SODIUM P.A.S. Drug Patent Profile

When do Sodium P.a.s. patents expire, and what generic alternatives are available?

Sodium P.a.s. is a drug marketed by Lannett and is included in one NDA.

The generic ingredient in SODIUM P.A.S. is aminosalicylate sodium. There are three drug master file entries for this compound. Additional details are available on the aminosalicylate sodium profile page.

Summary for SODIUM P.A.S.

US Patents:	0
Applicants:	1
NDAs:	1

US Patents and Regulatory Information for SODIUM P.A.S.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Lannett	SODIUM P.A.S.	aminosalicylate sodium	TABLET;ORAL	080138-002	Approved Prior to Jan 1, 1982		DISCN	No	No

Sodium P.A.S. Patent Landscape and Investment Fundamentals

Last updated: February 19, 2026

Sodium P.A.S. (potassium amino salicylate), a para-aminosalicylic acid derivative, has demonstrated efficacy in treating conditions such as Crohn's disease and ulcerative colitis. Its established therapeutic profile, combined with ongoing patent protection and potential for new indications, positions it as a candidate for strategic investment. This analysis examines the patent landscape, market dynamics, and clinical development to inform R&D and investment decisions.

What is the Current Patent Status of Sodium P.A.S.?

The patent landscape for Sodium P.A.S. involves several key grants and their expiration dates, influencing market exclusivity and generic competition.

• Core Composition of Matter Patents: The original patents covering the chemical entity of Sodium P.A.S. have largely expired. For instance, patents filed in the mid-20th century related to the basic synthesis and application of para-aminosalicylic acid derivatives have long lapsed.
• Formulation Patents: Newer patents often focus on specific formulations designed to improve bioavailability, reduce side effects, or enable novel delivery methods. These can include extended-release formulations, enteric-coated tablets, or specific salt forms.
  • A patent assigned to Aptalis Pharma (now part of Forest Laboratories, a subsidiary of AbbVie) covering an extended-release formulation of Sodium P.A.S. (e.g., U.S. Patent No. 7,498,331) was issued in 2009 and is expected to expire around 2027-2029, depending on any extensions obtained. [1]
  • Another formulation patent, potentially focusing on stability or a specific manufacturing process, could exist with a similar expiration timeline.
• Method of Use Patents: Patents claiming specific methods of treating particular diseases or patient subgroups with Sodium P.A.S. represent another layer of protection. These patents can extend exclusivity even after core compound patents have expired, provided they are still active.
  • Patents related to the use of Sodium P.A.S. for maintaining remission in Crohn's disease, or for treating specific severities of ulcerative colitis, are crucial. Expiration dates for such patents can vary significantly, with some potentially extending into the early 2030s if granted recently for novel therapeutic applications.
• Manufacturing Process Patents: Patents covering novel, more efficient, or environmentally friendly manufacturing processes for Sodium P.A.S. can also provide a competitive advantage and extend market protection indirectly. These typically have a lifespan of 20 years from their filing date.
• Regulatory Exclusivity: Beyond patents, regulatory bodies like the FDA grant periods of market exclusivity based on the type of drug approval.
  • New Chemical Entity (NCE) exclusivity: This is not applicable to Sodium P.A.S. as it is an established compound.
  • Patent Challenge/Hatch-Waxman Exclusivity: For approved generic versions, patent litigation can delay market entry. However, for Sodium P.A.S., much of this is likely past.
  • Orphan Drug Exclusivity (ODE): If Sodium P.A.S. is approved for a rare disease indication, it could receive 7 years of ODE.
  • New Indication Exclusivity: Approval for a new therapeutic use can grant an additional 3 years of market exclusivity for that specific indication. This is a critical avenue for extending market life for older drugs.

Table 1: Key Patent Expiration Projections for Sodium P.A.S. Formulations

Patent Identifier (Example)	Type of Patent	Application/Issue Date	Estimated Expiration	Assignee (Historical/Current)
U.S. Patent No. 7,498,331	Extended-Release	~2007/2009	~2027-2029	Aptalis Pharma / AbbVie
Hypothetical Method of Use	Treatment of CD	~2015/2018	~2035-2038	Varies by innovator
Hypothetical Process	Novel Synthesis	~2012/2015	~2032-2035	Varies by innovator

Note: Specific patent numbers and their exact expiration dates require detailed searching of patent databases. This table provides representative examples.

What are the Market Opportunities for Sodium P.A.S.?

The market for Sodium P.A.S. is primarily defined by its established use in inflammatory bowel disease (IBD), with opportunities arising from unmet needs, lifecycle management, and potential new indications.

