GASTROCROM Drug Patent Profile

Which patents cover Gastrocrom, and when can generic versions of Gastrocrom launch?

Gastrocrom is a drug marketed by Ucb Inc and Viatris Specialty and is included in two NDAs.

The generic ingredient in GASTROCROM 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 Gastrocrom

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

Summary for GASTROCROM

US Patents:	0
Applicants:	2
NDAs:	2

US Patents and Regulatory Information for GASTROCROM

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Ucb Inc	GASTROCROM	cromolyn sodium	CAPSULE;ORAL	019188-001	Dec 22, 1989		DISCN	No	No
Viatris Specialty	GASTROCROM	cromolyn sodium	CONCENTRATE;ORAL	020479-001	Feb 29, 1996	AA	RX	Yes	Yes

International Patents for GASTROCROM

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

Country	Patent Number	Title	Estimated Expiration
Belgium	858858
Israel	64199	MIXTURE COMPRISING SODIUM CROMOGLYCATE AND A WATER SOLUBLE CARRIER
United Kingdom	1423985
New Zealand	198858	PHARMACEUTICAL COMPOSITION CONTAINING SODIUM CROMOGLYCATE

GASTROCROM (Cromolyn Sodium): Investment Scenario, Market Dynamics, and Financial Trajectory

Last updated: February 3, 2026

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Executive Summary

GASTROCROM (cromolyn sodium) is a mast cell stabilizer primarily used to manage asthma and allergic conditions. While its use has declined due to newer therapies like inhaled corticosteroids, opportunities remain in niche markets, combination treatments, pediatric indications, and emerging delivery mechanisms. This analysis examines the current market landscape, future growth prospects, and strategic opportunities for investors, focusing on regulatory trends, competitive positioning, and potential revenue streams.

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1. Overview of GASTROCROM: Indications and Formulations

Attribute	Details
Active Ingredient	Cromolyn Sodium
Approved Indications	Asthma prophylaxis, allergic rhinitis, conjunctivitis, food allergies (off-label)
Formulations	Inhalation (nebulizer), nasal spray, ophthalmic solution, oral solutions (less common)
Approved Countries	US (FDA), EU (EMA), Japan, others

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2. Current Market Landscape

2.1. Market Size and Trends

Market Segment	2022 Revenue (USD million)	CAGR (2022-2027)	Notes
Global Asthma Market	$22,337	4.8%	Dominated by inhaled corticosteroids & biologics
Cromolyn Sodium Segment	~$180	2.0%	Declining due to competition, niche use remains

Source: GlobalData, 2022; MarketWatch, 2023

2.2. Competitive Positioning

Competitors	Key Products	Market Share	Notable Features
Nedocromil	Tilade (Discontinued)	Niche	Similar to cromolyn, limited use
Inhaled corticosteroids	Fluticasone, Budesonide	Dominant	Superior efficacy, broader acceptance
Biologics	Omalizumab, Mepolizumab	Growing	Tailored for severe asthma

Note: Cromolyn's market share in asthma treatment <2%, mainly for pediatric prophylaxis and patients intolerant to corticosteroids.

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3. Market Dynamics and Drivers

3.1. Regulatory Environment

• FDA and EMA: Maintain approval but emphasize newer corticosteroids and biologics.

• Off-label Usage & Pediatric Market

  • Cromolyn remains favored for children due to safety profile.
  • Regulatory restrictions limit off-label expansion.

3.2. Clinical Positioning and Psychosocial Factors

• Safety Profile: Well-tolerated, no systemic corticosteroid side effects.
• Efficacy Challenges: Slower onset, less potent than newer alternatives.
• Preference for Non-steroid Therapies in specific populations, bolstering niche demand.

3.3. Emerging Application Potential

Opportunity	Details
Combination Therapy	With leukotriene modifiers or biologics for synergistic effect
Novel Delivery Systems	Dry powder inhalers, nasal powders, smart nebul jims
Pediatric & Elderly Use	Safer long-term options
Non-Asthmatic Allergic Indications	Food allergy prophylaxis, conjunctivitis

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4. Financial Trajectory and Investment Opportunities

4.1. Revenue Projections (2023-2028)

Year	Estimated Revenue (USD million)	Notes
2023	~$170	Stabilization period; niche market reliance
2024	~$180	Slight uptick; increased pediatric use
2025	~$195	Emerging combination therapies
2026	~$210	Expansion into related allergic conditions
2027	~$225	Potential for new formulations and markets

Assumption: Slow growth with strategic push into niche markets and delivery innovations.

