CANASA Drug Patent Profile

Which patents cover Canasa, and when can generic versions of Canasa launch?

Canasa is a drug marketed by Abbvie and is included in one NDA. There are two patents protecting this drug and one Paragraph IV challenge.

This drug has thirteen patent family members in twelve countries.

The generic ingredient in CANASA 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 Canasa

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

Summary for CANASA

International Patents:	13
US Patents:	2
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	181
Clinical Trials:	2
Drug Prices:	Drug price information for CANASA
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for CANASA
What excipients (inactive ingredients) are in CANASA?	CANASA excipients list
DailyMed Link:	CANASA at DailyMed

See drug prices for CANASA

See drug sales revenues for CANASA

Recent Clinical Trials for CANASA

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

Sponsor	Phase
Sandoz	Phase 3
Forest Laboratories	Phase 3
Axcan Pharma	Phase 3

See all CANASA clinical trials

Pharmacology for CANASA

Drug Class

Aminosalicylate

Paragraph IV (Patent) Challenges for CANASA

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
CANASA	Suppository	mesalamine	1000 mg	021252	1	2013-05-24

US Patents and Regulatory Information for CANASA

CANASA is protected by two US patents.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Abbvie	CANASA	mesalamine	SUPPOSITORY;RECTAL	021252-002	Nov 5, 2004	AB	RX	Yes	Yes	8,217,083		Y
Abbvie	CANASA	mesalamine	SUPPOSITORY;RECTAL	021252-002	Nov 5, 2004	AB	RX	Yes	Yes	8,436,051		Y
Abbvie	CANASA	mesalamine	SUPPOSITORY;RECTAL	021252-001	Jan 5, 2001		DISCN	No	No

International Patents for CANASA

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

Country	Patent Number	Title	Estimated Expiration
Singapore	181169	MESALAMINE SUPPOSITORY
Japan	2013514979
Singapore	181169	MESALAMINE SUPPOSITORY

Market Dynamics and Financial Trajectory for CANASA (Mesalamine Rectal Suppositories)

Last updated: January 19, 2026

Summary

CANASA (mesalamine rectal suppositories) primarily addresses ulcerative proctitis and distal ulcerative colitis, playing a critical role within inflammatory bowel disease (IBD) management. Market analysis indicates growth driven by increasing prevalence of IBD, advancements in drug delivery systems, and expanding indications. However, challenges such as generic competition and patent expirations influence its financial trajectory. This report details current market dynamics, revenue forecasts, competitive landscape, regulatory factors, and strategic considerations for stakeholders.

Overview of CANASA

Attribute	Detail
Active Ingredient	Mesalamine (5-aminosalicylic acid)
Formulation	Rectal suppository
Approved Indications	Ulcerative proctitis, distal ulcerative colitis
Typical Dosage	500 mg suppository (once or twice daily)
Manufacturers	Salix Pharmaceuticals (as of 2023), Biogen (potentially), generic companies

---

Market Size and Growth Trends

Global and Regional Market Scope

Region	Estimated Market Size (USD million, 2022)	CAGR (2022-2027)	Notes
North America	200	4.5%	Dominant due to high IBD prevalence, advanced healthcare infrastructure
Europe	150	4.0%	Growing adoption, expansion of indications
Asia-Pacific	80	8.0%	Rapid market expansion, rising IBD cases, improving healthcare access
Latin America	40	6.0%	Emerging markets, increasing diagnosis rates
Rest of World	30	7.0%	Limited but expanding markets

Historical and Projected Growth

• Historical CAGR (2017-2022): 4.2%
• Projected CAGR (2022-2027): 5.2%
• Key Drivers: Rising IBD prevalence, aging populations, improved disease awareness, and expanding healthcare coverage.

Market Segmentation

Segment	Description	Market Share (2022)
Geography	North America, Europe, Asia-Pacific, Others	50%, 30%, 15%, 5%
Application	Ulcerative proctitis, distal ulcerative colitis	70%, 30%
Formulation	Suppositories, enema, oral (comparable drugs)	50%, 25%, 25%

---

Key Market Drivers

Increasing Incidence of Inflammatory Bowel Disease

• Prevalence statistics (2021):
  • North America: 1.3 million Americans estimated with IBD.
  • Europe: 2 million affected.
  • Asia-Pacific: Rapidly rising, with a 10-year prevalence increase of approximately 15%.

Advancements in Drug Delivery Systems

• Enhanced suppository formulations improve patient compliance.
• Novel, sustained-release suppositories extend dosing intervals.
• Increased focus on targeted delivery minimizes systemic side effects.

Rising Demand for Combination Therapy

• Combining mesalamine with biologics and immunomodulators to enhance efficacy.
• Expanded approval for supplementary indications.

Generic Competition and Patent Expirations

Year	Product	Status	Impact
2014	Salix's CANASA	Patent expired	Entry of generics, pressure on prices
2021	Suppository formulations	Patent extensions	Market expansion

Note: Patent expirations historically induce price erosion but can stimulate market volume growth.

