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

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

International Patents for INTAL

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

Country	Patent Number	Title	Estimated Expiration
Spain	455478
Ireland	781432
Germany	2831419

Investment Scenario and Fundamentals Analysis for INTAL (Mometasone Furoate)

Last updated: February 3, 2026

What is INTAL and its Market Position?

INTAL is the brand name for a corticosteroid nasal spray containing mometasone furoate. It is primarily prescribed for allergic rhinitis and nasal polyposis. Approved in multiple countries, including the US, EU, and Japan, INTAL has established a significant presence in the nasal corticosteroid segment.

Market Size and Growth Potential

The global allergic rhinitis treatment market was valued at approximately $8.6 billion in 2022. It is projected to grow at a compound annual growth rate (CAGR) of around 4.2% from 2023 to 2030. The corticosteroid nasal spray segment accounts for nearly 50% of this market, with mometasone furoate holding a leading share.

Key factors driving growth include:

• Increasing prevalence of allergic conditions worldwide.
• Rising awareness and diagnosis.
• Expanding aging populations.

Competitive Dynamics

INTAL competes primarily with other intranasal corticosteroids such as Fluticasone Propionate (Flonase), Beclomethasone Dipropionate (Beconase), and Betamethasone. Market dominance hinges on:

• Efficacy profiles.
• Side effect spectra.
• Brand loyalty and physician prescribing habits.
• Patent status and patent expiry timelines.

Patent Considerations:
Intal’s patent expired in key markets like the US in 2010, leading to generic competition. However, formulations with enhanced delivery mechanisms or combination therapies can retain premium pricing.

R&D and Pipeline Potential

Current research emphasizes:

• New delivery mechanisms to improve compliance.
• Combination products targeting multiple nasal or sinus conditions.
• Novel formulations with improved bioavailability or reduced side effects.

Investments into R&D could extend product lifecycle or open new indications, but the transition from established products involves high costs with uncertain regulatory approval outcomes.

Regulatory and Legal Environment

Most markets have approved INTAL for nasal allergies and polyposis. Regulatory trends favor biosimilars and generics, impacting branded sales. Patent litigations and exclusivity periods influence competitive positioning.

Financial Performance Indicators

While proprietary data varies, typical indicators for a mature pharmaceutical product include:

Indicator	Typical Range	Significance
Market share	10–20%, depending on region	Core component of revenue base
Pricing (USD/unit)	$20–$35	Determines gross margins
Annual sales revenue	$50–$150 million per regional market	Reflects product penetration and physician adoption
R&D expenditure	5-10% of sales	Investment into pipeline or reformulation innovations

Investment Risks and Challenges

• Patent expiry and generic proliferation erode margins.
• Regulatory hurdles in expanding indications.
• Competition from newer treatments, including biologics for severe nasal polyposis.
• Market saturation in mature regions.

Strategic Opportunities

• Expansion into emerging markets with increasing allergic disease prevalence.
• Developing combination therapies with antihistamines or other anti-inflammatory agents.
• Conducting clinical trials to establish new indications or improved formulations.

Conclusion

Investing in INTAL entails considering market maturity, patent landscape, and pipeline prospects. Robust growth in the broader allergic rhinitis market sustains demand, yet competitive and patent expiry pressures demand strategic positioning. R&D investments to innovate formulations or indications can offer long-term value.

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Key Takeaways

• INTAL competes in a saturated segment with sustained demand tied to allergy prevalence.
• Patent expiry has led to generic competition, pressuring margins.
• Growth opportunities lie in emerging markets and novel formulations.
• R&D efforts remain crucial for extending product life cycles.
• Regulatory and legal factors will influence future market share stability.

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FAQs

Q1: What is the primary indication for INTAL?
A: Treatment of allergic rhinitis and nasal polyposis.

Q2: How does patent expiry affect INTAL's market?
A: It enables generic competitors, reducing branded sales revenue.

Q3: Which regions offer the most growth potential?
A: Emerging markets like Asia-Pacific and Latin America.

Q4: What are the main competitors of INTAL?
A: Flonase (fluticasone), Beconase (beclomethasone), and other nasal corticosteroids.

Q5: What is the scope for R&D in this segment?
A: Developing new formulations, combination therapies, and expanding indications.

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Citations

[1] MarketsandMarkets, "Allergic Rhinitis Market," 2022.
[2] EvaluatePharma, "Pharmaceutical Market Data," 2023.
[3] US Patent Office records, expirations for mometasone furoate, 2010.