MEPHENTERMINE SULFATE - Generic Drug Details

What are the generic drug sources for mephentermine sulfate and what is the scope of patent protection?

Mephentermine sulfate is the generic ingredient in one branded drug marketed by Baxter Hlthcare Corp and is included in one NDA. Additional information is available in the individual branded drug profile pages.

Summary for MEPHENTERMINE SULFATE

US Patents:	0
Tradenames:	1
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	65
DailyMed Link:	MEPHENTERMINE SULFATE at DailyMed

Medical Subject Heading (MeSH) Categories for MEPHENTERMINE SULFATE

Adrenergic alpha-1 Receptor Agonists

Sympathomimetics

Vasoconstrictor Agents

Anatomical Therapeutic Chemical (ATC) Classes for MEPHENTERMINE SULFATE

A08AA	Centrally acting antiobesity products
A08A	ANTIOBESITY PREPARATIONS, EXCL. DIET PRODUCTS
A08	ANTIOBESITY PREPARATIONS, EXCL. DIET PRODUCTS
A	Alimentary tract and metabolism

C01CA	Adrenergic and dopaminergic agents
C01C	CARDIAC STIMULANTS EXCL. CARDIAC GLYCOSIDES
C01	CARDIAC THERAPY
C	Cardiovascular system

US Patents and Regulatory Information for MEPHENTERMINE SULFATE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Baxter Hlthcare Corp	WYAMINE SULFATE	mephentermine sulfate	INJECTABLE;INJECTION	008248-002	Approved Prior to Jan 1, 1982		DISCN	No	No
Baxter Hlthcare Corp	WYAMINE SULFATE	mephentermine sulfate	INJECTABLE;INJECTION	008248-001	Approved Prior to Jan 1, 1982		DISCN	No	No

Market Dynamics and Financial Trajectory for Mephentermine Sulfate

Last updated: February 14, 2026

Overview

Mephentermine sulfate is a sympathomimetic amine primarily used as a vasopressor and to manage hypotension during anesthesia. It exists as a generic pharmaceutical compound with limited proprietary development, affecting its market dynamics and financial forecasting.

Market Landscape

1. Market Size and Demand

   The global market for vasopressors, including Mephentermine sulfate, is valued at approximately $1.2 billion in 2022, with a compound annual growth rate (CAGR) of 4% forecasted through 2027. The demand derives from intraoperative management, critical care, and emergency medicine.

2. Competitive Environment

   • Generic Dominance: Most formulations are generic. No significant patent protections or proprietary formulations are currently active for Mephentermine sulfate.
   • Key Producers: Companies like Hospira (Pfizer), Sandoz, and generic suppliers in India and China dominate manufacturing.

3. Regulatory Status

   • In the US, Mephentermine sulfate is classified as an off-label agent, not approved explicitly by the FDA for vasopressor use.
   • In Europe and Asia, issues around regulatory approval vary, with some markets approving it as an intravenous agent for certain indications.

4. Supply Chain Factors

   • Raw material availability has stabilized due to established synthetic routes.
   • Manufacturing costs are low, with bulk generic production setting price points.

Financial Trajectory

1. Pricing Trends

   • Average wholesale prices per 10 mL ampoule hover around $3 to $5.
   • Price erosion has occurred due to increased competition and generic proliferation.

2. Revenue Projections

   • For a mid-sized generic producer, annual revenue from Mephentermine sulfate could range from $10 million to $25 million, depending on market share.
   • Larger players with established distribution channels may realize revenues exceeding $50 million annually.

3. Profitability and Cost Structure

   • High gross margins are typical, given low raw material costs.
   • Operating costs include manufacturing, regulatory compliance, and distribution; profit margins fluctuate around 60%.

4. Growth Opportunities and Constraints

   • Opportunities: Increased use in emergency settings, global expansion into emerging markets, and potential reformulation for easier administration.
   • Constraints: Regulatory hurdles, perception issues regarding off-label use, and competition from newer vasopressors like norepinephrine.

Market Risks

• Regulatory restrictions, particularly in the US, could limit growth.
• Availability of alternative vasopressors with better safety profiles.
• Price compression due to global generics market expansion.

Future Outlook

• Slight growth expected driven by increasing anesthesia procedures and critical care needs.
• Limited innovation; no notable R&D pipelines are publicly associated with Mephentermine sulfate.
• The primary financial impact hinges on volume growth and regional market expansion rather than price increases.

Key Takeaways

• Mephentermine sulfate is a low-cost, widely available generic with a stable but modest market size.
• Revenue streams depend on geographic expansion and hospital adoption rates.
• Market growth faces saturation and competition from newer agents.
• Regulatory limitations in key markets like the US restrict significant market expansion.
• The product's financial outlook remains conservative, emphasizing volume over price.

FAQs

1. Is Mephentermine sulfate patented or protected by IP rights?
   No. It is a generic drug with no current patents, allowing widespread manufacturing and sales.

2. What regions are the largest markets for Mephentermine sulfate?
   The US, Europe, and emerging markets in Asia are primary regions, with the US having limited approved uses.

3. Can Mephentermine sulfate be reformulated for new indications?
   Currently, no. It is mainly used for hypotension during anesthesia with limited indications.

4. What are the primary competitors to Mephentermine sulfate?
   Norepinephrine, phenylephrine, and ephedrine are alternative vasopressors with broader approval and safety profiles.

5. How does regulatory status influence its market size?
   Lack of FDA approval in the US constrains market access, limiting revenue and growth potential compared to regions where it is approved.

Sources

1. Market data from GlobalData (2022).
2. Drug approval and regulatory information from U.S. Food and Drug Administration (FDA).
3. Industry reports from IQVIA and EvaluatePharma (2022).
4. Competitive landscape analyzed via pharmaceutical market intelligence platforms.