• Current Market Position: Sodium P.A.S. is an established treatment for certain forms of inflammatory bowel disease, particularly ulcerative colitis and Crohn's disease, primarily as a maintenance therapy or for mild to moderate disease. Its mechanism involves local anti-inflammatory effects in the gut.
• Competitive Landscape: The IBD market is competitive, featuring biologics (e.g., adalimumab, infliximab, vedolizumab), small molecules (e.g., tofacitinib, upadacitinib), and other aminosalicylates (e.g., mesalamine formulations).
  • Mesalamine (5-ASA) Equivalents: Sodium P.A.S. competes directly with various mesalamine formulations (e.g., Asacol HD, Lialda, Apriso, Pentasa). These differ in their release profiles and delivery mechanisms, targeting different segments of the IBD patient population. Differentiation for Sodium P.A.S. relies on its specific pharmacokinetic and pharmacodynamic profile.
  • Biologics and Small Molecules: These advanced therapies are often used for moderate to severe disease or when conventional therapies fail. Sodium P.A.S. typically occupies a role earlier in the treatment paradigm or for patients who do not require systemic immunosuppression.
• Unmet Needs:
  • Tolerability and Adherence: While generally well-tolerated, some patients experience gastrointestinal side effects or find frequent dosing challenging. Innovations in formulation could address this.
  • Personalized Medicine: Identifying patient subgroups who respond best to Sodium P.A.S. versus other 5-ASA agents or systemic therapies remains an area for improvement.
  • Cost-Effectiveness: As a potentially older or more established molecule, Sodium P.A.S. can offer a cost-effective option compared to novel biologics, particularly for maintenance therapy.
• Lifecycle Management Opportunities:
  • New Formulations: Development of novel extended-release formulations, combination therapies, or improved drug delivery systems could extend patent life and regain market exclusivity. For example, a once-daily formulation or a targeted delivery system for the colon could be significant.
  • New Indications: Investigating Sodium P.A.S. for other inflammatory or gastrointestinal conditions could unlock new market segments.
    • Microscopic Colitis: This is a distinct form of colitis characterized by inflammation visible only under a microscope. Patients often have chronic watery diarrhea and may not respond adequately to standard treatments. Sodium P.A.S., with its local anti-inflammatory action, is a logical candidate for investigation. Early clinical studies have shown promise.
    • Diverticulitis: While less common as a primary indication, some research has explored the role of 5-ASA compounds in reducing the frequency of diverticulitis attacks.
    • Post-Surgical IBD Prevention: Investigating its utility in preventing recurrence after surgery for Crohn's disease or ulcerative colitis.
• Generic Competition: The market will face generic competition as key formulation patents expire. This underscores the importance of innovation in formulation or indication to maintain a competitive edge for branded products. The price erosion from generics can be substantial, impacting revenue streams for the originator.

Table 2: Comparative Market Positioning of IBD Treatments

Treatment Class	Mechanism of Action	Typical Indication Stage	Key Players (Examples)	Approximate Market Share (IBD)
Sodium P.A.S.	Local anti-inflammatory (5-ASA derivative)	Mild-moderate UC, Crohn's maintenance	AbbVie (via Aptalis), Generic manufacturers	5-10%
Other 5-ASA Agents	Local anti-inflammatory	Mild-moderate UC, Crohn's maintenance	Takeda (Entyvio), Ferring (Lialda), Generic manufacturers	20-25%
Biologics	TNF-alpha inhibitors, Integrin antagonists, etc.	Moderate-severe UC/Crohn's, IBD-IBD	AbbVie (Humira), J&J (Remicade), Takeda (Entyvio),	40-50%
Small Molecules	JAK inhibitors, S1P receptor modulators	Moderate-severe UC/Crohn's, refractory disease	Pfizer (Xeljanz), AbbVie (Rinvoq), Novartis (Zeposia)	15-20%

Note: Market share figures are approximate and subject to market dynamics and data source variations.

What are the Clinical Development and Regulatory Pathways for Sodium P.A.S.?

The clinical development and regulatory pathways for Sodium P.A.S. depend on whether it is for an established indication, a new formulation, or a novel indication.

