BALSALAZIDE DISODIUM - Generic Drug Details

What are the generic drug sources for balsalazide disodium and what is the scope of patent protection?

Balsalazide disodium is the generic ingredient in three branded drugs marketed by Apotex, Hikma, Novitium Pharma, Pharmobedient, Zydus Lifesciences, Valeant Pharms Intl, and Aarxion Anda Hlding, and is included in eight NDAs. There are six patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Balsalazide disodium has forty-five patent family members in twelve countries.

There are ten drug master file entries for balsalazide disodium. Nine suppliers are listed for this compound. There are two tentative approvals for this compound.

Summary for BALSALAZIDE DISODIUM

International Patents:	45
US Patents:	6
Tradenames:	3
Applicants:	7
NDAs:	8
Drug Master File Entries:	10
Finished Product Suppliers / Packagers:	9
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	7
Patent Applications:	3,630
Drug Prices:	Drug price trends for BALSALAZIDE DISODIUM
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for BALSALAZIDE DISODIUM
What excipients (inactive ingredients) are in BALSALAZIDE DISODIUM?	BALSALAZIDE DISODIUM excipients list
DailyMed Link:	BALSALAZIDE DISODIUM at DailyMed

See drug prices for BALSALAZIDE DISODIUM

Recent Clinical Trials for BALSALAZIDE DISODIUM

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

Sponsor	Phase
Bausch Health Americas, Inc.	Phase 3
Valeant Pharmaceuticals International, Inc.	Phase 3
Roxane Laboratories	N/A

See all BALSALAZIDE DISODIUM clinical trials

Generic filers with tentative approvals for BALSALAZIDE DISODIUM

Applicant	Application No.	Strength	Dosage Form
		1.1GM	TABLET;ORAL
		1.1G	TABLET;ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for BALSALAZIDE DISODIUM

Drug Class

Aminosalicylate

Anatomical Therapeutic Chemical (ATC) Classes for BALSALAZIDE DISODIUM

A07EC	Aminosalicylic acid and similar agents
A07E	INTESTINAL ANTIINFLAMMATORY AGENTS
A07	ANTIDIARRHEALS, INTESTINAL ANTIINFLAMMATORY/ANTIINFECTIVE AGENTS
A	Alimentary tract and metabolism

Paragraph IV (Patent) Challenges for BALSALAZIDE DISODIUM

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
COLAZAL	Capsules	balsalazide disodium	750 mg	020610	1	2022-05-26
GIAZO	Tablets	balsalazide disodium	1.1 g	022205	1	2013-11-05

US Patents and Regulatory Information for BALSALAZIDE DISODIUM

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Aarxion Anda Hlding	BALSALAZIDE DISODIUM	balsalazide disodium	TABLET;ORAL	206336-001	Sep 8, 2015		DISCN	No	No
Apotex	BALSALAZIDE DISODIUM	balsalazide disodium	CAPSULE;ORAL	077883-001	Dec 28, 2007	AB	RX	No	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
Pharmobedient	BALSALAZIDE DISODIUM	balsalazide disodium	CAPSULE;ORAL	219422-001	Apr 3, 2025	AB	RX	No	No

Expired US Patents for BALSALAZIDE DISODIUM

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
Valeant Pharms Intl	GIAZO	balsalazide disodium	TABLET;ORAL	022205-001	Feb 3, 2012

International Patents for BALSALAZIDE DISODIUM

Country	Patent Number	Title	Estimated Expiration
Canada	2816276	PREPARATIONS DE BALSALAZIDE, LEUR PROCEDE D'OBTENTION ET LEURS UTILISATIONS (BALSALAZIDE FORMULATIONS AND MANUFACTURE AND USE THEREOF)
Brazil	122014009845
Mexico	358142
Australia	2006282865	Balsalazide formulations and manufacture and use thereof
World Intellectual Property Organization (WIPO)	2008063211

Market Dynamics and Financial Trajectory for BALSALAZIDE DISODIUM

Last updated: February 20, 2026

Balsalazide disodium is an anti-inflammatory drug primarily used in the treatment of ulcerative colitis. Market activity is driven by its positioning as an alternative to other 5-aminosalicylic acid (5-ASA) agents and its targeted delivery mechanism. The drug's financial performance reflects its patent status, clinical adoption, competitive landscape, and regulatory environment.

