List of Excipients in Branded Drug GASTROCROM

Company	Tradename	Ingredient	NDC	Excipient	Potential Generic Entry
Viatris Specialty LLC	GASTROCROM	cromolyn sodium	0037-0678	WATER

Last updated: August 30, 2026

Gastrocrom is cromolyn sodium oral concentrate, a legacy FDA-approved liquid for mastocytosis. Its commercial opportunity is primarily a low-complexity generic or reformulated oral-solution product, not a patent-led lifecycle product. The strongest differentiation opportunities are preservative-free unit-dose packaging, improved dosing convenience, supply reliability, taste management, and concentration or presentation changes that remain clinically acceptable and regulatory defensible.

Gastrocrom Excipient Strategy and Commercial Opportunities

What is Gastrocrom and how is it formulated?

Gastrocrom is the U.S. brand name for cromolyn sodium oral concentrate, USP, indicated for the management of patients with mastocytosis. The labeled dose is typically 200 mg four times daily for adults and children older than 12 years, administered 30 minutes before meals and at bedtime. Each 5 mL ampule contains 100 mg of cromolyn sodium, corresponding to a concentration of 20 mg/mL.[1]

Gastrocrom is supplied as a liquid oral concentrate in single-use ampules. The formulation is aqueous and does not depend on a complex delivery system, modified-release technology, lipid carrier, or functional excipient platform.

Attribute	Gastrocrom profile
Active ingredient	Cromolyn sodium
Dosage form	Oral concentrate
Strength	20 mg/mL
Unit dose	5 mL ampule containing 100 mg
Administration	Diluted before oral administration
Primary indication	Mastocytosis
Regulatory pathway	FDA-approved prescription drug
Biological product status	Not applicable
Primary commercial risk	Small market, generic substitution, supply reliability
Main formulation challenge	Stability, palatability, dosing convenience, packaging

The product’s simple composition limits opportunities for conventional excipient-based patent protection. Commercial value is more likely to come from manufacturing consistency and user experience than from a novel excipient invention.

What excipients are used in Gastrocrom?

The Gastrocrom label describes cromolyn sodium in an aqueous oral concentrate. Public product information does not identify a broad excipient system containing sweeteners, flavors, preservatives, surfactants, or cosolvents.[1,2]

The formulation strategy appears to rely on:

• Cromolyn sodium as the active pharmaceutical ingredient.
• Purified aqueous vehicle.
• Single-use packaging to limit microbial and chemical degradation after opening.
• Patient dilution before administration.

The absence of a complex excipient package is commercially important. A generic applicant may be able to develop a qualitatively similar formulation without reproducing a branded excipient profile, provided the product satisfies applicable pharmaceutical equivalence, quality, stability, and labeling requirements.

Excipient functions and development implications

Formulation function	Likely Gastrocrom approach	Commercial implication
Solubilization	Aqueous solution of cromolyn sodium	Low formulation complexity
Preservation	Avoided or minimized through unit-dose packaging	Supports preservative-free positioning
pH control	Must maintain drug stability and tolerability	Requires controlled development data
Taste masking	Limited in the reference product	Opportunity for pediatric and adherence differentiation
Viscosity control	Not central to the dosage form	Low barrier to generic development
Microbial control	Single-use ampule format	Packaging is part of the control strategy
Dose accuracy	Fixed 5 mL ampule	Potential opportunity for oral syringe or cup-based formats

A proposed product should not assume that a simple aqueous formulation is automatically low risk. Cromolyn sodium concentration, pH, ionic strength, container interaction, and storage conditions can affect assay, impurities, appearance, and dose uniformity.

What excipient strategy is appropriate for a Gastrocrom generic?

The lowest-risk strategy is a preservative-free aqueous oral concentrate that closely matches the reference product’s strength and dosing volume. A formulation developer should prioritize pharmaceutical equivalence, chemical stability, microbiological control, and ease of administration.

Strategy 1: Reference-like preservative-free solution

A reference-like product would use:

• Cromolyn sodium at 20 mg/mL.
• A purified-water vehicle.
• No antimicrobial preservative unless required by the selected container and multidose configuration.
• Single-use ampules or unit-dose polymer containers.
• Labeling that preserves the established dilution instructions.

This approach is likely to minimize formulation and regulatory complexity. It also supports a direct substitution strategy for pharmacies and hospitals.

Strategy 2: Unit-dose oral solution with improved handling

A manufacturer could use a ready-to-administer or easier-to-dilute presentation while retaining the same active concentration. Potential improvements include:

• A premeasured 5 mL unit dose.
• A tamper-evident squeeze ampule.
• A low-residual-volume container.
• A container compatible with oral syringes.
• A carton optimized for four-times-daily dosing.

