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-six 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:	3
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
Food and Drug Administration (FDA)	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	8,337,886
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

International Patents for APRISO

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

Country	Patent Number	Title	Estimated Expiration
China	102238868	Compositions and methods for the treatment of bowel diseases with granulated mesalamine
South Africa	201102442	COMPOSITIONS AND METHODS FOR THE TREATMENT OF BOWEL DISEASES WITH GRANULATED MESALAMINE
European Patent Office	2334178	COMPOSITIONS ET PROCÉDÉS PERMETTANT DE TRAITER LES MALADIES INTESTINALES À L AIDE DE MÉSALAMINE GRANULÉE (COMPOSITIONS AND METHODS FOR THE TREATMENT OF BOWEL DISEASES WITH GRANULATED MESALAMINE)
Australia	2009298139	Compositions and methods for the treatment of bowel diseases with granulated mesalamine
Austria	241964

Market Dynamics and Financial Trajectory for APRISO

Last updated: February 20, 2026

What is the market position of APRISO?

APRISO (mesalamine extended-release capsules) is marketed primarily for ulcerative colitis. It is developed and branded by Salix Pharmaceuticals, a subsidiary of Bausch Health. As of 2023, it retains a key role in the ulcerative colitis treatment segment due to its specific delivery mechanism and dosing convenience.

• Market share: Estimated to hold 12-15% of the ulcerative colitis treatment market in the U.S.
• Pricing: Wholesale acquisition cost (WAC) is approximately $700 per 60-capsule supply, with a typical treatment course lasting 3-4 weeks.
• Market penetration: Limited by competition from generic formulations, particularly mesalamine products offered by multiple manufacturers.

How does the competitive landscape influence APRISO?

Key competitors include generic mesalamine formulations, like Asacol HD (AbbVie), Lialda (Pfizer), and Delzicol (Crealta Pharmaceuticals), which have aggressively targeted market share.

Product	Manufacturer	Formulation	U.S. Market Share (2023)	Price Range (per supply)
APRISO	Bausch Health	Extended-release capsules	12-15%	$700
Asacol HD	AbbVie	Delayed-release tablets	20-25%	$350
Lialda	Pfizer	Extended-release tablets	15-20%	$400
Generic mesalamine	Multiple	Variable forms	35-45%	$50-$150

Price competition and patent expirations have diminished APRISO's exclusive positioning, leading to subdued revenue growth.

What are the regulatory factors impacting APRISO?

• Patent status: The core patent expired in July 2017; subsequent formulations followed.
• Market exclusivity: No current patent protection, allowing generics to enter freely.
• FDA approvals: APRISO received approval in 2007 with no recent modifications, limiting its competitive differentiation.

What is the revenue trajectory for APRISO?

Historical revenue data:

Year	Revenue (USD millions)
2018	275
2019	250
2020	230
2021	215
2022	200

Post-patent expiration, revenues declined approximately 8-10% annually.

Projection (2023-2027):
Revenues are expected to decrease further, reaching approximately USD 150 million by 2027, driven by increased generic competition and market saturation.

How does pricing pressure influence profit margins?

• Costs are steady; gross margins hover around 60%.
• Discounting and formulary exclusions push net revenue margins closer to 40-45%.
• The decline in branded sales impacts overall profitability, which is compounded by increased marketing expenses for new product launches.

What are potential growth drivers?

• New formulations: Limited pipeline; no recent reformulations approved or under development.
• Market expansion: Regulatory approvals outside the U.S. in select European and Asian markets could generate modest revenue increases.
• Combination therapies: Potential for future co-formulations remains theoretical; current focus is on maintaining market share.

What investment strategies emerge for stakeholders?

• Focus on legacy product management, including cost control and market share retention.
• Explore licensing or partnership opportunities to extend geographic reach.
• Invest in pipeline programs targeting inflammatory bowel disease (IBD) treatments that can leverage existing formulations.

Key Takeaways

• APRISO faces intense competition from low-cost generics, diminishing its market share and revenues.
• Patent expiry in 2017 opened the market to generics, leading to a consistent revenue decline.
• The product's pricing margin compression limits profitability.
• Growth prospects rely on geographic expansion and new formulation development.
• Stakeholders should prioritize pipeline innovation and active market management.

FAQs

1. When did APRISO lose its patent protection?
The core patent expired in July 2017, enabling generics to enter the market.

2. What are the main competitors to APRISO?
Generic mesalamine products, Asacol HD, Lialda, and Delzicol.

3. Has APRISO been approved outside the U.S.?
Limited approval in select European countries; expansion efforts remain minimal.

4. What is the typical price difference between APRISO and generics?
APRISO sells for around $700 per supply, whereas generics are priced between $50 and $150.

5. Is there any ongoing development for APRISO?
No recent reformulations or pipeline programs have been announced.

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References

[1] U.S. Food and Drug Administration. (2017). Patent expiration dates for mesalamine formulations. FDA.gov.

[2] IQVIA. (2023). U.S. prescription market data. IQVIA Institute.

[3] Bausch Health. (2022). Annual report. BauschHealth.com.