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Last Updated: December 12, 2025

SOMA COMPOUND W/ CODEINE Drug Patent Profile


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

Soma Compound W/ Codeine is a drug marketed by Meda Pharms and is included in one NDA.

The generic ingredient in SOMA COMPOUND W/ CODEINE 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 W/ CODEINE
Drug patent expirations by year for SOMA COMPOUND W/ CODEINE

US Patents and Regulatory Information for SOMA COMPOUND W/ CODEINE

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 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

Market Dynamics and Financial Trajectory for SOMA COMPOUND W/ CODEINE

Last updated: July 28, 2025

Introduction

SOMA COMPOUND W/ CODEINE remains a notable analgesic in the pharmaceutical landscape, primarily indicated for moderate to severe pain management. With the ongoing evolution of pain management paradigms, regulatory scrutiny, and shifting consumer preferences, understanding its market dynamics and financial trajectory is crucial for stakeholders. This article offers a comprehensive analysis of current market factors, regulatory considerations, competitive landscape, and future growth prospects pertinent to SOMA COMPOUND W/ CODEINE.

Pharmacological Profile and Therapeutic Use

SOMA COMPOUND W/ CODEINE combines carisoprodol, a muscle relaxant, with codeine, an opioid analgesic. It functions synergistically to alleviate musculoskeletal pain, making it a staple prescription in pain management protocols [1]. Despite its efficacy, concerns over dependency, misuse, and regulatory restrictions have influenced its market performance.

Regulatory Environment and Its Impact

Regulatory developments significantly shape the market trajectory. In recent years, increasing opioid regulations, driven by the opioid epidemic, have curtailed prescribing practices. For example, the U.S. Drug Enforcement Agency (DEA) rescheduled certain formulations, impacting supply chains and prescribing patterns [2]. Conversely, stringent controls aim to mitigate misuse but may limit legitimate accessibility, affecting revenue streams.

Market Size and Geographic Trends

Global demand for opioid-containing analgesics like SOMA COMPOUND W/ CODEINE has traditionally been robust, especially in North America, Europe, and parts of Asia. North America accounts for approximately 60% of the global opioid analgesic market, driven by high prevalence of musculoskeletal conditions and pain-related disorders [3]. However, this segment's growth is tempered by regulatory hurdles and rising alternative pain management modalities.

Competitive Landscape

The market faces competition from non-opioid analgesics, including NSAIDs, acetaminophen, and emerging modalities such as nerve blocks and biologics. Additionally, the presence of generic formulations has increased price competition, compressing profit margins [4]. Key players include generic pharmaceutical manufacturers and a few branded drugs with established prescriber bases.

Market Drivers and Challenges

Drivers:

  • Growing incidence of chronic pain and musculoskeletal disorders.
  • Increasing awareness of pain management options.
  • Expansion of healthcare infrastructure and prescription access.

Challenges:

  • Tightening regulations restraining opioid prescriptions.
  • Rising public awareness of opioid dependency risks.
  • Competition from non-opioid analgesics and alternative therapies.
  • Patent expirations leading to generic competition.

Emerging Trends and Opportunities

  • Alternative formulations: Development of abuse-deterrent formulations could enhance marketability amidst regulatory scrutiny [5].
  • Patient-centric delivery: Oral solutions, patches, and multimodal therapies offer opportunities to capture new segments.
  • Regional expansion: Growth potential exists in emerging markets where analgesic needs are unmet but face regulatory barriers [6].

Financial Trajectory Analysis

Historical Performance:

Over the past decade, SOMA COMPOUND W/ CODEINE's revenues have experienced fluctuations mirroring regulatory impacts and market competition. In North America, sales peaked prior to the 2010s but declined post-regulatory tightenings [7]. Generic erosion accelerated profit declines, although some manufacturers reported stable margins through cost optimization.

Forecasted Trends:

Analysts project a compound annual growth rate (CAGR) of approximately 1-2% for opioid analgesics globally over the next five years. Market constraints due to regulatory policies may suppress growth in mature regions, but emerging markets and reformulated abuse-deterrent versions could offset declines, resulting in a relatively flat overall trajectory [8].

Profitability Outlook:

Profit margins are expected to remain pressured due to generic competition, with some manufacturers exploring biosimilars or niche markets. Licensing of newer formulations and strategic alliances could provide upside potential. However, legal liabilities related to opioid litigation could pose financial risks in certain jurisdictions.

Regulatory and Legal Considerations

Litigation surrounding opioid misuse continues to pose significant financial and reputational risks. Companies involved must navigate complex regulatory environments, adhering to evolving prescribing guidelines and classifying procedures. Future legal challenges could influence the availability and pricing of SOMA COMPOUND W/ CODEINE.

Conclusion

The market for SOMA COMPOUND W/ CODEINE is characterized by a delicate balance: ongoing demand driven by musculoskeletal conditions, countered by increasing regulatory controls and market competition. While growth prospects remain modest at best, niche opportunities exist through product innovation, regional expansion, and strategies addressing opioid misuse concerns. Investors and manufacturers must closely monitor regulatory trends and emerging alternatives to adapt their strategies effectively.

Key Takeaways

  • Regulatory pressures significantly influence SOMA COMPOUND W/ CODEINE's market dynamics; expect continued restrictions that may limit growth.
  • North America remains the dominant market but faces demographic and legal shifts that could impact supply and demand.
  • Competition from non-opioid analgesics and abuse-deterrent formulations presents both challenges and opportunities for market positioning.
  • Emerging markets offer growth potential due to unmet demand, although regulatory hurdles persist.
  • Strategic innovation, including abuse-deterrent and alternative delivery systems, will be critical for future profitability.

FAQs

  1. What is the primary use of SOMA COMPOUND W/ CODEINE?
    It is prescribed chiefly for the relief of moderate to severe musculoskeletal pain, combining muscle relaxation and opioid analgesic effects.

  2. How have regulatory changes impacted sales of SOMA COMPOUND W/ CODEINE?
    Stringent regulations, especially in North America, have reduced prescriptions due to concerns about dependency and misuse, leading to a decline in sales volume and revenue for some manufacturers.

  3. Are there alternatives to SOMA COMPOUND W/ CODEINE?
    Yes, non-opioid analgesics such as NSAIDs and acetaminophen are common alternatives. Emerging therapies include nerve blocks, biologics, and multimodal pain management strategies.

  4. What are the future opportunities for this drug?
    Development of abuse-deterrent formulations, regional expansion into emerging markets, and improved risk management strategies could help sustain or enhance market positioning.

  5. What legal risks are associated with SOMA COMPOUND W/ CODEINE?
    Legal risks stem from opioid misuse lawsuits, regulatory compliance issues, and potential restrictions that could affect manufacturing, marketing, and prescribing practices.

References

[1] U.S. Food & Drug Administration. (2020). Soma (carisoprodol) information.

[2] Drug Enforcement Administration. (2022). Rescheduling of opioid products.

[3] MarketWatch. (2021). Global opioid analgesics market analysis.

[4] IQVIA. (2022). Pharmaceutical market trends.

[5] Food & Drug Administration. (2021). Abuse-deterrent formulations overview.

[6] World Health Organization. (2020). Pain management in emerging markets.

[7] IMS Health. (2019). Opioid sales performance.

[8] Deloitte. (2022). Pharmaceutical outlook for pain management.

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