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Last Updated: December 12, 2025

Aspirin; carisoprodol; codeine phosphate - Generic Drug Details


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What are the generic drug sources for aspirin; carisoprodol; codeine phosphate and what is the scope of freedom to operate?

Aspirin; carisoprodol; codeine phosphate is the generic ingredient in two branded drugs marketed by Ingenus Pharms Nj, Oxford Pharms, Sandoz, and Meda Pharms, and is included in four NDAs. Additional information is available in the individual branded drug profile pages.

Summary for aspirin; carisoprodol; codeine phosphate
US Patents:0
Tradenames:2
Applicants:4
NDAs:4
DailyMed Link:aspirin; carisoprodol; codeine phosphate at DailyMed

US Patents and Regulatory Information for aspirin; carisoprodol; codeine phosphate

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
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
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
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 Aspirin, Carisoprodol, and Codeine Phosphate

Last updated: July 27, 2025

Introduction

The pharmaceutical landscape for drugs like aspirin, carisoprodol, and codeine phosphate is shaped by evolving market trends, regulatory frameworks, patent statuses, and societal health needs. Their long-standing therapeutic roles—analgesics, anti-inflammatory agents, and muscle relaxants—render them integral to global healthcare, yet each faces unique market and financial challenges. This analysis dissects the current market dynamics and forecasts the financial trajectory of these key pharmaceuticals, providing strategic insights for stakeholders.


Aspirin: An Enduring Classic with Evolving Market Forces

Historical Significance and Market Penetration

Aspirin, known chemically as acetylsalicylic acid, remains one of the world’s most widely used non-steroidal anti-inflammatory drugs (NSAIDs). Since its inception over 120 years ago, it has become a cornerstone in cardiovascular prophylaxis, pain relief, and anti-inflammatory therapy. Its generic status has helped maintain a competitive and low-cost marketplace, with an estimated global market size surpassing $2 billion annually (Research and Markets, 2021).

Market Dynamics

  • Patent and Regulatory Landscape: Aspirin’s patent expired decades ago, resulting in widespread generic manufacturing and price erosion. Regulatory scrutiny has increased, especially concerning its use in primary prevention of cardiovascular disease, as studies suggest increased bleeding risks without significant benefit in certain populations (Xie et al., 2020).

  • Market Drivers: The ongoing prevalence of cardiovascular disease sustains demand. Moreover, its recognition as an over-the-counter (OTC) medication augments sales volume, especially in emerging markets. Growing awareness of its anti-inflammatory and potential anticancer properties—though not yet standard—could unlock new segments.

  • Challenges: The rise of alternative analgesics and anti-inflammatory agents, coupled with concerns over gastrointestinal bleeding, may limit aspirin’s use in specific patient groups.

Financial Trajectory

While sales are plateauing in developed nations, emerging markets offer growth opportunities driven by increased healthcare access. Market value is projected to grow modestly at a CAGR of approximately 2% through 2028 (Fortune Business Insights, 2022). Cost pressures and regulatory hurdles are constraining profit margins but volume-driven growth remains robust globally.


Carisoprodol: From Prescription to Controlled Substance Challenges

Therapeutic Role and Market Presence

Carisoprodol is a centrally acting muscle relaxant prescribed for acute musculoskeletal pain. Its popularity peaked in the late 20th century but has waned due to safety concerns and regulatory shifts.

Market Dynamics

  • Regulatory and Safety Concerns: The drug’s potential for dependence and misuse prompted FDA warnings in 2012, leading to reclassification in several jurisdictions, including the U.S., where it was classified as a controlled substance Schedule IV (FDA, 2012). This reclassification increased regulatory burdens and disrupted supply chains.

  • Market Contraction: Prescriptions declined sharply following safety concerns. Many manufacturers exited the market, and supplies became limited.

  • Legal and Abuse Trends: Rising misuse and diversion have spotlighted the drug's abuse potential, prompting stricter controls and diminishing prescribing rates.

Financial Outlook

Given the declining demand and regulatory constraints, the market for carisoprodol is contracting. Few patented formulations remain; most generics have exited the market, exerting downward pressure on prices. As a result, the drug’s revenue prospects are bleak, with estimates indicating a compound decrease at a rate exceeding 5% annually post-2022 (IQVIA, 2022).

Potential for Market Re-entry or Alternatives

Research into safer muscle relaxants or combination therapies could further suppress demand. Any future re-approval would depend on evidence demonstrating improved safety profiles.


