GIAZO Drug Patent Profile

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

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

This drug has forty-five patent family members in twelve countries.

The generic ingredient in GIAZO 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 Giazo

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

Summary for GIAZO

International Patents:	45
US Patents:	4
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	102
Patent Applications:	4,079
Drug Prices:	Drug price information for GIAZO
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for GIAZO
DailyMed Link:	GIAZO at DailyMed

See drug prices for GIAZO

Paragraph IV (Patent) Challenges for GIAZO

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
GIAZO	Tablets	balsalazide disodium	1.1 g	022205	1	2013-11-05

US Patents and Regulatory Information for GIAZO

GIAZO is protected by four 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	GIAZO	balsalazide disodium	TABLET;ORAL	022205-001	Feb 3, 2012		DISCN	Yes	No
Valeant Pharms Intl	GIAZO	balsalazide disodium	TABLET;ORAL	022205-001	Feb 3, 2012		DISCN	Yes	No
Valeant Pharms Intl	GIAZO	balsalazide disodium	TABLET;ORAL	022205-001	Feb 3, 2012		DISCN	Yes	No

Expired US Patents for GIAZO

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Valeant Pharms Intl	GIAZO	balsalazide disodium	TABLET;ORAL	022205-001	Feb 3, 2012

International Patents for GIAZO

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

Country	Patent Number	Title	Estimated Expiration
South Korea	20140098863	FORMULATIONS AND USES OF 2-HYDROXY-5-PHENYLAZOBENZOIC ACID DERIVATIVES
New Zealand	603744	Balsalazide formulations and manufacture and use thereof
Brazil	PI0717859	mÉtodos para aumentar a biodisponibilidade de um composto de 5-aminossalicilato, para aumentar a biodisponibilidade de 5-asa para o càlon de um indivÍduo, para retardar o trÂnsito de 5-asa no càlon de um indivÍduo, para diminuir o nÍvel sistÊmico de 5-asa em um indivÍduo, para diminuir a concentraÇço plasmÁtica mÁxima de um composto de 5-aminossalicilato em um indivÍduo, para retardar a tmax de um composto de 5-aminossalicilato em um indivÍduo, para diminuir o grau de absorÇço de um composto de 5-aminossalicilato em um indivÍduo, para aumentar a razço sistÊmica de nasa para 5-asa em um indivÍduo, para aumentar a conversço de 5-asa para nasa em um indivÍduo, para diminuir a taxa e grau de absorÇço de uma forma de dosagem oral de balsalazida, para usar balsalazida, e, para inibir o crescimento de uma espÉcie bacteriana em um indivÍduo humano

GIAZO Market Analysis and Financial Projection

Market Dynamics and Financial Trajectory for the Drug: GIAZO

Introduction

GIAZO, a locally acting aminosalicylate, is indicated for the treatment of mildly to moderately active ulcerative colitis in male patients 18 years of age and older. Here, we delve into the market dynamics and financial trajectory of GIAZO, exploring its launch, clinical efficacy, market positioning, and the challenges it has faced.

Clinical Efficacy and Approval

GIAZO (balsalazide disodium) was approved by the FDA, but its approval process was not without challenges. The drug's efficacy was established in male patients through a single, placebo-controlled trial (Study BZUC3002), which showed significant clinical improvement in males but not in females[2][5].

Market Launch and Initial Reception

Despite its approval, GIAZO faced a tumultuous launch. The drug was initially expected to launch in 2010, but it encountered manufacturing issues and gender-specific efficacy concerns that delayed its market entry. The FDA highlighted these issues, particularly the large and unexplained difference in treatment effects between genders, which rendered the trial inadequate as a standalone support for marketing approval[2].

Market Positioning

GIAZO is positioned in the inflammatory bowel disease (IBD) market, specifically targeting ulcerative colitis. The IBD market is significant, with sales projected to grow from $3.5 billion in 2009 to $5.6 billion in 2019 across the seven major markets (US, 5EU, and Japan)[1].

