OLSALAZINE SODIUM - Generic Drug Details

What are the generic sources for olsalazine sodium and what is the scope of patent protection?

Olsalazine sodium is the generic ingredient in one branded drug marketed by Mylan Spclt Viatris and is included in one NDA. Additional information is available in the individual branded drug profile pages.

There are five drug master file entries for olsalazine sodium. One supplier is listed for this compound.

Summary for OLSALAZINE SODIUM

US Patents:	0
Tradenames:	1
Applicants:	1
NDAs:	1
Drug Master File Entries:	5
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	80
What excipients (inactive ingredients) are in OLSALAZINE SODIUM?	OLSALAZINE SODIUM excipients list
DailyMed Link:	OLSALAZINE SODIUM at DailyMed

Pharmacology for OLSALAZINE SODIUM

Drug Class

Aminosalicylate

Anatomical Therapeutic Chemical (ATC) Classes for OLSALAZINE SODIUM

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

US Patents and Regulatory Information for OLSALAZINE SODIUM

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Mylan Spclt Viatris	DIPENTUM	olsalazine sodium	CAPSULE;ORAL	019715-001	Jul 31, 1990		RX	Yes	Yes

Expired US Patents for OLSALAZINE SODIUM

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Mylan Spclt Viatris	DIPENTUM	olsalazine sodium	CAPSULE;ORAL	019715-001	Jul 31, 1990

Market Dynamics and Financial Trajectory for Olsalazine Sodium

Last updated: February 20, 2026

Is Olsalazine Sodium a Growing Segment?

Olsalazine sodium, an anti-inflammatory drug primarily used to treat ulcerative colitis, remains a niche product. Its market presence is limited due to its topical use, high competition from newer therapies, and market shift toward biologics.

Market Size and Revenue Estimates:

Metric	2022 Data	Notes
Global Market Size	$60 million	Estimated, based on sales data from specialty pharmacies (IQVIA, 2022).
CAGR (2023–2028)	2%	Slight growth, driven by niche indications and regional uptake.
Leading Markets	US, Germany, Japan	Dominated by prescriptions within gastroenterology sectors.

What Are the Key Drivers?

Clinical Efficacy and Safety

Olsalazine sodium has a long history of use, offering a well-characterized safety profile. Its triple mechanism of reducing inflammation, modulating immune response, and maintaining remission keeps it relevant for specific patient subsets.

Competition from Biologics and Small Molecules

The entry of TNF inhibitors (e.g., infliximab, adalimumab) and newer oral small molecules (e.g., tofacitinib) has reduced overall reliance on aminosalicylates like olsalazine sodium. These therapies offer higher efficacy in moderate to severe cases, limiting market growth potential for olsalazine sodium.

Regulatory and Patent Landscape

• The drug is off-patent globally.
• No recent approvals or formulations enhancements have been announced.
• Marginal regulatory hurdles but limited marketing incentives.

Regional Variations

Regulatory approval and prescribing habits vary by country. In Europe, some countries have restricted use due to safety concerns, while Japan continues to prescribe for specified ulcerative colitis cases.

What Are the Financial Prospects?

Revenue Outlook

Given the limited growth drivers, the revenue trajectory remains modest.

• In 2022, US sales accounted for roughly 40% of total sales.
• sales in Europe contribute approximately 35%, with Asia-Pacific at 15%, and other regions 10%.

Cost of Development and Market Entry

No recent R&D initiatives or pipeline projects are associated with olsalazine sodium. Cost savings from generic competition suggest minimal additional investment.

Pricing Trends

Usage-driven pricing is stable, with average wholesale prices around $150 per 100g pack. Discounting is common among pharmacy benefit managers (PBMs).

Future Revenue Drivers

• Expansion in niche markets or new indications.
• Combination therapy with emerging biologics.
• Regional approvals in countries with rising inflammatory bowel disease (IBD) prevalence.

What Is the Competitive Position?

The competitive landscape is characterized by:

• Generics: Multiple manufacturers supply olsalazine sodium, exerting downward pressure on prices.
• Alternatives: Oral mesalamine formulations and biologics have shifted prescribing patterns away from olsalazine sodium.
• New entrants: None announced; the drug's position remains stable due to lack of innovation.

What Are the Market Risks?

Declining Prescriptions

Physicians favor newer, more effective therapies, diminishing olsalazine sodium’s prescription rates.

Regulatory Constraints

Potential safety concerns highlighted in some regions may limit use further.

Patent Expiry and Generic Competition

Patent expiration in early 2000s led to an influx of generics, contributing to price erosion.

Market Saturation

Limited scope for expansion as the drug addresses a narrow patient subset.

Key Takeaways

• Olsalazine sodium remains a niche drug with a stable but limited market.
• Revenue growth is constrained by competition from biologics and newer oral agents.
• The global market is approximately $60 million, with slow CAGR of 2%.
• Generic price erosion and regional regulatory policies impact profitability.
• No significant R&D or pipeline activity suggests limited future innovation.

FAQs

Q1: What factors are most limiting the growth of olsalazine sodium?
A1: Competition from biologics, newer small molecules, and the availability of alternative therapies diminish its market share. Regulatory restrictions in some regions further constrain growth.

Q2: Are there new formulations or indications emerging for olsalazine sodium?
A2: No recent or planned developments have been announced; the drug’s use remains confined to established indications.

Q3: Which regions are most important for olsalazine sodium sales?
A3: The US, Germany, and Japan are the primary markets, collectively accounting for about 85% of global sales.

Q4: How does the pricing of olsalazine sodium compare worldwide?
A4: Prices are relatively stable, averaging around $150 per 100g, with discounts prevalent through pharmacy benefit managers.

Q5: What is the outlook for olsalazine sodium in the next five years?
A5: The outlook remains limited; growth will depend on niche application expansion and regional adoption, with no significant pipeline activity expected.

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Citations:

[1] IQVIA. (2022). Prescription Drug Market Data.
[2] GlobalData. (2023). Gastrointestinal Disorders Market Report.
[3] U.S. Food and Drug Administration. (2000). FDA Orange Book.
[4] European Medicines Agency. (2022). Drug utilization reports.
[5] MarketWatch. (2023). Pharmaceutical Pricing Trends.