PENTASA Drug Patent Profile

When do Pentasa patents expire, and when can generic versions of Pentasa launch?

Pentasa is a drug marketed by Takeda Pharms Usa and is included in one NDA.

The generic ingredient in PENTASA is mesalamine. There are twenty-eight drug master file entries for this compound. Thirty-eight suppliers are listed for this compound. Additional details are available on the mesalamine profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Pentasa

A generic version of PENTASA was approved as mesalamine by PADAGIS ISRAEL on September 17^th, 2004.

Summary for PENTASA

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	130
Clinical Trials:	25
Patent Applications:	1,465
Drug Prices:	Drug price information for PENTASA
Drug Sales Revenues:	Drug sales revenues for PENTASA
What excipients (inactive ingredients) are in PENTASA?	PENTASA excipients list
DailyMed Link:	PENTASA at DailyMed

See drug prices for PENTASA

See drug sales revenues for PENTASA

Recent Clinical Trials for PENTASA

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

Sponsor	Phase
Bogomolets National Medical University	N/A
Ukrainian Research and Practical Centre of Endocrine Surgery, Transplantation of Endocrine Organs and Tissues of the Ministry of Health of Ukraine	N/A
HIV Immunotherapeutics Institute	Phase 1/Phase 2

See all PENTASA clinical trials

Pharmacology for PENTASA

Drug Class

Aminosalicylate

US Patents and Regulatory Information for PENTASA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Takeda Pharms Usa	PENTASA	mesalamine	CAPSULE, EXTENDED RELEASE;ORAL	020049-001	May 10, 1993		RX	Yes	No
Takeda Pharms Usa	PENTASA	mesalamine	CAPSULE, EXTENDED RELEASE;ORAL	020049-002	Jul 8, 2004	AB	RX	Yes	Yes

Expired US Patents for PENTASA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Takeda Pharms Usa	PENTASA	mesalamine	CAPSULE, EXTENDED RELEASE;ORAL	020049-001	May 10, 1993
Takeda Pharms Usa	PENTASA	mesalamine	CAPSULE, EXTENDED RELEASE;ORAL	020049-001	May 10, 1993

International Patents for PENTASA

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

Country	Patent Number	Title	Estimated Expiration
Japan	S57500432
World Intellectual Property Organization (WIPO)	8102671

Market Dynamics and Financial Trajectory for PENTASA

Last updated: July 29, 2025

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Introduction

PENTASA (mesalamine), developed by Ferring Pharmaceuticals, is an established oral medication primarily prescribed for ulcerative colitis (UC), a chronic inflammatory bowel disease. Its market presence spans over two decades, reflecting a mature yet evolving therapeutic landscape. This analysis explores the current market dynamics and forecasts PENTASA's financial trajectory, considering regulatory, competitive, and innovation-driven factors shaping its future.

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Market Overview and Current Position

PENTASA was approved by the FDA in 1992 (original approval date varies by formulation). Its primary mechanism involves localized anti-inflammatory effects within the colon, offering a targeted approach for UC management. With its formulation designed for delayed release, PENTASA ensures drug delivery to the distal bowel, aligning with the pathophysiology of UC.

Globally, the ulcerative colitis segment has experienced consistent growth, driven by rising prevalence, improved diagnostics, and greater awareness. According to GlobalData, the UC treatment market was valued at approximately \$2.2 billion in 2022 and is projected to grow at a CAGR of 4-5% through 2030 [1].

PENTASA's market share remains significant within aminosalicylate class therapies, competing with agents such as olsalazine, balsalazide, mesalamine suppositories, and newer biologics. Despite increased competition, its proven efficacy and long-standing approval underpin its continued utilization.

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Market Dynamics Influencing PENTASA

1. Growing Ulcerative Colitis Prevalence

The rising incidence and prevalence of UC, notably in North America, Europe, and parts of Asia, underpin increased demand for aminosalicylates like PENTASA. The CDC reports UC prevalence in the U.S. at approximately 37.6 cases per 100,000 individuals, with rising diagnoses noted among younger populations [2].

2. Therapeutic Paradigm Shifts and Treatment Guidelines

While 5-aminosalicylates (5-ASAs) remain first-line therapy for mild to moderate UC, guidelines are increasingly incorporating biologics and small molecules for refractory cases. Nevertheless, for maintenance therapy, PENTASA's safety profile ensures its role remains prominent, especially in mild cases.

3. Patent Status and Generic Competition

PENTASA's patent exclusivity has largely expired, opening the market to generic formulations. Generic entry typically leads to substantial price reductions, impacting revenue streams. Nonetheless, Ferring has maintained brand relevance through formulary inclusion and patient preference, supported by its formulation-specific benefits.

4. Regulatory Environment

Regulatory agencies, including the FDA and EMA, enforce stringent standards. While PENTASA's formulations are well-established, ongoing approval processes for new indications or combination therapies could influence its market access.

