GASTROCROM Drug Patent Profile

Which patents cover Gastrocrom, and what generic alternatives are available?

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
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	83
Clinical Trials:	3
Patent Applications:	4,908
Drug Prices:	Drug price information for GASTROCROM
What excipients (inactive ingredients) are in GASTROCROM?	GASTROCROM excipients list
DailyMed Link:	GASTROCROM at DailyMed

See drug prices for GASTROCROM

Recent Clinical Trials for GASTROCROM

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

Sponsor	Phase
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)	Early Phase 1
Northwestern University	Early Phase 1
University of California, San Francisco	Phase 1

See all GASTROCROM clinical trials

Pharmacology for GASTROCROM

Drug Class	Mast Cell Stabilizer
Physiological Effect	Decreased Histamine Release

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

Expired US Patents for GASTROCROM

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Ucb Inc	GASTROCROM	cromolyn sodium	CAPSULE;ORAL	019188-001	Dec 22, 1989	4,395,421
Viatris Specialty	GASTROCROM	cromolyn sodium	CONCENTRATE;ORAL	020479-001	Feb 29, 1996	4,515,805
Viatris Specialty	GASTROCROM	cromolyn sodium	CONCENTRATE;ORAL	020479-001	Feb 29, 1996	4,421,762

International Patents for GASTROCROM

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

Country	Patent Number	Title	Estimated Expiration
Australia	530962
Singapore	62587
Australia	508134
Japan	S57106613	PHARMACETICAL MEDICINE
Germany	3169714
United Kingdom	1549229

Market Dynamics and Financial Trajectory for GASTROCROM (Cromolyn Sodium)

Last updated: August 2, 2025

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Introduction

GASTROCROM, known generically as Cromolyn Sodium, is an established pharmaceutical agent primarily indicated for managing allergic conditions such as asthma, allergic rhinitis, and other hypersensitivity reactions. Despite its long-standing presence in the market, ongoing developments, evolving market dynamics, and competitive pressures shape its current and future financial trajectory. This analysis explores the key market drivers, competitive landscape, regulatory environment, and projected financial outlook for GASTROCROM.

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Market Overview

Cromolyn Sodium holds a niche position within the broader allergy and asthma treatment markets. Its mechanism involves inhibiting mast cell degranulation, thereby reducing allergic mediator release—an effect that distinguishes it from other therapies like corticosteroids or beta-agonists. Historically, GASTROCROM has been prescribed as an inhaler and nasal spray, with formulations focusing on respiratory allergies and asthma prophylaxis.

The global allergic rhinitis and asthma markets are substantial, with estimates reaching nearly USD 25 billion combined, driven by rising prevalence rates worldwide. According to the World Health Organization (WHO), asthma affects over 300 million individuals globally, with increasing rates in both developed and emerging economies, fueling demand for antihistamines, corticosteroids, and mast cell stabilizers like Cromolyn Sodium [1].

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Market Dynamics

1. Therapeutic Positioning and Competition

GASTROCROM faces intense competition from newer, more convenient therapies such as corticosteroid inhalers (e.g., fluticasone) and biologic agents (e.g., omalizumab). While Cromolyn Sodium offers a favorable safety profile, especially for children and long-term use, its require frequent dosing and limited efficacy in severe cases have curtailed its growth potential.

Moreover, the advent of combination therapies—integrating antihistamines, corticosteroids, and leukotriene receptor antagonists—has diversified treatment options, challenging Cromolyn Sodium's market share.

2. Clinical Efficacy and Patient Preference

While Cromolyn Sodium remains effective for allergy prophylaxis with minimal systemic absorption, its rapid onset of action is comparatively limited. Patients often prefer inhalers with quick relief, favoring corticosteroids and bronchodilators. This preference influences prescribing patterns, particularly in acute episodes.

3. Regulatory and Patent Landscape

GASTROCROM's patent protection has expired or is nearing expiration in many jurisdictions, exposing it to generic competition, which exerts downward pressure on pricing. Despite this, the safety profile and cost advantages—particularly in pediatric populations—sustain its clinical relevance.

4. Market Penetration and Geographic Trends

Developed markets such as the U.S., Europe, and Japan display modest adoption rates for GASTROCROM, largely due to existing preferences for inhaled corticosteroids. Conversely, in emerging markets, particularly in rural or resource-constrained areas, Cromolyn Sodium maintains a noteworthy presence owing to affordability and safety.

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Financial Trajectory

1. Revenue Streams and Growth Potential

GASTROCROM’s revenue trajectory exhibits stagnation or slight decline in mature markets, driven by generic erosion and competition from advanced formulations. However, niche segments—such as pediatric prophylaxis—continue to offer steady revenue streams.

