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Last Updated: December 15, 2025

Meperidine hydrochloride - Generic Drug Details


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What are the generic sources for meperidine hydrochloride and what is the scope of patent protection?

Meperidine hydrochloride is the generic ingredient in four branded drugs marketed by Hospira, Quagen, Abbott, Baxter Hlthcare, Igi Labs Inc, Intl Medication, Parke Davis, Watson Labs, West-ward Pharms Int, Icu Medical Inc, Specgx Llc, Hikma, Barr, Duramed Pharms Barr, Epic Pharma Llc, Genus, Strides Pharma Intl, Sun Pharm Inds Inc, Sun Pharm Industries, and Wyeth Ayerst, and is included in forty-five NDAs. Additional information is available in the individual branded drug profile pages.

There are four drug master file entries for meperidine hydrochloride. Five suppliers are listed for this compound.

Summary for meperidine hydrochloride
US Patents:0
Tradenames:4
Applicants:20
NDAs:45
Drug Master File Entries: 4
Finished Product Suppliers / Packagers: 5
Raw Ingredient (Bulk) Api Vendors: 1
Clinical Trials: 77
Patent Applications: 4,833
What excipients (inactive ingredients) are in meperidine hydrochloride?meperidine hydrochloride excipients list
DailyMed Link:meperidine hydrochloride at DailyMed
Recent Clinical Trials for meperidine hydrochloride

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Ondokuz Mays UniversityNA
Tanta UniversityNA
Kasr El Aini HospitalNA

See all meperidine hydrochloride clinical trials

Pharmacology for meperidine hydrochloride
Drug ClassOpioid Agonist
Mechanism of ActionFull Opioid Agonists
Medical Subject Heading (MeSH) Categories for meperidine hydrochloride

US Patents and Regulatory Information for meperidine hydrochloride

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Specgx Llc MEPERIDINE HYDROCHLORIDE meperidine hydrochloride TABLET;ORAL 040352-001 Jun 13, 2000 DISCN No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Genus MEPERIDINE HYDROCHLORIDE meperidine hydrochloride TABLET;ORAL 040893-004 Jun 24, 2009 DISCN No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Abbott MEPERIDINE HYDROCHLORIDE meperidine hydrochloride INJECTABLE;INJECTION 080386-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Genus MEPERIDINE HYDROCHLORIDE meperidine hydrochloride TABLET;ORAL 040893-001 Jun 24, 2009 AA RX No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Baxter Hlthcare MEPERIDINE HYDROCHLORIDE meperidine hydrochloride INJECTABLE;INJECTION 088280-001 Jun 15, 1984 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 Meperidine Hydrochloride

Last updated: July 27, 2025

Introduction

Meperidine hydrochloride, historically known as Demerol, is a synthetic opioid analgesic primarily used for acute pain management. Introduced in the 1930s, it gained widespread acceptance for its potency and rapid onset. However, over decades, the drug’s clinical use has declined sharply owing to safety concerns, regulatory restrictions, and the advent of safer alternatives. This article examines the current market landscape, evolving dynamics, and future financial trajectory for meperidine hydrochloride.

Historical Context and Market Decline

Initially, meperidine hydrochloride was one of the leading opioids globally, favored for outpatient pain relief and anesthesia adjuncts. During the 20th century, it became a staple in both domestic and hospital settings, contributing significantly to the opioid market’s growth.

However, rising awareness of adverse effects—including neurotoxicity, seizures, and drug accumulation issues—precipitated declining clinical usage. The drug's metabolites, particularly normeperidine, pose risks of central nervous system toxicity, especially in prolonged therapy or renal impairment, prompting regulatory bodies to reevaluate its safety profile.

In the United States, the Food and Drug Administration (FDA) issued warnings and repositioned meperidine as a drug of limited use. The CDC’s opioid epidemic further exacerbated restrictions, leading to a substantial reduction in prescribing rates [1].

Current Market Dynamics

Regulatory Environment and Prescribing Trends

Regulatory agencies globally have tightened oversight of opioid analgesics, including meperidine hydrochloride. The FDA’s 2015 warning explicitly discouraged its use as a first-line agent, particularly emphasizing the availability of safer alternatives like morphine, hydromorphone, and fentanyl.

Many countries have also imposed scheduling restrictions, classifying meperidine as a controlled substance with stringent prescription mandates. As a result, physicians worldwide have shifted away from prescribing meperidine, favoring more effective and safer opioids.

Manufacturing and Supply

The decline in demand led to a significant reduction in manufacturing. Several major pharmaceutical companies have discontinued or deprioritized production of meperidine hydrochloride due to low market viability and impending patent or exclusivity expirations. Generic manufacturers, previously producing meperidine at scale, have similarly scaled back operations, contributing to supply shortages in certain regions.

Pricing and Market Valuation

The reduced prescribing and supply constraints have driven down the drug’s market value. Price points for meperidine products have stabilized at low levels, and in some markets, its availability is limited to niche applications or hospital stocks for specific cases.

