Phendimetrazine tartrate - Generic Drug Details

What are the generic drug sources for phendimetrazine tartrate and what is the scope of patent protection?

Phendimetrazine tartrate is the generic ingredient in nineteen branded drugs marketed by Valeant, Numark, Acertis Pharms, Graham Dm, Virtus, Shire Richwood, Mast Mm, Sandoz, Vitarine, Solvay, Teva, Ferndale Labs, Bausch, Abc Holding, Camall, Chartwell Rx, Pvt Form, Forest Pharms, Barr, Chartwell, Elite Labs Inc, Inwood Labs, Ivax Pharms, Ivax Sub Teva Pharms, Kv Pharm, Kvk Tech, Mfg Chemists, Mpp Pharma, Nexgen Pharma Inc, Upsher Smith Labs, Usl Pharma, Watson Labs, and Wyeth Ayerst, and is included in ninety-six NDAs. Additional information is available in the individual branded drug profile pages.

There are three drug master file entries for phendimetrazine tartrate. Twelve suppliers are listed for this compound.

Summary for phendimetrazine tartrate

US Patents:	0
Tradenames:	19
Applicants:	33
NDAs:	96
Drug Master File Entries:	3
Finished Product Suppliers / Packagers:	12
Raw Ingredient (Bulk) Api Vendors:	1
Patent Applications:	992
Drug Prices:	Drug price trends for phendimetrazine tartrate
What excipients (inactive ingredients) are in phendimetrazine tartrate?	phendimetrazine tartrate excipients list
DailyMed Link:	phendimetrazine tartrate at DailyMed

See drug prices for phendimetrazine tartrate

Pharmacology for phendimetrazine tartrate

Drug Class	Sympathomimetic Amine Anorectic
Physiological Effect	Appetite Suppression Increased Sympathetic Activity

US Patents and Regulatory Information for phendimetrazine tartrate

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Wyeth Ayerst	PLEGINE	phendimetrazine tartrate	TABLET;ORAL	012248-001	Approved Prior to Jan 1, 1982		DISCN	No	No
Chartwell Rx	CAM-METRAZINE	phendimetrazine tartrate	TABLET;ORAL	083922-001	Approved Prior to Jan 1, 1982		DISCN	No	No
Watson Labs	PHENDIMETRAZINE TARTRATE	phendimetrazine tartrate	TABLET;ORAL	085768-001	Approved Prior to Jan 1, 1982		DISCN	No	No
Graham Dm	PHENDIMETRAZINE TARTRATE	phendimetrazine tartrate	CAPSULE, EXTENDED RELEASE;ORAL	087214-001	May 26, 1982		DISCN	No	No

Market Dynamics and Financial Trajectory for Phendimetrazine Tartrate

Last updated: July 28, 2025

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Introduction

Phendimetrazine tartrate, a sympathomimetic amine classified as a Schedule III controlled substance in the United States, is primarily marketed as an appetite suppressant for obesity management. Its trajectory within pharmaceutical markets hinges on regulatory considerations, competitive dynamics, clinical efficacy, and emerging health trends. This analysis explores the current market landscape, projected financial trajectory, and key factors shaping the future of phendimetrazine tartrate.

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Regulatory and Clinical Context

Phendimetrazine's historical use as an anorectic agent began in the mid-20th century, attaining FDA approval for short-term weight loss interventions. Its pharmacological mechanism involves sympathomimetic activity, suppressing appetite via central nervous system stimulation. Despite its proven efficacy, safety concerns such as hypertension, elevated heart rate, and potential for abuse have prompted stricter regulatory oversight.

The drug's legal classification as a controlled substance limits widespread adoption, positioning it more as a niche therapy within weight management. Recent shifts toward multifactorial obesity treatments—combining pharmacotherapy, lifestyle changes, and technological interventions—may influence its market share.

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Market Dynamics

1. Competitive Landscape

The global obesity pharmacotherapy market has expanded with several agents vying for dominance. Notably, drugs like orlistat, phentermine, and newer agents such as liraglutide and semaglutide offer alternative mechanisms with varying efficacy and safety profiles. Phendimetrazine faces stiff competition from these agents, particularly as newer drugs have gained approval with more favorable safety data.

Key competitors include:

• Phentermine: Offers rapid appetite suppression, often in combination therapies, with a long history of use.
• Phentermine/topiramate: Demonstrates significant weight loss efficacy.
• Semaglutide: A GLP-1 receptor agonist with robust efficacy shown in clinical trials, coupled with favorable safety profiles.

