Aminosalicylate sodium - Generic Drug Details

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

Aminosalicylate sodium is the generic ingredient in six branded drugs marketed by Century Pharms, Hexcel, Panray, Lannett, Consolidated Midland, and Medpointe Pharm Hlc, and is included in six NDAs. Additional information is available in the individual branded drug profile pages.

Summary for aminosalicylate sodium

US Patents:	0
Tradenames:	6
Applicants:	6
NDAs:	6
Raw Ingredient (Bulk) Api Vendors:	329
Clinical Trials:	1
DailyMed Link:	aminosalicylate sodium at DailyMed

Recent Clinical Trials for aminosalicylate sodium

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

Sponsor	Phase
Beijing Chest Hospital	N/A

See all aminosalicylate sodium clinical trials

US Patents and Regulatory Information for aminosalicylate sodium

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Panray	PARASAL SODIUM	aminosalicylate sodium	TABLET;ORAL	006811-006	Approved Prior to Jan 1, 1982		DISCN	No	No
Medpointe Pharm Hlc	NEOPASALATE	aminosalicylate sodium; aminosalicylic acid	TABLET;ORAL	080059-002	Approved Prior to Jan 1, 1982		DISCN	No	No
Hexcel	SODIUM AMINOSALICYLATE	aminosalicylate sodium	POWDER;ORAL	080097-001	Approved Prior to Jan 1, 1982		DISCN	No	No

Aminosalicylate Sodium Market Dynamics and Financial Trajectory

Last updated: September 2, 2026

Aminosalicylate sodium, generally referring to sodium para-aminosalicylate (sodium PAS), is a legacy second-line antituberculosis medicine with a small, procurement-driven market. Its commercial outlook is limited by declining use in multidrug-resistant tuberculosis, competition from newer oral agents, low pricing, and limited manufacturer participation. Public sources do not report standalone global sales for sodium PAS, so its financial trajectory must be assessed through tuberculosis procurement, regulatory status, supply conditions, and substitution risk.

What is aminosalicylate sodium used for?

Sodium para-aminosalicylate is an antituberculosis drug related to para-aminosalicylic acid, or PAS. It inhibits mycobacterial folate metabolism and is used in combination regimens rather than as monotherapy.

Its clinical role has narrowed substantially. The World Health Organization places PAS among the medicines that may be used in selected drug-resistant tuberculosis regimens when preferred agents are unsuitable, unavailable, or ineffective. It is generally not a first-choice treatment for drug-susceptible tuberculosis or for most modern multidrug-resistant tuberculosis regimens.[1]

Attribute	Sodium aminosalicylate
Common name	Sodium para-aminosalicylate, sodium PAS
Therapeutic area	Tuberculosis
Primary use	Selected multidrug-resistant tuberculosis regimens
Drug class	Antituberculosis folate-pathway inhibitor
Commercial category	Generic or legacy essential medicine
Administration	Product-dependent; oral and injectable forms have existed
Market structure	Small, fragmented, procurement-led
Main substitutes	Bedaquiline, pretomanid, linezolid, delamanid, fluoroquinolones and other second-line agents
Patent position	Core compound is historically old and not protected by meaningful composition-of-matter exclusivity
Growth outlook	Flat to declining in high-income markets; episodic demand in public-health procurement

How large is the aminosalicylate sodium market?

No reliable public source reports a standalone global market size or revenue figure for sodium aminosalicylate. Commercial databases typically group it with anti-infective or tuberculosis products, while public procurement data often combine multiple PAS formulations and manufacturers.

The addressable market is structurally small for five reasons:

1. Tuberculosis treatment is dominated by public-sector purchasers, international agencies, and national programs.
2. PAS is used only in a minority of resistant-tuberculosis cases.
3. Treatment guidelines increasingly favor shorter, all-oral regimens that avoid PAS.
4. Generic pricing is constrained by donor procurement and tender competition.
5. The product has little private-pay demand in major pharmaceutical markets.

Demand is concentrated in countries with high tuberculosis burdens and in programs treating patients with resistance, intolerance, or contraindications to preferred medicines. The market is therefore sensitive to treatment-guideline changes, donor budgets, registration decisions, and temporary supply shortages.

What drives demand for sodium PAS?

Demand is linked to four variables:

• The number of patients with multidrug-resistant or rifampicin-resistant tuberculosis.
• The percentage of those patients receiving PAS-containing regimens.
• Availability of newer medicines through the Global Drug Facility and national programs.
• Local regulatory approval and procurement eligibility.

