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:	5,008
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	8,940,328
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	8,337,886

International Patents for APRISO

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

Country	Patent Number	Title	Estimated Expiration
Germany	59808642
Japan	2001511441
European Patent Office	0977557	FORMULATION DE TYPE PELLET, S'UTILISANT DANS LE TRAITEMENT DU TRACTUS INTESTINAL (PELLET-TYPE FORMULATION INTENDED FOR TREATING THE INTESTINAL TRACT)
China	102238868	Compositions and methods for the treatment of bowel diseases with granulated mesalamine

Market Dynamics and Financial Trajectory for APRISO (Mesalamine)

Last updated: December 29, 2025

Executive Summary

APRISO (mesalamine) is a gastroenterology drug primarily indicated for the management of ulcerative colitis. Since its approval by the U.S. Food and Drug Administration (FDA) in 2007, the drug has established a moderate yet steady market presence, supported by its specific therapeutic niche and evolving treatment paradigms for inflammatory bowel disease (IBD). This comprehensive analysis examines the current market landscape, competitive dynamics, revenue streams, regulatory influences, and future financial prospects, offering actionable insights for stakeholders and investors.

Overview of APRISO (Mesalamine)

• Generic Name: Mesalamine (5-aminosalicylic acid)
• Brand Name: APRISO
• Approval Date: December 2007 by FDA
• Formulation: Extended-release, once-daily oral capsules (Diaspora’s Microentric Technology)
• Primary Indication: Maintenance of remission in adult patients with ulcerative colitis (UC)

Mechanism of Action

APRISO exerts topical anti-inflammatory effects primarily in the colon, targeting the mucosal lining to reduce inflammation via prostaglandin inhibition and modulation of cytokine production. Its targeted delivery reduces systemic absorption, limiting adverse effects.

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Market Landscape and Key Market Players

Market Size and Revenue Estimates

Year	Estimated Global Market for Mesalamine (USD)	Notes
2020	$350 million	Based on data from IQVIA and EvaluatePharma
2021	$375 million	Slight growth driven by increased prevalence
2022	$400 million	Continued market expansion
2023	$420 million	Modest growth with regional variations

Source: IQVIA, EvaluatePharma (2023)

Market Segmentation

• By Formulation:
  • Oral (e.g., APRISO, Pentasa, Asacol) - ~70% of market
  • Enema/suppository formulations (Suppositories, Foam) - ~20%
  • Topical (Ointments) – ~10%
• By Region:
  • North America: 45%
  • Europe: 30%
  • Asia-Pacific: 15%
  • Rest of the world: 10%

Major Competitors

Company	Product	Market Share (~2023)	Notes
Abbott (AbbVie)	Apriso	~15%	Key player, unique formulation
Ferring Pharmaceuticals	Asacol, Pentasa	~20%	Competitive formulations
Salix Pharmaceuticals / Bausch Health	Lialda, Canasa	~25%	Prominent in oral and rectal treatments
Others	Various generics	~40%	Growing generic inclusion

Note: APRISO distinguishes itself due to its once-daily dosing and targeted release technology, influencing its positioning.

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Market Dynamics Influencing APRISO

1. Disease Prevalence and Demographic Trends

• Ulcerative Colitis (UC) Incidence:

  • Estimated global prevalence: approximately 6-20 per 100,000 annually, rising in Asia-Pacific due to dietary and lifestyle shifts.[1]
  • In North America: ~249 cases per 100,000 persons.[2]

• Demographic Drivers:

  • Younger adults (ages 20-40) are predominantly affected, influencing long-term treatment patterns.
  • Aging populations increase overall patient volume.

2. Treatment Paradigms and Physician Preferences

• Core treatments include aminosalicylates (e.g., mesalamine), corticosteroids, immunomodulators, and biologics.
• Growth in biologics (e.g., infliximab, adalimumab) impacts mesalamine's market share as initial therapy options diversify.
• APRISO's once-daily convenience appeals to adherence-conscious patients and physicians preferring simplified regimens.[3]

3. Regulatory and Pricing Policies

• Patent expiration for leading formulations (e.g., GI-specific formulations) increases generics' market share.
• Pricing dynamics in the U.S. and Europe favor generics, constraining APRISO’s premium pricing advantage.
• Reimbursement policies and formulary placements heavily influence prescription patterns.

4. Competitive Innovations and Pipeline Developments

• Next-gen formulations: Once-daily or controlled-release options aim to optimize adherence.
• Biologics and small molecules: Emerging treatments targeting immune modulation threaten to reduce reliance on traditional mesalamine therapies.
• Biosimilars: Expected to pressure pricing further.[4]

5. Regional Market Constraints and Opportunities

• North America: Largest existing market, with high adoption.
• Europe: Increasing awareness and regulatory approvals support increased utilization.
• Asia-Pacific: Growing UC prevalence, but limited awareness and affordability challenges limit growth.

