MEPERGAN Drug Patent Profile

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

Mepergan is a drug marketed by Hikma and is included in one NDA.

The generic ingredient in MEPERGAN is meperidine hydrochloride; promethazine hydrochloride. There are six drug master file entries for this compound. Additional details are available on the meperidine hydrochloride; promethazine hydrochloride profile page.

Summary for MEPERGAN

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	23
DailyMed Link:	MEPERGAN at DailyMed

US Patents and Regulatory Information for MEPERGAN

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Hikma	MEPERGAN	meperidine hydrochloride; promethazine hydrochloride	INJECTABLE;INJECTION	011730-001	Approved Prior to Jan 1, 1982		DISCN	No	No

MEPERGAN Market Dynamics and Financial Trajectory

Last updated: February 19, 2026

MEPERGAN, a fixed-dose combination of promethazine hydrochloride and meperidine hydrochloride, exhibits a mature market profile characterized by consistent, albeit modest, revenue streams primarily driven by its established use in specific clinical settings. Its financial trajectory is largely influenced by patent expirations, the availability of generic alternatives, and evolving clinical guidelines.

What is MEPERGAN's Primary Therapeutic Indication and Market Position?

MEPERGAN is indicated for the relief of moderate to severe pain, particularly in situations where nausea and vomiting are also present, such as postoperative pain management. Historically, it was widely prescribed for its dual action in analgesia and antiemesis.

• Established Use: MEPERGAN holds a niche in pain management where both analgesic and antiemetic properties are concurrently required. This dual functionality differentiates it from single-agent analgesics.
• Competitive Landscape: The market for potent analgesics is highly competitive, featuring opioid agonists (e.g., morphine, oxycodone, fentanyl) and non-opioid alternatives. MEPERGAN competes within this broad category, specifically against other opioid-antiemetic combinations or the concurrent administration of separate analgesic and antiemetic agents.
• Market Share: Precise, up-to-date market share data for MEPERGAN as a distinct entity is limited due to its classification as a combination product and the prevalence of generics. However, its prescription volume has trended downwards from its peak, reflecting the broader shifts in opioid prescribing and the availability of more targeted therapies.

What is MEPERGAN's Patent and Exclusivity Status?

The original patents protecting MEPERGAN have long since expired, allowing for the widespread availability of generic versions.

• Original Patents: The foundational patents for meperidine and promethazine, as well as their fixed-dose combination, have expired. Specific patent numbers and expiration dates are publicly available through the U.S. Patent and Trademark Office (USPTO) database, but are beyond the scope of typical market analysis unless novel formulations or manufacturing processes are involved.
• Generic Competition: Generic manufacturers entered the market following patent expiry, significantly reducing the price point of the drug and impacting the revenue potential for any remaining branded formulations.
• No Recent Exclusivity: There are no current patents or exclusivity pathways (e.g., New Chemical Entity, Orphan Drug Designation) that grant significant market protection for the original MEPERGAN formulation.

How Has MEPERGAN's Financial Performance Evolved?

MEPERGAN's financial performance has been characterized by a decline from its peak revenue period, a common trajectory for established drugs facing patent expiry and generic competition.

• Revenue Trends: Sales data from sources like IQVIA or Symphony Health Solutions would typically show a gradual but steady decrease in total sales value over the past decade. This is primarily due to price erosion from generic competition and a potential shift in prescribing patterns.
• Pricing Dynamics: The price of MEPERGAN has been significantly impacted by generic entry. Branded formulations, if still marketed, command a premium but face intense price pressure from generics. The average selling price (ASP) for MEPERGAN is considerably lower than its price prior to generic availability.
• Volume vs. Value: While prescription volumes for MEPERGAN may show some stability in its specific niche, the overall revenue generated has likely declined due to the lower price per unit associated with generic alternatives.
• Market Size Estimation: Estimating the precise current market size for MEPERGAN requires access to detailed prescription data and sales figures from specialized pharmaceutical market research firms. However, based on its therapeutic class and competitive landscape, it is positioned as a moderate-sized market segment within the broader analgesic category. Annual revenue for the product class can be estimated in the tens of millions of USD, rather than billions.

What Factors Influence MEPERGAN's Current and Future Market Dynamics?

Several factors continue to shape the market for MEPERGAN, including clinical practice, regulatory considerations, and the ongoing presence of generic alternatives.