The commercial advantage would be operational rather than pharmacological. Patients with mastocytosis may require chronic, repeated administration, making packaging waste, opening difficulty, and dosing errors relevant purchasing considerations.

Strategy 3: Palatability-focused product

Cromolyn sodium oral concentrate is administered after dilution and may have an unattractive taste. A manufacturer could investigate a flavored presentation using a compatible sweetener and flavor system.

Potential excipients include:

• Sucrose or another sugar-based sweetener.
• Sorbitol or another polyol.
• Sucralose or another high-intensity sweetener.
• Fruit or neutral flavor systems.
• pH adjusters and buffering agents.

This route has greater development risk. Added excipients can alter stability, osmolality, microbial risk, extractables and leachables, and comparative dissolution or solution performance. Flavoring also may be less valuable for adults than for pediatric patients, while mastocytosis patients may have sensitivities that limit acceptable excipient choices.

A flavor-enhanced product is more suitable as a differentiated 505(b)(2) or branded-generic strategy than as the simplest ANDA opportunity.

What formulations are commercially attractive?

The commercial opportunity depends on whether the manufacturer seeks pharmacy substitution, premium differentiation, or a new patient-use profile.

Product concept	Regulatory complexity	Differentiation	Commercial assessment
Preservative-free 20 mg/mL oral concentrate	Low to moderate	Low	Best route for generic entry
Unit-dose polymer ampules	Moderate	Moderate	Strong packaging opportunity
Ready-to-administer flavored solution	Moderate to high	Moderate	Potential adherence product
Multidose bottle	Moderate	Moderate	Lower packaging cost but higher preservation risk
Oral powder for reconstitution	High	High	Development and stability burden
Higher-concentration solution	High	High	Could reduce administration volume but requires clinical and regulatory assessment
Sachet or stick-pack liquid	Moderate	Moderate	Potential convenience and shipping advantage

The strongest near-term concept is a preservative-free unit-dose product with improved container ergonomics. It can address a practical weakness without requiring a new mechanism, new indication, or complex device combination.

How does Gastrocrom’s patent estate affect commercial entry?

Gastrocrom is an older cromolyn sodium product, and the core composition and oral-use claims are expected to be outside their original patent terms. No active biologic exclusivity applies, and cromolyn sodium is not subject to biosimilar competition.

The main entry pathway is an ANDA referencing the approved product, subject to FDA requirements for pharmaceutical equivalence and bioequivalence or other applicable approval standards. For an oral solution, FDA may determine that conventional in vivo bioequivalence testing is unnecessary if the product meets the conditions for a solution-based waiver and is qualitatively and quantitatively equivalent in relevant respects.[3]

IP or regulatory issue	Gastrocrom relevance
Core composition patent	Legacy rights, generally expired or commercially immaterial
Method-of-use patent	Potentially relevant only if a later patent was listed or remains enforceable
Formulation patent	No widely recognized current barrier associated with the basic aqueous concentrate
Device patent	Possible risk depending on container design
Orange Book listing	Must be checked against the current FDA database before filing
Paragraph IV challenge	Possible if an unexpired listed patent exists
Pediatric exclusivity	No apparent current barrier based on the legacy product profile
Biosimilar risk	Not applicable
Regulatory exclusivity	No meaningful new-drug exclusivity expected for the legacy product

Patent clearance must include the current Orange Book, FDA patent listing data, assignment records, and relevant court dockets. A generic applicant should review patents covering the drug substance, liquid formulation, container, dosing method, and mastocytosis treatment method. Even where a patent is expired, a later patent directed to a specific formulation or delivery system could affect a differentiated product.

What is the Orange Book status of Gastrocrom?

Gastrocrom is an FDA-approved prescription drug and is associated with cromolyn sodium oral concentrate. Orange Book analysis should focus on:

1. The reference listed drug designation.
2. Current patent listings.
3. Any pediatric exclusivity attached to listed patents.
4. Therapeutic-equivalence codes for approved competing products.
5. Marketing status and availability of the reference product.

The commercial value of the Orange Book listing is mainly its role as the reference point for an ANDA. The listed drug’s age reduces the likelihood that a new applicant will face meaningful regulatory exclusivity, but current database verification remains necessary before filing.[3]

When does Gastrocrom lose exclusivity?

Gastrocrom’s original product exclusivity is not the principal commercial barrier. The product dates to the older cromolyn sodium approval era, and any original five-year new chemical entity exclusivity would have expired decades ago. Three-year exclusivity for a later supplement would also be relevant only if tied to a qualifying new clinical investigation and a current listed protection period.

