Suppliers and packagers for generic pharmaceutical drug: BALSALAZIDE DISODIUM

BALSALAZIDE DISODIUM

Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Apotex	BALSALAZIDE DISODIUM	balsalazide disodium	CAPSULE;ORAL	077883	ANDA	AvPAK	50268-102-13	30 BLISTER PACK in 1 BOX (50268-102-13) / 1 CAPSULE in 1 BLISTER PACK (50268-102-11)	2014-11-06
Apotex	BALSALAZIDE DISODIUM	balsalazide disodium	CAPSULE;ORAL	077883	ANDA	Apotex Corp.	60505-2575-0	10 BLISTER PACK in 1 CARTON (60505-2575-0) / 10 CAPSULE in 1 BLISTER PACK	2007-12-28
Apotex	BALSALAZIDE DISODIUM	balsalazide disodium	CAPSULE;ORAL	077883	ANDA	Apotex Corp.	60505-2575-3	30 CAPSULE in 1 BOTTLE (60505-2575-3)	2007-12-28
Apotex	BALSALAZIDE DISODIUM	balsalazide disodium	CAPSULE;ORAL	077883	ANDA	Apotex Corp.	60505-2575-4	350 CAPSULE in 1 BOTTLE (60505-2575-4)	2007-12-28
Apotex	BALSALAZIDE DISODIUM	balsalazide disodium	CAPSULE;ORAL	077883	ANDA	Apotex Corp.	60505-2575-7	280 CAPSULE in 1 BOTTLE (60505-2575-7)	2007-12-28

Balsalazide Disodium Supplier Landscape and Patent Activity

Last updated: February 19, 2026

This report analyzes the supplier landscape for balsalazide disodium, a pharmaceutical ingredient used in treating inflammatory bowel disease. Key manufacturers and their production capacities are identified, alongside an examination of patent filings to understand market exclusivity and potential generic entry points.

Who Are the Primary Suppliers of Balsalazide Disodium?

The global supply chain for balsalazide disodium is concentrated among a limited number of manufacturers, primarily located in Asia. These suppliers are crucial for both branded and generic drug formulations.

• Salix Pharmaceuticals (a Bausch Health Companies Inc. company): As the original marketer of the branded drug, Colazal, Salix Pharmaceuticals is a significant player, although its manufacturing base for the active pharmaceutical ingredient (API) may be outsourced.
• Dr. Reddy's Laboratories: This Indian pharmaceutical company is a notable producer of balsalazide disodium API. Its manufacturing facilities are approved by major regulatory bodies.
• Teva Pharmaceuticals: A leading global generic drug manufacturer, Teva likely sources or manufactures balsalazide disodium for its own generic formulations.
• Sun Pharmaceutical Industries Ltd.: Another major Indian pharmaceutical company with a broad API portfolio, Sun Pharma is a potential supplier or manufacturer.
• Mylan N.V. (now Viatris): As a large generic manufacturer, Mylan, now part of Viatris, would require a consistent supply of balsalazide disodium for its products.

Production Capacity and Geographic Distribution:

Data on specific production capacities for balsalazide disodium is not publicly disclosed by individual manufacturers. However, the trend in API manufacturing indicates a strong concentration in India and China due to cost advantages and established chemical synthesis infrastructure. Regulatory approvals from the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) are critical indicators of a supplier's ability to serve regulated markets. Manufacturers often highlight their Good Manufacturing Practice (GMP) compliance and the number of international regulatory inspections passed.

What is the Patent Landscape for Balsalazide Disodium?

The patent landscape for balsalazide disodium is characterized by its original composition of matter patents and subsequent process patents and formulation improvements. The expiry of these core patents has paved the way for generic competition.

Key Patent Expirations:

• Composition of Matter Patent: The primary patent covering the balsalazide disodium molecule itself has long since expired. This allowed for the introduction of generic versions once other market exclusivity periods ended.
• Formulation Patents: Patents related to specific pharmaceutical formulations, such as delayed-release capsules or novel delivery systems, may have offered extended protection. However, these are often challenged or circumvented by generic manufacturers developing bioequivalent formulations.
• Process Patents: Patents covering novel or improved methods of synthesizing balsalazide disodium can offer a degree of protection. However, the existence of multiple known synthetic routes often limits the longevity of this type of patent exclusivity.

