INTAL Drug Patent Profile

When do Intal patents expire, and what generic alternatives are available?

Intal is a drug marketed by King Pharms Llc and Sanofi Aventis Us and is included in three NDAs.

The generic ingredient in INTAL is cromolyn sodium. There are ten drug master file entries for this compound. Thirteen suppliers are listed for this compound. Additional details are available on the cromolyn sodium profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Intal

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

Summary for INTAL

US Patents:	0
Applicants:	2
NDAs:	3
Raw Ingredient (Bulk) Api Vendors:	83
Patent Applications:	5,230
DailyMed Link:	INTAL at DailyMed

US Patents and Regulatory Information for INTAL

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
King Pharms Llc	INTAL	cromolyn sodium	AEROSOL, METERED;INHALATION	018887-001	Dec 5, 1985		DISCN	No	No
Sanofi Aventis Us	INTAL	cromolyn sodium	CAPSULE;INHALATION	016990-001	Approved Prior to Jan 1, 1982		DISCN	Yes	No
King Pharms Llc	INTAL	cromolyn sodium	SOLUTION;INHALATION	018596-001	May 28, 1982		DISCN	Yes	No

Expired US Patents for INTAL

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
King Pharms Llc	INTAL	cromolyn sodium	SOLUTION;INHALATION	018596-001	May 28, 1982
King Pharms Llc	INTAL	cromolyn sodium	AEROSOL, METERED;INHALATION	018887-001	Dec 5, 1985
King Pharms Llc	INTAL	cromolyn sodium	SOLUTION;INHALATION	018596-001	May 28, 1982
Sanofi Aventis Us	INTAL	cromolyn sodium	CAPSULE;INHALATION	016990-001	Approved Prior to Jan 1, 1982

International Patents for INTAL

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

Country	Patent Number	Title	Estimated Expiration
Austria	269138
Belgium	678175
Switzerland	476720	Procédé de préparation de composés bis-chromonylés à activité pharmaceutique
Switzerland	481912	Procédé de préparation de dérivés de la chromone à activité pharmaceutique

Last updated: June 8, 2026

INTAL (cromolyn sodium) market dynamics and financial trajectory: sales trends, share drivers, and generic risk

INTAL (cromolyn sodium) is an established anti-asthma mast cell stabilizer with limited modern revenue growth potential, driven by declining use versus inhaled corticosteroids and newer controller classes, and by the maturity of its generic market. Current commercial trajectory is shaped by (1) US and EU generic substitution, (2) channel and payer pressure in allergy and asthma therapy, and (3) supply and dosage-form constraints typical of older niche respiratory brands. Net income potential is constrained by commoditization and low pricing power, while litigation and exclusivity events are largely background rather than primary value inflection points.

How has INTAL’s sales trajectory evolved since launch-era dominance?

What phases define INTAL’s financial trajectory

INTAL’s revenue history follows a standard pattern for older niche respiratory products:

• Peak-era penetration (historical): Cromolyn sodium gained share as an alternative controller before broad adoption of inhaled corticosteroids (ICS).
• Loss of category share: ICS-based regimens displaced cromolyn sodium for persistent asthma control across major guidelines and prescribing preferences.
• Brand-to-generic migration: Once patent and exclusivity protection lapsed, price competition compressed margins.
• Residual demand: Use persists where patients tolerate cromolyn, in specific guideline niches, or as adjunctive therapy. Demand is steady but not expanding.

What market forces explain decline in growth

Core drivers for reduced growth and contracting margin include:

• Therapy displacement: ICS and ICS/LABA regimens are preferred for most persistent asthma. Cromolyn is rarely first-line.
• Ecosystem shift: Increased availability of modern inhalers reduced inhaled cromolyn’s comparative convenience and perceived efficacy.
• Payer economics: Formularies increasingly favor low-cost generics and preferred classes, limiting brand differentiation.
• Clinical guideline evolution: Guidelines reduced the role of cromolyn for routine controller therapy, sustaining only limited segments.

What market dynamics affect INTAL pricing, volume, and profitability?

How generic substitution changes revenue math

Once cromolyn sodium formulations moved into generic competition, the commercial center of gravity shifted from brand premium to:

• unit volume (continued but non-growing use),
• net price compression (channel discounts, PBM pressure),
• manufacturing cost discipline (scale economics),
• lot stability and supply continuity (older products can face periodic disruptions).

For holders of any remaining branded product SKUs, financial trajectory is typically dominated by:

• competitive pricing,
• contract manufacturing leverage,
• replacement by lower-cost equivalents.

Where residual demand concentrates

INTAL demand is most likely to persist in:

• pediatric and mild asthma subsets where physicians may still consider mast cell stabilization,
• adjunctive management where patients previously used cromolyn,
• specific allergy and respiratory settings where prescriber familiarity matters.

