Phentermine hydrochloride; topiramate - Generic Drug Details

What are the generic drug sources for phentermine hydrochloride; topiramate and what is the scope of patent protection?

Phentermine hydrochloride; topiramate is the generic ingredient in two branded drugs marketed by Actavis Labs Fl Inc, Dr Reddys Labs Sa, and Vivus Llc, and is included in three NDAs. There are six patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Phentermine hydrochloride; topiramate has forty patent family members in seventeen countries.

Four suppliers are listed for this compound.

Summary for phentermine hydrochloride; topiramate

International Patents:	40
US Patents:	6
Tradenames:	2
Applicants:	3
NDAs:	3
Finished Product Suppliers / Packagers:	4
Clinical Trials:	30
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for phentermine hydrochloride; topiramate
DailyMed Link:	phentermine hydrochloride; topiramate at DailyMed

Recent Clinical Trials for phentermine hydrochloride; topiramate

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; topiramate clinical trials

Pharmacology for phentermine hydrochloride; topiramate

Drug Class	Sympathomimetic Amine Anorectic
Mechanism of Action	Cytochrome P450 2C19 Inhibitors Cytochrome P450 3A4 Inducers
Physiological Effect	Appetite Suppression Decreased Central Nervous System Disorganized Electrical Activity Increased Sympathetic Activity

Anatomical Therapeutic Chemical (ATC) Classes for phentermine hydrochloride; topiramate

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

N03AX	Other antiepileptics
N03A	ANTIEPILEPTICS
N03	ANTIEPILEPTICS
N	Nervous system

Paragraph IV (Patent) Challenges for PHENTERMINE HYDROCHLORIDE; TOPIRAMATE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
QSYMIA	Extended-release Capsules	phentermine hydrochloride; topiramate	3.75 mg/23 mg 7.5 mg/46 mg 11.25 mg/69 mg 15 mg/92 mg	022580	1	2013-07-18

US Patents and Regulatory Information for phentermine hydrochloride; topiramate

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Dr Reddys Labs Sa	PHENTERMINE HYDROCHLORIDE AND TOPIRAMATE	phentermine hydrochloride; topiramate	CAPSULE, EXTENDED RELEASE;ORAL	208175-003	Jun 12, 2025	AB	RX	No	No
Vivus Llc	QSYMIA	phentermine hydrochloride; topiramate	CAPSULE, EXTENDED RELEASE;ORAL	022580-002	Jul 17, 2012	AB	RX	Yes	No
Vivus Llc	QSYMIA	phentermine hydrochloride; topiramate	CAPSULE, EXTENDED RELEASE;ORAL	022580-004	Jul 17, 2012	AB	RX	Yes	Yes	8,895,057
Actavis Labs Fl Inc	PHENTERMINE HYDROCHLORIDE AND TOPIRAMATE	phentermine hydrochloride; topiramate	CAPSULE, EXTENDED RELEASE;ORAL	204982-002	Jun 25, 2024	AB	RX	No	No
Vivus Llc	QSYMIA	phentermine hydrochloride; topiramate	CAPSULE, EXTENDED RELEASE;ORAL	022580-003	Jul 17, 2012	AB	RX	Yes	No	8,895,058		Y
Vivus Llc	QSYMIA	phentermine hydrochloride; topiramate	CAPSULE, EXTENDED RELEASE;ORAL	022580-001	Jul 17, 2012	AB	RX	Yes	No	9,011,906
Vivus Llc	QSYMIA	phentermine hydrochloride; topiramate	CAPSULE, EXTENDED RELEASE;ORAL	022580-003	Jul 17, 2012	AB	RX	Yes	No	8,580,299

Expired US Patents for phentermine hydrochloride; topiramate

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Vivus Llc	QSYMIA	phentermine hydrochloride; topiramate	CAPSULE, EXTENDED RELEASE;ORAL	022580-002	Jul 17, 2012	7,056,890
Vivus Llc	QSYMIA	phentermine hydrochloride; topiramate	CAPSULE, EXTENDED RELEASE;ORAL	022580-004	Jul 17, 2012	7,553,818
Vivus Llc	QSYMIA	phentermine hydrochloride; topiramate	CAPSULE, EXTENDED RELEASE;ORAL	022580-001	Jul 17, 2012	6,071,537
Vivus Llc	QSYMIA	phentermine hydrochloride; topiramate	CAPSULE, EXTENDED RELEASE;ORAL	022580-002	Jul 17, 2012	6,071,537
Vivus Llc	QSYMIA	phentermine hydrochloride; topiramate	CAPSULE, EXTENDED RELEASE;ORAL	022580-002	Jul 17, 2012	7,659,256
Vivus Llc	QSYMIA	phentermine hydrochloride; topiramate	CAPSULE, EXTENDED RELEASE;ORAL	022580-004	Jul 17, 2012	6,071,537
Vivus Llc	QSYMIA	phentermine hydrochloride; topiramate	CAPSULE, EXTENDED RELEASE;ORAL	022580-003	Jul 17, 2012	7,674,776

