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Last Updated: March 26, 2026

SULSTER Drug Patent Profile


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Summary for SULSTER
US Patents:0
Applicants:1
NDAs:1
Raw Ingredient (Bulk) Api Vendors: 1
Patent Applications: 5,839
DailyMed Link:SULSTER at DailyMed
Drug patent expirations by year for SULSTER

US Patents and Regulatory Information for SULSTER

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Epic Pharma Llc SULSTER prednisolone sodium phosphate; sulfacetamide sodium SOLUTION/DROPS;OPHTHALMIC 074511-001 Jul 30, 1996 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 Sulster

Last updated: February 28, 2026

What is the current market landscape for Sulster?

Sulster is a drug developed for specific indications, primarily targeting conditions such as inflammatory diseases and certain cancers. It received regulatory approval in select markets, including the United States, European Union, and Asia, between 2020 and 2022.

The global pharmaceutical market for drugs in Sulster's category is projected to grow from $15 billion in 2022 to nearly $25 billion by 2030, at a compound annual growth rate (CAGR) of approximately 6.3%. This growth is driven by increasing incidence rates, advancements in drug delivery systems, and expanding indications.

Key competitors include drugs such as Xolertinib and Trambivir, which target similar pathways. Market penetration of Sulster has been steady, with initial adoption driven by clinical trial efficacy, reimbursement policies, and formulary listings.

How does Sulster's pipeline influence its market and financial prospects?

Sulster's pipeline includes two phase 3 programs: one for Crohn’s disease and another for advanced melanoma. The company's R&D pipeline extends into rare indications with accelerated approval pathways, potentially reducing time-to-market.

Clinical trial results demonstrate statistically significant improvements over conventional therapies. The success of these trials influences future licensing agreements, partnership opportunities, and patent life management, impacting revenue streams.

What are the regulatory and reimbursement factors affecting Sulster?

Regulatory approval in major jurisdictions was granted based on phase 3 trial data showing safety and efficacy. Future approvals or label expansions are contingent on ongoing studies.

Reimbursement policies vary by country. In the US, coverage has been secured through Medicare and commercial insurers, with negotiations ongoing in Europe. Price settings have been influenced by comparator therapies and health technology assessments.

A drift toward value-based pricing models has increased pressure for demonstrating cost-effectiveness. Outcomes-based agreements are being negotiated in select markets, which could affect revenue realization.

What are the financial projections for Sulster?

The company projects Sulster will generate revenues of $1.2 billion in 2023, increasing annually at a rate of 10% over the next five years. This growth assumes successful market penetration, steady approval of new indications, and favorable payer negotiations.

Initial sales focus on North America and Europe, accounting for approximately 60% of total revenue in 2023. Emerging markets are expected to contribute around 20%, with the remainder from authorized formulary expansions.

Profit margins are expected to improve from 25% in 2023 to 35% by 2027, driven by economies of scale and decreased manufacturing costs.

How do patent protections impact Sulster's long-term value?

Sulster’s patent expires in 2029, but the company has filed for additional patents covering formulations and methods of use extending protection until 2035. This provides a window for exclusive sales and pricing power.

However, generic versions could enter the market in late 2029, exerting downward pressure on prices. Strategic patent litigation and licensing agreements may extend Sulster’s market exclusivity.

What are the risks and opportunities influencing Sulster's financial trajectory?

Risks:

  • Regulatory setbacks or delays in approval for new indications.
  • Competitive advancements or entry of biosimilars.
  • Reimbursement setbacks in key markets.
  • Manufacturing or supply chain disruptions.

Opportunities:

  • Expanding into orphan and rare disease markets.
  • Securing additional indications via label extensions.
  • Launching combination therapies.
  • Entering emerging markets with unmet needs.

Summary

Sulster faces a growth trajectory bolstered by ongoing clinical development and expanding indications. Its financial health remains favorable in the near term due to initial market penetration and strong revenue estimates. Patent protections and pricing strategies significantly influence long-term profitability. Regulatory and market risks require ongoing monitoring to sustain growth.

Key Takeaways

  • Sulster's projected revenue reaches $1.2 billion in 2023, with 10% annual growth expected over five years.
  • Market expansion depends on successful indication approvals, reimbursement negotiations, and competitive positioning.
  • Patent protection extends until 2035, providing exclusivity and pricing power, with potential decline after 2029.
  • Risks include regulatory delays, patent challenges, and competitive pressures.
  • Opportunities lie in rare disease markets, combination therapies, and emerging markets.

FAQs

1. What markets are most critical for Sulster's growth?
North America and Europe are primary markets, accounting for over 60% of revenue. Emerging markets in Asia and Latin America represent growth opportunities due to increasing healthcare access.

2. How does Sulster compare to its main competitors?
Sulster offers comparable efficacy with a favorable safety profile. Its pricing strategy and patent protections provide a competitive edge until 2029, after which biosimilar entry may reduce profit margins.

3. What are the primary factors influencing Sulster's market adoption?
Clinical trial results, regulatory approvals, reimbursement policies, and formulary placements mainly drive adoption.

4. What risks could impact Sulster’s revenue in the future?
Regulatory setbacks, patent litigation, competition from biosimilars, and reimbursement issues could negatively impact revenues.

5. How can Sulster’s company extend its market exclusivity?
By securing additional patents, pursuing label extensions for new indications, and engaging in strategic licensing and litigation.


References

  1. Smith, J. (2022). Global pharmaceutical market forecasts. Pharma Insights.
  2. Johnson, L. (2023). Patent strategies for biologics. Intellectual Property Journal.
  3. European Medicines Agency. (2022). Sulster approval details.
  4. U.S. Food and Drug Administration. (2022). Sulster regulatory review.
  5. World Health Organization. (2021). Reimbursement policies globally.

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