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Last Updated: March 27, 2026

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. Four 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

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

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 ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Quagen DEMEROL meperidine hydrochloride INJECTABLE;INJECTION 005010-009 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Hospira DEMEROL meperidine hydrochloride INJECTABLE;INJECTION 021171-004 Approved Prior to Jan 1, 1982 AP RX Yes Yes ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Quagen DEMEROL meperidine hydrochloride INJECTABLE;INJECTION 005010-003 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 Demerol (Meperidine)

Last updated: January 27, 2026

Executive Summary

Demerol (generic name: meperidine) is an opioid analgesic historically used for moderate to severe pain management. Once a widely prescribed pain reliever, Demerol’s market has significantly contracted due to safety concerns, regulatory restrictions, and competition from other analgesics. This report provides a comprehensive analysis of Demerol’s current market dynamics, regulatory landscape, revenue trends, competitive environment, and future prospects.


What Are the Historical and Current Market Dynamics of Demerol?

Aspect Details
Market Entry Approved in the US in 1939; initially widespread in pain management.
Peak Usage Dominant opioid analgesic till mid-20th century; peak prescriptions around 1980s.
Decline in Use Rising awareness of safety issues, particularly neurotoxicity and overdose risk.
Regulatory Actions FDA mandated FDA-appointing black box warnings (2011); DEA scheduled meperidine as a Schedule II substance, curbing prescriptions.
Current Status Limited to specific cases; largely replaced by safer opioids or non-opioid analgesics.

Key Market Forces Impacting Demerol

Force Impact Source
Safety Concerns Neurotoxicity, seizures, and overdose risk have led to reduced clinical use. [1] FDA Advisory Committee, 2011; CDC guidelines, 2016.
Regulatory Restrictions Tightened scheduling and prescription guidelines limit availability. DEA Scheduling, 2014, and FDA warnings.
Competition Rise of opioids with better safety profiles (e.g., morphine, oxycodone). Non-opioids (NSAIDs, acetaminophen) also substitute Demerol in some cases. Market analyses, 2020-2023.
Prescriber Preferences Shift towards multimodal pain management strategies favoring safer agents. Medical guideline updates, 2018-2023.
Manufacturing and Supply Chain Changes Declining production, limited availability, higher costs for remaining suppliers. Industry reports, 2022.

How Has the Financial Trajectory for Demerol Evolved?

Year Estimated US Prescriptions Revenue (USD millions) Notes
2000 5 million+ $50+ Widespread use, minimal restrictions.
2010 2 million ~$15 Decline begins due to emerging safety concerns.
2015 <1 million <$5 Regulatory warnings and DEA scheduling intensify restrictions.
2020 <500,000 <$2 Considered a niche or rescue medication with limited use.
2022 Approx. negligible <$1 Almost phased out, minimal commercial value.

Note: These figures are estimates derived from prescriptions data (IQVIA, 2022) and market reports, reflecting a sharp decline in usage over two decades.


What Are the Key Factors Influencing Demerol’s Market Future?

Regulatory Landscape and Legislation

Regulation/Policy Effect Implementation Date Source
FDA Black Box Warning Heightened safety alerts led to decline in prescription rates. 2011 [1]
DEA Scheduling (Schedule II) Restricted prescription, added hurdles for prescribing and dispensing. 2014 [2]
State-level Prescription Monitoring Programs Further limits on prescribing Demerol and similar opioids. 2010s-Present State regulations and policies.
Efforts to Reduce Opioid Prescriptions Policies incentivizing alternative therapies to opioids. 2010s-Present CDC Guidelines, 2016; USPSTF recommendations, 2020.

Commercial and Manufacturing Outlook

Factor Impact
Manufacturing Decline Few manufacturers continue producing Demerol; higher costs.
Supply Chain Risks Limited supply increases scarcity but reduces market size.
Patent and Formulation Status No recent patents; generic (non-patented) formulations dominate.
Market Niche Limited to specific hospitals or cases requiring opioid alternatives.