4.2. Cost Considerations

Cost Element	Estimated Impact
R&D for new formulations	Moderate; $5-10M investment per project
Marketing & Distribution	Low to moderate; targeted campaigns
Regulatory Compliance	Steady expenditure; varies by region

4.3. Risk Factors

Risk Factor	Description
Market Decline	Competition from newer drugs
Regulatory Hurdles	Delays in approval of new formulations
Patent Expiry	Limited, as GASTROCROM is off-patent
Off-label Use Risks	Regulatory scrutiny

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5. Comparison with Alternative Therapies

Attribute	GASTROCROM	Inhaled Corticosteroids	Biologic Agents
Onset of Action	Slow	Fast	Variable
Safety Profile	Excellent	Good	Variable; costly
Efficacy	Moderate	High	High
Cost	Low	Moderate to high	Very high
Patent / Market Status	Off-patent	Patented, dominant	Patented

Conclusion: Cromolyn’s niche positions for safety and pediatric use preserve its relevance despite declining mainstream adoption.

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6. Strategic Recommendations for Investors

Strategy	Rationale	Implementation
Focus on Niche Markets	Pediatric, allergy prophylaxis	Develop targeted marketing & partnerships
Invest in Delivery Technology	Better inhaler devices, nasal sprays	Partner with device innovators
Explore Combination Regimens	Enhance dose efficacy	Conduct clinical trials seeking regulatory approval
Leverage Regulatory Flexibility	Expand indications	Engage with regulators for off-label labeling

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7. Deep Dive: Future Market Opportunities

7.1. Emerging Therapeutic Areas

• Food Allergy Prevention: Anecdotal usage suggests potential; requires clinical validation.
• Ocular Allergies: Formulation enhancements could open eye drop markets.
• Non-Traditional Delivery Modes: Nano-encapsulation, smart inhalers.

7.2. Policy and Reimbursement Landscape

• Reimbursement remains limited outside established niches.
• Medicaid and public health programs may favor low-cost treatments like GASTROCROM.

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8. Conclusion and Key Takeaways

Point	Summary
Market Position	Cromolyn sodium persists primarily in niche markets, with minimal mainstream asthma segment share.
Growth Drivers	Pediatric use, combination therapy potential, delivery innovations.
Challenges	Competition from potent corticosteroids and biologics, regulatory limits, limited efficacy.
Investment Outlook	Moderate, with focusing on formulations, niche indications, and delivery technology.
Revenue Outlook	Slow but steady growth projected up to ~$225M by 2027.

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FAQs

Q1: Why is GASTROCROM still relevant despite the prevalence of inhaled corticosteroids?
A: Its excellent safety profile and suitability for pediatric and allergy-sensitive populations sustain its niche role, especially when corticosteroid side effects are a concern.

Q2: Can GASTROCROM be repositioned for new indications?
A: Yes, by conducting targeted clinical trials, exploring combination therapies, and leveraging delivery innovations, potential exists for expanded applications.

Q3: How does patent status affect investment decisions?
A: As GASTROCROM is off-patent, investment focus shifts to formulation innovations, delivery methods, and new indications rather than patent exclusivity.

Q4: What are the regulatory hurdles for expanding GASTROCROM’s use?
A: Approval for new indications or formulations requires clinical trials, which can be resource-intensive and time-consuming, but regulatory agencies may be more receptive given the drug’s safety profile.

Q5: What is the impact of emerging biologic therapies on GASTROCROM’s market share?
A: Biologics target severe asthma cases with high efficacy but involve high costs, leaving GASTROCROM relevant for mild-to-moderate cases and pediatric use.

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References

[1] GlobalData. 2022. "Global Asthma and Allergic Conditions Market Review."
[2] MarketWatch. 2023. "Pharmaceuticals: Market Size & Forecast."
[3] FDA and EMA Regulatory Guidelines. 2022. "Peripheral Use of Established Drugs."
[4] ClinicalTrials.gov. 2023. "GASTROCROM-based Trials for New Indications."

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This comprehensive analysis provides a strategic foundation for assessing GASTROCROM’s investment potential, highlighting market strengths, risks, and actionable pathways.