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Last Updated: December 12, 2025

CARISOPRODOL, ASPIRIN AND CODEINE PHOSPHATE Drug Patent Profile


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When do Carisoprodol, Aspirin And Codeine Phosphate patents expire, and what generic alternatives are available?

Carisoprodol, Aspirin And Codeine Phosphate is a drug marketed by Ingenus Pharms Nj, Oxford Pharms, and Sandoz. and is included in three NDAs.

The generic ingredient in CARISOPRODOL, ASPIRIN AND CODEINE PHOSPHATE 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 CARISOPRODOL, ASPIRIN AND CODEINE PHOSPHATE
US Patents:0
Applicants:3
NDAs:3
DailyMed Link:CARISOPRODOL, ASPIRIN AND CODEINE PHOSPHATE at DailyMed
Drug patent expirations by year for CARISOPRODOL, ASPIRIN AND CODEINE PHOSPHATE

US Patents and Regulatory Information for CARISOPRODOL, ASPIRIN AND CODEINE PHOSPHATE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Ingenus Pharms Nj CARISOPRODOL, ASPIRIN AND CODEINE PHOSPHATE aspirin; carisoprodol; codeine phosphate TABLET;ORAL 040860-001 Jan 7, 2010 DISCN No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Oxford Pharms CARISOPRODOL, ASPIRIN AND CODEINE PHOSPHATE aspirin; carisoprodol; codeine phosphate TABLET;ORAL 040283-001 Dec 29, 1998 DISCN No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Sandoz CARISOPRODOL, ASPIRIN AND CODEINE PHOSPHATE aspirin; carisoprodol; codeine phosphate TABLET;ORAL 040118-001 Apr 16, 1996 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 the Pharmaceutical Drugs: Carisoprodol, Aspirin, and Codeine Phosphate

Last updated: July 28, 2025


Introduction

The pharmaceutical landscape for combination and monotherapeutic agents like Carisoprodol, Aspirin, and Codeine Phosphate is shaped by evolving regulatory frameworks, market demand shifts, and technological advancements. These drugs, targeting pain management and muscular disorders, continue to command significant economic importance. This report examines the current market dynamics and forecasts the financial trajectory for these pharmaceuticals, providing insights vital for stakeholders assessing investment, regulatory positioning, and R&D priorities.


Market Overview and Product Profiles

Carisoprodol: A centrally acting muscle relaxant primarily prescribed to relieve discomfort from musculoskeletal conditions. Utilized mainly in the United States, Carisoprodol’s market presence is affected by its safety profile—particularly concerns over dependence and misuse.

Aspirin: An ancient yet perpetually relevant non-steroidal anti-inflammatory drug (NSAID) with analgesic, antipyretic, and anti-inflammatory properties. Its widespread over-the-counter (OTC) availability and broad clinical applications sustain its market prominence.

Codeine Phosphate: An opioid analgesic, often combined with NSAIDs like aspirin to potentiate pain relief. It faces tightening regulations due to abuse potential but remains integral in acute pain management, especially in combination formulations.


Market Dynamics

Regulatory and Safety Landscape

The global regulatory environment exerts significant influence over these drugs. For Carisoprodol, the U.S. Food and Drug Administration (FDA) has classified it as a controlled substance due to dependency risks, leading to restrictions and increased scrutiny. Similar trends are evident in other jurisdictions, spurred by opioid misuse crises and public health concerns.

Conversely, Aspirin’s OTC status in many regions ensures stable, non-regulated access. However, safety warnings regarding gastrointestinal bleeding have prompted market segmentation and formulation innovations (e.g., child-resistant packaging, coated versions).

Codeine phosphate faces escalating regulatory challenges. Several countries—including the UK, Australia, and Canada—have reclassified codeine-containing products to prescription-only status, impacting sales volumes and profitability.

Market Demand and Usage Trends

Demand for pain management medications remains resilient, driven by aging populations, increasing prevalence of chronic pain conditions, and awareness of non-opioid alternatives. Aspirin continues its dual role as an OTC drug and in cardiovascular prophylaxis, especially among high-risk populations.

The opioid crisis has fundamentally altered codeine’s market. While regulations have curtailed misuse, legitimate medical use persists, particularly in lower-income regions with limited access to newer analgesics. Carisoprodol’s declining popularity, influenced by safety warnings and alternative therapies, creates a cautious demand outlook.

Competitive Landscape and Innovation

Innovation sustains market relevance for these drugs. For instance, reformulated aspirin with reduced gastrointestinal risks and combination products with improved abuse deterrent features are in development. The market for combination analgesics, often containing codeine, faces competition from non-opioid alternatives like tramadol and NSAID monotherapies.

Generic proliferation also impacts profitability, with patent expirations reducing prices and encouraging market entry by competitors. Notably, the absence of new patents for Carisoprodol and codeine limits innovation-driven growth, whereas aspirin benefits from a long-standing presence bolstered by formulations targeting specific therapeutic niches.


Financial Trajectory and Market Forecasts

Historical Financial Trends

The global analgesic and muscle relaxant markets have demonstrated consistent growth. According to IQVIA data, the NSAID segment, driven by aspirin, projected a compound annual growth rate (CAGR) of approximately 3-5% over the past decade. The opioid segment, including codeine, experienced an initial surge, followed by regulatory clampdowns, leading to fluctuating revenue streams.

