COLAZAL Drug Patent Profile

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

Colazal is a drug marketed by Valeant Pharms Intl and is included in one NDA. There are two patents protecting this drug and one Paragraph IV challenge.

This drug has thirty-six patent family members in twelve countries.

The generic ingredient in COLAZAL is balsalazide disodium. There are ten drug master file entries for this compound. Nine suppliers are listed for this compound. Additional details are available on the balsalazide disodium profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Colazal

A generic version of COLAZAL was approved as balsalazide disodium by APOTEX INC on December 28^th, 2007.

Summary for COLAZAL

International Patents:	36
US Patents:	2
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	221
Clinical Trials:	4
Patent Applications:	4,188
Drug Prices:	Drug price information for COLAZAL
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for COLAZAL
What excipients (inactive ingredients) are in COLAZAL?	COLAZAL excipients list
DailyMed Link:	COLAZAL at DailyMed

See drug prices for COLAZAL

Recent Clinical Trials for COLAZAL

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

Sponsor	Phase
Roxane Laboratories	N/A
Mylan Pharmaceuticals	Phase 1

See all COLAZAL clinical trials

Pharmacology for COLAZAL

Drug Class

Aminosalicylate

Paragraph IV (Patent) Challenges for COLAZAL

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
COLAZAL	Capsules	balsalazide disodium	750 mg	020610	1	2022-05-26

US Patents and Regulatory Information for COLAZAL

COLAZAL 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
Valeant Pharms Intl	COLAZAL	balsalazide disodium	CAPSULE;ORAL	020610-001	Jul 18, 2000	AB	RX	Yes	Yes	7,452,872*PED				Y
Valeant Pharms Intl	COLAZAL	balsalazide disodium	CAPSULE;ORAL	020610-001	Jul 18, 2000	AB	RX	Yes	Yes	7,625,884*PED				Y

Expired US Patents for COLAZAL

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Valeant Pharms Intl	COLAZAL	balsalazide disodium	CAPSULE;ORAL	020610-001	Jul 18, 2000	4,412,992*PED

International Patents for COLAZAL

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

Country	Patent Number	Title	Estimated Expiration
Australia	2006282865	Balsalazide formulations and manufacture and use thereof
Canada	2620091	PREPARATIONS DE BALSALAZIDE, LEUR PROCEDE D'OBTENTION ET LEURS UTILISATIONS (BALSALAZIDE FORMULATIONS AND MANUFACTURE AND USE THEREOF)
Singapore	6885
Israel	198513	הרכבים ושימושים בתולדות חומצה 2-הידרוקסי-5-פנילאזובנזואית (Formulations and uses of 2-hydroxy-5-phenylazobenzoic acid derivatives)
World Intellectual Property Organization (WIPO)	2008063211
Japan	6067203
Brazil	PI0615195	preparaÇço farmacÊutica, embalagem, uso de balsalazida, e, mÉtodo para fabricar uma cÁpsula e para testar dissoluÇço de cÁpsulas de balsalazida

COLAZAL Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for COLAZAL

Introduction to COLAZAL

COLAZAL, also known as balsalazide disodium, is a medication primarily used to treat mild to moderate ulcerative colitis, a type of inflammatory bowel disease (IBD). It belongs to the class of 5-aminosalicylates, which are crucial in managing IBD.

Market Drivers

Increasing Prevalence of IBD

The rising incidence of ulcerative colitis and Crohn's disease is a significant driver for the COLAZAL market. As diagnostic capabilities improve and healthcare awareness increases, more individuals are being identified with these conditions, leading to a higher demand for effective treatments like balsalazide[1][4].

Technological Advancements

Technological developments in pharmaceutical formulations and administration methods are enhancing treatment outcomes and patient compliance. These advancements are driving up demand for balsalazide, as they improve the efficacy and ease of use of the medication[4].

Growing Awareness of Gastrointestinal Health

Increased awareness about gastrointestinal health and the importance of early diagnosis and treatment of IBD are contributing to the growth of the balsalazide market. This awareness is prompting more patients to seek medical care, thereby increasing the demand for COLAZAL[4].

Market Size and Forecast

Current Market Size

The balsalazide market, which includes COLAZAL, was valued at USD 100 billion in 2023. This valuation is part of a broader market that includes various applications and product forms such as capsules and tablets[4].