Emergence of Alternatives

The therapeutic landscape has transformed considerably. Non-opioid analgesics such as NSAIDs, acetaminophen, and adjuvants have reduced the reliance on opioids altogether. When opioids are necessary, drugs with better safety profiles are preferred.

In addition, newer opioids like remifentanil, sufentanil, and fentanyl derivatives offer rapid onset and shorter duration, making them more suitable for anesthesia and pain management, further eroding meperidine's clinical role.

Legal and Social Factors

The opioid crisis has prompted stricter controls and public health campaigns to curtail opioid prescribing. The implementation of Prescription Drug Monitoring Programs (PDMPs) and increased clinician awareness has minimized unnecessary or off-label use of meperidine hydrochloride. Consequently, market demand continues to decline.

Financial Trajectory Outlook

Short-Term Projection (1-3 Years)

In the immediate future, meperidine hydrochloride's market will likely continue to diminish. Pharmaceutical companies will maintain limited production, largely driven by existing hospital inventory and specific, entrenched clinical practices. Demand is expected to decline by approximately 10-20% annually, congruent with broader opioid prescribing trends [2].

In many regions, manufacturers may withdraw the product entirely due to marginal profitability, leading to supply shortages and potential off-label illegal manufacturing. Price points will remain low, reflecting diminished clinical relevance.

Medium to Long-Term Outlook (3-10 Years)

Over the next decade, meperidine hydrochloride is anticipated to transition toward an almost obsolete status in mainstream medicine. The drug’s absence from formularies and substitution by safer agents will solidify its decline. Potential for resurgence exists only if faced with unforeseen supply chain disruptions or regulatory relaxations, neither of which are imminent.

Market valuation could decline to negligible levels, with some regional markets ceasing production altogether. The overall financial potential for new investment in meperidine is minimal, with prospects favoring generic manufacturers gradually phasing out existing stockpiles.

Potential Niche Applications and Ethical Considerations

Despite its market contraction, some niche clinical scenarios—such as specific obstetric or surgical cases—may sustain minimal demand. Still, the trend favors complete phase-out. Ethical and legal concerns related to opioid misuse and toxicity will further constrain its utilization.

Implications for Stakeholders

  • Pharmaceutical Companies: Should deprioritize investment in meperidine hydrochloride, focusing R&D on safer, innovative analgesics.
  • Healthcare Providers: Must adhere to evolving guidelines favoring non-opioid or safer opioid alternatives.
  • Regulators: Continue to enforce restrictions, reducing misuse and adverse outcomes.
  • Investors: Likely see declining financial returns associated with products containing meperidine hydrochloride.

Conclusion and Future Outlook

The market for meperidine hydrochloride is in persistent decline, shaped by regulatory restrictions, safety concerns, and shifts toward safer analgesic options. While still available in some regions, its clinical and commercial relevance diminishes steadily.

Future trends point toward near-complete obsolescence, with minimal financial upside for manufacturers and investors. The drug’s trajectory exemplifies the broader shift in pain management priorities—favoring safety, efficacy, and regulation-driven prescribing—highlighting the importance of adaptive strategies for stakeholders engaged in the analgesic and opioid markets.


Key Takeaways

  • Market contraction: A decline of 10-20% annually over the next few years is expected due to regulatory and clinical shifts.
  • Regulatory influence: Increased restrictions and warnings limit meperidine's clinical use and supply.
  • Competition from alternatives: Safer opioids and non-opioid analgesics replace meperidine, reducing demand.
  • Supply chain considerations: Manufacturers are likely to phase out production, impacting availability.
  • Investment outlook: Low future profitability diminishes prospects for growth or new development.

FAQs

  1. Why has the clinical use of meperidine hydrochloride declined significantly?
    Due to safety concerns, including neurotoxicity, risk of seizures, and accumulation of toxic metabolites, regulatory agencies have discouraged its use. Safer analgesics now dominate, rendering meperidine obsolete in mainstream practice.

  2. Are there any regions where meperidine is still widely used?
    Usage persists minimally in some regions with limited regulatory enforcement or outdated prescribing practices. However, global trends uniformly favor withdrawal from the drug.

  3. What factors contributed to the decline in meperidine’s market value?
    Safety concerns, regulatory bans, the emergence of superior alternatives, and reduced manufacturing have collectively depressed its financial significance.

  4. Can we expect a resurgence of meperidine in the future?
    Unlikely. Current trajectories and regulatory environments strongly oppose a resurgence, barring unforeseen changes in safety or legal considerations.

  5. What should pharmaceutical investors consider regarding opioids like meperidine?
    Focus on developing or investing in safer, non-addictive analgesics. The opioid market is increasingly constrained by regulations and societal health initiatives, making classic opioids like meperidine unattractive for investment.


References

  1. Centers for Disease Control and Prevention. Opioid Overdose Static Data. CDC; 2022.
  2. U.S. Food and Drug Administration. FDA Drug Safety Communication: Risks of Neurotoxicity with Meperidine. FDA; 2015.

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