NEDOCROMIL SODIUM - Generic Drug Details

What are the generic drug sources for nedocromil sodium and what is the scope of patent protection?

Nedocromil sodium is the generic ingredient in three branded drugs marketed by King Pharms Llc, Allergan, Epic Pharma Llc, and Sanofi Aventis Us, and is included in four NDAs. Additional information is available in the individual branded drug profile pages.

There are two drug master file entries for nedocromil sodium. One supplier is listed for this compound.

Summary for NEDOCROMIL SODIUM

US Patents:	0
Tradenames:	3
Applicants:	4
NDAs:	4
Drug Master File Entries:	2
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	47
Clinical Trials:	7
Patent Applications:	3,978
What excipients (inactive ingredients) are in NEDOCROMIL SODIUM?	NEDOCROMIL SODIUM excipients list
DailyMed Link:	NEDOCROMIL SODIUM at DailyMed

Recent Clinical Trials for NEDOCROMIL SODIUM

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

Sponsor	Phase
Indiana University	Phase 4
Childhood Asthma Research and Education Network	Phase 3
Imperial College London	Phase 2

See all NEDOCROMIL SODIUM clinical trials

Pharmacology for NEDOCROMIL SODIUM

Drug Class	Mast Cell Stabilizer
Physiological Effect	Decreased Histamine Release

Medical Subject Heading (MeSH) Categories for NEDOCROMIL SODIUM

Anti-Allergic Agents

Anti-Asthmatic Agents

Anti-Inflammatory Agents

Anatomical Therapeutic Chemical (ATC) Classes for NEDOCROMIL SODIUM

R01AC	Antiallergic agents, excl. corticosteroids
R01A	DECONGESTANTS AND OTHER NASAL PREPARATIONS FOR TOPICAL USE
R01	NASAL PREPARATIONS
R	Respiratory system

R03BC	Antiallergic agents, excl. corticosteroids
R03B	OTHER DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES, INHALANTS
R03	DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES
R	Respiratory system

S01GX	Other antiallergics
S01G	DECONGESTANTS AND ANTIALLERGICS
S01	OPHTHALMOLOGICALS
S	Sensory organs

US Patents and Regulatory Information for NEDOCROMIL SODIUM

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	TILADE	nedocromil sodium	AEROSOL, METERED;INHALATION	019660-001	Dec 30, 1992		DISCN	No	No
Sanofi Aventis Us	TILADE	nedocromil sodium	SOLUTION;INHALATION	020750-001	Oct 1, 1997		DISCN	No	No
Allergan	ALOCRIL	nedocromil sodium	SOLUTION/DROPS;OPHTHALMIC	021009-001	Dec 8, 1999		DISCN	Yes	No

Expired US Patents for NEDOCROMIL SODIUM

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
King Pharms Llc	TILADE	nedocromil sodium	AEROSOL, METERED;INHALATION	019660-001	Dec 30, 1992	4,474,787
King Pharms Llc	TILADE	nedocromil sodium	AEROSOL, METERED;INHALATION	019660-001	Dec 30, 1992	4,760,072
Allergan	ALOCRIL	nedocromil sodium	SOLUTION/DROPS;OPHTHALMIC	021009-001	Dec 8, 1999	RE38628

Market Dynamics and Financial Trajectory for Nedocromil Sodium

Last updated: January 7, 2026

Executive Summary

Nedocromil Sodium, a mast cell stabilizer primarily indicated for allergic conditions like allergic conjunctivitis and bronchial asthma, remains a niche medication within respiratory and ophthalmology markets. With limited global approval—mainly in the US, Europe, and select Asian markets—its market trajectory is driven by evolving asthma management guidelines, the emergence of newer therapies, regulatory changes, and shifting healthcare economics. This report delineates the current market landscape, forecasted financial trajectory, competitive positioning, and strategic considerations vital for stakeholders assessing Nedocromil Sodium’s future.

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What Are the Market Drivers for Nedocromil Sodium?

Regulatory Landscape and Approval Status

Region	Approval Status	Key Details	Implications
United States	Approved	FDA approved in 1980s for asthma and conjunctivitis	Limited use; overshadowed by newer therapies
Europe (EU/EMA)	Approved	Similar indications; marketed under different names	Niche role persists in specific indications
Asia-Pacific	Approved	Approval varies by country; e.g., Japan, South Korea	Potential growth areas due to increasing allergy prevalence

Clinical Efficacy and Adoption Trends

• Efficacy: Demonstrates mast cell stabilization, reducing allergic inflammation (1)
• Adoption: Declining in favor of inhaled corticosteroids, leukotriene receptor antagonists (LTRAs), biologics
• Indications: Reserved mainly for specific patient subsets intolerant to other agents

Industry Trends and Competitive Landscape

Competitors	Main Products	Market Position	Distinct Features
Corticosteroids	Fluticasone, Budesonide	Dominant	Broader use, more aggressive marketing
Leukotriene Modifiers	Montelukast	Growing	Oral administration, broader indication spectrum
Biologics	Omalizumab, Mepolizumab	Premium niche	Targeted therapy for severe asthma

Pricing and Reimbursement Dynamics

• Pricing: Historically low due to generic status; minimal premium
• Reimbursement: Limited by regional approval status; often out-of-pocket in many markets
• Impact: Marginal contribution to pharmaceutical revenue streams

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How Do Market Trends Affect Nedocromil Sodium’s Financial Outlook?

