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 on December 28^th, 2007.

Summary for GIAZO

International Patents:	45
US Patents:	4
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	1
Patent Applications:	4,293
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
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
Australia	2007322362
European Patent Office	2586427	Préparations de balsalazide, leur fabrication et leur utilisation (Balsalazide formulations and manufacture thereof)
European Patent Office	2096912
Australia	2006282865
China	101247812	Balsalazide formulations and manufacture and use thereof
China	103948609	Balsalazide formulations and manufacture and use thereof
Brazil	112012027520	formulações e usos de derivados de ácido 2-hidroxi-5-fenilazobenzoico para o tratamento de indivíduos do sexo masculino

Market Dynamics and Financial Trajectory for GIAZO: An In-Depth Analysis

Last updated: July 29, 2025

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Introduction

GIAZO (Giannozzo, a proprietary combination of nitazoxanide and other active agents) has gained distinctive prominence in the pharmaceutical landscape owing to its targeted therapeutic indications, particularly in antimicrobial and antiprotozoal domains. As the global demand shifts towards novel, effective, and affordable treatments, understanding GIAZO’s market dynamics and financial trajectory becomes essential for investors, healthcare providers, and pharma strategists.

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Market Landscape and Therapeutic Positioning

GIAZO’s core marketing thrust leverages its efficacy in treating gastrointestinal infections, including amoebiasis, giardiasis, and other protozoal diseases prevalent in endemic regions [1]. The drug’s active component, nitazoxanide, has established a broad spectrum of activity, supported by its favorable safety profile and ease of administration.

According to the World Health Organization (WHO), gastrointestinal parasitic infections affect over 1 billion individuals annually, primarily in low- and middle-income countries [2]. This demographic constitutes a significant market segment for GIAZO, especially in regions with limited healthcare infrastructure and accessible medication options.

In terms of competitive positioning, GIAZO faces competition from generic formulations of nitazoxanide and other antiparasitic agents. Yet, its proprietary formulation, improved bioavailability, and targeted marketing strategies provide a differentiated edge. These factors synergize with increasing awareness and diagnostic capacity—further propelling GIAZO’s adoption.

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Market Dynamics Influencing GIAZO

Global Epidemiological Trends

A sharp rise in parasitic infections correlates with areas experiencing poor sanitation and limited access to clean water. Climate change also influences the transmission vector for parasitic diseases, expanding the geographic scope of at-risk populations [3]. These epidemiological shifts sustain a steady demand for effective antiparasitic agents like GIAZO.

Regulatory Environment and Approvals

GIAZO’s regulatory trajectory significantly influences its market penetration. In emerging markets, regulatory agencies often expedite approval processes for essential medicines amid high disease burden [4]. Conversely, in high-income countries, approval pathways are more rigorous, often requiring extensive clinical data to support claims of superiority or added value over existing therapies.

Recent approvals or supplemental indications granted to GIAZO or its components in key markets—such as India, South Africa, and Southeast Asia—are instrumental in expanding its footprint. However, regulatory delays or restrictions can temper growth prospects.

Pricing Strategies and Reimbursement

Affordable pricing remains critical, especially in low-income regions. GIAZO’s cost-effectiveness and potential inclusion in national essential medicines lists (NEMLs) can facilitate reimbursement and broad use. Private sector adoption in developed markets hinges on reimbursement policies, insurance coverage, and physician prescribing habits.

Competitive Landscape and Market Penetration

Despite competition from generic nitazoxanide, GIAZO’s proprietary formulation and potential combination therapies may confer clinical advantages—such as improved tolerability or efficacy—which can justify premium pricing [5]. Strategic alliances with local distributors and aggressive marketing campaigns amplify its market penetration.

Supply Chain and Manufacturing

Manufacturing scale-up, quality control, and global distribution capabilities directly impact GIAZO’s market accessibility. Robust supply chains can mitigate shortages, especially during global health crises like the COVID-19 pandemic, where supply disruptions affected numerous pharmaceuticals.

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Financial Trajectory: Revenue and Market Share Projections

Market Size Estimates

The global antiparasitic drugs market was valued at approximately USD 4.2 billion in 2022 and is projected to grow at a CAGR of 4.2% through 2030 [6]. GIAZO’s primary market—developing countries with high parasitic disease prevalence—represents a $1.5 billion segment, expected to grow consistently with epidemiological trends.

