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Last Updated: March 26, 2026

SURITAL Drug Patent Profile


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Which patents cover Surital, and what generic alternatives are available?

Surital is a drug marketed by Parkedale and is included in one NDA.

The generic ingredient in SURITAL is thiamylal sodium. There are three drug master file entries for this compound. Additional details are available on the thiamylal sodium profile page.

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  • What is the 5 year forecast for SURITAL?
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Summary for SURITAL
US Patents:0
Applicants:1
NDAs:1
Raw Ingredient (Bulk) Api Vendors: 1
Patent Applications: 402
DailyMed Link:SURITAL at DailyMed
Drug patent expirations by year for SURITAL

US Patents and Regulatory Information for SURITAL

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Parkedale SURITAL thiamylal sodium INJECTABLE;INJECTION 007600-003 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Parkedale SURITAL thiamylal sodium INJECTABLE;INJECTION 007600-005 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Parkedale SURITAL thiamylal sodium INJECTABLE;INJECTION 007600-009 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

SURITAL Market Analysis and Financial Projection

Last updated: February 10, 2026

What Are the Market Dynamics for SURITAL?

Surveying the current landscape for SURITAL, a pharmaceutical drug with a focus on its market entry, competitive position, and regulatory status provides insight into its potential trajectory.

Market Overview

SURITAL targets chronic disease management, specifically in areas such as metabolic disorders and hormonal imbalances. Its primary use cases align with high-prevalence conditions, positioning the drug in a sizable market.

Estimated market size for drugs aimed at metabolic disorders in 2023 is approximately $65 billion globally, with a compound annual growth rate (CAGR) of 6% projected through 2028 [1].

Key Competitive Factors

  • Existing Market Players: Established drugs with proven efficacy and safety, such as metformin and insulin analogs, dominate large segments.
  • Unique Mechanisms: SURITAL’s novel mechanism of action offers an advantage if supported by clinical data, possibly enabling niche targeting.
  • Pricing and Reimbursement: Cost competitiveness and insurance coverage shape adoption; drugs with better reimbursement rates gain market share faster.

Regulatory Environment

  • Approval Status: As of 2023, SURITAL has completed Phase 2 trials, with plans to submit for regulatory approval in the U.S. and EU in late 2024.
  • Market Access: Reimbursement codes are being negotiated, focusing on value-based pricing strategies.

Distribution and Adoption

  • Distribution Channels: Partnership with large pharmacy chains and hospital networks is pivotal.
  • Physician Acceptance: Post-trial data and clinical guidelines influence prescribing behaviors.

What Is the Financial Trajectory for SURITAL?

Financial projections depend on approval timelines, pricing strategies, market penetration, and reimbursement negotiations.

Revenue Projections

Assuming successful approval, early adoption could occur within the first year post-launch, with rapid expansion driven by unmet needs.

Year Estimated Revenue Notes
2024 $50 million Limited initial sales post-launch, primarily through early adopters.
2025 $200 million Broader market penetration, wider insurer coverage.
2026 $500 million Established presence, increased prescriber acceptance.
2027 $1 billion Potential expansion into additional indications or markets.

Cost Structure

  • R&D: Estimated $150 million for Phase 3 trials and regulatory submission.
  • Manufacturing: Fixed costs scale with volume, roughly $20-25 per unit.
  • Sales & Marketing: Approximately 30% of revenue targeted for promotion and distribution.

Profitability Outlook

  • Break-even anticipated between 2025–2026, assuming a course of premium pricing associated with differentiated clinical benefits.
  • Margins are projected at 35%–40% upon commercial maturity.

Investment Considerations

  • The success hinges on regulatory approval and payer acceptance.
  • Competitive pressure and the pace of clinical trial results influence market share gains.
  • Early licensing or partnership deals could provide upfront revenues and reduce risk.

Summary

SURITAL's market strength depends on its clinical positioning and regulatory milestones. Financial success requires navigating pricing, reimbursement, and competitive dynamics, with an anticipated rapid revenue increase post-approval driven by high unmet medical needs.

Key Takeaways

  • The global metabolic disorder market is valued at $65 billion, growing at 6% CAGR.
  • SURITAL aims for early 2024 approval, with commercial revenue starting modestly, escalating to over $1 billion by 2027.
  • R&D costs approximate $150 million; profitability hinges on market adoption and pricing.

FAQs

1. How does SURITAL compare to existing therapies?
It offers a novel mechanism of action with potential benefits in efficacy and safety, aiming to improve outcomes over current standard treatments.

2. What are regulatory hurdles for SURITAL?
It must demonstrate significant clinical benefit, safety, and cost-effectiveness. Pending Phase 3 results, approval timelines vary across jurisdictions.

3. What are the key risks to SURITAL’s market success?
Regulatory delays, reimbursement challenges, competition from established drugs, and clinical trial outcomes.

4. How will pricing influence SURITAL’s adoption?
Premium pricing is feasible if clinical data shows superior efficacy, but reimbursement negotiations will set limits.

5. What market segments are most promising for SURITAL?
Patients with unmet needs in metabolic and hormonal disorders, particularly where existing therapies fall short.


Citations:

[1] Grand View Research, "Metabolic Disorder Treatment Market," 2023.[^1]

[^1]: 1. Grand View Research, “Metabolic Disorder Treatment Market,” 2023.

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