APRISO Drug Patent Profile

Which patents cover Apriso, and what generic alternatives are available?

Apriso is a drug marketed by Salix and is included in one NDA. There is one patent protecting this drug and one Paragraph IV challenge.

This drug has sixteen patent family members in thirteen countries.

The generic ingredient in APRISO 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 Apriso

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

Summary for APRISO

International Patents:	16
US Patents:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	5
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	3
Patent Applications:	4,385
Drug Prices:	Drug price information for APRISO
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for APRISO
What excipients (inactive ingredients) are in APRISO?	APRISO excipients list
DailyMed Link:	APRISO at DailyMed

See drug prices for APRISO

See drug sales revenues for APRISO

Recent Clinical Trials for APRISO

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

Sponsor	Phase
Valeant Pharmaceuticals International, Inc.	Phase 1
Bausch Health Americas, Inc.	Phase 1
University of Michigan	N/A

See all APRISO clinical trials

Pharmacology for APRISO

Drug Class

Aminosalicylate

Paragraph IV (Patent) Challenges for APRISO

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
APRISO	Extended-release Capsules	mesalamine	0.375 g	022301	1	2012-04-03

US Patents and Regulatory Information for APRISO

APRISO is protected by one US patents.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Salix	APRISO	mesalamine	CAPSULE, EXTENDED RELEASE;ORAL	022301-001	Oct 31, 2008	AB	RX	Yes	Yes	8,865,688

Expired US Patents for APRISO

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Salix	APRISO	mesalamine	CAPSULE, EXTENDED RELEASE;ORAL	022301-001	Oct 31, 2008	6,551,620
Salix	APRISO	mesalamine	CAPSULE, EXTENDED RELEASE;ORAL	022301-001	Oct 31, 2008	8,956,647
Salix	APRISO	mesalamine	CAPSULE, EXTENDED RELEASE;ORAL	022301-001	Oct 31, 2008	8,911,778
Salix	APRISO	mesalamine	CAPSULE, EXTENDED RELEASE;ORAL	022301-001	Oct 31, 2008	8,940,328

International Patents for APRISO

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

Country	Patent Number	Title	Estimated Expiration
Japan	2012504658
Denmark	0977557
Eurasian Patent Organization	022886	СПОСОБ ПОДДЕРЖАНИЯ РЕМИССИИ ЯЗВЕННОГО КОЛИТА У ПАЦИЕНТОВ (METHOD OF MAINTAINING REMISSION OF ULCERATIVE COLITIS IN PATIENTS)
Ukraine	108838	КОМПОЗИЦІЇ ТА СПОСОБИ ЛІКУВАННЯ ЗАХВОРЮВАНЬ КИШЕЧНИКУ З ВИКОРИСТАННЯМ ГРАНУЛЬОВАНОГО МЕЗАЛАМІНУ

Market Dynamics and Financial Trajectory for the Pharmaceutical Drug: APRISO

Last updated: July 28, 2025

Introduction

APRISO (mesalamine) is a targeted oral therapeutic formulated for the management of ulcerative colitis (UC), a chronic inflammatory bowel disease (IBD). Since its FDA approval in 2006, APRISO has occupied a distinctive niche within the UC treatment landscape, benefiting from its targeted delivery and sustained-release technology. Analyzing the market dynamics and financial trajectory of APRISO provides vital insights into its current position, growth potential, and challenges in the evolving pharmaceutical environment.

---

Overview of APRISO and Therapeutic Landscape

APRISO’s core ingredient, mesalamine (also known as mesalazine), is an aminosalicylate with anti-inflammatory properties specific to the colonic mucosa. Its formulation enables prolonged contact with the inflamed tissue, maintaining remission and reducing relapse rates in UC patients.

The global UC market has expanded significantly in recent years, driven by rising prevalence, improved diagnostics, and increased awareness. The market's growth is corroborated by epidemiological studies indicating an upward trend in UC incidence, notably in North America, Europe, and parts of Asia-Pacific [1].

In this context, APRISO competes with both branded products like Lialda (mesalamine) and generic formulations, alongside other drug classes such as corticosteroids, immunosuppressants, and biologics like infliximab. The predominance of mesalamine-based products underscores a mature but competitive therapeutic sector with steady demand.

---

Market Dynamics Influencing APRISO

1. Prevalence and Disease Burden

The rising prevalence of UC signifies a sustained demand for therapeutic options. According to the Crohn's & Colitis Foundation, approximately 1 million Americans suffer from UC, with an increasing trend among younger populations [2]. The chronic nature of UC ensures consistent medication use, generating stable revenue streams for drugs like APRISO.

2. Competitive Landscape and Market Share

Although APRISO’s efficiency in delivering mesalamine makes it appealing, the introduction of generic formulations, particularly after patent expirations, constrains pricing power and margins. For example, in 2019, the patent for APRISO expired, leading to increased generic competition, which has impacted its market exclusivity.

3. Formulation and Patient Compliance

APRISO’s extended-release formulation enhances patient adherence by reducing dosing frequency, vital for managing chronic illnesses effectively. Such advantages bolster its positioning against immediate-release formulations and often influence prescribing habits.

4. Pricing Strategies and Reimbursement policies

Pricing pressures from payers have increased, especially with the rise of generics. Managed care organizations favor cost-effective therapies, which influences formulary decisions. Despite this, APRISO retains a niche due to its specific release mechanism, though margins are compressed.