2. Regulatory Environment

Strict prescribing limitations and increasing regulatory scrutiny constrain the market. In the U.S., phendimetrazine's Schedule III status implies potential for abuse but less than Schedule II drugs. However, tightening regulations may diminish its appeal both for clinicians and manufacturers.

3. Clinical Acceptance & Prescribing Patterns

Clinician preference shifts toward medications with comprehensive clinical data supporting safety and efficacy. As newer agents demonstrate superior outcomes and tolerability, phendimetrazine’s prescription rates are likely to decline unless new formulations or indications emerge.

4. Market Demand and Demographic Trends

Obesity prevalence continues to rise globally, fueling sustained demand for pharmacotherapies. However, the preference for safer, more effective drugs influences overall market growth potential for older agents such as phendimetrazine.

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Financial Trajectory

1. Revenue Projections

Given the current competitive landscape and regulatory restrictions, the market for phendimetrazine is expected to experience a decline in revenue generation over the next five years.

• Market Size: The global obesity pharmacotherapy market is projected to reach approximately USD 17 billion by 2027 (CAGR ~10.5%) [1]. However, phendimetrazine’s share is anticipated to shrink due to competition from newer agents.
• Sales Forecast: Sales may diminish at a compound annual rate of 2-5%, influenced by increased regulatory constraints and clinician preferences for alternative agents.

2. Market Entry & Development Opportunities

Limited pipeline development for phendimetrazine suggests minimal potential for innovative reformulations or indications, further constraining revenue prospects. Nonetheless, niche utilization in specific populations or combination therapies could temporarily sustain demand.

3. Pricing Dynamics

Pricing pressure from generic versions, coupled with insurance formulary restrictions, will likely depress per-unit revenues. Innovative delivery systems or combination formulations might offer marginally improved margins, but these are speculative.

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Future Outlook

Short-Term Outlook (1-3 years): Market decline is expected to continue slowly, driven by regulatory pressures and clinical preferences. Manufacturers may face challenges maintaining profitability.

Medium to Long-Term Outlook (3-10 years): Unless new clinical indications or formulations emerge, phendimetrazine will likely remain a marginal player. The obesity market’s evolution favors agents with superior safety and efficacy profiles, such as semaglutide.

Potential Disruption Factors:

• Regulatory Changes: Further scheduling or restrictions could eliminate market viability.
• Technological Advances: Novel delivery mechanisms or combination drugs could either cannibalize or create new opportunities.
• Emergence of Personalized Medicine: Tailoring obesity treatment might circumscribe the usage of older agents.

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Strategic Considerations

• Market Exit or Acquisition: Companies might opt to divest or acquire existing formulations, capitalizing on residual market segments.
• Repositioning: Developing combination therapies or exploring off-label uses may temporarily sustain revenues.
• Regulatory Engagement: Proactive regulatory strategies could mitigate declining trends.

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Key Takeaways

• Phendimetrazine tartrate faces an increasingly competitive and regulatory-challenged environment, constraining its market growth and profitability.
• The rise of newer, more effective obesity pharmacotherapies diminishes the sustainability of phendimetrazine’s market share.
• Future financial trajectory indicates a gradual decline in revenues unless innovative formulations or new indications are pursued.
• Companies should consider strategic repositioning or exit points to manage risks associated with declining demand.
• The evolving obesity treatment landscape rewards agents with proven safety and efficacy profiles, favoring newer therapies over traditional sympathomimetics like phendimetrazine.

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FAQs

1. Is phendimetrazine tartrate still commonly prescribed?
Its prescription rates are declining globally due to safety concerns, regulatory restrictions, and competition from more effective agents like semaglutide.

2. What are the main safety concerns associated with phendimetrazine?
Potential for cardiovascular side effects, abuse liability, hypertension, and central nervous system stimulation are primary safety issues impacting its clinical use.

3. Are there any new formulations or indications for phendimetrazine?
Currently, no significant new formulations or indications are in late-stage development; most efforts favor newer obesity agents.

4. How does regulation impact the market for phendimetrazine?
Its classification as a Schedule III drug imposes prescribing restrictions, contributes to stigma, and limits broader market penetration.

5. What is the outlook for companies holding patents or formulations of phendimetrazine?
Market decline suggests limited profitability; companies should consider strategic divestment or repositioning to manage risks effectively.

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References

[1] Grand View Research, "Obesity Drugs Market Analysis & Outlook," 2022.