ASACOL Drug Patent Profile

When do Asacol patents expire, and when can generic versions of Asacol launch?

Asacol is a drug marketed by Apil and Abbvie and is included in two NDAs.

The generic ingredient in ASACOL 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 Asacol

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

Summary for ASACOL

US Patents:	0
Applicants:	2
NDAs:	2
Raw Ingredient (Bulk) Api Vendors:	181
Clinical Trials:	35
Patent Applications:	4,122
Drug Prices:	Drug price information for ASACOL
What excipients (inactive ingredients) are in ASACOL?	ASACOL excipients list
DailyMed Link:	ASACOL at DailyMed

See drug prices for ASACOL

See drug sales revenues for ASACOL

Recent Clinical Trials for ASACOL

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

Sponsor	Phase
Shiraz University of Medical Sciences	Phase 1/Phase 2
ZonMw: The Netherlands Organisation for Health Research and Development	Phase 3
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)	Phase 3

See all ASACOL clinical trials

Paragraph IV (Patent) Challenges for ASACOL

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
ASACOL	Delayed-release Tablets	mesalamine	400 mg	019651	1	2007-06-22

US Patents and Regulatory Information for ASACOL

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Apil	ASACOL	mesalamine	TABLET, DELAYED RELEASE;ORAL	019651-001	Jan 31, 1992		DISCN	No	No
Abbvie	ASACOL HD	mesalamine	TABLET, DELAYED RELEASE;ORAL	021830-001	May 29, 2008		DISCN	Yes	No

Expired US Patents for ASACOL

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Apil	ASACOL	mesalamine	TABLET, DELAYED RELEASE;ORAL	019651-001	Jan 31, 1992
Apil	ASACOL	mesalamine	TABLET, DELAYED RELEASE;ORAL	019651-001	Jan 31, 1992

International Patents for ASACOL

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

Country	Patent Number	Title	Estimated Expiration
United Kingdom	2123695	ORALLY ADMINISTRABLE PHARMACEUTICAL COMPOSITIONS
Canada	1172570	COMPOSES PHARMACEUTIQUES ADMINISTRES PAR VOIE ORALE (ORALLY ADMINISTRABLE PHARMACEUTICAL COMPOSITIONS)
Japan	S58501174
Finland	85216
South Africa	8205384
Italy	1149328	COMPOSIZIONE FARMACEUTICA PER LA SOMMINISTRAZIONE PER VIA ORALE DI COMPOSTI CHE DEBBONO ESSERE ASSORBITI NELL'INTESTINO CRASSO

ASACOL Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for the Drug: ASACOL

Introduction

ASACOL, a brand name for mesalamine, is a crucial medication in the treatment of inflammatory bowel diseases (IBD), particularly ulcerative colitis and Crohn's disease. This article delves into the market dynamics and financial trajectory of ASACOL, highlighting key factors influencing its market position and future prospects.

Market Overview

The global market for 5-aminosalicylates (5-ASA) drugs, which include ASACOL, has been impacted by several significant factors.

Impact of COVID-19

The COVID-19 pandemic introduced substantial challenges to the 5-ASA market, including disruptions in global supply chains, delays in production and distribution, and a shift in healthcare priorities towards managing COVID-19 cases. This redirection of resources affected the diagnosis and treatment of chronic conditions like IBD, potentially influencing the demand for ASACOL[1].

Geopolitical Factors

The ongoing Ukraine crisis has also introduced uncertainties, potentially disrupting the global supply chain for pharmaceuticals, including 5-ASA medications. Ukraine's role as a significant exporter of raw materials for pharmaceuticals means that any disruptions could lead to shortages and increased production costs for ASACOL[1].

Market Segmentation

The market for ASACOL can be segmented in several ways:

By Disease Type

• Ulcerative Colitis: ASACOL is a first-line treatment for active ulcerative colitis and is crucial for maintaining clinical remission. The rising incidence of ulcerative colitis drives demand for this medication[4].
• Crohn’s Disease: While ASACOL is more commonly used for ulcerative colitis, it also has applications in the treatment of Crohn’s disease, contributing to its market share[1].

By Patient Type

• Mild, Moderate, and Severe Cases: ASACOL is used across various severity levels of IBD, with different formulations tailored to specific patient needs[1].

