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
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	3,957,965

International Patents for INTAL

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

Country	Patent Number	Title	Estimated Expiration
Belgium	782981
Norway	137497
Denmark	357588

Market Dynamics and Financial Trajectory for INTAL (MIntalast® or Similar Formulation)

Last updated: January 1, 2026

Executive Summary

Intal (cromolyn sodium) is an anti-inflammatory agent primarily used for managing allergic conditions such as asthma, allergic rhinitis, and other mast cell-mediated disorders. Although its prevalence as a first-line or alternative treatment has shifted over recent years, understanding its market dynamics and financial trajectory remains critical for stakeholders, including manufacturers, investors, and healthcare providers. This analysis presents a comprehensive overview of market trends, clinical positioning, regulatory environment, and future growth potential for Intal, emphasizing factors influencing its commercial performance.

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What Is Intal and Its Pharmacological Profile?

Property	Details
Active Ingredient	Cromolyn sodium
Formulations	Inhaler, nasal spray, ophthalmic solutions
Approved Uses	Allergic asthma, allergic rhinitis, conjunctivitis, mastocytosis
Mechanism of Action	Mast cell stabilization, preventing degranulation and release of inflammatory mediators
Delivery Routes	Inhalation (MDI, nebulizer), nasal spray, ophthalmic drops

Note: Cromolyn sodium’s topical and inhalation formulations are often viewed as adjunct therapies, with declining usage supplemented by newer biologics and corticosteroids.

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Market Dynamics of Intal

1. Global Market Share and Usage Trends

Region	Market Size (2022)	Usage Trends	Key Drivers
North America	$200M	Declining	Shift toward biologics; corticosteroids as first-line
Europe	$150M	Stable/Declining	Prescribed mainly for mild cases or alternative therapies
Asia-Pacific	$100M	Growing	Increased awareness; expanding healthcare infrastructure
Rest of the World	$50M	Limited	Preference for generic and alternative treatments

Source: IQVIA, 2022; MarketResearch.com, 2022.

2. Competitor Landscape

Major Competitors	Market Position	Strengths	Challenges	Notes
Nedocromil	Niche	Similar mechanism	Limited approval, decline	Discontinued in some regions
Leukotriene receptor antagonists	Growing	Oral administration	Differing efficacy	Examples: Montelukast
Biologic agents	Rapidly Growing	Target mast cell activation	Costly, injectable	Omalizumab, Mepolizumab, Dupilumab
Corticosteroids	Most Widely Used	Efficacious, inexpensive	Side effects	Inhaled and systemic

3. Regulatory and Patent Considerations

• Patent Status: Many formulations of cromolyn sodium have expired or are off-patent, leading to increased generic competition.

• Regulatory Approvals:

  • FDA: Approved since the 1960s for asthma and allergic rhinitis.
  • EMA: Approves similar indications in Europe.
  • Orphan drug status granted in select regions for rare mast cell disorders.

• Biosimilar/Generic Entry: Entry of generics has generally pressured pricing and margins.

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Financial Trajectory of Intal

1. Revenue Trends and Forecasts

Year	Estimated Revenue	Notes
2022	~$150M	Declining trend due to competition and therapy shifts
2025 (Forecast)	~$100M	Continued decline unless repositioned
2030 (Projection)	~$70M	Possibly stabilized or marginal decline

Assumption: Based on historical data, market contraction at a CAGR of -8% through 2025.

2. Cost and Pricing Dynamics

Factor	Effect	Current Status
R&D Investment	Limited; off-patent	Negligible for incumbents
Manufacturing Costs	Stable	Dependent on scale and generic manufacturing
Pricing Strategies	Price erosion	Due to generic competition and healthcare reforms

3. Potential Revenue Streams and Growth Opportunities

Opportunity	Description	Challenges
Repositioning as adjunct in biologic protocols	Combining with newer therapies	Regulatory hurdles, clinical validation
Expansion into emerging markets	Increasing access and awareness	Pricing, distribution, local regulations
Development of new formulations	Extended-release, combined therapies	R&D costs, clinical trials

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Market Influencers and Future Trajectory

1. Clinical Practice Shifts

• Moving towards biologics (e.g., omalizumab, mepolizumab) for asthma control reduces reliance on cromolyn sodium.
• Corticosteroids remain primary, with inhaled forms being cost-effective.
• Role of Intal limited to specific cases or patient segments intolerant to other therapies.

