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, 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:	45
Clinical Trials:	71
Patent Applications:	3,926
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
Medipol University	N/A
Assiut University	Phase 2/Phase 3
Tanta University	N/A

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
Quagen	DEMEROL	meperidine hydrochloride	INJECTABLE;INJECTION	005010-003	Approved Prior to Jan 1, 1982		DISCN	No	No
Igi Labs Inc	MEPERIDINE HYDROCHLORIDE	meperidine hydrochloride	INJECTABLE;INJECTION	089786-001	Mar 31, 1989		DISCN	No	No
Epic Pharma Llc	MEPERIDINE HYDROCHLORIDE	meperidine hydrochloride	TABLET;ORAL	040331-001	May 28, 1999	AA	RX	No	Yes
Genus	MEPERIDINE HYDROCHLORIDE	meperidine hydrochloride	TABLET;ORAL	040893-001	Jun 24, 2009	AA	RX	No	No

Meperidine hydrochloride Market Analysis and Financial Projection Experimental

Meperidine Hydrochloride Market Dynamics and Financial Trajectory

Market Overview

The meperidine hydrochloride market, often referred to by its brand name Demerol, is a segment of the broader opioid analgesics market. This market is driven by several key factors, including the increasing prevalence of chronic pain, advancements in drug delivery systems, and the growing demand for effective pain management solutions.

Market Size and Growth

The global meperidine drugs market is projected to grow at a Compound Annual Growth Rate (CAGR) of 4.1% from 2024 to 2029[1].

• By 2032, the market is expected to reach approximately $1.8 billion, growing from $0.64 billion in 2023 at a CAGR of 5.51%[4].

Regional Market Analysis

North America

North America holds the largest share in the meperidine market, primarily due to the high number of surgical procedures performed in the U.S. and the significant prevalence of chronic pain syndromes. The U.S. market dominates this region, with approximately 50 million adults dealing with chronic pain[4].

Asia-Pacific

The Asia-Pacific region is expected to witness the fastest growth, driven by increasing healthcare awareness, a rising geriatric population, and a higher volume of dental and cosmetic surgeries. China and India are key markets in this region, with India being the fastest-growing market[1][4].

Key Drivers of Market Growth

Increasing Prevalence of Chronic Pain

Diseases such as cancer, arthritis, and postsurgical pain are driving the demand for meperidine. Approximately 75% of patients who undergo surgery experience acute postoperative pain, which is often medium to high in severity[1].

Technological Advancements

Advancements in drug delivery systems and the cost efficiency of Over-The-Counter (OTC) analgesics are significant drivers. Injectable meperidine, in particular, is expected to witness high growth due to its cost efficiency and ease of availability[5].

Geriatric Population

The rising geriatric population in highly industrialized countries is increasing the demand for pain relief measures. This demographic shift is anticipated to further bolster market growth for meperidine[5].

Market Challenges and Restraints

Regulatory Actions

Stringent regulations and prescription controls are influencing market dynamics. Regulatory policy changes can significantly impact prescribing practices and market competition[4].

Alternative Pain Management Solutions

The emergence of non-opioid analgesics, physical therapy, and interventional procedures is changing the pain management landscape. This shift is driven by concerns over opioid abuse and addiction, which affects the demand for opioids like meperidine[4].

Side Effects and Misuse

Meperidine is associated with several side effects, including slow heartbeats, severe constipation, muscle tremors, and drowsiness. Additionally, its potential for misuse and addiction is a significant concern, with 21-29% of patients prescribed opioids for chronic pain misusing them[2][5].

Competitive Landscape

The meperidine market is moderately competitive, with key players including Sanofi Aventis, Mallinckrodt Pharmaceuticals, Pfizer Inc., Novartis (Sandoz Canada Inc.), Epic Pharma, Sun Pharmaceutical, Vintage Pharms, and Teva Pharmaceutical. These companies are investing heavily in research and development to expand their product lines and improve market retention through strategies such as new product launches, contractual agreements, mergers and acquisitions, and collaborations[1][4].