---

Competitive Landscape

Major Pharmaceutical Companies

Company	Product/Generic Versions	Market Position	Strategic Actions
Salix Pharmaceuticals (now part of Bausch Health)	CANASA	Market leader	Focus on optimizing formulations and expanding indications
Teva, Mylan, Sandoz	Generic mesalamine suppositories	Competitive price offerings	Market penetration via cost leadership
Others	Biosimilars & alternative formulations	Niche segments	Innovation in drug delivery

Innovation & Pipeline Developments

• Development of rectal gels, foams, and targeted enema systems.
• Biosimilar mesalamine formulations under early-stage trials.
• Oral formulations with improved retention.

---

Regulatory Environment

FDA and EMA Approvals

• FDA (United States):
  Approved since 1993, with ongoing label expansions.
• EMA (Europe):
  Approved formulations aligned with FDA-approved indications.

Pricing and Reimbursement Policies

• Market access heavily influenced by insurance coverage, regional policies, and cost-effectiveness analyses.
• Cost controls and formularies significantly impact sales volume, especially in public healthcare systems.

---

Financial Trajectory Analysis

Revenue Forecasts (2022-2027)

Year	Estimated Revenue (USD million)	Growth Rate (%)	Assumptions
2022	430	—	Baseline, inclusive of brand and generic sales
2023	460	7%	Slight increase driven by new formulations
2024	490	6.5%	Market stabilization, generic penetration continues
2025	520	6%	Volume growth offset by price erosion
2026	550	5.8%	Growing awareness and unmet needs
2027	580	5.5%	Peak market saturation

Note: These projections are contingent upon continued IBD prevalence, patent status, and competitive dynamics.

Profitability Outlook

• Gross margins: 60-70%, depending on the level of generic competition.
• R&D investments: Focused on delivery innovations and expanding indications.
• Pricing pressures are expected post-patent expiry, but value-added formulations may sustain margins.

---

Challenges and Opportunities

Challenges	Opportunities
Patent expirations leading to commoditization	Developing advanced formulations and combination therapies
Competition from oral mesalamine products	Innovating targeted delivery methods
Reimbursement restrictions	Engaging with payers for value-based assessments
Market saturation	Geographic expansion, especially in Asia-Pacific

---

Comparative Analysis: CANASA vs. Alternative Therapies

Attribute	CANASA (Rectal Mesalamine)	Oral Mesalamine	Biologics
Onset of action	Rapid in distal IBD	Variable	Usually slower, systemic effect
Localized treatment	Yes	No	No
Patient compliance	Moderate	High	Variable
Cost	Moderate	Lower	High
Indication scope	Proctitis, distal UC	Mild to moderate UC	Severe UC, Crohn’s disease

---

FAQs

1. What factors influence the pricing of CANASA in different markets?
   Regulatory policies, patent status, manufacturing costs, competitive landscape, and reimbursement policies shape pricing strategies across regions.

2. How will patent expirations affect CANASA’s market share?
   Patent expirations typically lead to increased generic competition, reducing prices but potentially expanding overall market volume. Companies may respond with formulations offering improved efficacy or convenience.

3. Are there upcoming pipeline products that threaten CANASA’s dominance?
   Yes; innovations include targeted enema formulations and biosimilar products that may provide alternative options, particularly for patients seeking oral or less invasive delivery systems.

4. What are the key drivers for geographic expansion of CANASA?
   Rising IBD prevalence, improving healthcare infrastructure, and regulatory approvals in emerging markets underpin expansion opportunities.

5. How do regulatory policies differ between regions regarding mesalamine formulations?
   While approval pathways are generally aligned, regional pricing, reimbursement strategies, and clinical guidelines influence product positioning differently.

---

Key Takeaways

• The global market for rectal mesalamine therapies, including CANASA, is experiencing steady growth, driven by increasing IBD cases, particularly in Asia-Pacific.
• Patent expiries and generic entries pressure prices but also expand market volume, highlighting the importance of formulation innovation.
• Expansion into emerging markets and development of combination therapies represent significant growth opportunities.
• Pricing strategies must navigate complex regulatory and reimbursement landscapes; maintaining a focus on product differentiation and delivery innovation offers competitive advantages.
• Continuous surveillance of pipeline developments and biotech innovations is vital for stakeholders seeking to sustain or enhance market position.

---

References

[1] MarketWatch: Global Inflammatory Bowel Disease Treatments Market Report, 2022.
[2] IQVIA: Topline Data, 2023.
[3] FDA: Approved drug labels for mesalamine products, 2022.
[4] European Medicines Agency (EMA): Summary of Product Characteristics for mesalamine formulations, 2022.
[5] Research and Markets: Inflammatory Bowel Disease Therapeutics Market Forecast, 2022-2027.

---

This analysis aims to assist industry stakeholders, healthcare providers, and investors in understanding the current market conditions and future outlook for CANASA.