CANASA Drug Patent Profile

When do Canasa patents expire, 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-seven 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
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for CANASA

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			Y
Abbvie	CANASA	mesalamine	SUPPOSITORY;RECTAL	021252-002	Nov 5, 2004	AB	RX	Yes	Yes			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
Canada	2784772	SUPPOSITOIRE DE MESALAMINE (MESALAMINE SUPPOSITORY)
Japan	2013514979
Singapore	181169	MESALAMINE SUPPOSITORY
Mexico	2012006902	SUPOSITORIO DE MESALAMINA. (MESALAMINE SUPPOSITORY.)
World Intellectual Property Organization (WIPO)	2011084638
Singapore	181169	MESALAMINE SUPPOSITORY
Canada	2690450	SUPPOSITOIRE A BASE DE MESALAMINE (MESALAMINE SUPPOSITORY)

Investment Scenario and Fundamentals Analysis for CANASA (Mesalamine Rectal Suppository, 1000 mg)

Last updated: February 20, 2026

What is the product profile of CANASA?

CANASA is a brand name for mesalamine (5-aminosalicylic acid), a drug approved by the U.S. Food and Drug Administration (FDA) for the treatment of ulcerative proctitis. It is available as a rectal suppository designed to deliver targeted therapy to the distal colon and rectum.

• Therapeutic class: Anti-inflammatory, aminosalicylate.
• Formulation: Suppository, 1000 mg.
• Indication: Mild to moderate ulcerative proctitis.
• Manufacturers: Historically marketed by Allergan, now by Salix Pharmaceuticals and other generics.

What are the market fundamentals for CANASA?

Market size and demand drivers

The global ulcerative colitis market is valued at approximately USD 5.5 billion as of 2022, with a compound annual growth rate (CAGR) of 4.8% projected through 2030[1]. Direct treatment segments for proctitis, a localized form of ulcerative colitis, account for 10-15% of this market.

• Prevalence: An estimated 1 million people in the U.S. suffer from ulcerative colitis, with 20-30% presenting with proctitis or distal disease[2].
• Treatment paradigm: Depends on disease severity, location, and patient response. Rectal formulations like CANASA are preferred for distal disease due to targeted delivery and fewer systemic side effects.

Competitive landscape

• Generic availability: Multiple generics exist, leading to price erosion.
• Alternative formulations: Oral mesalamine (e.g., Asacol, Apriso, Pentasa), enema formulations, and newer biologics for more severe cases.
• Market share: CANASA's penetration has declined moderately due to competition but remains standard for initial localized therapy.

Pricing and reimbursement

• Average wholesale price (AWP): Approximately USD 330 per suppository (as of 2022).
• Reimbursement rates: Favorable for prescriptions, though insurance coverage varies based on formulary status and regional policies.
• Cost-effectiveness: Due to its targeted approach, CANASA remains a first-line therapy for mild-to-moderate proctitis but faces pressure from cheaper generics.

What are the key economic and regulatory factors?

Regulatory landscape

• Patent status: The original patent expired in 2014, leading to significant generic competition.
• Regulatory approvals: Approved for rectal use by the FDA; no recent new indications or formulations pending approval.
• Reimportation and compounding: Regulatory restrictions limit the use of compounded forms; reimportation is not common.

Pricing pressures and market dynamics

• Generic competition: Dominates the market, reducing profit margins.
• Formulation innovations: No recent improvements or new delivery systems introduced.
• Market consolidation: Some independent generics manufacturers dominate local markets.

Patent extensions or exclusivity

• No patent exclusivity protections remain; market control is primarily through brand loyalty and clinician preference.

What are the R&D and pipeline considerations?

• Pipeline activity: Limited, as no new formulations or indications for CANASA are under development.
• Potential for reformulation: Market interest exists for sustained-release or novel systems but remains speculative.

What are the investment implications?

• Revenue prospects: Marginal growth expected; largely dependent on volume due to pricing pressures from generics.
• Profit margins: Likely declining or stabilized at low levels because of intense price competition.
• Market risks: Patent expiration impact, increasing generic competition, and pressure to develop new formulations.

Key risks and opportunities

Risks	Opportunities
Patent expiry and generic erosion	Market penetration for targeted delivery products
Price competition from generics	Potential reformulation for improved compliance
Limited pipeline for new indications	Market growth driven by rising incidence in UC

Summary

CANASA remains a niche product within a mature, highly competitive market. Its sales are primarily driven by standard-of-care indications for rectal ulcerative colitis. Financially, it faces limited growth and declining profitability due to patent expiration and generic competition, with little pipeline activity or recent innovation to offset these pressures.

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Key Takeaways

• Market size for rectal mesalamine is stable but constrained by generics.
• Price erosion and low margins are ongoing risks.
• No recent patent protection or significant pipeline activity.
• Prescription volume driven by localized ulcerative colitis treatment preferences.
• Future growth depends on reformulation opportunities or new indications, none currently in advanced development.

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FAQs

1. Why has CANASA's market share declined?
The decline results from increased availability of generics, lower-priced alternatives, and shifting treatment preferences toward oral formulations and biologics.

2. Are there opportunities for innovative formulations of mesalamine?
Yes, sustained-release systems and combination therapies are under exploration, but none are currently approved for rectal delivery specifically.

3. How does pricing pressure impact potential investment returns?
Pricing pressure, driven by generics and reimbursement policies, compresses profit margins and reduces revenue growth prospects.

4. What is the likelihood of regulatory hurdles affecting CANASA?
Regulatory hurdles are minimal; the product is already approved. The main concern is patent expiration and market competition.

5. Could new indications revive the product’s growth?
Possible, but no current pipeline suggests near-term development of additional indications or formulations.

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References

[1] Mordant, M. (2022). Global ulcerative colitis market insights. Pharmaceutical Market Watch.

[2] Silverberg, M. S., et al. (2019). Inflammatory Bowel Disease: Epidemiology and Management. Gastroenterology Clinics, 48(4), 671–686.