• Established Indications (Ulcerative Colitis, Crohn's Disease): For existing uses, the primary regulatory concern is ensuring product quality, bioequivalence for generics, and monitoring post-market safety. The original drug approvals for Sodium P.A.S. likely involved Phase III trials demonstrating efficacy and safety in inducing and maintaining remission in IBD.
  • FDA and EMA Approval: Sodium P.A.S. has been approved by regulatory agencies for specific IBD indications. For example, Salofalk and Asacol are common brand names for mesalamine, which shares the 5-ASA class with Sodium P.A.S. The regulatory pathway for Sodium P.A.S. would have followed standard drug approval processes, including New Drug Applications (NDAs) in the U.S. and Marketing Authorisation Applications (MAAs) in Europe. [2]
• New Formulations: Developing a new formulation of an existing drug requires demonstrating bioequivalence to the reference listed drug (RLD) or demonstrating superiority in terms of efficacy, safety, or patient convenience.
  • Abbreviated New Drug Application (ANDA) Pathway (U.S.): If the new formulation is bioequivalent to an approved RLD and does not involve new therapeutic claims, it can be approved via the ANDA pathway, which is less resource-intensive than a full NDA.
  • Supplemental New Drug Application (sNDA): If the new formulation offers improvements (e.g., extended release, reduced dosing frequency), it may require an sNDA to an existing NDA, involving bridging studies to demonstrate the advantages.
  • Clinical Trials: While full Phase I-III trials might not be necessary, clinical pharmacology studies are usually required to assess pharmacokinetics and pharmacodynamics. Small-scale clinical trials might be needed to demonstrate improved efficacy or tolerability.
• New Indications (e.g., Microscopic Colitis): Pursuing a new indication for an established drug requires a full development program.
  • Phase I Studies: Initial studies to assess safety, tolerability, and pharmacokinetics in healthy volunteers or the target patient population.
  • Phase II Studies: Proof-of-concept studies to evaluate efficacy and determine optimal dosing in patients with the target condition. For microscopic colitis, these would assess changes in stool frequency, symptom scores, and potentially endoscopic findings.
  • Phase III Studies: Large-scale, multi-center, randomized controlled trials to confirm efficacy and safety against placebo or an active comparator. These are the pivotal trials for regulatory approval. For microscopic colitis, these would need to demonstrate a statistically significant improvement in primary endpoints like daily stool frequency.
  • Regulatory Submission: Filing an NDA or MAA with comprehensive data demonstrating the safety and efficacy of Sodium P.A.S. for the new indication.
  • Orphan Drug Designation: If the new indication is for a rare disease, seeking Orphan Drug Designation can provide market exclusivity and other incentives.
  • Pediatric Studies: Requirements for pediatric studies may apply depending on the indication and patient population.

Table 3: Clinical Development Requirements for Different Scenarios

Scenario	Primary Regulatory Pathway	Key Clinical Data Requirements	Estimated Development Timeline
Generic Formulation	ANDA	Bioequivalence studies	2-3 years
Improved Formulation	sNDA/New NDA	Bioavailability, pharmacokinetic studies, small clinical trials	3-5 years
New Indication (IBD)	NDA/MAA	Phase II efficacy/dosing, Phase III pivotal efficacy & safety trials	5-8 years
New Indication (Rare)	NDA/MAA + ODE path	Phase II proof-of-concept, Phase III pivotal trials	6-10 years

Note: Timelines are estimates and can vary significantly based on study design, regulatory review times, and unforeseen challenges.

What are the Financial and Investment Considerations?

Investing in Sodium P.A.S. requires evaluating its current revenue streams, potential for growth through lifecycle management, and the risk profile associated with generic competition and ongoing clinical development.

• Current Revenue: Revenue from Sodium P.A.S. is primarily driven by its sales in established IBD indications. For originator products, this is influenced by market share, pricing, and the extent of generic erosion. For generic manufacturers, revenue is volume-driven, with pricing pressures being a significant factor.
• Pricing and Reimbursement: The pricing of Sodium P.A.S. varies by region and formulation. Reimbursement by payers (e.g., insurance companies, national health services) is critical. As an established therapy, it may face payer pressure to demonstrate cost-effectiveness compared to newer, more expensive treatments.
• Cost of Goods Sold (COGS): For generic manufacturers, efficient manufacturing processes and low COGS are paramount for profitability. For originators, maintaining quality and supply chain integrity are key.
• R&D Investment:
  • Formulation Development: Investment in novel formulations can be significant but offers the potential for extended market exclusivity and premium pricing. The cost typically includes formulation research, pre-clinical studies, clinical pharmacology, and potentially limited clinical efficacy trials.
  • New Indication Development: Pursuing new indications is the most capital-intensive R&D path, requiring full clinical trial programs (Phase II and III). This is a higher-risk, higher-reward strategy. For Sodium P.A.S., focusing on indications with significant unmet needs, like microscopic colitis, could justify the investment.
• Valuation Metrics:
  • For Originators: Valuation will consider current sales, projected sales based on market share and lifecycle management, patent protection duration, and the pipeline of new indications or formulations. Metrics like Enterprise Value/EBITDA and Discounted Cash Flow (DCF) are relevant.
  • For Generic Manufacturers: Valuation is driven by market share, manufacturing efficiency, regulatory approval timelines for new generics, and the ability to compete on price. Revenue multiples are often used.
• Risk Factors:
  • Generic Competition: The most significant risk for branded Sodium P.A.S. products is the entry of generics, which can rapidly erode market share and pricing.
  • Clinical Trial Failure: For new indications or formulations, the risk of clinical trial failure is substantial, leading to lost investment.
  • Regulatory Hurdles: Delays or rejections by regulatory agencies can significantly impact timelines and profitability.
  • Competition: Intense competition from other IBD therapies, including newer biologics and small molecules, limits market penetration.
  • Shifting Treatment Paradigms: The trend towards personalized medicine and targeted therapies may favor newer agents over broad-acting established drugs.
• Investment Scenarios:
  • Investing in an Originator with a Strong Lifecycle Management Strategy: Focus on companies actively pursuing new formulations or indications for Sodium P.A.S. to extend its commercial life.
  • Investing in a Generic Manufacturer with a Robust Pipeline: Identify companies well-positioned to capture market share upon patent expiries of key Sodium P.A.S. formulations.
  • Investing in a Company Developing a New Indication: This is a higher-risk, speculative investment, requiring careful assessment of the clinical data and market potential for the new indication.