Economic and Healthcare Considerations

Healthcare Expenditure and Reimbursement Policies

The affordability and accessibility of meperidine are influenced by healthcare expenditure and reimbursement policies. These factors impact patient access and healthcare provider prescribing patterns, thereby influencing market trends and competition[4].

Impact of COVID-19

The COVID-19 pandemic has indirectly affected the meperidine market by highlighting the importance of pharmaceutical and biotechnology industries in managing public health crises. However, the primary focus on COVID-19 management has not significantly altered the long-term growth trajectory of the meperidine market[5].

Market Segmentation

The meperidine market is segmented based on application, including pain relief, anesthesia, cough suppression, diarrhea suppression, and de-addiction. The pain relief category generates the most income, driven by the prevalence of acute and chronic painful disorders such as post-operative pain, injury-related pain, and cancer-related pain[4].

Key Market Trends

• Rise in Surgical Procedures: The growth in surgical procedures, especially in North America, is boosting the meperidine market. Anesthesia used in these procedures is a significant driver[5].
• Generic Formulations: The availability of generic meperidine formulations affects market dynamics by reducing prices and making the market more accessible. This competition forces pharmaceutical companies to focus on pricing tactics and product differentiation[4].
• Research and Development: Ongoing R&D efforts in pain management are driving innovation and market expansion. Companies are investing in the development of safer and more effective opioid analgesics and exploring novel pain management solutions[4].

"Meperidine’s rapid onset and short duration of action are key contributors to the development of tolerance and dependence, making it more likely to be misused compared to other opioids." - Marcia L. Buck (2011)[2]

Financial Trajectory

The financial trajectory of the meperidine market is positive, driven by increasing demand for pain relief solutions and advancements in drug delivery systems. Here are some key financial highlights:

• Market Size: The market is expected to grow from $0.64 billion in 2023 to $1.8 billion by 2032[4].
• CAGR: The market is projected to grow at a CAGR of 5.51% from 2023 to 2032[4].
• Regional Growth: North America will continue to dominate the market, while the Asia-Pacific region will experience the fastest growth[1][4].

Key Takeaways

• The meperidine market is driven by the increasing prevalence of chronic pain and advancements in drug delivery systems.
• North America holds the largest market share, while the Asia-Pacific region is expected to grow the fastest.
• Regulatory actions and the emergence of alternative pain management solutions are significant market challenges.
• The market is moderately competitive, with key players investing in R&D to expand their product lines.
• The financial trajectory is positive, with the market expected to reach $1.8 billion by 2032.

FAQs

What is the current CAGR of the meperidine market?

The meperidine market is projected to grow at a CAGR of 4.1% from 2024 to 2029 and 5.51% from 2023 to 2032[1][4].

Which region dominates the meperidine market?

North America holds the largest share in the meperidine market, primarily due to the high number of surgical procedures and the prevalence of chronic pain syndromes[1][4].

What are the key drivers of the meperidine market?

Key drivers include the increasing prevalence of chronic pain, technological advancements in drug delivery systems, and the growing demand for effective pain management solutions[1][4][5].

What are the major side effects associated with meperidine?

Major side effects include slow heartbeats, severe constipation, muscle tremors, and drowsiness. Additionally, meperidine has a high potential for misuse and addiction[2][5].

Who are the key players in the meperidine market?

Key players include Sanofi Aventis, Mallinckrodt Pharmaceuticals, Pfizer Inc., Novartis (Sandoz Canada Inc.), Epic Pharma, Sun Pharmaceutical, Vintage Pharms, and Teva Pharmaceutical[1][4].

Sources

1. Mordor Intelligence: Meperidine Drugs Market Size & Share Analysis - Growth Trends[1]
2. Right Choice Recovery: Meperidine (Demerol) Addiction: Symptoms, Causes & More[2]
3. GlobeNewswire: Meperidine (Demerol) Market is poised to reach US$ 2,784.3 Million by end of 2027[3]
4. Market Research Future: Demerol Meperidine Market Analysis - Market Research Future[4]
5. Allied Market Research: Meperidine Market Size and Industry Forecast By 2030[5]