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
Israel	189104
South Korea	20090118906	FORMULATIONS AND USES OF 2-HYDROXY-5-PHENYLAZOBENZOIC ACID DERIVATIVES
New Zealand	565974
Japan	2013032395	FORMULATION AND USE OF 2-HYDROXY-5-PHENYLAZOBENZOIC ACID DERIVATIVE

Market Dynamics and Financial Trajectory for GIAZO

Last updated: February 20, 2026

What is GIAZO?

GIAZO is a proprietary formulation combining a non-steroidal anti-inflammatory drug (NSAID), typically ursodiol or other active ingredients, with a proprietary delivery system designed for enhanced bioavailability. It is developed primarily for gastrointestinal disorders, including hepatitis B and C, cholelithiasis, and other inflammatory conditions affecting the liver and biliary tract.

Market Overview

The global gastrointestinal therapeutics market was valued at approximately USD 45.3 billion in 2021 and projected to reach USD 61.9 billion by 2027, growing at a CAGR of 5.2% (Fortune Business Insights, 2022). GIAZO's niche positions it within this expanding landscape, targeting liver-related indications often under-served by existing therapies.

Key Market Drivers

• Rising prevalence of fatty liver disease, hepatitis, and gallstone disease increases the demand for effective treatments.
• Advancements in drug delivery technology improve bioavailability, making formulations like GIAZO attractive.
• Unmet medical needs in chronic liver disease management sustain demand for innovative therapeutics.

Competitive Landscape

Major competitors include established NSAIDs and liver-specific drugs such as:

• Ursodiol (Actigall, Urso)
• Obeticholic acid (Ocaliva)
• Tenofovir and Entecavir for hepatitis B
• Novel pipeline agents for liver fibrosis

GIAZO distinguishes itself with proprietary formulation technology, promising improved efficacy and fewer side effects.

Regulatory Status and Approval Challenges

GIAZO's approval depends heavily on clinical trial data demonstrating safety, efficacy, and bioavailability advantages over existing therapies. Regulatory pathways vary:

• United States: Requires FDA approval via NDA submission backed by phase 3 trials showing clinical benefit.
• European Union: Needs a centralized or national authorization following quality, safety, and efficacy assessment.

Limited approvals globally as of 2023 suggest a cautious regulatory environment, slowing market entry.

Financial Trajectory

Revenue Potential

GIAZO's revenue forecast hinges on several factors:

• Market penetration rate of 1-5% in initial five years among target indications.
• Pricing assumptions: USD 500-1000 per treatment course, aligning with current NSAID and liver drug prices.
• Pricing strategy: Premium positioning due to proprietary technology.

Estimated five-year revenues:

Year	Units Sold (millions)	Average Price (USD)	Revenue (USD millions)
2023	1	800	0.8
2024	5	850	4.3
2025	15	900	13.5
2026	30	950	28.5
2027	50	1000	50.0

This indicates a gradually increasing revenue profile, assuming successful regulatory approval, market entry, and minimal competition.

Cost Considerations

Investments include:

• Development costs: Clinical trials, regulatory filings (~USD 150-200 million over five years).
• Manufacturing: Scale-up and quality assurance.
• Marketing: Launch campaigns, physician education, and distribution channels.

Break-even is projected around Year 4, contingent on market adoption.

Investment Risks

• Regulatory delays extending time-to-market.
• Competitive entry from existing or pipeline drugs diminishing market share.
• Pricing pressures driven by payers and reimbursement policies.
• Clinical efficacy risks if trial data underperform expectations.

Market Entry Strategies

• Early engagement with regulatory agencies.
• Strategic licensing or partnership deals with established pharma companies.
• Focused targeting of specialized hepatology and gastroenterology centers.

Long-term Outlook

If GIAZO secures approval and gains market acceptance, revenue streams could scale with expansion into additional indications or geographic markets. Out-licensing or partnership arrangements could further enhance financial prospects.

Key Takeaways

• GIAZO operates within a high-growth market for gastrointestinal and liver therapeutics.
• Proprietary formulation technology grants potential differentiation.
• Regulatory approval timelines and clinical trial success are critical determinants of financial trajectory.
• Revenue projections indicate a gradual ramp-up over five years, with substantial upside for successful commercialization.
• Competitive landscape and pricing pressures pose ongoing risks.

FAQs

1. What are the primary therapeutic indications for GIAZO?

GIAZO is designed for gastrointestinal ailments, including hepatitis B and C, liver inflammation, and gallstone disease.

2. How does GIAZO's technology improve upon existing NSAID formulations?

It uses a proprietary delivery system to enhance bioavailability, potentially reducing side effects and improving efficacy.

3. What is the core regulatory challenge for GIAZO?

Securing approval requires robust clinical trial data demonstrating safety, superior efficacy, and bioavailability over existing therapies.

4. What is the revenue outlook for GIAZO in the next five years?

Forecasted revenues range from USD 0.8 million in 2023 to USD 50 million in 2027, assuming successful market entry and adoption.

5. Who are GIAZO’s main competitors?

Existing drugs such as ursodiol (Actigall), obeticholic acid (Ocaliva), and other hepatitis or liver-targeted therapies.

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Citations

[1] Fortune Business Insights. (2022). Gastrointestinal therapeutic market size, share & industry analysis. Retrieved from https://www.fortunebusinessinsights.com

[2] U.S. Food and Drug Administration. (2023). Drug approval process overview. Retrieved from https://www.fda.gov

[3] European Medicines Agency. (2023). Marketing authorization procedures. Retrieved from https://www.ema.europa.eu