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Last Updated: December 15, 2025

DEMEROL Drug Patent Profile


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Which patents cover Demerol, and what generic alternatives are available?

Demerol is a drug marketed by Hospira and Quagen and is included in two NDAs.

The generic ingredient in DEMEROL is meperidine hydrochloride. There are six drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the meperidine hydrochloride profile page.

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Summary for DEMEROL
Drug patent expirations by year for DEMEROL
Drug Prices for DEMEROL

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Recent Clinical Trials for DEMEROL

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SponsorPhase
Centre hospitalier de l'Université de Montréal (CHUM)Phase 3
Monica BhatiaPhase 1
Ufuk UniversityPhase 4

See all DEMEROL clinical trials

Pharmacology for DEMEROL
Drug ClassOpioid Agonist
Mechanism of ActionFull Opioid Agonists

US Patents and Regulatory Information for DEMEROL

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Hospira DEMEROL meperidine hydrochloride INJECTABLE;INJECTION 021171-001 Approved Prior to Jan 1, 1982 AP RX Yes Yes ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Quagen DEMEROL meperidine hydrochloride INJECTABLE;INJECTION 005010-009 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Hospira DEMEROL meperidine hydrochloride INJECTABLE;INJECTION 021171-004 Approved Prior to Jan 1, 1982 AP RX Yes Yes ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Quagen DEMEROL meperidine hydrochloride INJECTABLE;INJECTION 005010-003 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Hospira DEMEROL meperidine hydrochloride INJECTABLE;INJECTION 021171-002 Approved Prior to Jan 1, 1982 AP RX Yes Yes ⤷  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 Demerol

Last updated: July 28, 2025

Introduction

Demerol, the brand name for meperidine (pethidine), is an opioid analgesic historically used to treat moderate to severe pain. As a synthetic narcotic, Demerol's market presence has significantly evolved amid shifting regulatory landscapes, growing opioid awareness, and the advent of alternative therapies. This analysis delineates the economic factors influencing Demerol's market dynamics and forecasts its financial trajectory within the context of current healthcare trends.


Historical Context and Market Lifecycle

Introduced in the 1930s, Demerol gained prominence in the mid-20th century as a potent alternative to morphine. Its widespread utilization persisted until mounting concerns over safety, dependency, and adverse effects prompted regulatory scrutiny. The advent of the 21st century witnessed a steep decline in Demerol's clinical use, driven by the emergence of safer opioids and non-opioid analgesics, alongside regulatory restrictions.

In the United States, the Drug Enforcement Administration (DEA) classifies Demerol as a Schedule II controlled substance, reflecting its high potential for abuse and dependence. Over recent decades, prescribing patterns have shifted markedly, with Demerol largely phased out from routine pain management protocols in favor of drugs with lower risk profiles.


Current Market Dynamics

  1. Regulatory Environment and Prescribing Trends

    The opioid epidemic's escalation prompted stringent regulations on opioid prescribing, directly impacting Demerol’s availability. Federal agencies like the Centers for Disease Control and Prevention (CDC) issued guidelines discouraging the use of short-acting opioids like Demerol. Many healthcare institutions have explicitly removed Demerol from their formularies, citing safety concerns [1].

  2. Manufacturing and Supply Chain Challenges

    The production of Demerol faced disruptions amid regulatory actions and manufacturing shifts. With several pharmaceutical manufacturers withdrawing Demerol from the market, supply constraints have ensued. The drug remains available through a limited number of generic manufacturers, which elevates prices due to decreased competition.

  3. Market Demand and Clinical Usage

    Current demand for Demerol has diminished substantially. The drug's sole remaining clinical indications are limited, such as in certain anesthesia protocols or specific diagnostic procedures. Its use in routine analgesia is negligible, mostly confined to legacy systems in hospital settings or niche applications.

  4. Pricing and Market Share

    The decline in demand, combined with regulatory restraints, has led to a significant reduction in Demerol’s market share. Prices have stabilized at a higher level for the remaining stock, reflecting scarcity and manufacturing costs, but overall revenues have plummeted.