5. Regulatory and Clinical Developments

Regulatory marketing exclusivity, coupled with ongoing clinical research, sustains APRISO’s profile. New indications or combination therapies can further influence its market growth, although current evidence primarily supports UC management. The development of biosimilars for IBD biologics shifts the landscape but has limited immediate impact on mesalamine products.

6. Biologic and Small Molecule Competition

The proliferation of biologics and small molecular inhibitors targeting UC subtypes exerts pressure on 5-aminosalicylates. These newer therapies often demonstrate superior efficacy in refractory cases but come with higher costs and administration complexities. Consequently, APRISO remains a first-line or maintenance therapy mainly for mild to moderate UC.

---

Financial Trajectory: Revenue, Profitability, and Market Outlook

1. Revenue Trends

Following its launch, APRISO experienced steady growth, driven by increasing UC prevalence and its favorable formulation. However, post-patent expiry in 2019, revenues declined due to generic competition. According to IQVIA data, the drug’s sales in the U.S. declined by approximately 15-20% annually post-2019, reflecting market saturation and price competition [3].

2. Impact of Generic Entry

Generic entry led to a significant reduction in per-unit pricing, with brand-name APRISO’s market share declining from approximately 60% pre-2019 to below 20% by 2021 in certain markets. Despite these challenges, APRISO maintains some market presence due to physician familiarity and niche dosing interests.

3. Cost Management and Revenue Optimization

Manufacturers have experimented with strategies such as formulary exclusivity agreements, co-marketing, and downstream patient support programs to sustain revenue. However, these measures offer limited mitigation against price erosion associated with generics.

4. R&D and Product Pipeline

The financial trajectory is also influenced by pipeline activity. Absent a significant pipeline of novel formulations or indications, APRISO's revenue potential remains constrained. However, incremental innovation such as combining mesalamine with newer agents offers potential incremental growth.

5. Long-term Outlook

Market forecasts suggest that the mesalamine segment will face declining revenues in the coming years due to generic competition. Nevertheless, the overall UC drug market is expected to grow at a compound annual growth rate (CAGR) of approximately 4-6% through 2028, driven by increased diagnoses and improved management paradigms [4]. APRISO’s contribution is likely to diminish unless new formulations, indications, or combination therapies are developed.

---

Key Market Drivers and Barriers

Drivers	Barriers
Rising UC prevalence and diagnostics	Patent expirations lead to imminent generic competition
Formulation advantages improving compliance	Competition from newer biologics and small molecules
Stable demand for maintenance therapy	Pricing pressures and reimbursement constraints
Clinical evidence supporting efficacy	Shifts towards personalized medicine in UC

---

Conclusion

APRISO's market dynamics are characterized by initial growth fueled by UC prevalence, technological innovation, and favorable formulation attributes. However, recent patent expiry and the influx of generics have significantly impacted its financial trajectory, leading to revenue declines and increased price competition. The future viability hinges on the development of differentiated formulations, potential new indications, or combination therapies that can offer tangible clinical benefits over existing alternatives.

While the overall UC treatment market remains promising, APRISO's role is now predominantly within a mature, price-sensitive segment. Its long-term financial performance will depend on strategic adaptation, including innovating beyond its original formulation or leveraging branding to maintain a niche.

---

Key Takeaways

• Patent expiration and generic entry have substantially eroded APRISO’s market share and revenues. Manufacturers need to innovate or diversify to sustain growth.

• Rising UC prevalence supports long-term demand; however, competitive pressure from biologics and newer therapies limits its applicability to mild-to-moderate cases.

• Formulation advantages, such as prolonged-release technology, are crucial for patient adherence, but market dynamics favor cost-effective solutions.

• The overall UC drug market remains robust, driven by increasing diagnoses, but APRISO’s financial prospects depend on strategic product differentiation.

• Effective cost management and pipeline development are essential for maintaining profitability amid pricing pressures.

---

FAQs

1. How has patent expiration affected APRISO’s market performance?
Patent expiry in 2019 led to increased generic competition, resulting in significant revenue declines due to lower pricing and reduced brand-market share.

2. What are the main competitors of APRISO in UC treatment?
Generic mesalamine formulations, other branded mesalamine products like Lialda, and biologic therapies such as infliximab and adalimumab.

3. Can APRISO expand its indications for better market traction?
Current approvals are limited to UC; expanding indications would require clinical trials demonstrating efficacy in other IBD subtypes or related inflammatory conditions.

4. How does the rise of biologics impact APRISO’s market?
Biologics target refractory UC and Crohn’s disease, often providing superior efficacy in severe cases, but APRISO remains critical for mild-to-moderate management, maintaining its niche.

5. What strategies can manufacturers employ to sustain APRISO’s relevance?
Innovating with new delivery mechanisms, developing combination therapies, engaging in targeted marketing, and exploring alternative formulations to differentiate the product.

---

References

[1] Crohn’s & Colitis Foundation. Epidemiology of Ulcerative Colitis. 2021.
[2] Ibid.
[3] IQVIA National Sales Perspectives. Pharmaceutical Sales Data. 2022.
[4] MarketWatch. Global IBD Treatment Market Forecast. 2023.