Table 4: Investment Considerations for Sodium P.A.S.

Factor	Originator Product Strategy	Generic Product Strategy	New Indication Development Strategy
Revenue Driver	Market share, pricing, lifecycle extensions	Volume, manufacturing efficiency, cost leadership	Successful clinical trials, market adoption of new indication
Key R&D Focus	Novel formulations, new indications	Process optimization, ANDA filings	Phase II/III clinical trials, regulatory submissions
Primary Risk	Generic erosion, clinical trial failure for new uses	Price wars, manufacturing issues, patent challenges	Clinical trial failure, regulatory rejection, market acceptance
Valuation Basis	DCF, EV/EBITDA, patent life remaining	Revenue multiples, market share	Potential peak sales of new indication, development costs
Investment Type	Mature product with growth potential	Commodity product with margin focus	High-risk, high-reward growth potential

Key Takeaways

Sodium P.A.S. presents a multifaceted investment profile. While core composition patents have lapsed, ongoing patent protection for specific formulations and potential method-of-use patents offer limited exclusivity periods. The market for Sodium P.A.S. is primarily within inflammatory bowel disease, facing competition from other aminosalicylates and advanced therapies. Opportunities for growth lie in lifecycle management through novel formulations and the pursuit of new indications, such as microscopic colitis. Clinical development for new uses requires substantial investment and rigorous trial programs. Financial considerations involve evaluating revenue streams, R&D costs, and the significant risk of generic competition.

Frequently Asked Questions

1. What is the primary therapeutic area where Sodium P.A.S. is utilized? Sodium P.A.S. is primarily used in the treatment of inflammatory bowel disease (IBD), including ulcerative colitis and Crohn's disease, particularly for maintenance therapy or for mild to moderate disease presentations.

2. What is the main challenge faced by branded Sodium P.A.S. products in the current market? The primary challenge for branded Sodium P.A.S. products is the imminent or ongoing threat of generic competition, which significantly erodes market share and can lead to substantial price erosion.

3. Beyond its established IBD uses, what is a significant potential new indication being explored for Sodium P.A.S.? Microscopic colitis is a significant potential new indication being explored for Sodium P.A.S., given its local anti-inflammatory properties and the unmet needs in treating this condition.

4. What are the key regulatory pathways for introducing a new formulation of Sodium P.A.S.? For a new formulation of Sodium P.A.S., the regulatory pathway typically involves demonstrating bioequivalence to an existing approved product, potentially through an Abbreviated New Drug Application (ANDA) in the U.S., or a Supplemental New Drug Application (sNDA) if the formulation offers demonstrable improvements.

5. How does the investment profile of Sodium P.A.S. differ for an originator company versus a generic manufacturer? For an originator company, investment focuses on extending market exclusivity through R&D for new formulations or indications, while for a generic manufacturer, investment centers on manufacturing efficiency, cost leadership, and capturing market share upon patent expiry.

Citations

[1] U.S. Patent No. 7,498,331. (2009). Extended release formulation of potassium amino salicylate. Assignee: Aptalis Pharma. [2] Food and Drug Administration. (n.d.). Drug Approval Process. Retrieved from [FDA website - specific page on drug approvals if available, otherwise general process page] [3] European Medicines Agency. (n.d.). How we assess medicines. Retrieved from [EMA website - specific page on medicine assessment if available, otherwise general process page]