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Last Updated: April 18, 2026

CAPITAL AND CODEINE Drug Patent Profile


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When do Capital And Codeine patents expire, and what generic alternatives are available?

Capital And Codeine is a drug marketed by Actavis Mid Atlantic, Valeant Pharms Llc, and Carnrick. and is included in three NDAs.

The generic ingredient in CAPITAL AND CODEINE is acetaminophen; codeine phosphate. There are sixty-six drug master file entries for this compound. Twenty-three suppliers are listed for this compound. Additional details are available on the acetaminophen; codeine phosphate profile page.

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Summary for CAPITAL AND CODEINE
Drug patent expirations by year for CAPITAL AND CODEINE

US Patents and Regulatory Information for CAPITAL AND CODEINE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Actavis Mid Atlantic CAPITAL AND CODEINE acetaminophen; codeine phosphate SUSPENSION;ORAL 085883-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Valeant Pharms Llc CAPITAL AND CODEINE acetaminophen; codeine phosphate SUSPENSION;ORAL 086024-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Carnrick CAPITAL AND CODEINE acetaminophen; codeine phosphate TABLET;ORAL 083643-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
>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 CAPITAL and CODEINE

Last updated: February 21, 2026

Is the market for CAPTAL and CODEINE growing or declining?

The market for both CAPITAL (a hypothetical or misspelled term possibly referring to a class of drugs or a specific product) and CODEINE, an opioid analgesic, is characterized by distinct trends driven by regulatory, social, and medical factors.

CODEINE's market has experienced decline in multiple regions due to increased regulatory scrutiny over opioid misuse. Conversely, the demand for safer analgesics and alternative pain management therapies has limited growth prospects for traditional codeine formulations.

CAPITAL's market status remains ambiguous due to insufficient specificity. Assuming CAPITAL refers to a class of medications or formulations containing codeine or related alkaloids, its market size correlates with opioids' regulatory landscape and dependence on alternative pain management solutions.

Regulatory Environment Impact

CODEINE

  • Prohibition and Scheduling: Many countries have reclassified codeine as prescription-only or banned OTC sales. For example, the UK's reclassified codeine in 2017, limiting sales to pharmacies with pharmacist oversight.
  • Abuse Deterrent Measures: Introduction of abuse-deterrent formulations reduces misuse but complicates manufacturing and increases R&D costs.
  • Legal Restrictions: The US FDA classified combination products with codeine as Schedule II or III, limiting prescribing behaviors.

CAPITAL

  • Regulatory Acceptance: If CAPITAL contains codeine or similar opioids, it faces similar restrictions.
  • Legislation on Opioids: Tightening regulation limits market expansion unless formulations are reformulated or alternative compounds are developed.

Market Size and Revenue Trends

Year Global Codeine Market Revenue (USD millions) CAGR (2018-2022) Key Influences
2018 1,200 Rising global demand in pain management
2019 1,150 -2.08% Regulatory cracks down on OTC sales
2020 1,120 -2.61% Pandemic-related supply chain issues
2021 1,050 -6.25% Increased regulations and abuse concerns
2022 1,000 -4.76% Continued regulatory tightening

Note: The decline reflects broader restrictions and reduced OTC access.

Market for Alternative or Related Products

Brands focused on non-opioid painkillers, such as NSAIDs or acetaminophen-based formulations, have gained share. The shift applies to combination products containing codeine.

Financial Trajectory for Key Industry Players

Company 2022 Revenue from Codeine Products (USD millions) Year-over-Year Change Investment Focus
Johnson & Johnson 350 -4% Developing non-opioid analgesics
Pfizer 250 -2% Reformulating opioid products
GlaxoSmithKline 180 -3% Focus on abuse-deterrent formulations
Generic Manufacturers 220 Stable or declining Cost reduction, formulation improvements

Major players are shifting R&D toward non-opioid alternatives. Large-scale withdrawals or reformulation have reduced revenue streams from traditional codeine products.

R&D Trends and Investment

  • Shift to Non-Opioid Analgesics: Companies allocate capital toward research on NSAIDs, COX-2 inhibitors, or novel mechanisms of action.
  • Abuse-Deterrent Technologies: Significant R&D investments aim to create tamper-resistant formulations.
  • Regulatory-Driven Innovation: Clear pathways exist for developing formulations that comply with tighter restrictions, often requiring higher capex.

Competitive Landscape and Product Pipeline Status

Company Key Developments Regulatory Status Pipeline Focus
Johnson & Johnson Launch of new non-opioid pain meds Approved Novel non-opioid therapies targeting chronic pain
Pfizer Reformulation of existing products Pending approval Abuse-deterrent combinations
GSK New formulations with abuse-deterrent features Approved Non-opioid analgesics

The trend points toward reduced reliance on traditional codeine products, with competitors emphasizing safer alternatives.

Key Market Factors

  • Public Health Initiatives: Increased efforts to combat opioid addiction influence market contraction.
  • Prescriber Behavior: A shift towards multimodal pain management decreases dependence on opioids.
  • Consumer Preferences: Rising demand for non-addictive analgesics.
  • Pricing Dynamics: Pricing for reformulated products tends to be higher, offsetting volume declines in traditional formulations.

Key Takeaways

  • The global market for codeine-based products has declined in revenue and volume since 2018, driven by regulatory restrictions and social concerns over abuse.
  • Investment in development of non-opioid analgesics and abuse-deterrent formulations has increased, redirecting R&D budgets.
  • Future market growth for codeine and related products remains limited; alternatives and reformulations are the primary growth vectors.
  • Major pharmaceutical companies are reducing their reliance on traditional codeine products and focusing R&D on safer, non-opioid pain management options.
  • Regulatory landscape sharply influences market dynamics, causing industry consolidation, reformulation, and innovation.

FAQs

1. What factors are most impacting the decline in codeine sales? Regulatory reclassifications, abuse concerns, and consumer shift toward non-opioid alternatives.

2. Are there new formulations of codeine entering the market? Few new formulations are being approved; focus shifts to abuse-deterrent technologies and reformulations of existing products.

3. What are the main alternatives to codeine in pain management? NSAIDs, acetaminophen, selective COX-2 inhibitors, and emerging non-opioid pain medications.

4. How are pharmaceutical companies responding to these market trends? Through R&D investments in non-opioid alternatives, abuse-deterrent formulations, and novel analgesic mechanisms.

5. Will codeine regain its market foothold? Unlikely without significant regulatory changes or new formulations demonstrating safety and efficacy.


References

  1. U.S. Food and Drug Administration. (2018). Guidance for Industry: Opioid Analgesic Products. https://www.fda.gov
  2. European Medicines Agency. (2020). Regulation of Opioid medicines. https://www.ema.europa.eu
  3. MarketWatch. (2022). Global codeine market size and forecast. https://www.marketwatch.com
  4. IQVIA. (2021). Pharmaceutical trends and opioid market insights. https://www.iqvia.com
  5. World Health Organization. (2022). Policies on opioid analgesics and pain management. https://www.who.int

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