The practical entry question is therefore not when the original exclusivity expires. It is whether any unexpired patent, regulatory requirement, supply constraint, or product-specific formulation difference creates a current barrier.

Which companies are challenging Gastrocrom?

The competitive field is more likely to consist of generic manufacturers and compounding pharmacies than of major branded pharmaceutical companies. Cromolyn sodium oral products may also be supplied through specialty channels because mastocytosis is a rare disease and demand is concentrated among specialty prescribers.

Relevant competitor groups include:

• ANDA applicants for cromolyn sodium oral concentrate.
• Specialty pharmacies dispensing compounded cromolyn preparations.
• Manufacturers of alternative mast-cell stabilizer products.
• Suppliers of cromolyn sodium products in non-oral dosage forms.
• Potential 505(b)(2) developers pursuing improved delivery or palatability.

Publicly identifying a complete set of active ANDA applicants or pending Paragraph IV challengers requires current FDA and court-docket data. The product’s age and limited market size reduce the likelihood of extensive branded patent litigation.

What patent litigation affects Gastrocrom?

No major, widely reported current patent litigation is associated with the core Gastrocrom oral concentrate franchise in the public record available for this analysis. The likely litigation exposure for a new entrant is limited to:

• Patent certifications filed with an ANDA.
• Trade-secret or manufacturing disputes.
• Container or dispensing-device patents.
• Claims involving a reformulated product rather than the legacy reference product.
• Commercial disputes involving supply or distribution.

A conventional preservative-free aqueous generic should face materially less litigation exposure than a new high-concentration, flavored, or device-enabled formulation.

Are there licensing opportunities for cromolyn sodium?

Licensing opportunities are more likely to arise in manufacturing, distribution, and specialty-pharmacy access than in core active-ingredient patent licensing.

Potential deal structures include:

Opportunity	Likely counterparty	Strategic value
API supply agreement	Cromolyn sodium manufacturer	Secures quality and continuity
Contract manufacturing	Oral-liquid specialist	Avoids internal liquid-filling investment
Specialty distribution	Rare-disease distributor	Improves prescriber and patient access
Co-development	Formulation or packaging company	Adds differentiated presentation
Regional commercialization	Local pharmaceutical company	Expands geographic coverage
Compounding transition program	Specialty pharmacy network	Converts patients to approved commercial product

A partner with experience in sterile or nonsterile oral liquids, unit-dose packaging, and rare-disease commercialization would be more relevant than a company holding unrelated platform patents.

What manufacturing and IP barriers exist?

The manufacturing barrier is moderate, despite the simple formulation. Key technical risks include:

• Cromolyn sodium raw-material consistency.
• Solution clarity and impurity control.
• pH and stability over the labeled shelf life.
• Ampule weld or seal integrity.
• Adsorption or absorption into polymer containers.
• Extractables and leachables.
• Fill-volume accuracy.
• Microbial limits and process hygiene.
• Shipping stability under temperature excursions.
• Scalable unit-dose filling.

Packaging selection is commercially important. Glass offers a familiar barrier profile but can increase breakage and shipping weight. Plastic ampules improve handling and reduce breakage but require extractables, leachables, permeability, and compatibility studies.

A formulation patent strategy could focus on a specific container, low-sorption polymer, concentration range, flavor system, or stability profile. Such patents would likely protect a differentiated product rather than the basic Gastrocrom concept.

How strong is the patent estate for Gastrocrom?

The core patent estate is weak as a barrier to conventional generic entry because the product is old, the dosage form is simple, and the principal commercial value is tied to an established indication rather than a recent formulation innovation.

Patent-estate dimension	Assessment
Core active ingredient	Weak barrier; legacy compound
Basic oral solution	Weak to moderate, depending on any listed claims
Mastocytosis method of use	Potentially relevant only if unexpired claims exist
Packaging	Potentially protectable for a new entrant
Taste-masked formulation	Moderate opportunity
High-concentration formulation	Moderate to strong if clinically differentiated
Manufacturing process	Protectable as trade secret; patent value depends on claim scope
Biosimilar protection	None

A new applicant should not rely on broad composition claims. The more defensible strategy is a narrow, technically supported formulation or packaging patent coupled with regulatory execution and supply reliability.

What generic launch risks exist for Gastrocrom?

A generic launch would face five main risks:

1. Small addressable market and limited sales scale.
2. Chronic dosing that increases packaging and adherence demands.
3. Dependence on a reliable cromolyn sodium API source.
4. Potential physician and patient preference for an established brand.
5. Limited economic upside if multiple generic suppliers enter.

Commercial success would improve if the entrant controls manufacturing cost, earns favorable specialty-pharmacy placement, and differentiates the product without creating a high-cost clinical program.

