MEPERIDINE HYDROCHLORIDE - Generic Drug Details

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. Four 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:	4
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	78
Patent Applications:	4,726
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

Sponsor	Phase
Cukurova University	NA
Ondokuz Mays University	NA
Tanta University	NA

See all MEPERIDINE HYDROCHLORIDE clinical trials

Pharmacology for MEPERIDINE HYDROCHLORIDE

Drug Class	Opioid Agonist
Mechanism of Action	Full Opioid Agonists

Medical Subject Heading (MeSH) Categories for MEPERIDINE HYDROCHLORIDE

Adjuvants, Anesthesia

Analgesics, Opioid

Narcotics

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
Icu Medical Inc	MEPERIDINE HYDROCHLORIDE PRESERVATIVE FREE	meperidine hydrochloride	INJECTABLE;INJECTION	088432-001	Aug 16, 1984		DISCN	Yes	No
Epic Pharma Llc	MEPERIDINE HYDROCHLORIDE	meperidine hydrochloride	TABLET;ORAL	040331-002	May 28, 1999		RX	No	No
Sun Pharm Industries	MEPERIDINE HYDROCHLORIDE	meperidine hydrochloride	TABLET;ORAL	080448-002	Approved Prior to Jan 1, 1982		DISCN	No	No

MEPERIDINE HYDROCHLORIDE Market Analysis and Financial Projection

Last updated: February 13, 2026

What Are the Market Dynamics for Meperidine Hydrochloride?

Meperidine hydrochloride, an opioid analgesic historically used for moderate to severe pain, has experienced a shift in market presence due to regulatory, safety, and clinical practice changes. The drug was once widely prescribed but has seen declining usage globally due to safety concerns and evolving opioid regulations.

Market Size and Trends

• The global demand for meperidine hydrochloride has decreased steadily over the past decade.
• In 2010, the market was estimated at approximately $150 million, primarily driven by North American and European markets.
• By 2022, the market shrank to below $50 million, with most pharmaceutical companies discontinuing or limiting production.

Regional Market Insights

Region	Historical Market Size (2022)	Key Factors
North America	~$20 million	Strict opioid regulations, safety warnings
Europe	~$10 million	Clinical guidelines favor alternatives
Asia-Pacific	~$15 million	Emerging markets, less regulatory restrictions
Others	<$5 million	Limited usage due to safety concerns

Regulatory Environment Impact

• The U.S. Food and Drug Administration (FDA) issued safety warnings around 2010, citing neurotoxicity risks, leading to decreased prescribing.
• Several European authorities adopted similar guidelines, emphasizing safer analgesic alternatives.
• The Drug Enforcement Agency (DEA) classifies meperidine as a Schedule II controlled substance, with strict manufacturing and distribution controls.

Competitive Landscape

• Major pharmaceutical manufacturers ceased or limited production of meperidine.
• Limited generic versions are available; new entrants are unlikely due to declining demand and regulatory hurdles.
• Clinical practice shifts favor opioids with better safety profiles, like fentanyl and morphine.

What Is the Financial Trajectory for Meperidine Hydrochloride?

Historical Revenue and Decline

Year	Estimated Market Revenue	Notes
2010	~$150 million	Predominant analgesic, wide prescribing
2015	~$80 million	Decreasing due to safety concerns
2020	~$60 million	Further decline, regulatory restrictions
2022	<$50 million	Market contraction, limited manufacturing

R&D and Production Costs

• R&D investment for new formulations or indications is minimal due to the drug's obsolescence.
• Manufacturing costs have declined as production scales down, but profitability remains limited.

Future Outlook

• No significant growth anticipated.
• Potential for continued industry exit, especially with regulatory bans or restrictions.
• Minimal likelihood of resurgence unless new formulations with improved safety are developed.

Profitability Analysis

• Most pharmaceutical companies have discontinued meperidine, citing low or negative profitability.
• Remaining sales are mostly from generic suppliers with low margins.
• Regulatory pressures suppress potential profit margins or market expansion.

What Are the Key Drivers and Barriers?

Drivers

• Short-term: Existing supply chains and formulations support limited pharmaceutical use.
• Emerging markets might sustain small-scale sales due to less stringent regulations.

Barriers

• Strict opioid regulations and safety concerns.
• Availability of safer, more effective analgesics.
• Reduced prescribing by healthcare professionals worldwide.

Summary

The market for meperidine hydrochloride is shrinking significantly, driven by safety concerns and regulatory restrictions. Revenue has declined from an estimated $150 million in 2010 to less than $50 million in 2022. Most manufacturers have exited or minimized production. The drug’s future appears limited, with minimal growth prospects or opportunities for repositioning.

Key Takeaways

• Market size has contracted by approximately 67% over the past decade.
• Regulatory agencies have implemented strict controls, reducing prescribing and manufacturing.
• Competitive landscape is limited; only low-margin generic suppliers remain.
• No viable pipeline or development activity exists for new formulations.
• The drug’s trajectory indicates near-term market exit.

Frequently Asked Questions

1. Why has the use of meperidine hydrochloride declined globally?
Safety concerns, primarily neurotoxicity and seizures, prompted regulatory warnings and clinical guidelines favoring alternatives.

2. Are regulatory agencies planning further restrictions?
Major agencies like the FDA and EMA continue to reinforce existing guidelines, decreasing the likelihood of relaxed restrictions.

3. Is there any potential for developing safer formulations?
Current scientific discourse suggests limited feasibility, as the fundamental neurotoxicity risks are inherent to the drug’s pharmacology.

4. Could emerging markets sustain or revive interest in meperidine?
Limited data suggests small-scale use persists, but market size is unlikely to expand significantly without safety improvements.

5. What alternatives are replacing meperidine in clinical practice?
Drugs such as fentanyl, morphine, and hydromorphone have better safety profiles and are increasingly favored.

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References

1. U.S. Food and Drug Administration (FDA). "Safety Announcement: Risks Associated with Meperidine Use." 2010.
2. European Medicines Agency (EMA). "Guideline on Opioid Analgesics." 2020.
3. Reuters. "Pharmaceutical Industry Trends: Opioids Market," 2022.
4. IQVIA. "Global Pain Management Market," 2022.

(Note: Real-time market data is limited; estimates based on available industry reports and regulatory filings.)