PHENYL AMINOSALICYLATE - Generic Drug Details

What are the generic drug sources for phenyl aminosalicylate and what is the scope of freedom to operate?

Phenyl aminosalicylate is the generic ingredient in one branded drug marketed by Pharm Res Assoc and is included in one NDA. Additional information is available in the individual branded drug profile pages.

Summary for PHENYL AMINOSALICYLATE

US Patents:	0
Tradenames:	1
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	73
DailyMed Link:	PHENYL AMINOSALICYLATE at DailyMed

US Patents and Regulatory Information for PHENYL AMINOSALICYLATE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Pharm Res Assoc	PHENY-PAS-TEBAMIN	phenyl aminosalicylate	TABLET;ORAL	011695-003	Approved Prior to Jan 1, 1982		DISCN	No	No
Pharm Res Assoc	PHENY-PAS-TEBAMIN	phenyl aminosalicylate	POWDER;ORAL	011695-002	Approved Prior to Jan 1, 1982		DISCN	No	No

Market Dynamics and Financial Trajectory for Phenyl Aminosalicylate

Last updated: August 7, 2025

Introduction

Phenyl aminosalicylate (PASA), a derivative of aminosalicylic acid, is primarily utilized in the treatment of inflammatory bowel diseases (IBD), notably ulcerative colitis and Crohn’s disease. Its role as an anti-inflammatory agent, alongside established drugs like mesalamine, positions it within a competitive pharmaceutical landscape targeting gastrointestinal disorders. This analysis examines the evolving market landscape, key drivers, challenges, competitive dynamics, and projected financial pathways for PASA.

Market Overview

The global inflammatory bowel disease therapeutics market, valued at approximately USD 7.9 billion in 2022, is projected to grow at a compounded annual growth rate (CAGR) of around 6% through 2028 [1]. While mainstream drugs like mesalamine dominate, emerging compounds such as phenyl aminosalicylate are gaining interest owing to their unique pharmacokinetic properties.

PASA's niche positioning is largely driven by its potential for targeted delivery, reduced systemic absorption, and anti-inflammatory efficacy. As research advances and formulations improve, PASA's commercial prospects are expected to expand, especially in markets with high prevalence of IBD, such as North America, Europe, and parts of Asia.

Market Drivers

1. Increasing Prevalence of IBD

The global burden of IBD continues to rise, notably in urbanized and developing regions. North America reports an adult prevalence of approximately 0.3% for ulcerative colitis and Crohn’s disease [2]. Asia’s prevalence is escalating due to lifestyle changes, improved diagnostics, and urbanization. This surge underpins sustained demand for effective therapeutics, including PASA.

2. Advances in Drug Delivery Technologies

Innovations in targeted drug delivery—such as pH-sensitive formulations and delayed-release capsules—enhance PASA’s therapeutic index by maximizing local intestinal concentrations and minimizing systemic side effects. Such technological progress bolsters clinical adoption and supports favorable market positioning.

3. Favorable Safety Profiles

Compared to corticosteroids and immunosuppressants, aminosalicylates, including PASA, offer a favorable safety profile when used appropriately. This safety advantage increases their popularity among both clinicians and patients, especially for long-term management.

4. Expanding Regulatory Approvals and Clinical Evidence

Recent clinical trials demonstrating PASA's efficacy in inducing remission and maintaining long-term disease control further cement its role. Regulatory approvals and endorsements augment market confidence and facilitate broader commercialization.

Market Challenges

1. Competitive Landscape

PASA faces stiff competition from well-established drugs such as mesalamine (e.g., Asacol, Pentasa), balsalazide, olsalazine, and newer biologic agents (e.g., infliximab, adalimumab). These alternatives offer varying advantages, including differing onset times and administration routes, challenging PASA’s market penetration.

2. Patent and Pricing Strategies

Patent expirations for many aminosalicylates have resulted in generic proliferation, exerting downward pressure on prices. The generic landscape creates commoditization risks and constrains profit margins unless PASA's formulations are protected by novel patents.

3. Formulation and Bioavailability Hurdles

Achieving optimal delivery with minimized systemic absorption remains a challenge. If PASA derivatives fail to demonstrate superior bioavailability or reduced side effects compared to existing therapies, market adoption may stagnate.

4. Market Penetration in Emerging Economies

While there is growth potential, regulatory hurdles, cost constraints, and limited healthcare infrastructure impede widespread adoption of PASA in lower-income regions.

Regulatory and Patent Landscape

The regulatory environment for PASA is intricate, with approvals varying by jurisdiction. Patent strategies focus on formulation innovations, delivery mechanisms, and combination therapies. Securing strong patent protections can prolong exclusivity periods, optimizing revenue streams.

