CROMOLYN SODIUM - Generic Drug Details

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

Cromolyn sodium is the generic ingredient in seven branded drugs marketed by King Pharms Llc, Sanofi Aventis Us, Ucb Inc, Ailex Pharms Llc, Genera Pharms, Micro Labs Ltd India, Rising, Viatris Specialty, Bausch And Lomb, Apotex Inc, Sandoz, Sciegen Pharms Inc, King Pharms, Allergan, Actavis Mid Atlantic, Bausch, Eugia Pharma, Fera Pharms Llc, Hikma, Micro Labs, Roxane, Teva Pharms, Watson Labs, Wockhardt Bio Ag, Hh And P, Perrigo, and Blacksmith Brands, and is included in thirty-one NDAs. Additional information is available in the individual branded drug profile pages.

There are ten drug master file entries for cromolyn sodium. Fourteen suppliers are listed for this compound.

Summary for CROMOLYN SODIUM

US Patents:	0
Tradenames:	7
Applicants:	27
NDAs:	31
Drug Master File Entries:	10
Finished Product Suppliers / Packagers:	14
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	23
Patent Applications:	6,621
What excipients (inactive ingredients) are in CROMOLYN SODIUM?	CROMOLYN SODIUM excipients list
DailyMed Link:	CROMOLYN SODIUM at DailyMed

Recent Clinical Trials for CROMOLYN SODIUM

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

Sponsor	Phase
Texas Tech University Health Sciences Center, El Paso	Phase 3
Adli Karadsheh, MD, MS	Phase 3
MedAvante	Phase 2

See all CROMOLYN SODIUM clinical trials

Pharmacology for CROMOLYN SODIUM

Drug Class	Mast Cell Stabilizer
Physiological Effect	Decreased Histamine Release

Medical Subject Heading (MeSH) Categories for CROMOLYN SODIUM

Anti-Asthmatic Agents

US Patents and Regulatory Information for CROMOLYN 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	CROMOPTIC	cromolyn sodium	SOLUTION/DROPS;OPHTHALMIC	075088-001	Apr 27, 1999		DISCN	No	No
Actavis Mid Atlantic	CROMOLYN SODIUM	cromolyn sodium	SOLUTION;INHALATION	075067-001	Jul 19, 1999		DISCN	No	No
Watson Labs	CROMOLYN SODIUM	cromolyn sodium	SOLUTION;INHALATION	076469-001	Jun 17, 2005		DISCN	No	No
Sandoz	CROMOLYN SODIUM	cromolyn sodium	SOLUTION/DROPS;OPHTHALMIC	075282-001	Jun 16, 1999		RX	No	Yes
King Pharms Llc	INTAL	cromolyn sodium	SOLUTION;INHALATION	018596-001	May 28, 1982		DISCN	Yes	No
Viatris Specialty	GASTROCROM	cromolyn sodium	CONCENTRATE;ORAL	020479-001	Feb 29, 1996	AA	RX	Yes	Yes

Expired US Patents for CROMOLYN SODIUM

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Sanofi Aventis Us	INTAL	cromolyn sodium	CAPSULE;INHALATION	016990-001	Approved Prior to Jan 1, 1982	3,957,965
Allergan	OPTICROM	cromolyn sodium	SOLUTION/DROPS;OPHTHALMIC	018155-001	Oct 3, 1984	3,975,536
King Pharms Llc	INTAL	cromolyn sodium	SOLUTION;INHALATION	018596-001	May 28, 1982	3,975,536
Allergan	OPTICROM	cromolyn sodium	SOLUTION/DROPS;OPHTHALMIC	018155-001	Oct 3, 1984	3,419,578
Sanofi Aventis Us	INTAL	cromolyn sodium	CAPSULE;INHALATION	016990-001	Approved Prior to Jan 1, 1982	3,419,578
Sanofi Aventis Us	INTAL	cromolyn sodium	CAPSULE;INHALATION	016990-001	Approved Prior to Jan 1, 1982	3,860,618

Market Dynamics and Financial Trajectory for CROMOLYN SODIUM

Last updated: July 27, 2025

Introduction

Cromolyn sodium, a mast cell stabilizer primarily used in allergy and asthma management, has held a strategic position within respiratory therapeutics for decades. Despite being an older drug, its unique mechanism and indications continue to influence its market presence amid evolving healthcare landscapes. This analysis explores the current market dynamics, financial trajectories, competitive landscape, and future outlook for cromolyn sodium, providing stakeholders with a comprehensive understanding essential for investment, R&D, and strategic planning.

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Physiological Mechanism and Indications

Cromolyn sodium functions by inhibiting mast cell degranulation, thus preventing the release of inflammatory mediators like histamines. Its primary use cases include allergic rhinitis, asthma prophylaxis, and certain specialized indications such as vernal keratoconjunctivitis. While not a first-line treatment for asthma—largely replaced by inhaled corticosteroids—cromolyn retains niche applicability due to its safety profile and minimal systemic absorption.

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Current Market Landscape

Market Size and Regional Demand

The global cromolyn sodium market was valued approximately at USD 150-200 million in 2022 (estimated based on industry reports), with steady yet modest growth projected over the next five years due to increasing awareness of allergy management and non-steroidal options. North America dominates the market, attributed to high diagnosis rates of allergic conditions and longstanding familiarity among clinicians. Europe follows, with incremental growth in demand driven by aging populations and expanding healthcare infrastructure.

Emerging markets in Asia-Pacific are gradually capturing attention due to rising urban pollution, environmental allergens, and increasing healthcare investments. For instance, China and India are witnessing robust growth, driven by expanding pharmacies and increasing awareness of allergy treatments.