The first variable remains substantial globally, but the second is declining. WHO estimated approximately 400,000 people developed multidrug-resistant or rifampicin-resistant tuberculosis in 2022, with a much smaller number receiving treatment.[1] The relevant commercial pool for PAS is only the subset for whom clinicians or national programs select the medicine.

What is the financial trajectory for aminosalicylate sodium?

The financial trajectory is best characterized as low-growth to declining, with periodic supply-driven revenue spikes.

Historical phase

PAS was commercially important when treatment options for resistant tuberculosis were limited. It was frequently used as a companion drug in longer, toxic regimens. Sales were supported by clinical necessity rather than by strong pricing power.

Current phase

The current market is a maintenance market. Revenue is generated mainly through:

• Government tenders.
• International tuberculosis procurement.
• Hospital and specialty pharmacy orders.
• Emergency or shortage-related purchases.
• Limited private-market sales in countries where the product remains registered.

The product does not have the profile of a conventional branded pharmaceutical. There is no widely disclosed originator franchise, no major consumer market, and no public consensus revenue forecast.

Forward trajectory

Base-case revenue is likely to remain under pressure as newer medicines displace PAS. The main exception is a supply interruption involving preferred drugs, an increase in difficult-to-treat resistance, or a country-specific requirement for expanded treatment access.

Scenario	Market effect	Financial implication
Base case	Continued replacement by newer oral agents	Gradual volume decline and stable-to-lower prices
Supply shortage of preferred agents	Temporary demand increase	Short-term revenue and price uplift
Expanded resistance burden	More salvage-regimen use	Moderate volume support
New WHO restriction	Reduced eligible patient pool	Accelerated decline
Manufacturer exit	Concentration and procurement risk	Potential price volatility and stock-outs
New low-cost entrant	More tender competition	Lower prices and weaker margins

Which companies manufacture or supply aminosalicylate sodium?

The supplier landscape is fragmented and changes by country. Products may be manufactured by regional generic companies, state-linked suppliers, contract manufacturers, or tuberculosis-focused organizations. Publicly visible commercial data are more available for PAS formulations than for sodium PAS itself.

PASER, marketed by Jacobus Pharmaceutical Company, is a notable U.S. product containing aminosalicylic acid in delayed-release granules. It is not the same as sodium para-aminosalicylate. The distinction matters because procurement, regulatory status, dosage form, and patent analysis differ between the two products.[2]

How competitive is the supplier base?

The supplier base has several weaknesses:

• Low expected commercial return discourages new entrants.
• Small volumes reduce manufacturing economies of scale.
• Stability and packaging requirements can be demanding.
• Public-sector tenders create intense price competition.
• Registration in multiple countries may not justify the regulatory cost.
• API supply can be vulnerable to limited-source manufacturing.

A product can therefore have low patent risk but high operational risk. Manufacturing continuity, quality compliance, and tender eligibility may matter more than intellectual-property exclusivity.

What is the FDA regulatory status of aminosalicylate sodium?

The U.S. regulatory record must distinguish sodium PAS from aminosalicylic acid products.

PASER is an FDA-approved delayed-release oral granule product containing aminosalicylic acid for use in combination therapy for tuberculosis.[2] The active ingredient is not presented as sodium para-aminosalicylate.

No widely recognized U.S. branded sodium para-aminosalicylate franchise has the commercial visibility of PASER. A company seeking to market sodium PAS in the United States would need to establish the applicable regulatory pathway, product quality, bioequivalence where relevant, and a compliant manufacturing supply chain.

Regulatory issue	Assessment
U.S. branded sodium PAS market	Limited or not commercially prominent
PASER status	FDA-approved aminosalicylic acid delayed-release granules
Generic substitution	Depends on the exact active ingredient, dosage form and reference product
International registration	Varies materially by country
Procurement qualification	Often more commercially important than U.S. approval
Regulatory barrier	Moderate for a new finished dosage form; lower for a well-established generic with a recognized pathway

What patents protect aminosalicylate sodium?

The sodium PAS molecule is an old active ingredient. Its core composition-of-matter protection is not a meaningful commercial barrier in the current market.

The relevant intellectual-property questions concern:

• Specific crystal or salt forms.
• Stabilized formulations.
• Injectable compositions.
• Delayed-release or enteric-coated products.
• Manufacturing processes.
• Combination regimens.
• Dosing methods for resistant tuberculosis.

Patent protection for the active ingredient itself is therefore weak or expired in major jurisdictions. Any surviving rights would more likely relate to a particular formulation, process, or method of use.

What formulation patents affect PAS products?

