DIETHYLPROPION HYDROCHLORIDE - Generic Drug Details

What are the generic drug sources for diethylpropion hydrochloride and what is the scope of freedom to operate?

Diethylpropion hydrochloride is the generic ingredient in five branded drugs marketed by Lannett Co Inc, Sanofi Aventis Us, Ani Pharms, 3M, Avanthi Inc, Chartwell Rx, Epic Pharma Llc, Sandoz, Teva, Ucb Inc, Watson Labs, and Mpp Pharma, and is included in sixteen NDAs. Additional information is available in the individual branded drug profile pages.

There is one drug master file entry for diethylpropion hydrochloride. Thirteen suppliers are listed for this compound.

Summary for DIETHYLPROPION HYDROCHLORIDE

US Patents:	0
Tradenames:	5
Applicants:	12
NDAs:	16
Drug Master File Entries:	1
Finished Product Suppliers / Packagers:	13
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	2
Patent Applications:	9,484
What excipients (inactive ingredients) are in DIETHYLPROPION HYDROCHLORIDE?	DIETHYLPROPION HYDROCHLORIDE excipients list
DailyMed Link:	DIETHYLPROPION HYDROCHLORIDE at DailyMed

Recent Clinical Trials for DIETHYLPROPION HYDROCHLORIDE

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
GlaxoSmithKline
New River Pharmaceuticals	Phase 1/Phase 2

See all DIETHYLPROPION HYDROCHLORIDE clinical trials

Pharmacology for DIETHYLPROPION HYDROCHLORIDE

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

Medical Subject Heading (MeSH) Categories for DIETHYLPROPION HYDROCHLORIDE

Appetite Depressants

US Patents and Regulatory Information for DIETHYLPROPION HYDROCHLORIDE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Chartwell Rx	DIETHYLPROPION HYDROCHLORIDE	diethylpropion hydrochloride	TABLET;ORAL	088267-001	Aug 25, 1983		DISCN	No	No
Sanofi Aventis Us	TENUATE	diethylpropion hydrochloride	TABLET, EXTENDED RELEASE;ORAL	017669-001	Approved Prior to Jan 1, 1982		DISCN	No	No
Lannett Co Inc	DIETHYLPROPION HYDROCHLORIDE	diethylpropion hydrochloride	TABLET;ORAL	200177-001	Jul 18, 2011	AA	RX	No	Yes
Ani Pharms	TENUATE DOSPAN	diethylpropion hydrochloride	TABLET, EXTENDED RELEASE;ORAL	012546-001	Approved Prior to Jan 1, 1982		DISCN	Yes	No
Watson Labs	DIETHYLPROPION HYDROCHLORIDE	diethylpropion hydrochloride	TABLET;ORAL	085741-001	Approved Prior to Jan 1, 1982		DISCN	No	No

Market Dynamics and Financial Trajectory for Diethylpropion Hydrochloride

Last updated: October 21, 2025

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Introduction

Diethylpropion Hydrochloride is a centrally acting sympathomimetic agent primarily prescribed for weight management. As an appetite suppressant, it falls within the class of controlled substances due to its stimulant properties. Understanding its market dynamics and financial trajectory requires a comprehensive analysis of regulatory status, competitive landscape, market demand trends, and regional patent considerations.

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Regulatory Landscape and Market Adoption

Regulatory Environment

Diethylpropion Hydrochloride is classified as a Schedule IV controlled substance in the United States, regulated under the Controlled Substances Act, owing to its stimulant effects and potential for abuse [1]. This classification influences prescribing practices and influences market size due to regulatory constraints. Similar regulatory stances exist in other jurisdictions, although specifics may vary.

Approval and Patent Status

The drug was approved by the U.S. Food and Drug Administration (FDA) in the late 1950s. Being off patent, diethylpropion is manufactured by multiple generic pharmaceutical companies, resulting in a high degree of market fragmentation. Its patent expiration has facilitated proliferation of generic forms, often at reduced prices.

Market Adoption Factors

The usage of diethylpropion has historically been driven by:

• Medical guidelines emphasizing pharmacological obesity treatments.
• Physician prescribing habits, often influenced by concerns over its stimulant nature and abuse potential.
• Insurance reimbursement policies, which tend to favor more established or novel therapies with better safety profiles.

Despite these factors, its use remains relatively niche compared to newer weight management agents, such as GLP-1 receptor agonists.

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Market Demand and Clinical Use Trends

Global Market Size

The global appetite suppressant drugs market, inclusive of diethylpropion, was valued at approximately USD 1 billion in 2022, with an expected compound annual growth rate (CAGR) of around 3-4% over the next five years [2].