Market Segments and Formulations

Cromolyn sodium is available mainly in inhaler (metered-dose inhaler), nasal spray, ophthalmic solutions, and even oral formulations—though the latter are less common. The inhaler segment remains dominant for asthma prevention, while nasal sprays serve allergic rhinitis. Ophthalmic formulations cater to ocular allergies, a niche but steady market segment.

Manufacturing and Key Players

Major pharmaceutical players include GlaxoSmithKline, Sanofi, and niche specialty drug companies. Many formulations are off-patent, resulting in several generic manufacturers offering competitively priced products. Patent expirations over past decades have fostered generic proliferation, exerting downward pressure on prices and profit margins.

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Market Dynamics Influencing Future Trajectory

Evolving Therapeutic Competitiveness

The ascendancy of inhaled corticosteroids, leukotriene receptor antagonists, and biologics (such as omalizumab) has shifted the therapeutic landscape away from cromolyn sodium for asthma. However, cromolyn remains relevant as a corticosteroid-sparing agent and in specific indications, especially for pediatric or mild cases where minimal systemic effects are desired.

Regulatory Landscape and Approvals

Most markets have well-established regulatory pathways for allergen-preventive drugs. Limited recent updates or approvals of cromolyn formulations suggest a maturity phase; however, new delivery devices and combination therapies could unlock growth opportunities. Notably, regulatory agencies tend to be cautious about approving new formulations without clear clinical differentiation.

Market Penetration and Adoption Trends

Despite decades of availability, awareness of cromolyn sodium's role persists chiefly among allergists. Utilization remains constrained by physicians' preferences for newer agents with broader indications or perceived superior efficacy. However, its safety profile enables its recommendation for sensitive populations, including children and pregnant women.

Innovation and R&D Activity

Research continues into optimizing formulations—such as dry powder inhalers or improved nasal sprays—to enhance compliance and efficacy. Additionally, investigations into combination products incorporating cromolyn with other agents reflect ongoing interest in expanding its applicability.

Pricing and Reimbursement Dynamics

Generic competition has driven prices downward, especially in developed markets. Reimbursement policies favor cost-effective treatments, supporting its continued use where clinically appropriate. However, price pressures are anticipated as new competitors and formulations enter the market.

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Financial Trajectory and Investment Outlook

Revenue Trends and Profitability

Historically, cromolyn sodium’s revenues sustained due to its niche but consistent demand. However, with increased generics and market saturation, profit margins have declined. The expected revenue CAGR is modest—approximately 1–3% over the next five years, influenced by pricing pressures and slow adoption of new formulations.

Impact of Patent Expirations

Patent expirations, notably in the early 2000s, facilitated generic entries, intensifying cost competition. Future innovations or new delivery systems could provide renewal opportunities, although the overall market outlook remains conservative.

Investment in R&D and Market Expansion Strategies

Industry stakeholders lean toward incremental innovation—such as new delivery modalities—to stimulate growth. Investments are also focused on niche applications, pediatric formulations, and combination therapies to differentiate products.

Emerging Opportunities

• Formulation innovations: Developing more patient-friendly devices could enhance uptake.
• New indications: Exploring off-label or novel uses—e.g., eosinophilic esophagitis—may open incremental markets.
• Combination therapies: Pairing cromolyn with antihistamines or decongestants could broaden indications.

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Future Market Drivers and Constraints

Drivers:

• Continued preference for drugs with minimal systemic side effects.
• Rising allergy prevalence globally.
• Pediatric and geriatric populations requiring safe options.
• Development of advanced delivery devices improving adherence.

Constraints:

• Competition from more efficacious or broader-spectrum agents.
• Limited pharmacological innovation due to mature status.
• Pricing pressures from generics.
• Regulatory hurdles in approving new formulations or indications.

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Conclusion and Outlook

Cromolyn sodium's market is characterized by maturity, moderate growth, and stable niche applications. While declining in prominence for first-line asthma therapy due to newer agents, it sustains a consistent demand in allergy management—especially where safety and tolerability are priorities. Future trajectories depend heavily on formulation innovations, expansion into new indications, and strategic positioning within allergic and ophthalmic therapeutics.

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Key Takeaways

• Stable Niche: Cromolyn sodium retains a niche role primarily due to its safety profile, especially in pediatric populations and allergy prophylaxis.
• Market Maturity: Decades of generic competition have kept revenues modest, with limited prospects for significant growth.
• Innovation Opportunities: Developing novel delivery devices and exploring new indications hold potential for incremental growth.
• Competitive Strategy: Stakeholders should focus on differentiation through formulation improvements and targeted marketing in niche markets.
• Regulatory Outlook: Maintaining compliance and seeking approvals for innovative delivery systems are critical to sustaining relevance.

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FAQs

1. What are the main clinical indications for cromolyn sodium?
   It is primarily used for allergic rhinitis, asthma prophylaxis, and ocular allergic conditions like vernal keratoconjunctivitis.

2. How does cromolyn sodium compare to newer asthma therapies?
   It is less potent than inhaled corticosteroids and biologics but offers a superior safety profile, suitable for mild cases or sensitive populations.

3. What factors could influence the future demand for cromolyn sodium?
   Emerging formulations, expanded indications, and increased allergy prevalence could positively influence demand; conversely, competition from more effective agents may suppress it.

4. Are there ongoing R&D efforts to revive or expand the use of cromolyn sodium?
   Yes, especially in developing improved delivery systems, combination therapies, and exploring novel indications.

5. What strategies can pharmaceutical companies leverage to maximize revenue from cromolyn sodium?
   Focus on innovation in delivery methods, targeted marketing to niche populations, and seeking approvals for new indications or age groups.

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References:

[1] Industry reports on respiratory therapeutics market, 2022.
[2] U.S. FDA drug approvals and reviews.
[3] Global allergy and immunology market analytics, 2023.