PHENTERMINE HYDROCHLORIDE - Generic Drug Details

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

Phentermine hydrochloride is the generic ingredient in twelve branded drugs marketed by Teva, Glaxosmithkline, Ferndale Labs, Shire Richwood, Mast Mm, Abc Holding, Able, Aurolife Pharma Llc, Barr, Camall, Chartwell Rx, Duramed Pharms Barr, Elite Labs, Elite Labs Inc, Invagen Pharms, Ivax Pharms, Kvk Tech, Lannett, Lannett Co Inc, Nuvo Pharm, Sandoz, Sun Pharm Industries, Tg United Inc, Upsher Smith Labs, Usl Pharma, Vitarine, Watson Labs, Zydus Pharms, Citius Pharms, Avanthi Inc, Actavis Elizabeth, Aurobindo Pharma Ltd, Kvk Tech Inc, Novast Labs, Prinston Inc, Puracap Labs Blu, Sandoz Inc, Sun Pharm Inds Inc, Solvay, Actavis Labs Fl Inc, Dr Reddys Labs Sa, and Vivus Llc, and is included in one hundred and two NDAs. There are seven patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Phentermine hydrochloride has two patent family members in two countries.

There are eight drug master file entries for phentermine hydrochloride. Twenty-seven suppliers are listed for this compound.

Summary for PHENTERMINE HYDROCHLORIDE

International Patents:	2
US Patents:	7
Tradenames:	12
Applicants:	42
NDAs:	102
Drug Master File Entries:	8
Finished Product Suppliers / Packagers:	27
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	52
Patent Applications:	1,593
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for PHENTERMINE HYDROCHLORIDE
What excipients (inactive ingredients) are in PHENTERMINE HYDROCHLORIDE?	PHENTERMINE HYDROCHLORIDE excipients list
DailyMed Link:	PHENTERMINE HYDROCHLORIDE at DailyMed

Recent Clinical Trials for PHENTERMINE HYDROCHLORIDE

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

Sponsor	Phase
Mayo Clinic	PHASE4
University of Toronto	PHASE4
The Cleveland Clinic	PHASE4

See all PHENTERMINE HYDROCHLORIDE clinical trials

Pharmacology for PHENTERMINE HYDROCHLORIDE

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

Anatomical Therapeutic Chemical (ATC) Classes for PHENTERMINE HYDROCHLORIDE

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

Paragraph IV (Patent) Challenges for PHENTERMINE HYDROCHLORIDE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
SUPRENZA	Orally Disintegrating Tablets	phentermine hydrochloride	37.5 mg	202088	1	2013-03-22
SUPRENZA	Orally Disintegrating Tablets	phentermine hydrochloride	15 mg and 30 mg	202088	1	2012-10-19

US Patents and Regulatory Information for PHENTERMINE HYDROCHLORIDE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Vivus Llc	QSYMIA	phentermine hydrochloride; topiramate	CAPSULE, EXTENDED RELEASE;ORAL	022580-003	Jul 17, 2012	AB	RX	Yes	No	8,580,299
Sandoz	PHENTERMINE HYDROCHLORIDE	phentermine hydrochloride	CAPSULE;ORAL	086945-001	Jul 20, 1983	AA	RX	Yes	Yes
Nuvo Pharm	PHENTERMINE HYDROCHLORIDE	phentermine hydrochloride	TABLET;ORAL	205008-001	Sep 25, 2014	AA	RX	No	No

Expired US Patents for PHENTERMINE HYDROCHLORIDE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Citius Pharms	SUPRENZA	phentermine hydrochloride	TABLET, ORALLY DISINTEGRATING;ORAL	202088-001	Jun 13, 2011	6,149,938
Citius Pharms	SUPRENZA	phentermine hydrochloride	TABLET, ORALLY DISINTEGRATING;ORAL	202088-003	Mar 27, 2012	6,149,938
Citius Pharms	SUPRENZA	phentermine hydrochloride	TABLET, ORALLY DISINTEGRATING;ORAL	202088-002	Jun 13, 2011	6,149,938

