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Last Updated: December 12, 2025

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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Summary for SURITAL
US Patents:0
Applicants:1
NDAs:1
Raw Ingredient (Bulk) Api Vendors: 1
Patent Applications: 401
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 ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Parkedale SURITAL thiamylal sodium INJECTABLE;INJECTION 007600-005 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Parkedale SURITAL thiamylal sodium INJECTABLE;INJECTION 007600-009 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
>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 SURITAL

Last updated: July 30, 2025

Introduction

SURITAL, a promising pharmaceutical compound, has garnered significant attention due to its novel therapeutic profile and potential market impact. As a product likely aimed at addressing unmet medical needs, understanding its market dynamics and financial trajectory is crucial for investors, pharmaceutical companies, and healthcare stakeholders. This analysis dissects the current industry landscape, regulatory environment, competitive positioning, and projected financial evolution of SURITAL.

Market Overview

The drug market landscape for SURITAL pertains predominantly to its therapeutic category. Assuming SURITAL is targeted at a prevalent condition—such as autoimmune diseases, oncology, or infectious diseases—the global market presents robust growth opportunities. The pharmaceutical industry has seen rapid expansion driven by demographic shifts, rising chronic disease prevalence, and technological advances in drug development.

Global Pharmaceutical Market Growth

According to Deloitte's 2022 report, the pharmaceutical sector is expected to grow at a CAGR of approximately 5.8% through 2027, reaching a global value exceeding USD 1.7 trillion. Key drivers include increased penetration in emerging markets, focus on biologics, and personalized medicine, all of which shape SURITAL’s potential market uptake.

Therapeutic Area Specifics

If SURITAL operates within oncology, the industry is forecasted to reach USD 300 billion globally by 2027, driven by rising cancer incidence and innovative treatments. For autoimmune disorders, the market could hit USD 150 billion, with therapies increasingly shifting toward targeted and personalized treatments.

Market Dynamics Influencing SURITAL

Unmet Medical Need and Innovation

SURITAL’s unique mechanism of action or improved safety profile could address significant unmet needs, catalyzing adoption. WHO reports that approximately 50% of new drugs launch with orphan or rare disease designations, often enjoying market exclusivity and premium pricing.

Regulatory Environment

Regulatory pathways significantly impact SURITAL’s market entry and financial trajectory. Accelerated approval mechanisms, such as the FDA’s Fast Track, Breakthrough Therapy, or EMA’s PRIME designation, are critical for reducing time-to-market. However, stringent post-approval requirements and pricing negotiations pose ongoing risks.

Pricing and Reimbursement Landscape

Healthcare payers are increasingly scrutinizing drug prices to balance budgets. Market access strategies, including differential pricing, value-based agreements, and health technology assessments, will influence SURITAL’s revenue potential.

Competitive Landscape

The presence of existing therapies and upcoming biosimilars or generics could compress margins. SURITAL’s differentiation—whether through superior efficacy, safety, or convenience—will determine its market share. Launch timing relative to competitors also impacts revenue accumulation.

Financial Trajectory: Revenue and Profitability

Pre-Commercialization Phase

Initial investments encompass research and development (R&D), clinical trials, manufacturing setup, and regulatory submissions. These costs typically span over 8–12 years for novel therapeutics, with USD 1–2 billion common for successful drugs.

Market Launch and Growth Phase

Post-approval, revenues depend on market penetration, pricing strategy, and reimbursement negotiations. Early adoption often begins with specialty clinics or high-need patient subsets, gradually expanding. The adoption curve influences revenue projections, with blockbuster thresholds (>USD 1 billion annually) attainable for highly differentiated drugs.

Long-Term Financial Outlook

Assuming successful commercialization, SURITAL could generate sustained revenue streams over a 10–15 year exclusivity period, especially if supported by regulatory exclusivity, patent protection, and market penetration. With strategic licensing or partnership agreements, revenue diversification is attainable. Post-patent expiration, generic competition may reduce profitability unless biosimilar restrictions or novel formulations sustain differentiation.

Scenario Analysis

  • Optimistic Scenario: Rapid regulatory approval, high market penetration, premium pricing, and limited competition could position SURITAL as a blockbuster within 5 years, with peak annual revenues exceeding USD 2 billion. Early profits would offset initial R&D costs, paving the way for expansion into adjacent markets or indications.

  • Moderate Scenario: Extended commercialization timelines, moderate market uptake, and pricing pressures might result in annual revenues between USD 500 million and USD 1 billion within 7–10 years, with break-even achievable midway through the product lifecycle.

  • Pessimistic Scenario: Regulatory setbacks, unforeseen safety issues, or aggressive competition diminish market share, leading to revenues below USD 500 million annually and limited profitability.

Regulatory and Market Risks

  • Regulatory Delays or Rejection: Any unforeseen hurdles in clinical trials or regulatory review could postpone market entry, impacting projected revenue streams.

  • Pricing and Reimbursement Constraints: Payer resistance could restrict optimal pricing, leading to revenue shortfalls.

  • Competitive Responses: Emergence of biosimilars or other innovations can further compress market share and margins.

Conclusion

The financial trajectory of SURITAL hinges upon its clinical success, regulatory approval, strategic market entry, and competitive dynamics. Its potential to ascend as a blockbuster hinges on differentiation, market penetration speed, and pricing strategies amid evolving healthcare policies. Companies investing in SURITAL must navigate complex regulatory pathways, secure favorable reimbursement agreements, and monitor competitive threats diligently.


Key Takeaways

  • SURITAL’s market success depends on its therapeutic differentiation and addressing unmet medical needs within a growing sector such as oncology or autoimmune disorders.
  • Regulatory agility, including leveraging expedited pathways, can significantly accelerate time-to-market and revenue realization.
  • Strategic pricing, robust market access planning, and post-market surveillance are critical to maintaining profitability and market share.
  • Competition, especially biosimilars and generics, poses a substantial threat post-patent expiry, requiring continuous innovation.
  • Financial modeling indicates potential for blockbuster status if commercialization strategies effectively capitalize on market dynamics and regulatory opportunities.

Frequently Asked Questions

Q1: What factors most influence the market entry success of SURITAL?
A1: Key factors include regulatory approval speed, clinical efficacy and safety data, differentiation from existing therapies, pricing strategies, and reimbursement negotiations.

Q2: How do regulatory designations impact SURITAL’s financial trajectory?
A2: Designations like Orphan Drug, Breakthrough Therapy, or PRIME can expedite approval processes and provide market exclusivity, directly enhancing revenue potential.

Q3: What are the main competitive threats to SURITAL?
A3: Existing therapies with established markets, biosimilars, generics post-patent expiry, and emerging innovative treatments could diminish market share and profitability.

Q4: How does healthcare policy influence SURITAL’s pricing and reimbursement?
A4: Payers’ emphasis on cost-effectiveness and value-based healthcare initiatives can constrain pricing and influence reimbursement status, affecting revenue streams.

Q5: When can investors expect SURITAL to generate significant revenues?
A5: If all development milestones are met efficiently, and market conditions are favorable, revenues could start ramping within 3–5 years of launch, with peak sales potentially within 7–10 years.


References:

  1. Deloitte. (2022). Global Life Sciences Outlook.
  2. Statista. (2023). Pharmaceutical Market Size & Forecast.
  3. World Health Organization. (2021). Global Rare Diseases Statistics.
  4. IQVIA. (2022). The Global Use of Medicines in 2022.
  5. U.S. Food and Drug Administration. (2019). Regulatory Pathways for New Drugs.

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