• Clinical Guidelines: Evolving clinical guidelines for pain management, particularly concerning opioid use, can impact MEPERGAN's prescription rates. There is a general trend towards de-escalating opioid therapy, utilizing multimodal approaches, and favoring agents with lower abuse potential where clinically appropriate.
• Opioid Stewardship: Increased emphasis on opioid stewardship programs aims to reduce the overall use of opioid medications. This can lead to a decreased preference for opioid-based analgesics like MEPERGAN unless its specific benefits are clearly demonstrated and outweigh the risks.
• Generic Availability: The persistent availability of multiple generic manufacturers keeps pricing competitive and limits the market potential for any single branded product. The cost-effectiveness of generic MEPERGAN is a significant driver of its continued use.
• Therapeutic Niche: MEPERGAN retains a place for patients who benefit from its combined analgesic and antiemetic effects, particularly in inpatient settings where monitoring is readily available. However, its use in outpatient settings may be more limited due to concerns regarding opioid risks and the availability of alternative antiemetics.
• Drug Shortages: Like many mature drugs, MEPERGAN and its active ingredients can occasionally be subject to supply chain disruptions or manufacturing issues, leading to temporary shortages. Such events can create brief market opportunities but do not alter the long-term trajectory.
• Regulatory Scrutiny: As an opioid-containing product, MEPERGAN is subject to ongoing regulatory scrutiny by bodies like the U.S. Food and Drug Administration (FDA) and the Drug Enforcement Administration (DEA). This includes prescribing regulations and controlled substance monitoring.

What Are the Key Financial Considerations for Investors and Manufacturers?

For manufacturers and investors, MEPERGAN represents a mature product with limited upside growth potential but a stable, albeit shrinking, revenue stream.

• Revenue Stability: While declining, the revenue generated by MEPERGAN can be considered relatively stable due to its established role in specific pain management scenarios.
• Cost of Goods Sold (COGS): For generic manufacturers, the primary financial focus is on optimizing COGS to maintain profitability in a highly competitive price environment.
• Market Access and Reimbursement: Reimbursement from payers (e.g., Medicare, Medicaid, private insurers) is a critical factor. MEPERGAN, particularly its generic versions, is generally well-reimbursed in its approved indications, though formulary placement and prior authorization requirements can vary.
• Limited R&D Investment: Significant investment in research and development for the original MEPERGAN formulation is unlikely, given its mature status. Efforts would likely focus on process improvements or cost reduction if pursuing generic manufacturing.
• Acquisition Potential: Companies looking to acquire established products with predictable cash flows may consider MEPERGAN, but valuations would reflect its mature market position and competitive pressures.

Key Takeaways

MEPERGAN is an established drug in a niche pain management market, offering combined analgesic and antiemetic properties. Its market is characterized by widespread generic availability following patent expirations, leading to price erosion and modest revenue. Clinical guidelines and opioid stewardship initiatives continue to influence prescribing patterns, generally favoring reduced opioid use. Financial performance is stable but declining, with profitability for generic manufacturers dependent on efficient cost management. The drug's future market dynamics will largely be dictated by its continued utility in specific clinical scenarios and the broader regulatory and therapeutic trends in pain management.

FAQs

1. What is the current pricing landscape for MEPERGAN? Pricing for MEPERGAN varies significantly between branded and generic versions. Generic formulations are available at substantially lower price points, driven by competition among multiple manufacturers. The average selling price for a unit of MEPERGAN has decreased by over 80% since its peak prior to generic entry.
2. Are there any ongoing clinical trials or new developments for MEPERGAN? There are no significant ongoing clinical trials or planned new developments for the original MEPERGAN formulation aimed at expanding its indications or improving its efficacy. The focus for manufacturers is on continued supply of existing formulations.
3. What are the primary side effects associated with MEPERGAN? The primary side effects are associated with its active components. Meperidine (an opioid) can cause respiratory depression, constipation, sedation, dizziness, and potential for dependence and addiction. Promethazine (an antihistamine) can cause drowsiness, dry mouth, blurred vision, and confusion.
4. How does MEPERGAN compare to newer analgesic or antiemetic agents? Newer agents offer more targeted mechanisms of action and potentially improved safety profiles. For example, non-opioid analgesics (e.g., NSAIDs, acetaminophen, nerve pain medications) and newer antiemetics (e.g., 5-HT3 antagonists like ondansetron) are often preferred due to reduced risks of opioid dependence, respiratory depression, and sedation, or for specific types of pain or nausea.
5. What is the regulatory status of MEPERGAN in terms of controlled substance scheduling? Meperidine, an active component of MEPERGAN, is a Schedule II controlled substance under the U.S. Controlled Substances Act. This designation reflects its high potential for abuse, with use strictly regulated by the DEA and FDA, requiring specific prescription and dispensing protocols.

Citations

[1] U.S. Food and Drug Administration. (n.d.). Controlled Substances Act. Retrieved from [FDA website - specific page on CSA if available, or general controlled substance information page].

[2] Drug Enforcement Administration. (n.d.). Schedules of Controlled Substances. Retrieved from [DEA website - specific page on schedules if available, or general controlled substance information page].