Codeine Phosphate: Controlled Opioid with Growing Market Complexity

Therapeutic Use and Market Size

Codeine phosphate is an opioid analgesic and antitussive frequently used worldwide. Its extensive OTC availability in many countries amplifies global consumption, estimated to top $3 billion annually.

Market Dynamics

  • Regulatory Trends: Growing opioid regulation to curb misuse influences market growth. Multiple nations have reclassified codeine from OTC to prescription-only, affecting sales volumes. For example, the UK mandated pharmacist-only sales, reducing misuse without entirely curbing legitimate usage.

  • Demand Drivers: The ongoing need for pain management and cough suppression sustains demand, especially in regions with limited access to stronger opioids or alternatives.

  • Supply Chain and Abuse Issues: The persistent problem of opioid addiction and illicit diversion has led authorities to impose stricter controls, including tracking, quotas, and public health campaigns.

  • Alternative Therapies: The rise of non-opioid analgesics, including NSAIDs and acetaminophen combinations, offers substitutes, contributing to a stabilized or declining market share in some regions.

Financial Forecast

In markets with strict controls, sales are expected to decline at a CAGR of around 3% over the next five years. Conversely, in certain emerging markets with lax regulations, usage continues to grow, presenting localized growth opportunities.

Innovation and Reformulation

Efforts to develop abuse-deterrent formulations or combine codeine with non-addictive agents could bolster long-term prospects, but regulatory hurdles and safety concerns remain significant.


Integrated Market outlook and Future Trajectory

The combined outlook indicates a heterogeneous landscape shaped by regulatory, societal, and scientific factors. Aspirin’s mature but stable market may see slight growth in emerging economies. Carisoprodol faces a shrinking market due to safety concerns and regulatory clampdowns. Codeine’s trajectory balances between managed decline in regulated markets and potential growth in underserved regions.

The convergence of regulatory actions, societal health priorities, and technological innovations—such as development of non-addictive analgesics and improved formulations—defines the pathway forward. Companies must adapt to shifting policies, monitor abuse trends, and invest in R&D to navigate these complex markets.


Key Takeaways

  • Aspirin sustains a resilient, globally expansive market with slow but steady growth prospects, mainly driven by emerging markets and potential new indications.
  • Carisoprodol faces obsolescence amid safety concerns; its market is expected to shrink further, with little prospect of re-entry without safety improvements.
  • Codeine phosphate maintains significant demand but is increasingly subjected to regulatory restrictions, leading to regional market variances and a need for reformulation or alternative solutions.
  • Regulatory landscapes are paramount; proactive engagement with evolving policies enhances market stability.
  • Innovation and diversification—through the development of non-opioid pain relievers or abuse-deterrent formulations—are essential for sustainable growth.

FAQs

1. Will aspirin's market continue to grow globally?
Yes. While mature markets experience stability, emerging economies with expanding healthcare infrastructure and increasing lifestyle-related health issues present growth opportunities, particularly for indications beyond cardiovascular prevention.

2. Are there ongoing efforts to develop safer alternatives to carisoprodol?
Yes. Pharmaceutical research is focused on newer muscle relaxants with better safety profiles, though none have yet displaced carisoprodol significantly, especially given its withdrawal in certain markets.

3. How is regulatory pressure affecting the codeine phosphate market?
Stricter classification and control measures in multiple countries are reducing access and consumption, thereby constraining market size but also addressing misuse concerns.

4. What role does patent status play in the financial outlook of these drugs?
A drug’s patent life influences pricing and innovation incentives. Aspirin, being off-patent, faces price competition, while newer formulations or reformulations of codeine or muscle relaxants may extend patent protections and revenue streams.

5. Could new formulations turn around the declining market segments for these drugs?
Potentially. Abuse-deterrent formulations, combination products, or repurposing for new indications can rejuvenate markets—but regulatory approval and safety validation are critical hurdles.


References

[1] Research and Markets, "Global Aspirin Market," 2021.
[2] Fortune Business Insights, "NSAIDs Market Size & Share," 2022.
[3] FDA, "Reclassification of Carisoprodol," 2012.
[4] Xie, et al., "Aspirin in Cardiovascular Disease Prevention," The Lancet, 2020.
[5] IQVIA, "Global Opioid Market Analysis," 2022.

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