Recent Patent Filings and Litigation:

While core patents have expired, ongoing patent filings may relate to:

• Polymorphs: New crystalline forms of balsalazide disodium could be patentable if they offer distinct therapeutic or manufacturing advantages.
• Impurity Profiles: Patents claiming specific, controlled impurity profiles might offer a niche form of protection.
• Combination Therapies: New uses or combinations of balsalazide disodium with other active ingredients could be subject to new patent applications.

Patent litigation is common in the pharmaceutical sector. Generic companies often challenge existing patents, and brand-name companies defend their intellectual property. For balsalazide disodium, litigation would likely center on whether a generic product infringes any valid, unexpired patents related to formulation or manufacturing processes.

What are the Regulatory Considerations for Balsalazide Disodium Suppliers?

Suppliers of balsalazide disodium must adhere to stringent regulatory requirements to ensure the quality, safety, and efficacy of the API.

• Good Manufacturing Practice (GMP): All manufacturing facilities must comply with GMP standards as defined by regulatory bodies like the FDA (21 CFR Parts 210 and 211) and the EMA. This includes rigorous controls over raw materials, manufacturing processes, quality control, and documentation.
• Drug Master Files (DMFs): API manufacturers typically submit DMFs to regulatory agencies. A DMF contains confidential, detailed information about facilities, processes, or articles used in the manufacturing, processing, packaging, and storing of human drug products. This allows regulatory bodies to review API quality without disclosing proprietary information to the drug product applicant.
• Inspections and Audits: Facilities are subject to regular inspections by regulatory authorities (e.g., FDA, EMA) and audits by their pharmaceutical clients. Successful inspection outcomes are critical for market access.
• Impurity Limits: Regulatory agencies set strict limits for impurities in APIs. Suppliers must demonstrate robust analytical methods to identify and quantify all process-related impurities and degradation products. For balsalazide disodium, potential impurities could arise from synthesis intermediates or degradation of the active molecule.
• Stability Data: Suppliers must provide comprehensive stability data demonstrating that the API remains within its specifications under defined storage conditions for its intended shelf life.

What is the Market Demand for Balsalazide Disodium?

The demand for balsalazide disodium is driven by the prevalence of ulcerative colitis and other inflammatory bowel diseases.

• Ulcerative Colitis Prevalence: Ulcerative colitis affects an estimated 1 million people in the United States and a similar number in Europe. Treatment options include aminosalicylates like balsalazide disodium, corticosteroids, and immunomodulators.
• Balsalazide Disodium as a Treatment: Balsalazide disodium is a prodrug that delivers 5-aminosalicylic acid (5-ASA) to the colon, where it exerts anti-inflammatory effects. It is prescribed for the treatment of active ulcerative colitis.
• Generic Market Impact: The availability of generic balsalazide disodium has increased accessibility and likely led to price erosion, potentially expanding overall market volume.
• Therapeutic Trends: While newer biologic therapies have gained traction for severe IBD, aminosalicylates remain a foundational treatment for mild to moderate ulcerative colitis.

Projected Demand Factors:

• Aging Population: The global aging population may contribute to an increased incidence of chronic diseases, including IBD.
• Diagnostic Advancements: Improved diagnostic capabilities can lead to earlier and more accurate identification of IBD cases.
• Healthcare Access: Expanding healthcare access in developing regions could increase the patient pool seeking treatment.

What are the Risks and Opportunities for Balsalazide Disodium Suppliers?

Suppliers of balsalazide disodium face a dynamic market with both inherent risks and emerging opportunities.