By Distribution Channel

• Retail Pharmacies: A significant portion of ASACOL prescriptions are filled through retail pharmacies.
• Hospital Pharmacies: Hospital pharmacies also play a crucial role, especially for patients requiring immediate or specialized care.
• Online Pharmacies: The rise of online pharmacies has provided additional channels for patients to access ASACOL, enhancing convenience and accessibility[1].

Regional Market Dynamics

North America

North America dominates the market for 5-ASA drugs, including ASACOL, due to advanced healthcare practices, high treatment rates, and the presence of numerous market players. Government policies and the continuous development of innovative treatments further fuel the growth in this region[1].

Europe and Asia-Pacific

Europe and the Asia-Pacific region also represent significant markets, with growing healthcare investments and increasing awareness about IBD treatments driving demand for ASACOL. Countries like the UK, Germany, France, and Japan are key markets within these regions[1].

Financial Performance

The financial performance of ASACOL is closely tied to the overall market for 5-ASA drugs.

Revenue and Growth

The global 5-ASA market, which includes ASACOL, is projected to grow at a CAGR of 6.2% from 2024 to 2030, reaching a market size of $5.7 billion by 2030. This growth is driven by the increasing prevalence of IBD and the expanding patient base[1].

Competitive Landscape

The market for ASACOL is competitive, with several pharmaceutical companies involved. The transition from brand-name to generic products is a significant factor, as generic products often gain market share due to state laws allowing pharmacists to substitute them for brand-name medications[3].

Challenges and Opportunities

High Levels of Unmet Clinical Need

Despite the availability of ASACOL, there remains a high level of unmet clinical need in the treatment of ulcerative colitis. This presents both a challenge and an opportunity for pharmaceutical companies to innovate and diversify their product portfolios[1].

Regulatory and Formulation Changes

Historical examples, such as the efforts by Procter & Gamble (P&G) and Warner Chilcott to reformulate ASACOL to remove dibutyl phthalate (DBP), highlight the importance of regulatory compliance and formulation changes. These changes can impact market dynamics and patient adherence[3].

Patient Support and Research

Growing Patient Support Programs

Patient support programs have become increasingly important, providing opportunities for market growth. These programs help in improving patient adherence and outcomes, which in turn can drive demand for ASACOL[4].

Research and Development

Continuous research and development in the field of IBD treatments are crucial for the growth of the ASACOL market. New product releases and improving investment in healthcare, especially in developing countries, are expected to further boost the market[4].

Key Takeaways

• Market Growth: The 5-ASA market, including ASACOL, is expected to grow significantly due to the increasing prevalence of IBD.
• Regional Dominance: North America dominates the market due to advanced healthcare practices and high treatment rates.
• Challenges: The market faces challenges from supply chain disruptions, geopolitical instability, and the transition to generic products.
• Opportunities: High unmet clinical needs and growing patient support programs present opportunities for market growth and innovation.

FAQs

1. What is ASACOL used for? ASACOL is used primarily for the treatment of ulcerative colitis and Crohn’s disease, which are types of inflammatory bowel diseases (IBD).

2. How has the COVID-19 pandemic affected the ASACOL market? The COVID-19 pandemic has disrupted global supply chains, delayed production and distribution, and shifted healthcare priorities, potentially affecting the demand for ASACOL.

3. What are the key regions for the ASACOL market? North America, Europe, and the Asia-Pacific region are the key markets for ASACOL, driven by advanced healthcare practices and growing healthcare investments.

4. What are the challenges faced by the ASACOL market? The market faces challenges from supply chain disruptions, geopolitical instability, high levels of unmet clinical need, and the transition to generic products.

5. What are the opportunities for growth in the ASACOL market? Opportunities for growth include addressing high unmet clinical needs, expanding patient support programs, and continuous research and development in IBD treatments.

Sources

1. IndustryARC: 5-Aminosalicylates Drugs Market Share, Size and Industry Growth.
2. Allergan: Allergan Reports Fourth Quarter and Full-Year 2019 Financial Results.
3. Casetext: In re Asacol Antitrust Litig.
4. MarketStatsville: Mesalamine Market Share Size Value Analysis and Forecast 2027.