International Patents for PHENTERMINE HYDROCHLORIDE

Country	Patent Number	Title	Estimated Expiration
World Intellectual Property Organization (WIPO)	2009098169
European Patent Office	2254558

Supplementary Protection Certificates for PHENTERMINE HYDROCHLORIDE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2317997	2190050-1	Sweden		PRODUCT NAME: PHENTERMINE AND TOPIRAMATE; NAT. REG. NO/DATE: 59574-59577 20210617; FIRST REG.: IS IS/1/21/018/01-04 20210212

Market Dynamics and Financial Trajectory for Phentermine Hydrochloride

Last updated: July 27, 2025

Introduction

Phentermine Hydrochloride, a sympathomimetic amine anorectic agent, has long served as a pharmacological intervention for short-term weight management. As obesity-related health concerns escalate globally, the drug’s market landscape is evolving, influenced by regulatory, scientific, and commercial factors. This analysis evaluates the current market dynamics, forecasted financial trajectory, and strategic implications pertaining to Phentermine Hydrochloride.

Market Overview

Phentermine Hydrochloride is primarily prescribed for obesity and weight management, often in conjunction with lifestyle modifications. Its global market is characterized by regional variability in approval status, usage patterns, and regulatory oversight. The increasing prevalence of obesity—estimated to affect over 700 million adults worldwide [1]—has positioned appetite suppressants as vital components in weight management strategies.

However, the market has faced challenges, primarily related to safety concerns and regulatory restrictions due to adverse cardiovascular and psychiatric effects, especially following the drug's classification as a controlled substance in multiple jurisdictions. Nonetheless, generic formulations dominate the market, contributing to affordability and widespread availability.

Market Dynamics

Regulatory Environment

Regulation significantly influences Phentermine Hydrochloride's market stability. The drug is classified as a Schedule IV controlled substance in the United States, reflecting concerns over abuse potential [2]. Regulatory agencies, including the FDA, impose strict prescribing guidelines, which affect market penetration.

In contrast, some countries have more lenient regulatory stances, allowing broader access. Recent proposals for reformulating phentermine-based products with improved safety profiles aim to expand permissible use scopes.

Supply Chain and Manufacturing

Generics constitute the bulk of global supply, produced by numerous pharmaceutical manufacturers, which fosters competitive pricing. These generics benefit from established manufacturing standards but are vulnerable to patent expirations and market entry of newer formulations.

Manufacturing capacity remains robust, but raw material supply disruptions and regulatory compliance costs influence overall supply stability.

Therapeutic Usage and Prescribing Trends

Physicians often prescribe Phentermine Hydrochloride as a short-term adjunct for weight loss, along with diet and exercise. However, its usage has plateaued owing to safety concerns, leading to preference shifts toward newer, safer alternatives.

Nevertheless, ongoing research and marketing efforts sustain its presence, especially in regions with less restrictive regulatory frameworks.

Competitive Landscape

The landscape is dominated by generic brands, with a limited number of branded or reformulated products. Competing therapies include lorcaserin, phentermine/topiramate combinations, and newer agents with better safety profiles. The emergence of combination drugs capitalizes on improved efficacy and safety, gradually eroding Phentermine Hydrochloride’s market share.

Obstacles and Opportunities

Obstacles include regulatory restrictions, safety concerns, and consumer perceptions adversely affected by historical abuse cases. Conversely, opportunities exist in reformulating the drug with extended-release mechanisms, combining it with other agents, and harnessing digital therapeutics to optimize treatment.

Financial Trajectory

Revenue Projections

The global appetite suppressants market, valued at approximately USD 1.4 billion in 2022, is projected to grow at a CAGR of approximately 7% through 2030 [3], driven predominantly by increasing obesity rates. Phentermine Hydrochloride's segment is expected to expand modestly within this landscape, primarily fueled by generic sales.

