitive but faces stiff competition from agents with better tolerability and shorter treatment courses. Systemic market decline further diminishes its competitive role.

Q4. Which markets hold the greatest growth potential for INTAL?
A4. Emerging economies such as India, China, and Southeast Asia, where affordability and widespread dermatophyte infections sustain demand, are the primary growth markets.

Q5. What strategic moves can manufacturers consider to sustain INTAL’s market presence?
A5. Manufacturers should focus on expanding regional licensing agreements, investing in innovative topical formulations, and exploring new indications or combination therapies to offset declining systemic use.

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References

1. Allied Market Research. "Antifungal Market Size, Share & Trends Analysis Report." 2022.
2. U.S. Food and Drug Administration. “FDA Drug Safety Communication: Safety Review of Topical Ketoconazole.” 2013.
   [Additional references can be appended based on actual data sources.]