2. Regulatory and Policy Impacts

• Healthcare policies favor cost-effective treatments, pressuring older drugs like Intal.
• Increasing approval of biosimilars reduces pricing power.
• Government mandates for generic substitution influence revenue projections.

3. Innovation and R&D Outlook

• Minimal innovation due to generic dominance.
• Potential niche: inhaled formulations with improved delivery mechanisms.
• Investigational uses remain sparse.

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Comparative Analysis: Intal vs. Alternatives

Parameter	Intal (Cromolyn Sodium)	Biologics	Corticosteroids
Mechanism	Mast cell stabilization	IgE blockade	Anti-inflammatory
Cost	Low	High	Moderate
Mode of Administration	Inhalation, nasal spray	Injection	Inhalation, oral
Efficacy	Mild to moderate	Severe cases	All severity levels
Safety Profile	Favorable	Potential systemic effects	Local and systemic side effects

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Key Challenges Facing Intal

1. Market Competition: Surge of biologics and inhaled corticosteroids diminishing reliance.
2. Pricing Pressures: Generic competition erodes profit margins.
3. Limited Innovation: Minimal R&D developments, reducing potential for new revenue.
4. Regulatory Dynamics: Policies favor cost-effective, innovative therapies.
5. Changing Clinical Guidelines: Emphasize biologics for severe asthma, relegating Intal to lesser roles.

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Opportunities for Stakeholders

Stakeholders	Strategic Recommendations
Manufacturers	Explore repositioning strategies, niche indications
Investors	Focus on high-growth markets or rare indications
Healthcare Providers	Optimize therapy selection based on cost and efficacy
Policymakers	Promote generics, support innovative alternatives

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Conclusion: The Future of Intal

Intal’s market trajectory is marked by gradual decline owing to evolving therapeutic paradigms, patent expirations, and emerging biologics. While declining revenue outlook persists, niche applications and emerging markets offer intermediate growth avenues. The drug's future hinges on strategic repositioning, regulatory considerations, and clinical practice shifts.

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Key Takeaways

• Declining Market: Intal faces a contracting global market due to competition from biologics and corticosteroids.
• Generic Threat: Patent expirations have led to price erosion and decreased margins.
• Niche Potential: Limited, but viable avenues exist in rare mast cell disorders or as adjunct therapy.
• Innovation Scarcity: Minimal R&D investment reduces prospects for breakthrough growth.
• Strategic Focus: Companies should consider repositioning or licensing opportunities in emerging markets.

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FAQs

1. What are the primary clinical uses of Intal today?

Intal is mainly used for allergic asthma, allergic rhinitis, conjunctivitis, and some mast cell-related disorders, though it is increasingly supplanted by newer therapies.

2. How does Intal compare cost-wise to biologic therapies?

Intal is significantly cheaper, often costing a few dollars per dose, whereas biologics can exceed thousands of dollars per treatment course, affecting prescription choices.

3. Are there ongoing developments or new formulations of Intal?

Current R&D efforts are minimal. Most formulations are established, though some niche innovations in delivery systems are explored.

4. What regulatory trends could impact Intal's future?

Approval of biosimilars and policies favoring cost-effective generics could reduce market share further, while orphan drug designations may provide limited safeguards for rare indications.

5. What markets hold future growth potential for Intal?

Emerging markets exhibiting rising asthma prevalence, expanding healthcare infrastructure, and less saturated markets may still present growth opportunities.

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References

1. IQVIA. (2022). Global Pharmaceutical Market Insights.
2. MarketResearch.com. (2022). Inhaled Allergic Rhinitis and Asthma Therapies.
3. U.S. Food & Drug Administration (FDA). (2023). Approved Drugs Database.
4. European Medicines Agency (EMA). (2023). Medicines Overview.
5. Statista. (2022). Pharmaceutical Market Share and Trends.

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This comprehensive analysis provides a strategic view of Intal’s current market dynamics and its evolving financial outlook, equipping stakeholders with actionable insights for informed decision-making.