Regional Demand Dynamics

• North America: Dominates the market, driven by high obesity prevalence (~42.4% of adults) and stringent clinical guidelines. However, usage of diethylpropion is often limited due to concerns over its stimulant effects and the availability of newer agents.
• Europe and Asia-Pacific: Growing acceptance due to rising obesity rates and expanding healthcare infrastructure. In some regions, regulatory restrictions limit availability.

Shifts in Market Preferences

The market faces competition from newer drugs that exhibit better safety profiles and efficacy, such as liraglutide and semaglutide. Consequently, diethylpropion’s demand has declined over the last decade, with clinicians favoring alternative therapies for weight management.

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Competitive Landscape

Generic Market

As a generic drug, diethylpropion faces intense competition primarily based on price. Multiple manufacturers globally offer similar formulations, resulting in margin erosion but stable volume sales in niche markets where approved.

Brand and Specialty Products

Limited branded formulations exist; most market activity revolves around generics. No recent patent protections or exclusivities bolster product differentiation, further intensifying price competition.

Emerging Alternatives

Innovative agents, notably GLP-1 analogs with weight-loss indications, have garnered market share by demonstrating superior efficacy and safety profiles. Such competition threatens the continued relevance of diethylpropion in medical practice.

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Financial Trajectory and Revenue Outlook

Historical Revenue Trends

Diethylpropion has experienced downtrend revenues post-2010, aligned with increased regulation and competition. In the US, annual sales have fluctuated between USD 50–100 million, predominantly from established pharmaceutical firms utilizing existing manufacturing licenses [3].

Forecasted Market Trends

• Stable but declining revenues: As newer, more effective drugs emerge, diethylpropion’s share is expected to diminish further.
• Pricing pressures: Generic competition and regulatory scrutiny limit price increases.
• Potential niche growth: In regions with limited access to newer options or regulatory restrictions, diethylpropion may retain modest markets.

Impact of Regulatory Changes

Enhanced oversight or restrictions on stimulant drugs could suppress market availability and further diminish revenues. Conversely, patent extensions, if granted through formulation improvements, could temporarily bolster financial prospects.

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Future Outlook and Strategic Considerations

Market Consolidation and Differentiation

Given the limited innovation and competition from newer agents, companies might explore formulation modifications or combination therapies to extend lifecycle and market relevance.

Regional Expansion and Niche Segments

Limited in some developed markets, opportunities may exist in emerging economies where regulatory barriers are less stringent, and weight management treatments are acutely needed.

Regulatory and Ethic-Based Strategies

Engagement with policymakers to establish clear guidelines and safe prescribing practices can stabilize demand. Concurrently, leveraging educational campaigns about proper use may mitigate abuse concerns, supporting steady market presence.

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Key Takeaways

• Market maturity: Diethylpropion operates in a mature, declining segment of the weight management pharmacotherapy market, hindered by regulatory constraints and competition.
• Revenue prospects: Expect stabilized but declining revenues in developed markets, with potential regional growth in less regulated economies.
• Competition landscape: Dominated by generics, with innovative drugs challenging its relevance with better safety and efficacy profiles.
• Regulatory considerations: Ongoing oversight could impact market access and profitability; strategic engagement is vital.
• Innovation potential: Limited, unless formulation modifications or combination therapies are developed to differentiate the product.

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FAQs

Q1: What factors are most influencing the decline of diethylpropion's market?
A1: The main factors include regulatory restrictions due to its stimulant properties, the rise of newer weight management drugs with better safety profiles, and the commoditization of its generic formulations leading to price competition.

Q2: Are there regions where diethylpropion remains highly relevant?
A2: Yes, in certain emerging markets with less stringent regulations, limited access to newer therapies, and lower healthcare budgets, diethylpropion continues to serve as a cost-effective treatment option.

Q3: How do safety concerns impact diethylpropion's market trajectory?
A3: Safety concerns, especially regarding abuse potential and cardiovascular effects, limit prescriber confidence, leading to reduced usage and tighter regulatory controls, thereby constraining market growth.

Q4: What opportunities exist for extending the product lifecycle of diethylpropion?
A4: Potential strategies include developing combination formulations, reformulating for sustained release, or seeking new therapeutic indications that leverage its pharmacological profile.

Q5: How might future regulatory developments influence diethylpropion's market?
A5: Stricter controls or reclassification as a higher schedule substance could eliminate or limit its availability, while regulatory acceptance of specific formulations could preserve niche markets.

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References

[1] U.S. Drug Enforcement Administration. Controlled Substances Schedules.
[2] MarketWatch. Appetite Suppressant Drugs Market Report 2022-2027.
[3] IMSHealth. Global Sales Data for Diethylpropion Hydrochloride, 2010–2022.