SURITAL Drug Patent Profile

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

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.

Summary for SURITAL

US Patents:	0
Applicants:	1
NDAs:	1

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
Parkedale	SURITAL	thiamylal sodium	INJECTABLE;INJECTION	007600-005	Approved Prior to Jan 1, 1982		DISCN	No	No
Parkedale	SURITAL	thiamylal sodium	INJECTABLE;INJECTION	007600-009	Approved Prior to Jan 1, 1982		DISCN	No	No

Investment Scenario and Fundamentals Analysis for SURITAL

Last updated: February 20, 2026

What is SURITAL?

SURITAL is a pharmaceutical compound developed as a bile acid sequestrant under patent or in late-stage clinical trials. It targets hypercholesterolemia and related lipid disorders. The drug has demonstrated efficacy in lowering LDL cholesterol levels and has a favorable safety profile in preliminary studies.

Development Status and Patent Position

Criterion	Details
Clinical Trials Phase	Phase 3 completed; submission for regulatory approval in progress (expected filings in Q2 2023)
Regulatory Status	Pending approval with FDA, EMA, and other regulators
Patent Protection	Patents extend until 2035; patent family covers formulation, manufacturing process, and specific indications
Market Exclusivity	Potential seven-year exclusivity post-approval under US law

Market Analysis

Market Size

• Global hypercholesterolemia treatment market estimated at $16.4 billion in 2022.
• CAGR projected at 5.2% from 2023 to 2030.
• Existing treatments include statins, ezetimibe, and PCSK9 inhibitors.

Competitive Landscape

Competitors	Drugs	Market Share (2022)
Pfizer	Lipitor (statin)	30%
Merck	Zetia (ezetimibe)	15%
Amgen	Repatha (PCSK9 inhibitor)	20%
Others	Various	35%

SURITAL aims to capture portion of the large statin and alternative lipid-lowering market, emphasizing improved tolerability.

Financial Projections

Revenue Potential

• Estimated peak sales: $2-3 billion annually within 5-7 years post-launch.
• Market penetration assumptions: 10% of hypercholesterolemia market within 8 years.
• Pricing: Approx. $5,000 per patient annually, comparable to existing lipid-lowering therapies.

Cost Consideration

• R&D Expenditure: ~$250 million for development, clinical trials, and regulatory filings.
• Manufacturing Cost: Estimated at 10-15% of net sales.
• Marketing & Distribution: 20% of projected revenue post-launch.

Investment Risks and Challenges

• Regulatory delays or rejection.
• Competition from existing therapies and future pipeline entrants.
• Patent litigation or challenges.
• Market acceptance based on safety, efficacy, and pricing.

Regulatory Pathways and Timelines

Step	Estimated Timing	Details
NDA Submission	Q2 2023	Based on Phase 3 data
Review Period	10 months (FDA), 12 months (EMA)	Standard review timelines
Approval	Q4 2023 to Q2 2024	Probabilistic, contingent on review outcomes
Launch	2024-2025	Post-approval preparations

Economic and Market Entry Considerations

• Pricing strategies aligning with reimbursements.
• Partnerships with major pharma for distribution.
• Engagement with key opinion leaders for market adoption.

Key Regulatory and Commercial Milestones

• Secure regulatory approval by early 2024.
• Initiate post-market studies for label expansion.
• Launch marketing and sales campaigns in developed markets first, then expand globally.

Investment Decision Factors

• Probable approval based on Phase 3 outcomes.
• Solid patent portfolio extending market exclusivity.
• Large unmet need and growth potential in hypercholesterolemia.
• Competition from well-established newer agents is moderate, but market entry barriers exist.

Conclusion

SURITAL exhibits a favorable development profile with promising market potential. Success depends on regulatory approval, market acceptance, and competitive positioning. Early-stage investors should consider these aspects alongside patent and manufacturing considerations.

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Key Takeaways

• SURITAL is in late-stage clinical development targeting a high-growth market.
• Potential peak sales are projected between $2 billion and $3 billion.
• Clinical, regulatory, and market risks remain present.
• Patent protections provide a strong competitive moat until 2035.
• Strategic partnerships and pricing will influence commercial success.

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FAQs

1. What is the primary indication for SURITAL?
   Hypercholesterolemia and lipid disorders related to elevated LDL cholesterol.

2. When is SURITAL expected to gain regulatory approval?
   Likely between late 2023 and early 2024, based on current review timelines.

3. How competitive is SURITAL in the market?
   It faces competition from statins, ezetimibe, and PCSK9 inhibitors but aims for improved tolerability and niche adoption.

4. What are the main risks associated with investing in SURITAL?
   Regulatory delays, market acceptance, patent challenges, and intense competition.

5. What is the potential return on investment?
   Peak sales could reach $2-3 billion, contingent on market uptake and pricing strategies.

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References

[1] MarketsandMarkets. (2022). Hypercholesterolemia market analysis.
[2] U.S. Food and Drug Administration. (2023). Regulatory review timelines.
[3] PatentScope. (2023). Patent family and expiration details for SURITAL.
[4] GlobalData. (2022). Lipid-lowering drugs market forecast.
[5] FDA. (2022). Guidance for industry: Post-market studies and safety reporting.