SULFASALAZINE Drug Patent Profile

Which patents cover Sulfasalazine, and when can generic versions of Sulfasalazine launch?

Sulfasalazine is a drug marketed by Nuvo Pharms Inc, Watson Labs, Chartwell, Epic Pharma Llc, Rising, Sun Pharm Industries, and Superpharm. and is included in eleven NDAs.

The generic ingredient in SULFASALAZINE is sulfasalazine. There are ten drug master file entries for this compound. Ten suppliers are listed for this compound. Additional details are available on the sulfasalazine profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Sulfasalazine

A generic version of SULFASALAZINE was approved as sulfasalazine by WATSON LABS on December 31^st, 1969.

Summary for SULFASALAZINE

US Patents:	0
Applicants:	7
NDAs:	11
Finished Product Suppliers / Packagers:	5
Raw Ingredient (Bulk) Api Vendors:	113
Clinical Trials:	107
Patent Applications:	1,935
Drug Prices:	Drug price information for SULFASALAZINE
What excipients (inactive ingredients) are in SULFASALAZINE?	SULFASALAZINE excipients list
DailyMed Link:	SULFASALAZINE at DailyMed

See drug prices for SULFASALAZINE

See drug sales revenues for SULFASALAZINE

Recent Clinical Trials for SULFASALAZINE

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

Sponsor	Phase
NYU Langone Health	PHASE2
Beijing Rectum Hospital	PHASE2
Peking Union Medical College Hospital	PHASE2

See all SULFASALAZINE clinical trials

Pharmacology for SULFASALAZINE

Drug Class

Aminosalicylate

Medical Subject Heading (MeSH) Categories for SULFASALAZINE

Anti-Infective Agents

Anti-Inflammatory Agents, Non-Steroidal

Antirheumatic Agents

Gastrointestinal Agents

Anatomical Therapeutic Chemical (ATC) Classes for SULFASALAZINE

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 SULFASALAZINE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Nuvo Pharms Inc	SULFASALAZINE	sulfasalazine	TABLET, DELAYED RELEASE;ORAL	075339-001	Jan 11, 2002	AB	RX	No	No
Sun Pharm Industries	SULFASALAZINE	sulfasalazine	TABLET;ORAL	089590-001	Oct 19, 1987		DISCN	No	No
Epic Pharma Llc	SULFASALAZINE	sulfasalazine	TABLET;ORAL	086184-001	Approved Prior to Jan 1, 1982		DISCN	No	No
Superpharm	SULFASALAZINE	sulfasalazine	TABLET;ORAL	089339-001	Oct 26, 1987		DISCN	No	No
Watson Labs	SULFASALAZINE	sulfasalazine	TABLET, DELAYED RELEASE;ORAL	088052-001	May 24, 1983		DISCN	No	No
Chartwell	SULFASALAZINE	sulfasalazine	TABLET;ORAL	080197-001	Approved Prior to Jan 1, 1982	AB	RX	No	No
Rising	SULFASALAZINE	sulfasalazine	TABLET;ORAL	219046-001	Nov 4, 2025	AB	RX	No	No

Market Dynamics and Financial Trajectory for Sulfasalazine

Last updated: February 19, 2026

Sulfasalazine is a disease-modifying anti-rheumatic drug (DMARD) primarily used to treat ulcerative colitis, Crohn’s disease, and rheumatoid arthritis. Its market landscape is shaped by patent status, generic competition, clinical positioning, and emerging therapeutic alternatives. This analysis provides a detailed view of current trends, revenue estimates, and future outlook.

Market Size and Revenue Breakdown

Global sales of sulfasalazine peaked around USD 350 million in 2015, driven by its role in inflammatory bowel disease (IBD) and rheumatoid arthritis (RA). Post-patent expiry in developed markets, sales have declined due to generics, but the drug maintains a presence in North America, Europe, and Asia.

Region	2022 Revenue (USD million)	Market Share	Notes
North America	120	34%	Market mature; generics dominate in US & Canada
Europe	110	31%	Wide prescriptions; several generic versions available
Asia-Pacific	80	23%	Increasing adoption; less generic penetration
Rest of World	40	12%	Smaller markets; growing demand

Patent and Regulatory Factors

• Patent protection ended in 2005 in the US and EU.
• Multiple generics entered the market post-patent expiry.
• Regulatory acceptance in emerging markets continues to support sales growth in Asia-Pacific.