5. Competitive Landscape

Biologics such as infliximab and vedolizumab have shifted treatment for moderate-to-severe UC but are less relevant for maintenance of mild cases—PENTASA remains critical here. Additionally, emerging oral small molecules like Janus kinase (JAK) inhibitors (e.g., tofacitinib) are expanding options, potentially impacting PENTASA's market share.

6. Pricing and Reimbursement

Price sensitivity is elevated post-patent expiry. Reimbursement policies vary across regions, affecting accessibility. PENTASA’s favorable safety profile and convenience support its continued use, particularly where reimbursement favors established therapies.

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Financial Trajectory Projections

1. Revenue Trends

Post-patent expiration has historically caused revenue declines in branded drugs like PENTASA. However, persistent demand and formulary preferences mitigate steep drops initially. In 2022, PENTASA’s estimated global sales hovered around \$300 million, with North America accounting for approximately 60% of revenues [3].

2. Impact of Generic Competition

Generic versions, introduced circa 2010, prompted a sharp decline in PENTASA's U.S. sales, with subsequent stabilization due to brand loyalty and physician preference. Price erosion can be estimated at 25-40% for generics versus branded products, depending on market dynamics.

3. Market Share Forecast

While generic competition constrains growth, steady revenue is supported by ongoing UC diagnosis and treatment adherence. The global UC market's CAGR of 4-5% suggests PENTASA’s revenues could modestly decline or stabilize, depending on market penetration and patient access initiatives.

4. Growth Opportunities

Aligned with healthcare trends, PENTASA might benefit from:

• Formulation innovations: New drug delivery mechanisms or fixed-dose combinations.
• Expanding indications: Potential use in prevention or combination therapies.
• Geographic expansion: Increased acceptance in emerging markets, where UC prevalence is rising, could offset mature market declines.

5. Future Outlook

Given the market’s maturity, PENTASA's revenues are expected to plateau or decline gradually over the next 3-5 years. However, strategic initiatives, including partnerships, biosimilar acceptance, and potential token pricing strategies, might mitigate erosion.

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Strategic Factors Affecting Financial Trajectory

• Pipeline Development: Ferring's focus on extending its pipeline with newer formulations or combination therapies can bolster long-term relevance.
• Biosimilars and Generics: Regulatory approval of biosimilars and generics will influence pricing pressure, especially in key markets.
• Healthcare Policy: Emphasis on cost-effective treatments and push for biosimilars could reduce PENTASA revenues unless differentiation is maintained.
• Patient Preferences: The preference for oral agents over injectable biologics favors PENTASA's sustained use in mild UC.

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Conclusion

PENTASA’s market dynamics are shaped by a mature yet stable niche within UC management. While patent expiries and generic competition limit growth, steady demand driven by disease prevalence, formulary positioning, and the drug’s safety profile support its ongoing financial relevance. Future growth hinges upon innovation, market expansion, and strategic positioning in an evolving therapeutic landscape that more prominently features biologics and small molecules.

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Key Takeaways

• Market Stability: PENTASA remains a cornerstone therapy for mild-to-moderate UC, with stable demand supported by clinical guidelines.
• Revenue Trajectory: Likely to decline gradually due to generic competition, with potential stabilization via formulary control and expansion into emerging markets.
• Competitive Challenges: Biologics and small-molecule therapies are reshaping the treatment paradigm, necessitating strategic innovation.
• Growth Drivers: Advances in formulations, expansion into new regions, and combination therapies could sustain or grow revenue streams.
• Long-term Outlook: PENTASA’s prospects depend on balancing competitive pressures with its established safety profile and patient preference for oral therapies.

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FAQs

1. How has patent expiration impacted PENTASA’s market share?
Patent expiration led to the introduction of generic versions, significantly reducing prices and market share for the branded product. Nonetheless, brand loyalty and formulary preferences have limited steep declines, allowing for continued revenue streams.

2. Are there new formulations or indications for PENTASA under development?
Currently, there are no widely announced new formulations or indications. Ferring focuses on optimizing existing formulations and exploring combination approaches, potentially extending the drug’s relevance.

3. How does PENTASA compare to biologics in UC treatment?
PENTASA is primarily used for mild to moderate UC, serving as a first-line maintenance therapy. Biologics are reserved for moderate to severe UC cases, with higher efficacy but increased cost and administration complexity.

4. What regions present growth opportunities for PENTASA?
Emerging markets in Asia and Latin America show increasing UC prevalence, offering growth potential contingent on pricing strategies and regulatory approval.

5. What factors could threaten PENTASA’s market position in the future?
Intensified competition from biosimilars, novel oral small molecules, and shifts toward personalized medicine could erode its market share unless the drug adapts through innovation or strategic initiatives.

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References

[1] GlobalData. (2022). Ulcerative Colitis Treatment Market Analysis.
[2] CDC. (2020). Ulcerative Colitis Prevalence.
[3] Ferring Pharmaceuticals. Financial reports and market disclosures, 2022.