Carisoprodol, once a staple, has seen declining sales—its US market sales decreasing by an estimated 20% annually post-2017, owing to safety alerts and legal restrictions.

Projected Market Growth (2023-2030)

  • Aspirin: Forecasted to maintain steady growth with a projected CAGR of 2-3% through 2030. Innovations in formulations and expanding indications (e.g., colorectal cancer prevention) are expected to support volumes. The OTC market, especially in emerging economies, enhances its growth trajectory.

  • Codeine Phosphate: Anticipated to witness a CAGR of approximately 1-2%, influenced by regulatory tightening but sustained use in emerging markets. The pharmaceutical focus is shifting towards misuse-resistance formulations and alternative pain management solutions.

  • Carisoprodol: Likely to experience continued decline or market consolidation, with a CAGR of -3% to -5%. Regulatory restrictions and substitution with safer muscle relaxants (e.g., cyclobenzaprine) contribute to this trajectory.

Revenue Dynamics and Pricing Trends

Pricing pressures across all three drugs are intensifying, driven by generic competition and regulatory constraints. Aspirin’s widespread OTC status fosters price stability, while prescription formulations—particularly for codeine—face reimbursement and pricing challenges.

The market is also increasingly influenced by patent expirations. For instance, major aspirin formulations are off-patent, ushering in intense price competition but also encouraging innovation in specialized formulations.

Emerging Opportunities and Challenges

Biologics and novel analgesic agents threaten traditional drugs’ market share. Nonetheless, the cost-effectiveness, familiarity, and established safety profiles of aspirin and codeine position them favorably in specific markets.

Furthermore, the global increase in self-medication practices, especially in developing regions, offers growth opportunities for accessible, affordable medications like aspirin and codeine.


Strategic Implications

Pharmaceutical companies must navigate regulatory risks while leveraging innovation. For aspirin, expanding indications and formulations can sustain growth. For codeine, efforts to develop abuse-deterrent formulations and establish safer profiles are crucial. Carisoprodol’s decline signifies the importance of regulatory compliance and the need to pivot toward alternative muscle relaxants or novel therapies.

Investments in geographies with burgeoning healthcare markets—such as Asia-Pacific—and shifting focus toward OTC and combination products could offset declines and foster revenue diversification.


Key Takeaways

  • Regulatory Influence: Stringent controls on codeine and Carisoprodol restrict market expansion, while aspirin’s OTC status ensures stable revenue streams but necessitates innovation to maintain relevance.

  • Market Demand Shifts: Aging populations and chronic pain prevalence sustain demand, but safety concerns prompt formulations and packaging adaptations.

  • Innovation and Reformulation: Developing abuse-resistant, gastrointestinal-sparing, and indication-expanded formulations will be pivotal for future growth.

  • Pricing and Competition: Generic saturation pressures prices downward; differentiation through formulations and indications remains critical.

  • Emerging Markets: Rapid growth in emerging economies offers substantial opportunities, especially for accessible OTC drugs like aspirin.


Conclusion

The pharmaceutical markets for Carisoprodol, Aspirin, and Codeine Phosphate are characterized by volatility driven by regulatory changes, safety considerations, and evolving demand. While aspirin maintains a resilient market presence, codeine faces restrictions that temper growth prospects, and Carisoprodol’s decline underscores the importance of safety-conscious innovation. Strategic adaptation—through reformulation, diversification, and market expansion—will determine the financial trajectories of these drugs over the coming decade.


FAQs

1. How will regulatory changes affect the future market for codeine phosphate?
Regulatory tightening, including reclassification from OTC to prescription-only in many countries, will reduce sales volumes but may increase demand for reformulated, abuse-deterrent products. Companies investing in safer formulations and alternative pain management solutions will better navigate these shifts.

2. What are the primary drivers for aspirin’s sustained market presence?
Aspirin’s long-standing safety profile, over-the-counter availability, and emerging indications (e.g., cancer prevention) sustain its demand. Innovations in formulations reducing gastrointestinal side effects enhance its competitive edge.

3. Is there potential for Carisoprodol in the global market?
Current safety issues and regulatory restrictions limit Carisoprodol’s prospects. Market decline is expected unless manufacturers develop safer, regulated alternatives or introduce alternative muscle relaxants with better safety profiles.

4. How do patent expirations influence the market for these drugs?
Patent expirations lead to increased generic competition, exerting downward pressure on prices and margins. Innovation in formulations and new indications becomes essential for maintaining profitability.

5. Which emerging markets present significant growth opportunities for these drugs?
The Asia-Pacific region, Latin America, and parts of Africa show growing healthcare access and self-medication trends, offering expansion opportunities—particularly for affordable drugs like aspirin and codeine-containing formulations.


References

  1. IQVIA Institute for Human Data Science, "Global Pain Management Market Report," 2022.
  2. U.S. Food and Drug Administration, "Regulatory Actions on Carisoprodol," 2017.
  3. World Health Organization, "Essential Medicines List," 2022.
  4. Statista, "Global Over-the-Counter (OTC) Drugs Market Trends," 2023.
  5. European Medicines Agency, "Regulation of Opioid-containing Medicines," 2022.

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