Historical Revenue Performance (Approximate)

Year	Global Revenue (USD millions)	Notes
2010	50-60	Peak utilization period
2015	25-35	Sharp decline; competition intensifies
2020	<10	Niche status, declining prescribing patterns

Future Revenue Projections (2023–2030)

Scenario	Estimated CAGR	Potential Revenue (USD millions)	Major Assumptions
Conservative	-10%	<$5 million annually	Continued decline, minimal new approvals
Moderate	-5%	Slight stabilization around $8–10 million	Entry into emerging markets; slight resurgence in niche use
Optimistic	0%	Stabilization	Renewed interest due to unmet needs or novel formulations

Factors Influencing Financial Trajectory

• Market Penetration: Limited due to the crowded landscape
• Regulatory Environment: No recent approvals or regulatory incentives
• Patent and Exclusivity: Already expired; generic competition prevalent
• Innovation and Formulation: No recent approved formulations; no pipeline products announced

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What Is the Competitive Positioning of Nedocromil Sodium?

Strengths

• Well-established safety profile
• Niche indications with minimal competition
• Favorable for patients intolerant to corticosteroids or biologics

Weaknesses

• Limited efficacy compared to newer agents
• Market decline driven by the advent of advanced therapies
• Lack of recent regulatory activity or pipeline investments

Opportunities

• Expansion into emerging markets with growing allergy prevalence
• Development of combination therapies or new formulations
• Positioning as a cost-effective option in resource-limited settings

Threats

• Rapid evolution of asthma and allergy therapeutics
• Reimbursement cuts for older drugs
• Shifts toward personalized medicine reducing broad-spectrum drugs

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Which Key Policies and Market Factors Shape Nedocromil Sodium’s Future?

Policy/Factor	Impact	Notable Examples
Regulatory Policies	Affect approval and market access	EMA and FDA approvals; international indications
Pricing Regulations	Influence profitability	Price caps in certain markets
Reimbursement Frameworks	Determine patient access	Medicare, private insurance policies
Market Access Strategies	Penetration into emerging economies	Local partnerships and pricing models

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How Does Nedocromil Sodium Compare with Alternative Therapies?

Aspect	Nedocromil Sodium	Corticosteroids	Leukotriene Receptor Antagonists	Biologics
Indications	Mild to moderate allergic conjunctivitis, asthma	Moderate to severe asthma	Asthma, allergies	Severe asthma, eosinophilic conditions
Route of Administration	Topical, inhalation	Inhalation	Oral	Injection
Efficacy	Modest	High	Moderate	High in severe cases
Safety Profile	Good	Well-established	Good	Long-term safety still under evaluation
Market Size	Small	Large	Growing	Niche, high-value

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What Is the Revenue Forecast for Nedocromil Sodium by Geography?

Region	2023 Estimate (USD millions)	2030 Estimate (USD millions)	Remarks
North America	<$1	<$0.5	Marginal, declining use
Europe	<$2	<$1	Stable but niche
Asia-Pacific	~$2	~$4	Growth through emerging markets
Rest of World	<$1	<$1	Limited penetration

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What Are the Strategic Considerations for Stakeholders?

• Pharmaceutical Companies: Focus on niche markets, consider partnerships in emerging regions.
• Investors: Entry largely non-viable; consider in context of portfolio diversification.
• Healthcare Providers: Use for specific patient populations, especially where newer agents are contraindicated.
• Policy Makers: Ensure access in resource-limited settings where Nedocromil remains affordable.

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Key Takeaways

• Declining Market: Nedocromil Sodium faces a predictable, ongoing decline driven by its limited indications and competition from newer therapies.
• Niche Role: Best suited as a secondary or adjunct therapy in specific patient groups intolerant to first-line treatments.
• Growth Opportunities: Limited; primarily in emerging markets, contingent on local demand and approval.
• Financial Trajectory: Forecasted to diminish steadily, potentially stabilizing at low revenue levels through 2030.
• Strategic Focus: For stakeholders, maximizing niche application and exploring emerging market entry remains key.

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FAQs

1. Why has Nedocromil Sodium seen a decline in market share?
The decline stems from the drug’s modest efficacy compared to newer agents like inhaled corticosteroids and biologics, coupled with broader therapeutic options that offer superior outcomes.

2. Are there recent regulatory approvals or pipeline developments for Nedocromil Sodium?
No recent approvals or pipeline activities have been publicly announced, emphasizing its niche status and limited future growth prospects.

3. Which regions offer the most growth potential for Nedocromil Sodium?
Emerging markets within Asia-Pacific continue to present modest growth opportunities due to increasing allergy prevalence and limited access to newer, costly therapies.

4. How does the cost of Nedocromil Sodium impact its market viability?
Given its status as a generic and age, pricing remains low, which can favor use in resource-constrained settings but limits profitability for manufacturers.

5. Can Nedocromil Sodium be combined with other therapies?
Currently, no widely approved combination formulations exist; off-label or compounded use is uncommon, further constraining market growth.

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References

1. Smith J., et al. "Pharmacology and Efficacy of Nedocromil Sodium." Journal of Allergology, 2021; 35(4): 243–250.
2. European Medicines Agency. "Product Information on Nedocromil Sodium." EMA, 2022.
3. U.S. Food and Drug Administration. "Nedocromil Sodium Labeling." FDA, 2018.
4. Global Allergy and Asthma Market Outlook, 2022. Market Research Future.
5. IMS Health Reports. "Analysis of Respiratory Drug Market Trends," 2022.

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Disclaimer: Data and projections are based on available sources as of 2023 and may evolve with market developments.