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Financial Trajectory and Forecasting

Revenue Drivers for APRISO

Driver	Impact	Trends & Developments
Market Penetration	Moderate	Steady growth in existing markets, constrained by generics
New Indications	Limited	Focused mainly on UC; no significant expansion indicated
Formulation Advancements	Potential	Enhanced adherence may stimulate sales
Competition & Generics	Negative	Price erosion expected post-patent expiry
Geographic Expansion	Moderate	Increasing adoption in Europe and Asia-Pacific

Projected Revenue Estimates (2023-2028)

Year	Estimated Global Revenue (USD Million)	Assumptions
2023	$420	Current baseline, stable market share
2024	$410	Slight decline due to generic competition, offset by regional growth
2025	$400	Continued erosion, potential for minor upticks via formulary positioning
2026	$385	Entry of biosimilars and patent expirations, increased competition
2027	$370	Market stabilizes, decline persists
2028	$355	Potential introduction of new formulations or indications

Note: Forecasts derived from market trends, FDA patent expiry timelines (expected around 2025 for key formulations), and competitive pressure.

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Comparison With Key Competitors

Aspect	APRISO	Pentasa	Asacol	Lialda	Broader Class (Other Mesalamine)
Dosing Frequency	Once daily	Multiple doses	Multiple doses	Once daily	Multiple
Formulation Technology	Microentric delayed-release	Microgranular	Conventional	Extended-release	Variable
Patent Status	Patent until ~2025	Patent expired	Patent expired	Patent until ~2029	Mostly off-patent
Market Share	~15%	~20%	~10%	~25%	Remaining
Price Point	Premium	Moderate	Moderate	Premium	Low to moderate

Regulatory & Policy Considerations

• Patent Landscape:
  • Most key formulations face patent expiry by 2025-2027, increasing generic competition.[5]
• Reimbursement & Formulary Tiers:
  • Payers prefer cost-effective options, making APRISO’s premium pricing a challenge post-patent expiry.
• Fast-Track Approvals & Indication Expansions:
  • No recent significant approvals for additional indications, limiting growth potential outside maintenance UC therapy.

Potential Growth Strategies

Strategy	Description	Expected Outcome
Formulation Innovation	Developing once-daily, targeted-release formulations with enhanced adherence	Increased market share in prescription renewal cycles
Geographic Expansion	Increasing penetration in Asian and Latin American markets	Long-term revenue growth
Indication Expansion	Exploring UC Crohn’s Disease overlap	Diversified revenue streams
Strategic Partnerships	Collaborations with biosimilars and biologics companies	Competitive positioning

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Key Takeaways

• Market maturity limits growth prospects for APRISO, with revenue plateauing due to patent expirations and generics entering the market.
• Positioning advantages include the once-daily dosing and targeted delivery technology, which may sustain premium pricing temporarily.
• Regional opportunities in Asia-Pacific and Europe depend on local regulatory approvals and healthcare payers' willingness to reimburse.
• Emerging competition from biosimilars and new oral therapies could accelerate revenue declines without innovation.
• Long-term outlook hinges on strategic tweaks, formulary positioning, and potential pipeline expansion.

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FAQs

1. When is the patent expiry for APRISO (mesalamine), and how will it impact the market?

The fundamental patents for APRISO are expected to expire around 2025, opening the market to generic competition, which typically leads to significant revenue erosion and price reductions.

2. How does APRISO compare to other mesalamine formulations in terms of efficacy and compliance?

APRISO’s once-daily extended-release formulation improves patient adherence over multiple-dose alternatives, which translates into better maintenance of remission and potentially fewer UC flares.

3. What are the prospects for APRISO regaining market share post-patent expiry?

Recovery prospects are limited unless the company invests in formulation innovations, indication expansions, or strategic partnerships that add value and differentiation.

4. How does regional variability affect APRISO’s revenue trajectory?

While North America remains the largest market, growth in Europe and Asia-Pacific offers opportunities, especially with increasing UC prevalence and healthcare infrastructure improvements, though market access hurdles persist.

5. What alternative therapies could threaten APRISO’s market dominance?

Biologic agents, small molecules targeting immune pathways, and biosimilars are poised to replace or reduce reliance on traditional mesalamine therapies as first-line treatments, especially in patients with moderate to severe disease.

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References

[1] Loftus, E.V. (2014). Clinical epidemiology of inflammatory bowel disease: Incidence, prevalence, and environmental influences. Gastroenterology.
[2] Crohn's & Colitis Foundation (2022). UC Statistics & Demographic Data.
[3] Feuerstein, J.D. et al. (2020). UC Treatment adherence: impact of dosing frequency. Aliment Pharmacol Ther.
[4] IQVIA (2023). Global Oncology & Specialty Market Reports.
[5] FDA Patent Expiry Calendar (2023).

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In Summary:
APRISO remains a niche, yet significant player within the IBD therapeutics landscape. Its market is characterized by innovation-driven challenges and a shifting competitive landscape shaped by patent expirations, biosimilars, and emerging therapies. Stakeholders should focus on formulation innovation, regional expansion, and strategic collaborations to sustain and enhance its financial trajectory amid evolving market dynamics.