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. Forty 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:	6
Raw Ingredient (Bulk) Api Vendors:	181
Clinical Trials:	3
Patent Applications:	3,421
Drug Prices:	Drug price information for APRISO
Drug Sales Revenues:	Drug sales revenues 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

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
Salix	APRISO	mesalamine	CAPSULE, EXTENDED RELEASE;ORAL	022301-001	Oct 31, 2008
Salix	APRISO	mesalamine	CAPSULE, EXTENDED RELEASE;ORAL	022301-001	Oct 31, 2008
Salix	APRISO	mesalamine	CAPSULE, EXTENDED RELEASE;ORAL	022301-001	Oct 31, 2008

International Patents for APRISO

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

Country	Patent Number	Title	Estimated Expiration
Germany	19732903
World Intellectual Property Organization (WIPO)	9906027
Canada	2739465	COMPOSITIONS ET PROCEDES PERMETTANT DE TRAITER LES MALADIES INTESTINALES A L'AIDE DE MESALAMINE GRANULEE (COMPOSITIONS AND METHODS FOR THE TREATMENT OF BOWEL DISEASES WITH GRANULATED MESALAMINE)
World Intellectual Property Organization (WIPO)	2010040021

APRISO Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Apriso

Introduction to Apriso

Apriso, a brand name for the drug mesalamine, is a member of the 5-aminosalicylates drug class. It is commonly used to treat inflammatory bowel diseases (IBD), including ulcerative colitis and Crohn’s disease. Here, we will delve into the market dynamics and financial trajectory of Apriso.

Market Context: Inflammatory Bowel Diseases (IBD)

The global IBD drug market has been growing steadily, driven by increasing prevalence of IBD and advancements in treatment options. In 2018, the global IBD drug market was estimated at $7.2 billion, with biologic therapies dominating the market with a 65% share[1].

Drug Class and Competition

Apriso falls under the aminosalicylates category, which is one of the traditional and widely used drug classes for IBD treatment. However, the market is highly competitive, with other drug classes such as biologics, immunomodulators, and corticosteroids also playing significant roles. Biologics, in particular, have been growing at a CAGR of 3.6% in the early part of the forecast period, posing a competitive challenge to traditional drugs like Apriso[1].

Pricing and Cost

The cost of Apriso can be substantial. For a supply of 120 capsules of Apriso 0.375 g oral capsule, extended release, the price is around $547 for cash-paying customers. This price can vary depending on the pharmacy and does not include discounts or insurance coverage. A generic version of mesalamine is available, which can significantly reduce the cost, with prices starting from $79.78 for 20 capsules[5].

Revenue Forecasts

Historical data indicates that Apriso, along with other mesalamine-based drugs like Asacol and Lialda, has contributed significantly to the revenue in the IBD drug market. However, the revenue growth for these drugs has been impacted by the introduction of generic versions and the increasing market share of biologics. For instance, the generic competition has led to a scenario where the sales of branded mesalamine products like Apriso are expected to decline unless there are significant marketing and promotional efforts[4].

Distribution Channels

Apriso is distributed through various channels including hospital pharmacies, online pharmacies, and retail pharmacies. The distribution channel can influence the pricing and accessibility of the drug. For example, hospital pharmacies might have different pricing dynamics compared to retail pharmacies, affecting the overall revenue and market penetration of Apriso[1].

Regulatory and Market Trends

Regulatory changes and market trends play a crucial role in the financial trajectory of Apriso. For instance, the FDA's oversight and any warnings or letters related to promotional activities can impact sales. In the past, companies like Shire and Salix Pharmaceuticals have faced such issues, which can affect the brand's market performance[4].

Impact of Generic Competition

The availability of generic versions of mesalamine has significantly impacted the sales of branded products like Apriso. Generic competition reduces the pricing power of branded drugs, leading to lower revenues. For example, the generic version of mesalamine priced at $79.78 for 20 capsules is substantially cheaper than the branded Apriso, making it a more attractive option for cost-conscious patients and payers[5].

Strategic Partnerships and Corporate Trends

Companies involved in the IBD drug market, including those marketing Apriso, often engage in strategic partnerships, licensing arrangements, and acquisitions to stay competitive. These strategies can help in advancing new products, expanding market reach, and mitigating the impact of generic competition. For instance, collaborations between companies like Salix Pharmaceuticals and other pharmaceutical firms have been common in this market[4].

Patient Assistance Programs

To mitigate the high cost of Apriso and maintain market share, patient assistance programs, coupons, and copay cards are often offered. These programs help reduce the out-of-pocket costs for patients, making the drug more accessible and potentially stabilizing sales despite generic competition[5].

Financial Projections and Savings

Given the competitive landscape and the impact of generic competition, the financial projections for Apriso are likely to be modest. The drug's revenue is expected to decline as more patients opt for generic alternatives. However, the overall IBD drug market is expected to continue growing, driven by new drug launches and the increasing prevalence of IBD.

Key Takeaways

• Market Competition: Apriso faces significant competition from biologics and generic versions of mesalamine.
• Pricing Dynamics: The cost of Apriso is high, but generic versions offer a cheaper alternative.
• Distribution Channels: The drug is distributed through various channels, affecting its pricing and accessibility.
• Regulatory Impact: FDA actions and market trends can influence sales and market performance.
• Generic Competition: The availability of generic mesalamine significantly impacts Apriso's sales and revenue.
• Strategic Partnerships: Companies engage in partnerships and licensing to stay competitive.

FAQs

Q: What is Apriso used for? A: Apriso is used to treat inflammatory bowel diseases (IBD), including ulcerative colitis and Crohn’s disease.

Q: How much does Apriso cost? A: The cost of Apriso can be around $547 for a supply of 120 capsules, but generic versions are available at a significantly lower cost.

Q: What is the impact of generic competition on Apriso? A: Generic competition has reduced the sales and revenue of Apriso, as patients opt for the cheaper generic versions.

Q: How do patient assistance programs affect Apriso sales? A: Patient assistance programs help reduce the out-of-pocket costs for patients, making Apriso more accessible and stabilizing sales to some extent.

Q: What are the key trends in the IBD drug market affecting Apriso? A: The key trends include the growing market share of biologics, the impact of generic competition, and the importance of strategic partnerships and licensing arrangements.

Sources

1. Visiongain: Global Inflammatory Bowel Diseases (IBD) Drug Market forecasts from 2019-2029[1].
2. CMS: Medicare Drug Price Negotiation Program[2].
3. NBER: The Economics of Drug Development: Pricing and Innovation in a Changing Market[3].
4. FiercePharma: Reportlinker Adds Commercial Insight: Inflammatory Bowel Disease[4].
5. Drugs.com: Apriso Prices, Coupons, Copay Cards & Patient Assistance[5].