  5. Legal and Ethical Considerations

    The heightened awareness of opioid misuse has led to increased scrutiny over all opioid products, including Demerol. Pharmaceutical companies face reputational risks associated with opioids, influencing their investment decisions. As a result, direct marketing and sales efforts have diminished sharply.


Forecasting Financial Trajectory

The future financial outlook for Demerol is characterized by contraction, obsolescence, and minimal revenue generation, underpinned by several key factors:

  1. Market Shrinkage

    As prescribing practices continue to favor drugs with better safety profiles, Demerol’s clinical usage will diminish further. Market projections suggest a near-complete phase-out within the next decade, barring unexpected clinical re-evaluations or regulatory liberalization.

  2. Potential Revival Scenarios

    Although unlikely in the near term, Demerol might see limited niche applications, such as in specific anesthetic procedures. However, these markets are small, and demand is unlikely to generate significant revenue.

  3. Regulatory and Litigation Risks

    The ongoing opioid crisis improves regulatory stringency, which could further hinder Demerol's market. Conversely, any regulatory relaxations or legal settlements could temporarily stabilize or slightly increase its market value but are unlikely to reverse long-term decline.

  4. Patent and Market Exclusivity

    Demerol’s original patents have long since expired, with multiple generics available. This erodes pricing power for remaining suppliers, keeping revenues minimal and margins low.

  5. Market Exit Considerations

    Given the shrinking market and increasing liabilities associated with opioids, pharmaceutical companies may choose to exit Demerol production entirely. This will further diminish any remaining revenue streams.


Strategic Implications for Industry Stakeholders

  • Manufacturers: Should anticipate continued decline and evaluate whether maintaining production aligns with strategic objectives or if divestiture is prudent.
  • Healthcare Providers: Mandated to reduce or eliminate Demerol from treatment protocols, focusing instead on safer alternatives.
  • Regulators: Will likely enforce stricter controls, contributing to further decline.
  • Investors: Should recognize Demerol's diminishing market potential and associated risks, favoring investments in emerging analgesic therapies.

Conclusion

Demerol’s market landscape is characterized by obsolescence driven by regulatory, safety, and economic factors. Its financial trajectory indicates near-zero revenue prospects within the foreseeable future. Manufacturers and stakeholders should align strategies accordingly, prioritizing safer and more effective analgesics, and preparing for a complete phase-out of Demerol in routine clinical practice.


Key Takeaways

  • Demerol’s historical dominance has declined sharply due to safety concerns and regulatory restrictions.
  • The current supply is limited; demand is negligible, predominantly confined to niche or legacy applications.
  • The drug’s market share is plummeting, with revenues expected to approach zero within a decade.
  • Future prospects for Demerol are minimal, barring unforeseen clinical or regulatory developments.
  • Industry stakeholders should consider divestment or discontinuation, redirecting focus toward safer analgesic alternatives.

FAQs

  1. Is Demerol still approved for medical use globally?
    Demerol remains approved in some countries but is widely restricted or withdrawn in regions like the United States due to safety concerns and regulatory restrictions.

  2. What are the main reasons for Demerol’s decline in clinical use?
    Concerns over dependency, adverse effects, safer alternatives, and regulatory restrictions have led to its decline.

  3. Could Demerol resurface as a preferred analgesic?
    Unlikely, given current safety data, regulatory stance, and the availability of superior analgesics with lower abuse potential.

  4. Are there any legal liabilities associated with Demerol production?
    While not currently prominent, the broader opioid litigation landscape may impact manufacturers’ decisions; ongoing scrutiny increases compliance risks.

  5. What alternative therapies are replacing Demerol?
    Safer opioids like oxycodone, hydromorphone, and non-opioid options such as NSAIDs, acetaminophen, and adjuvant therapies are replacing Demerol in most settings.


References

[1] Centers for Disease Control and Prevention (CDC). "Guideline for Prescribing Opioids for Chronic Pain — United States," 2016.

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