Forecasted Growth

The market is expected to grow at a Compound Annual Growth Rate (CAGR) of 10% from 2024 to 2031, reaching a projected value of USD 194.5 billion by 2031. This growth is driven by the increasing incidence of IBD, technological advancements, and rising healthcare costs and accessibility[4].

Financial Performance of COLAZAL

Historical Revenue

Prior to 2008, COLAZAL accounted for a majority of the revenue for Salix Pharmaceuticals, the company that developed and marketed the drug. For example, in the nine months ended September 30, 2012, Salix Pharmaceuticals reported net product revenues of $537.271 million, with a significant portion attributed to COLAZAL[2].

Cost and Expenses

The financial reports of Salix Pharmaceuticals indicate that the costs associated with producing and marketing COLAZAL, including the cost of products sold and amortization of product rights and intangibles, were substantial. For instance, in the nine months ended September 30, 2012, the cost of products sold was $93.918 million, and the amortization of product rights and intangible assets was $34.034 million[2].

Net Income and Cash Flow

Despite significant costs, Salix Pharmaceuticals reported a net income of $46.623 million for the nine months ended September 30, 2012. The company also experienced a net increase in cash and cash equivalents, reflecting positive cash flow from operations and financing activities[2].

Geographical Segmentation

The market for COLAZAL is segmented across various geographical regions, including North America, Europe, Asia-Pacific, South America, and the Middle East and Africa. Each region presents different market dynamics, with North America and Europe being key markets due to higher healthcare costs and greater awareness of IBD[1][4].

Distribution Channels

The distribution of COLAZAL occurs through various channels, including hospitals, drugstores, and online pharmacies. The expansion of online pharmacies and improved healthcare infrastructure are facilitating easier access to the medication, contributing to market growth[4].

Competitive Landscape

The market for 5-aminosalicylates, including COLAZAL, is competitive with several pharmaceutical companies involved in the development and marketing of similar drugs. Companies like Bausch Health, which has a significant presence in the gastrointestinal health market with products like XIFAXAN, are also players in this competitive landscape[5].

Challenges and Opportunities

Unmet Clinical Needs

Despite the growth potential, the 5-aminosalicylates market, including COLAZAL, faces challenges related to unmet clinical needs in ulcerative colitis. Addressing these needs through innovative products and formulations presents opportunities for market expansion[1].

Research and Development

Continuous research and development efforts aimed at improving treatment regimens for IBD offer opportunities for COLAZAL and similar drugs. Collaborations with research institutions and the development of new pipeline products are crucial for maintaining market relevance[3].

Key Takeaways

• The market for COLAZAL is driven by the increasing prevalence of IBD, technological advancements, and growing awareness of gastrointestinal health.
• The balsalazide market is expected to grow significantly, reaching USD 194.5 billion by 2031.
• COLAZAL has historically been a significant revenue generator for Salix Pharmaceuticals.
• Geographical segmentation and distribution channels play critical roles in the market dynamics.
• The competitive landscape is marked by several pharmaceutical companies, and addressing unmet clinical needs presents opportunities for growth.

FAQs

What is COLAZAL used for?

COLAZAL, or balsalazide disodium, is primarily used to treat mild to moderate ulcerative colitis, a type of inflammatory bowel disease (IBD).

What are the key drivers of the COLAZAL market?

The key drivers include the increasing prevalence of IBD, technological advancements in pharmaceutical formulations, and growing awareness of gastrointestinal health.

What is the forecasted growth rate of the balsalazide market?

The balsalazide market is expected to grow at a CAGR of 10% from 2024 to 2031.

Which regions are key markets for COLAZAL?

North America and Europe are key markets due to higher healthcare costs and greater awareness of IBD.

What are the main distribution channels for COLAZAL?

The main distribution channels include hospitals, drugstores, and online pharmacies.

Sources

1. IndustryARC: 5-Aminosalicylates Drugs Market Share, Size and Industry Growth.
2. EDGAR Online: SALIX PHARMACEUTICALS LTD (Form.
3. Annual Reports: 2018 - Annual Reports.
4. Market Research Intellect: Global balsalazide market size and forecast.
5. Bausch Health: 2022 ANNUAL REPORT - Bausch Health Companies Inc.