Formulation rights can be more relevant than molecule patents. PAS is associated with gastrointestinal tolerability and stability challenges, creating potential patentable subject matter around:

• Controlled release.
• Granule coating.
• Moisture protection.
• Taste masking.
• Dispersion and dissolution.
• Salt stability.
• Packaging systems.

PASER’s delayed-release formulation illustrates the commercial distinction between a legacy active ingredient and a protected delivery system. A sodium PAS manufacturer would need to assess freedom to operate separately for the API, dosage form, manufacturing method, and packaging configuration.

Are there Orange Book patents for sodium aminosalicylate?

The FDA Orange Book is product-specific. It lists patents and exclusivity associated with approved drug products, not every historical patent relating to a chemical substance.

The principal U.S. reference relevant to PASER is the approved aminosalicylic acid delayed-release product. A sodium PAS product would not automatically inherit PASER’s regulatory or patent position. The presence of patents for PASER would not establish protection over every sodium PAS product.

Are there Paragraph IV challenges involving aminosalicylate sodium?

There is no prominent, widely reported Paragraph IV litigation campaign surrounding sodium para-aminosalicylate comparable to high-value branded drugs.

Any Paragraph IV strategy would likely depend on an abbreviated new drug application referencing an FDA-approved product with listed patents. The commercial incentive is limited because:

• The market is small.
• Expected sales are low.
• Litigation costs could exceed the value of a first generic launch.
• The most relevant branded product uses a specific dosage form and active-ingredient presentation.
• Public-sector procurement may not reward a litigation-based launch sufficiently.

For a PASER-related generic, a company would need to analyze listed patents, formulation equivalence, regulatory exclusivity, and the commercial value of a 180-day exclusivity period. The economics appear materially weaker than in large primary-care markets.

What is the biosimilar risk for aminosalicylate sodium?

There is no biosimilar risk because sodium PAS is a small-molecule chemical drug, not a biologic. The relevant competitive threat is generic substitution and therapeutic substitution.

Therapeutic substitution is the larger risk. Bedaquiline-based regimens and other modern oral agents can replace PAS in eligible patients. As guideline-preferred regimens expand, the market may contract even without a new sodium PAS generic entrant.

How does sodium PAS compare with newer tuberculosis medicines?

Factor	Sodium PAS	Bedaquiline	Pretomanid
Market role	Reserve or selected companion agent	Core medicine in many resistant-TB regimens	Used in defined resistant-TB combinations
Patent exposure	Low for core compound	Higher historical product and formulation exposure	Higher than PAS
Clinical positioning	Limited by tolerability and regimen complexity	Stronger guideline position	Strong but restricted to specific regimens
Commercial outlook	Flat or declining	Larger procurement market	Smaller but strategically important
Pricing power	Low	Higher than legacy generics	Higher than legacy generics
Substitution risk	High	Lower	Moderate
Manufacturing risk	Supplier fragmentation	Greater production scale	More concentrated commercial ecosystem

PAS retains value as a backup medicine. It has limited ability to command premium pricing because treatment programs can substitute other agents when supply and access permit.

What generic launch risks exist?

A generic sodium PAS launch would face five principal risks.

Demand risk

The eligible patient population is small and difficult to forecast. National programs can remove PAS from standard regimens rapidly after a guideline revision.

Pricing risk

International tenders can force prices toward manufacturing cost. A low-cost entrant may increase volume without producing attractive margins.

Regulatory risk

A company must establish the correct product classification, bioequivalence requirements, manufacturing controls, and country registrations. These requirements differ between sodium PAS, aminosalicylic acid, delayed-release granules, and injectable products.

Supply-chain risk

The API and finished product may rely on a narrow manufacturing base. A quality failure or plant interruption can result in stock-outs, but shortages do not guarantee durable pricing power.

Clinical-substitution risk

Newer medicines can reduce demand independently of patent expiry. This is the central commercial threat.

What licensing deals affect the market?

There is no widely disclosed major licensing transaction centered specifically on sodium para-aminosalicylate. The commercial model is generally direct supply, contract manufacturing, government procurement, or distribution agreements rather than high-value branded licensing.

Licensing value is constrained by:

• The absence of meaningful composition patents.
• Low expected sales.
• Limited differentiation between generic suppliers.
• Dependence on public tenders.
• Weak private-market demand.

A transaction involving PAS would more likely concern manufacturing capacity, regional registration, distribution rights, or a broader tuberculosis portfolio than a standalone royalty-bearing license.

What geographic markets matter most?

