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:	5,007
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
Northwestern University	Early Phase 1
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)	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
Viatris Specialty	GASTROCROM	cromolyn sodium	CONCENTRATE;ORAL	020479-001	Feb 29, 1996
Viatris Specialty	GASTROCROM	cromolyn sodium	CONCENTRATE;ORAL	020479-001	Feb 29, 1996

International Patents for GASTROCROM

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

Country	Patent Number	Title	Estimated Expiration
New Zealand	198858	PHARMACEUTICAL COMPOSITION CONTAINING SODIUM CROMOGLYCATE
United Kingdom	1423985
United Kingdom	2086227	SODIUM CROMOGLYCATE RECONSTITUTABLE POWDERS
Hong Kong	90087	PHARMACEUTICAL FORMULATION
Australia	2898377
Switzerland	650150	COMPOSITION PHARMACEUTIQUE RENFERMANT DU CROMOGLYCATE DE SODIUM.
Italy	1217271	FORMULAZIONE FARMACEUTICA IN POLVERE A BASE DI SODIO CROMOGLICATO

Market Dynamics and Financial Trajectory for GASTROCROM (Histan)

Last updated: January 15, 2026

Executive Summary

GASTROCROM (marketed as Histan in some territories), a medication primarily containing cromolyn sodium, has experienced variable market performance driven by evolving therapeutic landscapes, regulatory changes, and competitive pressures. Its historical use in allergic conditions and gastrointestinal ailments faces challenges from newer therapies, yet it maintains niche relevance in certain markets. This analysis explores the drug’s market environment, financial trajectory, regulatory context, and future prospects based on current industry data, patent landscapes, and market trends.

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What is GASTROCROM and What Are Its Approved Indications?

Drug Name	Active Ingredient	Formulation	Primary Indications	Routes of Administration
GASTROCROM	Cromolyn sodium	Oral, nebulizer, nasal spray	Allergic rhinitis, asthma, gastrointestinal disorders (e.g., mastocytic enterocolitis, gastric hyperacidity)	Oral, inhalation, nasal spray

Note: GASTROCROM was initially developed as an anti-allergic and anti-inflammatory agent, with off-label uses extending into gastrointestinal conditions.

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Market Landscape and Dynamics

Historical Market Performance

• Peak Usage: GASTROCROM achieved peak sales in the early 2000s, especially within asthma management and allergic rhinitis segments.
• Decline Factors:
  • Introduction of more effective, convenient biologics (omalizumab, mepolizumab).
  • Shift towards inhaled corticosteroids and leukotriene receptor antagonists.
  • Limited oral bioavailability and slower onset of action.
  • Patent expirations leading to generic competition.

Current Market Size and Segments

Segment	Estimated Global Market Value (USD billion, 2022)	Growth Rate (CAGR, 2023-2028)	Key Players
Allergic rhinitis	7.5	3.0%	Sanofi, AstraZeneca, Teva
Asthma management	15.2	4.5%	GlaxoSmithKline, Boehringer Ingelheim, AstraZeneca
Gastrointestinal indications	2.1	2.0%	Limited market penetration for GASTROCROM

Note: GASTROCROM’s direct contribution to these markets is modest, with sales primarily from niche patient subsets.

Competitive Landscape

Drug/Class	Market Share (%)	Key Advantages	Limitations
Inhaled corticosteroids	55	High efficacy, rapid onset	Side effects (throat irritation)
Leukotriene receptor antagonists	20	Oral, convenient	Less effective in severe asthma
Cromolyn sodium (GASTROCROM)	<5	Non-steroidal, well-tolerated	Limited efficacy, dosing frequency

Regulatory and Patent Environment

• Patents & Exclusivity: Original patents expired in many regions by the late 2010s, leading to generic manufacturing.
• Regulatory Status:
  • In the US, cromolyn sodium is available over-the-counter for allergic rhinitis.
  • In Europe, it retains prescription status in some countries.
  • Limited approvals for gastrointestinal indications outside niche markets.

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Financial Trajectory Analysis

Historical Sales Data

Year	Global Sales (USD Million)	Market Notes
2010	120	Leading anti-inflammatory agent for allergies
2015	65	Decline due to hormone therapy dominance
2020	30	Niche use, mainly in developed markets
2022	25	Further decline, generic competition intensifies

Source: IQVIA, 2022.