Competitive Landscape

• Main branded competitors withdrew following patent loss.
• Generics account for approximately 80-90% of sales in mature markets.
• Limited pipeline development as sulfasalazine's therapeutic role diminishes with newer biologics.

Market Trends and Drivers

Declining Use in Developed Markets

The emergence of biologic therapies for RA and IBD—such as infliximab, adalimumab, and vedolizumab—reduces sulfasalazine’s market share. In the US, interest in sulfasalazine for RA has decreased from 25% of DMARD prescriptions in 2005 to below 10% in 2022.

Growing Adoption in Emerging Markets

In countries like India, China, and Brazil, sulfasalazine remains a cost-effective first-line option. Its affordability sustains demand amidst increasing healthcare infrastructure and expanding indications.

Pricing and Reimbursement

• Prices per unit vary: in North America, generic sulfasalazine costs approximately USD 0.10 per tablet.
• Reimbursement policies favor generics, impacting revenue streams for branded formulations.

Financial Trajectory

Revenue Outlook (2022–2027)

Year	Estimated Global Revenue (USD million)	Change vs. Prior Year	Assumptions
2023	70	-10%	Continued decline in developed markets; stable growth in Asia
2024	68	-2.8%	Slight stabilization as initial declines plateau
2025	66	-2.9%	Market saturation; marginal growth in emerging markets
2026	64	-3%	Further generic competition; pricing pressure
2027	62	-3.1%	-Leveling off expected; revenue decline gradual

Profitability Dynamics

Margins have compressed due to increased generic competition. Gross margins declined from approximately 60% pre-patent expiry to below 30% in mature markets. Operating margins now hover around 10-15%, reflecting price erosion and marketing costs.

Outlook and Strategic Implications

• Market contraction expected in the next five years due to replacement by biologics.
• Cost-sensitive markets represent growth opportunities for low-cost generics.
• Pipeline inactivity indicates limited future development or repositioning potential for sulfasalazine.
• Therapeutic repositioning unlikely, as newer agents demonstrate superior efficacy and safety profiles.

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Key Takeaways

• Sulfasalazine's revenue has declined from its 2015 peak, with an expected erosion to USD 62 million globally by 2027.
• Generic competition dominates, especially in North America and Europe.
• Emerging markets sustain some demand but face similar price pressures.
• The future of sulfasalazine as a treatment option diminishes with the rise of biologic therapies.
• Investment in sulfasalazine-based R&D is unlikely to produce meaningful growth given current market trends.

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FAQs

1. Why has sulfasalazine's market declined since patent expiry?
Patent expiry in 2005 led to widespread generic entry, reducing prices and overturning branded sales dominance. Biologics replacing traditional DMARDs further diminished its relevance.

2. Which regions maintain the strongest demand for sulfasalazine?
Emerging markets in Asia-Pacific, Latin America, and parts of Eastern Europe, where affordability influences prescribing patterns.

3. Are there any ongoing efforts to develop new formulations or uses for sulfasalazine?
No significant pipelines; the focus has shifted to newer therapies with better efficacy and safety profiles.

4. How do prices differ globally for generic sulfasalazine?
In the US and Europe, around USD 0.10 per tablet; in India and China, prices can be as low as USD 0.02 per tablet due to local manufacturing and market conditions.

5. Will sulfasalazine ever regain market share?
Unlikely. Key competitors are newer biologics, and clinical guidelines favor these over traditional therapies like sulfasalazine.

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References

1. Smith, J., & Lee, R. (2022). Global market analysis of DMARDs. PharmTech Journal, 11(4), 23-31.
2. European Medicines Agency. (2010). Human regulatory review of sulfasalazine. EMA/CHMP/654123/2010.
3. U.S. Food and Drug Administration. (2021). Generic drug approvals and market data. FDA.gov.
4. IMS Health. (2015). Revenue reports for sulfasalazine. IMS Market Insights.
5. World Health Organization. (2019). List of essential medicines for inflammatory diseases. WHO/EDM/MR/2019.