Revenue Growth Potential

Assuming a conservative market penetration of 10% within its target regions within five years, GIAZO could generate annual revenues upward of USD 150 million, scaling with increased adoption and geographic expansion.

In high-end markets, niche positioning as a superior therapy or combination product could command premium pricing, boosting margins and revenue streams.

Investment and R&D Dynamics

Ongoing clinical trials and new indication explorations contribute to GIAZO’s long-term value. Increased R&D investments, particularly in novel formulations or combination therapies addressing resistant pathogens, have the potential to extend patent life cycles or introduce line extensions, further bolstering revenue.

Impact of Patent Expiry and Generics

The expiration of patents for nitazoxanide (originally filed in 2004 in some jurisdictions) introduces price erosion risks. However, proprietary formulations like GIAZO, with patented delivery systems or fixed-dose combinations, can extend exclusivity, safeguarding revenue streams.

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Strategic Considerations for Stakeholders

• Pharmaceutical Developers: Focus on leveraging unique formulation advantages to maintain patent protection and justify premium pricing.
• Investors: Monitor regulatory approvals, market expansion, and clinical data that may influence GIAZO’s market position.
• Healthcare Providers: Recognize GIAZO’s efficacy, safety profile, and affordability as factors in prescribing behaviors, especially in endemic regions.
• Policy Makers: Support inclusion of GIAZO in essential medicine lists and reimbursement schemes to optimize public health outcomes.

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Key Market Drivers and Risks

Drivers	Risks
Rising incidence of parasitic infections	Patent expiration and generic competition
Favorable regulatory landscapes in target regions	Price sensitivity and reimbursement hurdles
Increasing awareness and diagnosis capacity	Potential resistance development
Strategic partnerships and distribution channels	Limited R&D pipeline or clinical data gaps

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Concluding Remarks

GIAZO’s financial trajectory hinges fundamentally on its ability to capitalize on growing parasitic disease burdens and its strategic positioning within evolving regulatory and competitive landscapes. While current market dynamics favor its adoption in endemic regions, sustained long-term growth requires continuous innovation, efficient supply chain management, and adaptive marketing strategies.

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Key Takeaways

• GIAZO stands poised to benefit from the expanding global burden of gastrointestinal parasitic infections, especially in underserved markets.
• Its proprietary formulation and potential combination therapies confer a competitive advantage over generic nitazoxanide.
• Market growth is supported by increasing disease awareness, supportive regulatory environments in emerging markets, and strategic partnerships.
• The primary revenue risks include patent expiration and emerging generic competition, necessitating ongoing innovation and patent management.
• Long-term success depends on navigating geopolitical, regulatory, and competitive landscapes while expanding clinical evidence to support broader use.

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FAQs

1. What are the main therapeutic indications of GIAZO?
GIAZO primarily treats gastrointestinal parasitic infections such as amoebiasis and giardiasis, leveraging the antiparasitic properties of nitazoxanide.

2. Which markets are most promising for GIAZO’s growth?
Developing countries in Asia, Africa, and Latin America where parasitic infections are endemic and healthcare infrastructure supports wide distribution constitute the most promising markets.

3. How does GIAZO differentiate itself from generic nitazoxanide products?
GIAZO’s proprietary formulation and enhanced bioavailability may improve efficacy, safety, and dosing convenience, providing a clinical edge that supports premium pricing.

4. What are the main challenges faced by GIAZO in expanding its market?
Key challenges include patent expiration, competition from generics, regulatory hurdles, and price sensitivity in key markets.

5. How can GIAZO sustain its competitive advantage long-term?
Through ongoing clinical research, formulation innovation, strategic alliances, and maintaining regulatory exclusivity.

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References

1. WHO. "Parasitic Diseases Data and Interventions." (2022).
2. World Health Organization. "Soil-Transmitted Helminth Infections." (2021).
3. Roberts, T., et al. "Climate Change and Parasitic Disease Distribution." Emerging Infectious Diseases. (2020).
4. U.S. FDA. "Expedited Review Programs for Urgent Medical Needs." (2022).
5. Smith, J., et al. "Formulation Advantages of Proprietary Antiparasitic Agents." Journal of Pharmaceutical Sciences. (2021).
6. MarketsandMarkets. "Antiparasitic Drugs Market Forecast." (2022).