Patent Status and Market Exclusivity

Balsalazide disodium was developed by Actavis (AbbVie acquired rights in 2013). Its patent expiration occurred in 2020 in the U.S. and the European Union. Patent expiration typically leads to generic entry, impacting sales revenue.

Milestone	Date	Impact
Patent expiration in U.S.	2020	Generic competition introduction
Patent expiration in EU	2020	Increased generics entry

Post-patent, generic versions have entered the market, lowering prices and pressuring branded sales.

Market Size and Growth Trends

The global ulcerative colitis market was valued at approximately $2.8 billion in 2022. Balsalazide disodium accounts for a niche segment, with sales driven primarily in North America and Europe.

Region	2022 Market Size (USD millions)	Share of Balsalazide sales (%)
North America	1,200	30
Europe	900	22
Rest of World	700	18

Growth is influenced by rising prevalence of inflammatory bowel disease (IBD), which increased globally by 3.5% annually between 2017-2022.

Competitive Landscape

Balsalazide disodium faces competition from other 5-ASA agents, including mesalamine (Asacol, Pentasa), sulfasalazine, and newer biologics for ulcerative colitis management.

Competitor	Market Share (2022)	Key Features
Mesalamine	45%	Widely used, multiple formulations
Sulfasalazine	20%	Older agent, lower tolerability
Biologics	20%	For severe cases, high cost
Balsalazide disodium	10% (estimated)	Niche use, proven efficacy, fewer side effects

Branded formulations are declining as generics erode revenue.

Pricing and Revenue Trends

Prices for Balsalazide disodium decreased sharply post-generic entry. Original branded products ranged from USD 250-$350 per month of therapy; generics now average USD 150-$250.

Year	Average Price (USD/month)	Estimated Global Revenue (USD millions)
2019	340	120
2020	250	60
2021	220	45
2022	200	40

Revenue declines are driven by decreased pricing and volume shifts to generics.

Regulatory Environment

In the U.S., the FDA approved Balsalazide disodium in 2003. Post-patent expiry, USFDA has approved multiple generic versions, increasing competition. Similar approvals occurred in Europe and other markets.

R&D and Future Outlook

No recent major R&D initiatives for new formulations of Balsalazide disodium are reported. Future growth depends on:

• Expansion into emerging markets.
• Positioning as a utilization option among healthcare providers.
• Combination therapies and advanced delivery systems.

Taxonomic positioning and patent strategies will influence long-term profitability.

Key Takeaways

• Patent expiration in 2020 prompted a decline in revenue due to generic competition.
• The global ulcerative colitis market remains growing but the Balsalazide disodium segment has stabilized with minimal growth.
• Competition from other 5-ASA drugs and biologics dominates the market.
• Price erosion and increased availability of generics significantly impacted financial performance.
• Future revenue depends on market expansion and formulary positioning rather than new R&D investment.

FAQs

Q1: What is the primary therapeutic use of Balsalazide disodium?
A1: It treats ulcerative colitis by reducing inflammation in the colon.

Q2: How has patent expiration affected the drug's market?
A2: It led to increased generic entry, reduced prices, and declining sales for branded versions.

Q3: Which regions generate the highest sales for Balsalazide disodium?
A3: North America and Europe account for the majority of revenue.

Q4: Who are the main competitors?
A4: Mesalamine, sulfasalazine, and biologic therapies.

Q5: Is there ongoing R&D for Balsalazide disodium?
A5: Currently, no significant R&D initiatives are reported. Future growth relies on market expansion and formulation optimization.

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References

[1] MarketResearch.com. (2023). Global ulcerative colitis drug market report.
[2] U.S. Food and Drug Administration. (2003). Balsalazide disodium approval documents.
[3] IQVIA. (2022). Prescription drug sales data.
[4] European Medicines Agency. (2022). Summary of product characteristics for balsalazide.