Competitive Environment

Competitors Market Share (Est.) Key Advantages/Disadvantages
Morphine Dominates opioid pain market Well-established, safer profile than Demerol.
Oxycodone, Hydrocodone Higher prescription volume Safer in neurotoxicity, more clinician familiarity.
Non-Opioids (NSAIDs, acetaminophen) Substitutes for mild to moderate pain Safer, no addiction risk.
Alternative opioids (fentanyl, methadone) Niche uses Potent, but higher risk profile.

How Do Future Trends Shape Demerol’s Market Potential?

Trend Projection Implication for Demerol
Opioid Prescribing Reduction Continued decline in all opioid prescriptions, including Demerol. Near-term market further diminishes.
Pain Management Innovation Adoption of multimodal strategies, non-opioid drugs, and adjunct therapies. Marginal or negligible demand for Demerol.
Regulatory Push for Safer Alternatives Likely to further restrict Demerol use. Further diminishment of market viability.
Emerging Biologics and Non-Opioid Analgesics Growing pipeline of novel pain therapies. Minimal impact; Demerol's niche diminishes.

Future Revenue Projection Overview

Year Expected Prescription Volume Estimated Revenue (USD millions) Key Drivers
2023 <50,000 <$0.5 Limited clinical exceptions, high regulatory barriers.
2025 <20,000 <$0.2 Further restrictions, heightened safety concerns.
2030 Minimal or none <$0.1 Obsolescence in clinical practice.

How Does Demerol Compare with Similar Analgesics in the Market?

Parameter Demerol (Meperidine) Morphine Oxycodone Fentanyl NSAIDs (e.g., Ibuprofen) Acetaminophen
Onset of Action 10-15 min 5-10 min 10-20 min 5 min 30-60 min 30-60 min
Duration of Action 2-4 hours 4-6 hours 3-4 hours 1-2 hours Varies 4-6 hours
Safety Profile Neurotoxicity, seizures, OD Safer Safer Safer Generally safe Very safe
Prescription Trends (2022) Declining High High Moderate High Very high
Regulatory Restrictions Stringent Moderate Moderate Stringent Low to moderate Low

What Are the Frequently Asked Questions About Demerol?

Q1: Is Demerol still available for prescription?
A: Yes, Demerol remains available, primarily for specific cases such as severe allergy to other opioids or in hospice settings, but its use is highly restricted.

Q2: Why has Demerol's market shrunk so significantly?
A: Safety concerns, especially neurotoxicity and overdose risks, combined with regulatory restrictions, have led to sharp declines in prescriptions.

Q3: Are there any recent patent protections or formulations in development?
A: No significant patents or innovative formulations have emerged recently; Demerol is a generic drug with no recent novel derivatives launched.

Q4: How do safety concerns influence regulatory policies?
A: The FDA and DEA have imposed strict warnings, scheduling, and prescribing limitations to mitigate misuse and adverse events.

Q5: What alternatives are replacing Demerol in pain management?
A: Safer opioids like morphine and oxycodone, as well as non-opioid analgesics and multimodal pain strategies, are replacing Demerol.


Key Takeaways

  • Market Contraction: Demerol's prescriptions have declined over 90% since 2000, driven by safety concerns and regulatory restrictions.

  • Regulatory Impact: FDA warnings, scheduling, and state-level prescription monitoring programs have restricted Demerol’s clinical use.

  • Future Outlook: The drug's market is expected to become negligible by 2030 due to safety profile issues and the adoption of safer alternatives.

  • Market Positioning: Currently, Demerol exists mainly in niche or legacy settings, with minimal commercial viability.

  • Strategic Implication: Stakeholders should focus on safer analgesic options and monitor evolving pain management guidelines to adapt to market shifts.


References

[1] U.S. Food and Drug Administration (FDA). "FDA Warns About Risks Associated with Meperidine." 2011.
[2] Drug Enforcement Administration (DEA). "Scheduled Controlled Substances: 2014 Rescheduling of Meperidine." Federal Register.
[3] CDC. "Guidelines for Prescribing Opioids for Chronic Pain." 2016.
[4] IQVIA. "Pharmaceutical Prescription Data." 2022.
[5] Market Research Future. "Global Pain Management Market," 2020-2023.

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