Competitive Landscape

The IBD market is highly competitive, with several established brands and new therapies in development. GIAZO competes with other aminosalicylates like Lialda (mesalazine MMX) and Apriso (mesalazine), as well as biologics and immunomodulators. The market is driven by new drug launches, increased use of biologics, and changes in treatment guidelines[1].

Financial Projections and Performance

Initial Sales Projections

GIAZO was not expected to achieve high sales figures. Datamonitor forecasted that GIAZO would not exceed sales of $20 million, which is relatively modest compared to other drugs in the same category[1].

Pricing and Cost Considerations

The financial trajectory of GIAZO is also influenced by pricing and cost considerations. The drug's pricing strategy must balance the need for revenue with the pressure from healthcare systems to control costs. In the IBD market, cost and safety are critical factors that dictate future market prospects[1].

Challenges and Threats

Gender-Specific Efficacy

One of the significant challenges for GIAZO is its lack of demonstrated efficacy in female patients. This limitation restricts its market potential and makes it less competitive compared to drugs with broader efficacy profiles[2][5].

Manufacturing Issues

The drug faced manufacturing issues that led to a Complete Response (CR) letter from the FDA, delaying its approval and affecting its market entry. These issues had to be resolved before the drug could be approved and marketed effectively[2].

Regulatory Environment

The regulatory environment, particularly in the US, poses additional challenges. The FDA's tightening of marketing controls and the potential for increased generic competition can impact GIAZO's market share and financial performance[1].

Opportunities

Market Expansion

Despite the challenges, there are opportunities for GIAZO in markets with high IBD diagnosis rates. For example, Japan has one of the highest IBD diagnosis rates among the major markets, offering potential for expansion[1].

Changing Treatment Guidelines

Changes in treatment guidelines, such as the 2010 ECCO guidelines, can also create opportunities for GIAZO. These guidelines can influence prescribing practices and increase the use of certain therapies, including aminosalicylates like GIAZO[1].

Key Takeaways

• Limited Efficacy: GIAZO's efficacy is established only in male patients, limiting its market potential.
• Competitive Market: The IBD market is highly competitive, with GIAZO competing against established brands and new therapies.
• Pricing and Cost: Cost and safety considerations are crucial in the IBD market, affecting GIAZO's pricing strategy and financial performance.
• Regulatory Challenges: Manufacturing issues and regulatory hurdles have impacted GIAZO's market entry and approval.
• Market Opportunities: Despite challenges, GIAZO has potential in markets with high IBD diagnosis rates and through changes in treatment guidelines.

FAQs

Q: What is GIAZO indicated for?

GIAZO is indicated for the treatment of mildly to moderately active ulcerative colitis in male patients 18 years of age and older[4][5].

Q: Why did GIAZO face delays in its market entry?

GIAZO faced delays due to manufacturing issues and concerns over its efficacy, particularly the significant difference in treatment effects between genders[2].

Q: How does GIAZO compare to other IBD treatments?

GIAZO competes with other aminosalicylates and biologics in the IBD market. Its limited efficacy in only male patients makes it less competitive compared to drugs with broader efficacy profiles[1][4].

Q: What are the key challenges for GIAZO in the market?

Key challenges include its limited efficacy, manufacturing issues, regulatory hurdles, and the competitive nature of the IBD market[1][2].

Q: Are there any opportunities for GIAZO in the market?

Yes, GIAZO has potential in markets with high IBD diagnosis rates and through changes in treatment guidelines that could favor its use[1].

Sources

1. Reportlinker Adds Commercial Insight: Inflammatory Bowel Disease
   • Reportlinker.com, August 25, 2010
2. 022205Orig1s000 - FDA
   • accessdata.fda.gov
3. Trajectories of prices in generic drug markets: what can we infer
   • PubMed, July 11, 2022
4. Giazo (Balsalazide Disodium): Side Effects, Uses, Dosage
   • RxList
5. Giazo - BauschHealth Prescribing Information
   • BauschHealth