What channel mechanics matter most

Older respiratory drugs often see:

• lower average wholesale prices and tighter spread to generics,
• rebate-driven formulary outcomes,
• inventory pull-through tied to seasonality and local formulary status.

Which geographies shape INTAL’s revenue exposure most?

US dynamics

US commercialization is strongly shaped by FDA approval status, generic entry, and Orange Book-driven substitution patterns. For cromolyn sodium products, US revenue exposure is typically:

• limited at the brand level due to generic availability,
• meaningful at the molecule level due to ongoing use of generics.

EU dynamics

EU pricing and reimbursement typically exert stronger pressure through:

• reference pricing,
• tendering and hospital procurement,
• tighter reimbursement criteria for older respiratory controllers.

This structure usually slows any branded re-acceleration even if clinical use persists.

How does INTAL compare with modern asthma controllers on commercial outcomes?

Competitive set

INTAL is economically disadvantaged versus:

• inhaled corticosteroids (ICS),
• ICS/LABA combinations,
• newer add-on classes (e.g., leukotriene receptor antagonists and biologics for severe disease subsets).

Commercial impact of comparative positioning

Modern controllers support:

• better guideline alignment for persistent asthma,
• broader adoption patterns,
• stronger payer preference and educational spend.

INTAL’s commercial model stays anchored to:

• clinician familiarity,
• niche patient persistence,
• low-cost generic availability rather than premium differentiation.

What patents and exclusivity historically constrained INTAL, and what is the current generic risk profile?

Why patent estates matter less for INTAL today

For INTAL, the commercial reality is that the drug is old enough that most meaningful value from patent-driven exclusivity has already been realized and then eroded by generic substitution.

Generic entry risk

The principal risk for any remaining branded or late-cycle reformulated INTAL product is:

• generic price undercutting, and
• formulation or method-of-use workaround, if any remaining patents exist on specific dosage forms or labeling.

Without active brand exclusivity, revenue trajectory tends to be stable-to-declining and highly sensitive to:

• new generic approvals,
• supply shocks,
• payer contract changes.

What FDA and regulatory status considerations shape INTAL market access?

Label and indication constraints

INTAL remains tied to specific asthma-related labeling and patient use patterns. Commercial growth is limited by:

• narrowness of preferred controller adoption in guideline-based practice,
• dependence on prescriber preference for mast cell stabilization.

Supply and regulatory compliance

For older molecules, the regulatory risk profile is dominated by:

• manufacturing site integrity,
• sterile or delivery system compliance where applicable,
• batch release timelines affecting continuity.

What INTAL formulations exist, and how do formulation-level economics affect sales?

Dose form and delivery system matters

Cromolyn sodium has historically been marketed in forms relevant to respiratory use. Formulation choices affect:

• patient adherence,
• dispensing patterns,
• therapeutic interchangeability with competing agents,
• generic equivalence feasibility.

Where formulation-level complexity is low, generic competition advances faster and margins compress earlier.

How many competitors does INTAL face, and what share drivers govern them?

Generic competition pattern

INTAL’s competitive structure is usually:

• multiple generic cromolyn sodium manufacturers,
• price-led rivalry,
• contractual rebate and formulary dynamics.

Share drivers typically include:

• lowest net price,
• uninterrupted supply,
• formulary access,
• pharmacy benefit design.

What financial trajectory should investors assume for an INTAL-like older respiratory brand?

Base-case trajectory

For mature, commoditized respiratory products, the typical pattern is:

• flat-to-down net sales, with
• margin compression due to pricing and rebates,
• limited upside unless a narrow reformulation, lifecycle extension, or supply advantage emerges.

Value inflection points

The main catalysts that can shift trajectory in either direction are:

• supply constraints lifting price temporarily,
• favorable payer contracting or tender wins,
• new litigation that delays generic entry (often not applicable for mature products).

Key Takeaways

• INTAL’s market dynamics reflect the classic lifecycle of an older asthma controller: displacement by ICS-based regimens, followed by generic commoditization.
• Financial trajectory is likely stable but constrained, with net sales supported by residual niche use and margins pressured by generic pricing and payer rebates.
• Competitive advantage is mainly operational (supply continuity, contracting) rather than clinical differentiation.
• Current generic risk is structurally high for any branded remnants, driven by the molecule’s maturity and limited patent-driven leverage.

FAQs

1. What are the main drivers of cromolyn sodium (INTAL) persistence in asthma treatment?
2. Do any INTAL formulations face higher generic substitution risk than others?
3. How do PBM formularies and rebate structures typically affect older respiratory drugs like INTAL?
4. What supply or manufacturing events most often move pricing for niche generics of cromolyn sodium?
5. How does the presence of ICS/LABA alternatives change the commercial ceiling for INTAL?

References

1. [No sources were cited because no verifiable INTAL financial or market-dynamics dataset was provided in the prompt.]