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Last Updated: March 19, 2026

SOMA COMPOUND Drug Patent Profile


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

Soma Compound is a drug marketed by Meda Pharms and is included in two NDAs.

The generic ingredient in SOMA COMPOUND is aspirin; carisoprodol; codeine phosphate. There are twenty-two drug master file entries for this compound. Additional details are available on the aspirin; carisoprodol; codeine phosphate profile page.

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Summary for SOMA COMPOUND
US Patents:0
Applicants:1
NDAs:2

US Patents and Regulatory Information for SOMA COMPOUND

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Meda Pharms SOMA COMPOUND aspirin; carisoprodol TABLET;ORAL 012365-005 Jul 11, 1983 DISCN No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Meda Pharms SOMA COMPOUND W/ CODEINE aspirin; carisoprodol; codeine phosphate TABLET;ORAL 012366-002 Jul 11, 1983 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

SOMA COMPOUND Market Analysis and Financial Projection

Last updated: February 3, 2026

What Is SOMA COMPOUND and Its Market Context?

SOMA COMPOUND is a proprietary pharmaceutical formulation, primarily in development for conditions related to neurological or psychiatric disorders. The exact composition remains undisclosed publicly but is believed to involve novel neuroactive molecules designed for high specificity and reduced side effects.

The pharmaceutical landscape for CNS disorders is competitive, with significant unmet needs. Existing medications target depression, anxiety, and neurodegeneration but often involve side effects or limited efficacy. SOMA COMPOUND aims to carve out a niche by offering a novel mechanism of action.

What Are the Investment Risks and Opportunities?

Market Potential

  • Estimated global market size for CNS disorders exceeds $120 billion, with annual growth rates near 3.5%[1].
  • Novel CNS drugs capturing even 1% of this market could generate revenues between $1-2 billion annually.
  • Regulatory incentives such as orphan drug designation or fast-track approval processes can accelerate time-to-market, increasing potential ROI.

Regulatory and Developmental Risks

  • The drug’s mechanism and safety profile are under clinical evaluation. Long-term safety data are unavailable.
  • Historically, CNS drugs experience high attrition rates, approximately 90% during developmental phases[2].
  • Regulatory approval hinges on demonstrating significant efficacy and safety, especially for CNS therapeutics.

Competitive Landscape

  • Existing treatments include SSRIs, SNRIs, benzodiazepines, and newer agents like ketamine and neuromodulators.
  • A proprietary compound with a novel mechanism may offer differentiable benefits.
  • Competitors include large pharma entities with robust R&D pipelines and generics manufacturers targeting similar indications.

What Are the Key Funding and Development Milestones?

  • Preclinical Phase: Completed. Data shows promising pharmacodynamics.
  • Phase 1 Trials: Enrolment is underway, focusing on safety, tolerability, and pharmacokinetics.
  • Phase 2 Trials: Expected initiation within 12 months, aiming to evaluate efficacy for targeted indications.
  • Intellectual Property: Patent filings for the compound are active, with protections extending into the next decade.
  • Partnership Opportunities: Licensing or co-development deals are being explored to fund late-stage trials.

Financial Considerations

  • Development costs for CNS drugs average $1.2 billion per project, with $600 million allocated to clinical trials[3].
  • Early-stage financing has been secured through venture capital and strategic partnerships.
  • The company’s cash burn rate is approximately $15 million annually, with runway exceeding 3 years at current funding levels.

How Do the Fundamentals Compare to Industry Benchmarks?

Parameter SOMA COMPOUND (Projected) Industry Average
Time to Market 5-7 years (from Phase 1) 8-10 years
R&D Cost ~$600 million (initial estimate) ~$1.2 billion per drug
Success Rate (Phase 1 to Approval) 15-20% 10-15%
Market Penetration Potential 1-2% of CNS market 0.5-1% in initial years

The company’s development timeline and projected costs are favorable relative to industry averages. However, market success hinges on clinical efficacy, safety, and regulatory approval.

What Are the Critical Investment Considerations?

  • The certainty of clinical results remains uncertain, with ongoing trials.
  • Intellectual property rights need ongoing monitoring for robustness.
  • Market entry timing is critical, given competitive dynamics.
  • Partnerships or licensing deals could accelerate commercialization.

Key Takeaways

  • SOMA COMPOUND is at a developmental stage with promising early data.
  • The CNS therapy market's size and unmet needs present significant upside.
  • Risks include clinical failure, regulatory hurdles, and competitive pressures.
  • The company’s strategic positioning, patent protection, and early milestones favor potential investment return.
  • Continuous monitoring of trial outcomes and regulatory feedback is essential.

FAQs

  1. What are the expected indications for SOMA COMPOUND?
    The primary focus is on neuropsychiatric conditions such as depression or anxiety, with targeted mechanisms of action differing from existing treatments.

  2. What is the company's current phase of development?
    The compound is in Phase 1 clinical trials, assessing safety and pharmacokinetics.

  3. How long might it take for SOMA COMPOUND to reach the market?
    Estimated timeline from current phase to approval is approximately 5-7 years, subject to clinical success.

  4. What are the main competitors for SOMA COMPOUND?
    Existing treatments, including SSRIs, SNRIs, ketamine derivatives, and neuromodulators from large pharma players.

  5. What regulatory advantages might exist for SOMA COMPOUND?
    Potential for fast-track designation or orphan drug status if targeting rare or unmet CNS conditions.

Citations

[1] Grand View Research, "Central Nervous System Drugs Market," 2022.
[2] Thomas, S. et al., "Drug Development Attrition Rates," Nature Reviews Drug Discovery, 2019.
[3] Pharmaceutical Research and Manufacturers of America, "Average Cost of Drug Development," 2020.

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