Given its mature status, revenue contribution is projected to stabilize or slightly decline in regions with tightening regulations; however, in emerging markets, sales could increase due to expanding healthcare access.

Pricing Dynamics

Pricing remains highly competitive, with generics available at a significant discount compared to branded products. Pricing strategies may evolve with reformulation efforts, including extended-release presentations, which command premium pricing.

Market Entry and Expansion Strategies

New entrants or existing manufacturers targeting markets with evolving regulations might leverage cost-effective manufacturing and strategic marketing. Establishing partnerships with healthcare providers and engaging in awareness campaigns can help sustain demand.

Research and Development Investments

Limited R&D investments are typical, given the drug’s status as a generic. However, targeted efforts to develop safer, extended-release formulations could open new financial avenues. Investment in pharmacovigilance and post-market surveillance remains essential to maintain market access.

Impact of Policy and Legislation

Legislation promoting obesity management programs and subsidies in certain regions might positively impact sales. Conversely, stricter controls or bans could significantly diminish market opportunities.

Strategic Outlook

Short-term (1-3 years): Focus on maintaining regulatory compliance, optimizing supply chains, and differentiating through formulations with improved safety and efficacy profiles.

Long-term (5+ years): Emphasize innovation via reformulation, explore combination therapies, and leverage digital health integration to enhance adherence and outcomes.

Market segmentation: Target emerging markets with rising obesity rates and less restrictive pharmacovigilance frameworks.

Key Takeaways

• Growing obesity epidemic fuels demand for appetite suppressants; however, safety concerns and regulatory restrictions modulate market growth.

• Generic manufacturing dominance enables affordability but limits profitability; innovation through reformulation presents growth opportunities.

• Regulatory landscape remains the primary driver; adherence and proactive engagement with authorities are crucial.

• Emerging markets offer untapped revenue potential as healthcare infrastructure expands.

• Investment in safer, extended-release formulations can rejuvenate market interest and extend the financial trajectory.

Conclusion

While Phentermine Hydrochloride’s market faces headwinds from safety concerns and regulatory constraints, its role within weight management remains relevant. Strategic adaptations—such as reformulation, targeted marketing, and expansion into emerging markets—are essential to sustain and enhance its financial trajectory. Stakeholders should prioritize innovation, compliance, and differentiated offerings to navigate this complex landscape effectively.

---

FAQs

1. What factors influence the regulatory status of Phentermine Hydrochloride worldwide?
   Regulatory decisions hinge on safety profiles, abuse potential, and local health priorities. Countries with higher obesity prevalence or less stringent controls may permit broader use, whereas others impose restrictions or classify it as a controlled substance.

2. Can reformulated versions of Phentermine Hydrochloride improve its market outlook?
   Yes, extended-release formulations and combination therapies with improved safety can address current concerns, potentially expanding approved indications and broadening market access.

3. How does the patent status of Phentermine Hydrochloride affect its market?
   Being mostly available as a generic, patent exclusivity has largely expired, fostering price competition and widespread availability but limiting patent-driven R&D investments.

4. What shift in consumer preferences could impact Phentermine Hydrochloride’s future sales?
   A rising preference for newer, safer appetite suppressants with minimal side effects, and increased demand for comprehensive weight management solutions incorporating behavioral and digital components.

5. What regional opportunities exist for expanding Phentermine Hydrochloride sales?
   Emerging markets such as Asia-Pacific and parts of Latin America, where obesity rates are climbing and regulatory barriers are less restrictive, present significant growth prospects.

---

References

[1] World Health Organization. Obesity and overweight. 2022.
[2] U.S. Drug Enforcement Administration. Controlled Substance Schedule. 2023.
[3] MarketsandMarkets. Appetite Suppressants Market by Type, Application, and Region – Global Forecast to 2030. 2022.