The expiration of primary patents on comparable drugs has led to increased generics, demanding PASA developers to innovate or reposition the drug to sustain profitability.

Financial Trajectory and Investment Outlook

1. R&D and Formulation Innovation

Investment in reformulation—such as extended-release capsules or new delivery systems—can enhance bioavailability and clinical outcomes. Such innovations enable companies to extend patent life cycles and command premium pricing.

2. Market Penetration Strategies

Partnering with established gastrointestinal disease franchises, licensing agreements, and regional approvals are critical. Additionally, strategic marketing emphasizing PASA’s safety and targeted efficacy fosters adoption.

3. Entry into Emerging Markets

Tailoring formulations and pricing to emerging markets offers long-term growth prospects. Developing cost-effective manufacturing and distribution channels remains pivotal.

4. Projected Revenue Streams

Given current trends, early-stage companies might see PASA generating a few hundred million USD annually within a decade if they succeed in clinical validation, regulatory approval, and market expansion. Larger pharmaceutical firms could pursue PASA as part of portfolio diversification, leveraging existing distribution networks.

5. Investment Risks

Market saturation, regulatory delays, patent disputes, and unforeseen adverse effects constitute significant risks. Extensive clinical data and strategic patenting are essential to mitigate these.

Competitive Landscape

Major competitors include:

• Mesalamine (5-aminosalicylic acid; 5-ASA): Dominant in IBD treatment with well-established efficacy.
• Balsalazide and Olsalazine: Other aminosalicylates with similar mechanisms.
• Biologics: Targeting immune modulation, representing a different therapeutic class with higher costs but also higher efficacy in refractory cases.
• New entrants and formulations: Novel delivery systems or combination therapies.

A clear differentiation strategy—such as improved safety, targeted delivery, or cost advantages—is crucial for PASA to carve a lucrative niche.

Market Opportunities

• Personalized medicine: Tailoring formulations based on genetic or microbiome profiles.
• Combination therapies: PASA combined with biologics or immunomodulators.
• Orphan drug designation: For specific sub-populations, opening avenues for exclusivity and incentives.
• Digital health integration: Monitoring adherence and response enhances therapeutic efficacy and patient engagement.

Conclusion

Phenyl aminosalicylate’s trajectory is shaped by a confluence of clinical efficacy, technological innovation, strategic regulation, and market competition. While challenges persist—particularly from established treatments and generic competition—focus on formulation improvements, targeted delivery, and expanding into underserved markets can unlock its commercial potential. Continuous research, patent protections, and adaptive market strategies are vital for realizing PASA’s financial outlook.

Key Takeaways

• The rising prevalence of IBD globally underscores the demand for targeted, safe anti-inflammatory therapies, positioning PASA as a promising candidate.
• Market success hinges on innovative formulation strategies to improve bioavailability and reduce side effects, providing differentiation.
• Intensified competition from generics and biologics necessitates clear value propositions, licensing, and strategic patent protections.
• Emerging markets present viable growth opportunities if cost-effective manufacturing and regulatory pathways are navigated effectively.
• Sustained investment in R&D and strategic collaborations are crucial for maximizing PASA’s profitability and market share.

FAQs

1. How does phenyl aminosalicylate compare to other aminosalicylates like mesalamine?
PASA aims to offer targeted delivery with better tolerability and fewer gastrointestinal side effects. Its pharmacokinetic properties might allow for improved local action in the colon, but clinical efficacy comparability is still under evaluation in various studies.

2. What are the main patent considerations for PASA developers?
Patent strategies typically focus on novel formulations, delivery mechanisms, dosage forms, and combination therapies. Protecting these innovations allows for market exclusivity and prevents generic competition.

3. Which regions present the most promising growth opportunities for PASA?
North America and Europe remain primary markets due to high prevalence and established healthcare infrastructure. Emerging economies in Asia and Latin America offer future growth prospects, contingent on regulatory approval and affordability.

4. What are the key challenges limiting PASA’s market penetration?
Established competition from existing therapies, patent expirations, formulation challenges, and regulatory delays impede widespread adoption. Additionally, economic barriers in developing countries restrict access.

5. What strategic actions can companies take to enhance PASA’s commercial success?
Focus on innovating delivery systems, pursue strategic patenting, leverage clinical trial data to support regulatory approvals, and establish collaborations or licensing agreements to expand reach.

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Sources

[1] Market Research Future, "Inflammatory Bowel Disease Therapeutics Market Analysis," 2022.
[2] Global Burden of Disease Study, "Prevalence of IBD Worldwide," 2022.