In emerging regions, increased access to affordable respiratory medications sustains modest growth prospects. The World Bank projects increased healthcare access and urbanization will expand treatment rates for asthma and allergies, maintaining demand for mast cell stabilizers.

2. Impact of Generic Competition

As patents expire, generic Cromolyn Sodium products will flood markets, significantly reducing wholesale and retail prices. Analyses suggest generic versions could undercut branded formulations by 30-50%, impacting profit margins [2].

Manufacturers might respond via cost optimization or repositioning strategies; however, price competition remains fierce.

3. R&D and Formulation Innovation

Limited ongoing R&D efforts suggest that GASTROCROM’s financial future hinges more on market penetration than innovation. Nonetheless, some companies explore new delivery mechanisms—such as nasal powders or sublingual forms—to enhance convenience and adherence, potentially opening new revenue avenues, albeit with considerable regulatory hurdles.

4. Commercial Strategy and Market Expansion

Targeting pediatric and elderly populations who benefit from a safe, non-steroidal option offers growth leverage. Additionally, expanding into national immunization programs or prophylactic health initiatives could bolster sales.

Collaborations with public health entities in emerging markets may also foster increased distribution and acceptance, stabilizing revenue streams amidst competitive challenges.

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Regulatory Environment

Regulatory processes impact GASTROCROM’s financial trajectory. In many markets, Cromolyn Sodium is off-patent, with regulatory barriers mainly comprising formulation approvals and labeling. Regulatory agencies increasingly favor cost-effective, generic medications, fostering market entry but simultaneously compressing profit margins.

However, regulatory scrutiny over efficacy claims remains strict, necessitating rigorous post-marketing surveillance to maintain approvals.

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Future Outlook and Market Opportunities

While GASTROCROM’s role in the global allergy landscape is well-established, its growth potential is modest due to competition, limited innovation, and patent expirations. The drug’s future may depend on niche market sustainment and strategic diversification, such as combination drug development or novel delivery platforms.

Emerging markets offer opportunities for increased usage driven by affordability and prevalence of allergic diseases. Additionally, targeted advertising emphasizing safety and long-term prophylaxis maintains its relevance among clinicians mindful of corticosteroid side effects.

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Key Challenges

• Market Saturation: Maturity in established regions reduces growth likelihood.
• Price Erosion: Generics diminish revenue potential.
• Competitive Alternatives: Broader options with rapid onset and higher efficacy outpace Cromolyn Sodium for acute management.

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Key Opportunities

• Niche Positioning: Pediatric and long-term allergy management segments.
• Formulation Innovation: Development of more patient-friendly delivery systems.
• Market Expansion: Focus on emerging markets and prophylactic health programs.
• Regulatory Endorsements: Leveraging safety profiles to promote use in sensitive populations.

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Summary of Financial Implications

In conclusion, GASTROCROM’s financial traction will likely remain stable in existing niches but face persistent downward pressure due to patent expiry and competition. Lower manufacturing costs and strategic positioning may help sustain margins, particularly in markets where affordability remains paramount.

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Key Takeaways

• GASTROCROM sustains a niche role in allergy and asthma management, with modest growth prospects.
• Patent expirations introduce significant generic competition, compressing prices and margins.
• Emerging markets represent a growth frontier, driven by affordability and disease prevalence.
• Limited R&D investment constrains innovation, necessitating strategic repositioning.
• Patient preference shifts favor faster, more effective therapies, challenging Cromolyn Sodium’s market share.

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Frequently Asked Questions (FAQs)

Q1: How does GASTROCROM compare to inhaled corticosteroids in managing asthma?
A1: Cromolyn Sodium offers a safer, non-steroidal option suitable for prophylaxis and long-term management, especially in children. However, it has a slower onset and less potency than corticosteroids, limiting its use in acute or severe asthma.

Q2: What impact will patent expiration have on GASTROCROM’s market share?
A2: Patent expirations will likely lead to increased generic competition, reducing prices and profitability. Market share may decline unless manufacturers innovate or focus on niche patient populations.

Q3: Is there potential for reformulation or new delivery methods of GASTROCROM?
A3: Yes, developing more convenient formulations, such as nasal powders or sublingual tablets, could enhance adherence, particularly if supported by favorable regulatory approvals.

Q4: Which regions offer the most growth opportunities for GASTROCROM?
A4: Emerging markets in Asia, Latin America, and Africa present growth opportunities due to rising allergy prevalence and affordability considerations.

Q5: How does the safety profile of GASTROCROM influence its market prospects?
A5: Its minimal systemic absorption and low side-effect profile make it attractive for long-term use, especially in pediatric and sensitive populations, sustaining niche demand.

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References

[1] World Health Organization. Global Surveillance, Prevention and Control of Chronic Respiratory Diseases. WHO Report, 2021.

[2] IMS Health Data. Market Trends in Generic Pharmaceuticals, 2020.

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