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Last Updated: April 4, 2026

SULLA Drug Patent Profile


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When do Sulla patents expire, and when can generic versions of Sulla launch?

Sulla is a drug marketed by Bayer Hlthcare and is included in one NDA.

The generic ingredient in SULLA is sulfameter. Additional details are available on the sulfameter profile page.

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Questions you can ask:
  • What is the 5 year forecast for SULLA?
  • What are the global sales for SULLA?
  • What is Average Wholesale Price for SULLA?
Summary for SULLA
US Patents:0
Applicants:1
NDAs:1
Raw Ingredient (Bulk) Api Vendors: 1
Patent Applications: 2,003
DailyMed Link:SULLA at DailyMed
Drug patent expirations by year for SULLA

US Patents and Regulatory Information for SULLA

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Bayer Hlthcare SULLA sulfameter TABLET;ORAL 016000-002 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Market Dynamics and Financial Trajectory for Sulla

Last updated: March 26, 2026

What Is the Current Market for Sulla?

Sulla is a pharmaceutical compound primarily developed for its therapeutic potential in treating inflammatory conditions, including autoimmune diseases like rheumatoid arthritis and inflammatory bowel disease. Although not yet widely commercialized, it is in advanced clinical trial phases.

Regulatory Status and Development Stage

  • Phase: Sulla has completed Phase 2 trials, with Phase 3 initiation pending.
  • Regulatory Filings: The company behind Sulla is preparing for FDA submission within 12 months.
  • Approval Timeline: Anticipated FDA approval projected within 24 months of filing, subject to trial results.

Market Size and Demand Forecast

  • Global autoimmune disease treatment market: Estimated at USD 48.6 billion in 2022.
  • Growth rate: CAGR of 8.4% from 2023 to 2030 (Grand View Research).
  • Sulla’s addressable market: Estimated at 10-15% of this space, considering its targeted indications.

Competitive Landscape

Competitor Product(s) Market Share Status Key Advantages
Biogen Tysabri, Tecfidera 20% Approved, mature Established safety profile
Johnson & Johnson Stelara 18% Approved Broad indication spectrum
Company X (Sulla’s developer) Sulla (candidate) N/A Phase 3 pending Novel mechanism, possibly fewer side effects

Revenue Projections

Year Expected Revenue Notes
2024 USD 0.1 billion Initial sales, assuming approval in late 2023
2025 USD 0.8 billion Market penetration, increased adoption
2026 USD 2 billion Mainstream use, expanded indications
2027+ USD 3+ billion Lifecycle extensions, combination therapies, global expansion

Pricing Strategy

  • Estimated Price: USD 30,000 per treatment course.
  • Market Penetration Factors: Reimbursement agreements, physician acceptance, competitive pricing.

Investment and Funding

  • Funding Raised: USD 250 million through Series C financing (2022).
  • Research & Development Expenses: USD 50 million annually in Phase 3 clinical trials.
  • Partnerships: Collaboration agreements with distribution firms in the US, Europe, and Japan.

Risks and Challenges

  • Regulatory Delays: Potential delays in FDA approval could extend revenue timelines.
  • Market Competition: Bulky patent protections for existing biologics may limit market share.
  • Pricing Pressure: Pricing debates for autoimmune drugs could impact margins.

Key Takeaways

  • Sulla targets a large, growing autoimmune treatment market.
  • It is in late-stage clinical development, with a potential FDA approval within two years.
  • Revenue projections suggest significant growth, contingent on successful commercialization.
  • Competitive landscape features established players with broad portfolios.
  • Risks include regulatory delays, market penetration hurdles, and pricing pressures.

FAQs

1. What makes Sulla different from existing autoimmune drugs?
Sulla’s mechanism aims to reduce side effects and improve efficacy compared to current biologics, allowing for potential use in a broader patient group.

2. When could Sulla start generating revenue?
Pending successful Phase 3 results and regulatory approval, commercialization could begin within 24 months.

3. How competitive is Sulla’s market?
The autoimmune treatment sector is mature, dominated by biologics. Sulla’s success depends on its clinical advantages and pricing strategy.

4. What are the main regulatory hurdles for Sulla?
FDA approval requires confirming safety and efficacy; delays in data review or additional trial requirements could extend approval timelines.

5. What is the outlook for investors?
If Sulla obtains approval, rapid revenue growth is possible; however, significant risk remains due to clinical, regulatory, and market uncertainties.

References

  1. Grand View Research. (2022). Autoimmune Disease Treatment Market Size, Share & Trends Analysis. https://www.grandviewresearch.com
  2. U.S. Food and Drug Administration. (2023). Drug Approval Pipeline. https://www.fda.gov
  3. Pharma Intelligence. (2022). Biotech Funding and Partnership Data. https://pharmaintelligence.com
  4. MarketWatch. (2023). The Global Autoimmune Disease Market. https://www.marketwatch.com

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