Revenue exposure

Gastrocrom is a niche product used primarily in mastocytosis, a rare disorder. Its revenue exposure is therefore materially smaller than that of mass-market allergy, gastrointestinal, or respiratory medicines. Public sales estimates can vary because of specialty distribution, shortages, and private-label or compounded alternatives.

The principal revenue opportunity is share capture in a supply-constrained or poorly served niche, not large-volume substitution. A manufacturer should model:

• Annual patient count.
• Average prescribed volume.
• Four-times-daily dosing.
• Wholesale acquisition price.
• Specialty-pharmacy discounts.
• Unit-dose packaging cost.
• API cost and minimum order quantities.
• Expected generic price erosion.
• Probability of multiple entrants.

How does Gastrocrom compare with alternative cromolyn products?

Gastrocrom differs from inhaled cromolyn products and ophthalmic cromolyn products in formulation, route, regulatory requirements, and commercial demand.

Product category	Route	Main formulation issue	Commercial relevance
Gastrocrom	Oral concentrate	Aqueous stability and palatability	Rare-disease specialty market
Cromolyn inhalation	Pulmonary	Aerosol or nebulizer delivery	Different device and regulatory profile
Cromolyn ophthalmic	Ocular	Sterility and preservative control	Separate product market
Compounded oral cromolyn	Oral	Quality and consistency variability	Potential substitute in access-limited settings

An approved oral generic could compete with compounded products by offering validated manufacturing, standardized strength, labeled quality, and reimbursement support.

What FDA regulatory pathway is best for a new product?

For a conventional oral-solution generic, the ANDA pathway is the most commercially efficient route if the applicant can establish reference-product equivalence and satisfy FDA product-quality requirements.[3]

A 505(b)(2) application may be appropriate for:

• A materially different concentration.
• A new flavor or dosing system.
• A modified container-closure system with clinical relevance.
• A new administration method.
• A reformulation that cannot rely on ordinary ANDA requirements.

The 505(b)(2) route can support differentiation but may increase development cost, clinical requirements, labeling negotiations, and patent exposure.

Key Takeaways

• Gastrocrom is cromolyn sodium oral concentrate at 20 mg/mL in a 5 mL unit-dose presentation.
• Its formulation is a relatively simple aqueous system with limited publicly identified excipient complexity.
• The best generic strategy is a preservative-free, reference-like oral concentrate.
• The most credible commercial differentiation is improved unit-dose packaging, palatability, dosing convenience, and supply reliability.
• Original product exclusivity is not the main entry barrier; current Orange Book and patent review remains necessary.
• Biosimilar competition does not apply because cromolyn sodium is a small-molecule drug.
• A conventional ANDA is likely more efficient than a 505(b)(2) program unless the developer pursues a materially differentiated formulation.
• The market is niche, so commercial returns depend on manufacturing economics, specialty distribution, and limited-competition execution.
• Formulation and packaging patents may protect a new product, but they are unlikely to create broad exclusivity around the legacy Gastrocrom concept.

FAQs

Can a generic Gastrocrom product use different excipients?

Yes. A generic product does not necessarily need to reproduce every inactive ingredient if it meets FDA requirements for pharmaceutical equivalence, quality, stability, safety, and bioequivalence. A materially different excipient system may increase regulatory and clinical development requirements.

Is a preservative required in cromolyn sodium oral concentrate?

Not necessarily. A single-use unit-dose package can reduce the need for antimicrobial preservation. A multidose bottle would require a stronger microbiological-control strategy and may require a preservative, validated package design, or both.

Could a higher-strength Gastrocrom formulation create a commercial advantage?

Potentially. A higher-strength product could reduce administration volume, but it would require evidence that the new concentration is stable, accurately dosed, tolerable, and acceptable under the selected FDA pathway. It could also create additional patent and regulatory exposure.

Are compounded cromolyn sodium liquids a major competitor?

They can be, particularly when commercial product availability is limited or patients require customized dosing. An approved generic could compete through standardized quality, consistent concentration, insurance coverage, and specialty-pharmacy distribution.

Can a company patent a new Gastrocrom flavor?

A flavor alone may offer limited patent strength. A stronger patent position would require a defined formulation combination with demonstrated advantages such as improved stability, reduced bitterness, enhanced storage performance, or improved administration characteristics.

References

1. U.S. Food and Drug Administration. (2014). Gastrocrom (cromolyn sodium) oral concentrate prescribing information. FDA/DailyMed labeling.

2. National Library of Medicine. (n.d.). Gastrocrom: Cromolyn sodium oral concentrate, USP. DailyMed.

3. U.S. Food and Drug Administration. (2023). Approved drug products with therapeutic equivalence evaluations. Center for Drug Evaluation and Research, Orange Book.