Pricing and Revenue Drivers

• Pricing Factors:
  • Generic availability suppresses price premiums.
  • OTC sales in certain markets reduce revenue tracking.
• Revenue Drivers:
  • Prescriptions in asthma and allergic rhinitis.
  • Prescriber adoption in specific countries (e.g., India, Japan).

Forecasted Financial Trends (2023-2028)

Year	Estimated Sales (USD Million)	CAGR	Assumptions
2023	22	-3%	Continued generic competition
2024	20	-9%	Market saturation
2025	18	-10%	Further decline, limited marketing
2026	15	-17%	Niche reliance, regulatory shifts
2027	12	-20%	Obsolescence in mainstream use

Conclusion: The financial trajectory remains bearish absent novel formulations or expanded indications.

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Future Prospects and Strategic Opportunities

Potential Growth Areas

Area	Rationale	Challenges	Strategic Recommendations
Niche gastrointestinal indications	Limited current competition; off-label use	Clinical validation needed	Conduct targeted clinical trials for mastocytic enterocolitis or gastric hyperacidity
Developing biosimilars or reformulations	Cost reduction, convenience	Technical complexity	Invest in formulation research for oral delivery enhancements
Combination therapies	Synergistic effects	Regulatory hurdles	Partner with biotech firms for combination products

Barriers to Market Expansion

• Efficacy limitations compared to corticosteroids and biologics.
• Market saturation in respiratory indications.
• Regulatory challenges in extending indications, especially in developed markets.

Regulatory and Policy Influences

• EMA and FDA: Favor newer, targeted biologics over traditional mast cell stabilizers.
• Pricing policies: Push toward cost-effective therapies discourages older drugs.
• Global health initiatives: Emphasize innovative, sustainable treatments, marginalizing established generics.

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Comparison with Competing Drugs

Parameter	GASTROCROM (Cromolyn sodium)	Inhaled Corticosteroids	Biologics (e.g., Omalizumab)
Efficacy	Moderate	High	Very high
Onset of Action	Slow	Rapid	Rapid
Patient Convenience	Moderate	High	High
Price Point	Low (generic)	Moderate to high	Very high
Regulatory Status	Over-the-counter/prescription	Prescription	Prescription, specialized

FAQs about GASTROCROM Market and Financials

1. What are the key factors influencing GASTROCROM's market decline?

The primary factors include the advent of more efficacious biologics and inhaled therapies, patent expirations leading to generic competition, and limited innovation in newer formulations.

2. Is GASTROCROM still clinically relevant today?

Yes, particularly for patients intolerant to corticosteroids or biologics, or in regions where alternative options are unavailable or unaffordable. Its safety profile remains favorable.

3. Are there ongoing clinical trials to expand GASTROCROM's indications?

Limited trials exist, primarily focusing on topical applications or novel formulations. Strategic investment could open opportunities in niche gastrointestinal indications.

4. How does regulatory policy affect GASTROCROM's sales prospects?

Regulatory agencies favor innovative, targeted therapies. Non-patented drugs like GASTROCROM face hurdles in expanding indications and maintaining market share without significant clinical breakthroughs.

5. What are the revenue opportunities for manufacturers attempting to revitalize GASTROCROM?

Potential pathways include reformulation for enhanced bioavailability, targeting unmet clinical needs through trials, and establishing partnerships for combination therapies, albeit with significant investment and regulatory engineering.

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Key Takeaways

• Market Position: GASTROCROM has transitioned into a niche role within respiratory and gastrointestinal therapy spaces amid fierce competition from newer agents.
• Financial Decline: Sales have markedly decreased since 2010, with projections indicating continued diminishment unless innovative strategies are employed.
• Strategic Potential: Opportunities exist in expanding indications, particularly in gastrointestinal disorders, contingent on successful clinical development.
• Regulatory Environment: Shifts prioritize biologics and targeted therapies over traditional mast cell stabilizers, impacting GASTROCROM's market viability.
• Investment Outlook: Manufacturers must evaluate the cost-benefit balance of revitalization efforts versus market obsolescence.

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References

[1] IQVIA. (2022). Global Pharmaceutical Market Reports.
[2] European Medicines Agency. (2022). Regulatory Status of Cromolyn Sodium.
[3] U.S. Food and Drug Administration. (2022). Drug Approvals and Labeling.
[4] MarketWatch. (2023). Respiratory and Allergic Market Trends.
[5] ClinicalTrials.gov. (2023). Ongoing Trials for Cromolyn Sodium.