Risks:

• Pricing Pressure: Intense competition from multiple generic manufacturers, particularly those with low-cost production bases, exerts significant downward pressure on API prices.
• Regulatory Scrutiny: Evolving regulatory requirements, stricter impurity limits, and increased inspection frequency can raise compliance costs and pose challenges for less sophisticated manufacturers.
• Supply Chain Disruptions: Geopolitical instability, natural disasters, or unexpected plant shutdowns at key suppliers can disrupt the global supply chain, leading to shortages and price volatility.
• Patent Challenges: While core patents have expired, ongoing litigation or the emergence of new, albeit narrow, patents can create uncertainty and legal expenses.
• Emergence of Alternative Therapies: The development of novel and more effective treatments for ulcerative colitis, such as advanced biologics or small molecule inhibitors, could reduce the reliance on aminosalicylates over the long term.

Opportunities:

• Emerging Markets: Growing healthcare infrastructure and increased access to treatment in emerging economies represent a significant growth opportunity for API suppliers.
• Process Optimization: Developing and patenting more efficient, cost-effective, or environmentally friendly synthesis routes can provide a competitive advantage and potentially create new intellectual property.
• Quality and Reliability Differentiation: Suppliers who consistently demonstrate superior quality, robust regulatory compliance, and reliable supply chain management can command premium pricing and secure long-term contracts with major generic and branded pharmaceutical companies.
• Vertical Integration: Companies may explore backward integration into key starting materials or forward integration into finished dosage forms to capture more value along the supply chain.
• Specialty Formulations: Although balsalazide disodium is a mature product, there may be opportunities in developing novel delivery systems or combination products that offer specific patient benefits.

Key Takeaways

• The global supply of balsalazide disodium API is concentrated among a limited number of manufacturers, predominantly based in India and China.
• The original composition of matter patent for balsalazide disodium has expired, enabling generic competition.
• Suppliers must maintain strict adherence to GMP regulations, comprehensive DMF filings, and pass regular regulatory inspections.
• Demand is driven by the prevalence of ulcerative colitis, with generic availability increasing market access.
• Key risks for suppliers include intense pricing pressure, regulatory challenges, and supply chain disruptions, while opportunities lie in emerging markets, process innovation, and quality differentiation.

Frequently Asked Questions

1. What is the primary mechanism of action for balsalazide disodium? Balsalazide disodium is a prodrug that is cleaved in the colon by bacterial azoreductases into two molecules: 4-aminobenzoyl-beta-alanine and 5-aminosalicylic acid (5-ASA). The 5-ASA is the active moiety, which exerts local anti-inflammatory effects in the colonic mucosa.

2. Are there any known active patents that prevent the manufacturing of generic balsalazide disodium? While the core composition of matter patent has expired, manufacturers must ensure they do not infringe on any unexpired formulation, process, or polymorph patents that might be held by brand manufacturers or other entities. A thorough freedom-to-operate analysis is essential.

3. What regulatory agencies have authority over balsalazide disodium API manufacturing? Key regulatory agencies include the U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMA), Japan's Pharmaceuticals and Medical Devices Agency (PMDA), and national regulatory bodies in other major markets.

4. How does balsalazide disodium compare in efficacy to other aminosalicylates like mesalamine? Studies suggest comparable efficacy among various aminosalicylates for mild to moderate ulcerative colitis. The choice of agent can depend on factors such as delivery site, dosing regimen, patient tolerability, and cost. Balsalazide disodium is designed to deliver 5-ASA specifically to the colon.

5. What are the typical impurity profiles that API manufacturers must control for balsalazide disodium? Typical impurities can include unreacted starting materials, intermediates from the synthesis process, degradation products (e.g., from oxidation or hydrolysis), and potential byproducts of the azoreductase cleavage in vivo or during manufacturing. Manufacturers must identify, quantify, and control these to meet regulatory specifications.

Citations

[1] U.S. Food and Drug Administration. (n.d.). Code of Federal Regulations Title 21. Retrieved from https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm [2] European Medicines Agency. (n.d.). Guidance Documents. Retrieved from https://www.ema.europa.eu/en/human-regulatory/research-and-development/scientific-guidelines/pharmaceuticals [3] National Institute of Diabetes and Digestive and Kidney Diseases. (n.d.). Ulcerative Colitis. Retrieved from https://www.niddk.nih.gov/health-information/digestive-diseases/ulcerative-colitis