Demand is concentrated in countries with high tuberculosis burdens, large drug-resistant tuberculosis programs, and reliance on international procurement.

Region	Commercial relevance
South and Southeast Asia	High patient burden and established public tuberculosis programs
Sub-Saharan Africa	Significant disease burden, donor dependence and procurement sensitivity
Eastern Europe and Central Asia	Historical use in drug-resistant tuberculosis and variable regimen adoption
Latin America	Selective demand through national programs
United States and Western Europe	Limited volume, specialist use and regulatory-driven access
Global procurement markets	Important for supplier qualification and tender volume

The strongest commercial opportunity is usually not the largest total population. It is the combination of resistant-TB incidence, national guideline inclusion, registration status, and procurement access.

How strong is the commercial patent estate?

The patent estate is weak at the molecule level and potentially relevant at the product level.

IP layer	Strength
Sodium PAS composition patent	Historically old; no material current exclusivity expected
New chemical entity protection	Not commercially relevant
Delayed-release formulation	Potentially meaningful for a specific product
Manufacturing process	Depends on claim scope and jurisdiction
Combination therapy	Narrow and vulnerable to clinical-use changes
Packaging and stability	Possible but usually limited commercial value
Trademark and brand	Can protect market identity without blocking generic entry

The market’s defensibility is therefore operational rather than patent-driven. Reliable supply, regulatory approvals, quality history, and access to tuberculosis procurement channels are more important assets than the core active ingredient.

What litigation and settlement issues affect the market?

No major current litigation or settlement agreement is widely associated with sodium PAS itself. Litigation risk is more likely to arise around:

• Product quality and manufacturing compliance.
• Distribution contracts.
• Tender awards.
• Regulatory approval of a formulation.
• Patent claims covering a delayed-release product.
• Supply obligations under public procurement agreements.

For a generic entrant, the critical legal review would focus on the specific reference product and dosage form. A sodium PAS product should not be assumed to infringe or avoid patents associated with aminosalicylic acid granules without a claim-by-claim analysis.

Key Takeaways

• Sodium aminosalicylate is a legacy antituberculosis medicine with a small, procurement-led market.
• Standalone global revenue is not publicly disclosed.
• The financial trajectory is flat to declining because newer oral tuberculosis medicines are replacing PAS.
• The core molecule has little meaningful remaining patent protection.
• Formulation, manufacturing and packaging patents may matter for specific products.
• Sodium PAS must be distinguished from PASER, which contains aminosalicylic acid in delayed-release granules.
• There is no material biosimilar issue; generic and therapeutic substitution are the relevant risks.
• A generic launch would face low demand visibility, tender price pressure, fragmented supply and clinical substitution.
• The strongest commercial assets are regulatory approvals, reliable manufacturing and procurement access.
• No major licensing transaction, Paragraph IV campaign or settlement is widely associated with sodium PAS.

FAQs

Is sodium aminosalicylate still used to treat tuberculosis?

Yes. It remains available for selected drug-resistant tuberculosis cases, but it is generally a reserve or companion medicine rather than a preferred first-line option.

Is sodium PAS the same as PASER?

No. PASER is a delayed-release product containing aminosalicylic acid. Sodium para-aminosalicylate is a different salt form and requires separate regulatory and product analysis.

Can a generic manufacturer launch sodium aminosalicylate without patent litigation?

Possibly, but the answer depends on the country, reference product, formulation and any surviving process or formulation patents. The core molecule itself is not expected to provide meaningful current exclusivity.

Why can a shortage of sodium PAS occur if its patents are expired?

Expired patents do not guarantee supply. Low demand, limited manufacturers, API shortages, quality failures and weak commercial incentives can all reduce availability.

Does sodium aminosalicylate have investment potential?

Its investment profile is defensive and supply-driven rather than growth-oriented. Value would depend on manufacturing efficiency, procurement contracts, geographic registration and the ability to serve resistant-tuberculosis programs at sustainable margins.

References

1. World Health Organization. (2023). WHO consolidated guidelines on tuberculosis: Module 4: Treatment - drug-resistant tuberculosis treatment. World Health Organization.

2. U.S. Food and Drug Administration. (n.d.). PASER (aminosalicylic acid) delayed-release granules prescribing information. FDA.

3. World Health Organization. (2023). Global tuberculosis report 2023. World Health Organization.

4. World Health Organization. (2024). WHO operational handbook on tuberculosis: Module 4: Treatment - drug-resistant tuberculosis treatment. World Health Organization.

5. Global Drug Facility. (n.d.). Tuberculosis medicines and diagnostics procurement resources. Stop TB Partnership.