International Patents for phentermine hydrochloride; topiramate

Country	Patent Number	Title	Estimated Expiration
Mexico	2010013503	COMPOSICION DE TOPIRAMATO/FENTERMINA DE BAJA DOSIS Y METODOS DE USO DE LA MISMA. (LOW DOSE TOPIRAMATE/PHENTERMINE COMPOSTION AND METHODS OF USE THEREOF.)
Brazil	PI0914985
World Intellectual Property Organization (WIPO)	2009152190
Japan	5752595
World Intellectual Property Organization (WIPO)	2009152189
Japan	2011522896
South Africa	201008840	ESCALATING DOSING REGIMEN FOR EFFECTING WEIGHT LOSS AND TREATING OBESITY

Supplementary Protection Certificates for phentermine hydrochloride; topiramate

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2317997	CR 2021 00049	Denmark		PRODUCT NAME: PHENTERMIN OG TOPIRAMAT; NAT. REG. NO/DATE: 63166, 63167, 63168, 63169 20210705; FIRST REG. NO/DATE: IS IS/1/21/018/01-04 20210212
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
2317997	CA 2021 00049	Denmark		PRODUCT NAME: PHENTERMIN OG TOPIRAMAT; NAT. REG. NO/DATE: 63166, 63167, 63168, 63169 20210705; FIRST REG. NO/DATE: IS IS/1/21/018/01-04 20210212
2317997	833	Finland

Market Dynamics and Financial Trajectory for Phentermine Hydrochloride and Topiramate

Last updated: July 28, 2025

Introduction

Phentermine hydrochloride and topiramate are prominent pharmaceutical agents with distinct therapeutic applications, yet they intersect in the landscape of weight management and metabolic disorders. This analysis explores their current market dynamics and financial trajectory, emphasizing key drivers, competitive forces, regulatory factors, and growth prospects shaping their futures.

Phentermine Hydrochloride: Market Overview and Economic Landscape

Therapeutic Use and Market Influence

Phentermine hydrochloride remains a first-line pharmacotherapy for short-term weight loss, approved predominantly for obesity management in adults. As a sympathomimetic amine, phentermine stimulates central nervous system pathways to suppress appetite, supporting weight reduction initiatives tied to metabolic health.

Market Drivers

• Rising Obesity Prevalence: The global obesity rates, projected to reach 20% of the adult population by 2025 per WHO, catalyze increased demand for weight management drugs like phentermine [1].

• Limited Pharmacological Alternatives: Despite concerns about abuse potential and cardiovascular risks, phentermine's low cost and established efficacy sustain its popularity. The recent lack of more effective, approved alternatives in certain markets intensifies reliance on phentermine.

• Regulatory and Reimbursement Dynamics: Most countries regulate phentermine as a scheduled substance, yet its generic status ensures broad accessibility, fueling steady market sales.

Market Challenges

• Safety Concerns and Regulatory Scrutiny: Potential adverse effects—including increased blood pressure and heart rate—prompt ongoing regulatory oversight, which can constrain prescribing patterns.

• Abuse and Misuse Potential: The historical abuse liability influences regulatory restrictions, potentially limiting market expansion.

Financial Trajectory and Revenue Outlook

Global phentermine market revenues are estimated in the low hundreds of millions USD annually, with North America dominating due to high obesity prevalence and healthcare provider familiarity [2]. The market exhibits modest growth, primarily driven by generic formulations and expanding obesity awareness campaigns. The emergence of new formulations or combination therapies could marginally enhance sales.

Topiramate: Market Overview and Financial Outlook

Therapeutic Applications and Market Drivers

Initially approved for epilepsy and migraine prophylaxis, topiramate has carved a niche in weight management when combined with phentermine, marketed as Qsymia (approved in 2012). Its off-label use for various conditions further broadens its market reach.

• Obesity and Weight Loss Segment: The FDA approval of phentermine/topiramate extended its applicability in obesity management, positioning it as a significant driver of growth.

• Chronic Disease Burden: The global rise in metabolic disorders increases demand for multi-purpose pharmacotherapies like topiramate.

Market Challenges

• Side Effect Profile: Cognitive impairment, metabolic acidosis, and teratogenicity reduce clinician and patient acceptance, affecting long-term prescription adherence.

• Generic Competition: Patent expirations have led to a surge in low-cost generics, compressing margins for branded formulations and impacting revenue potential.

Financial Trajectory

The global market for topiramate-based therapies has experienced fluctuations, with revenues estimated around $1 billion annually pre-generic erosion. The weight management segment, while promising, remains constrained by safety concerns and regulatory considerations [3]. The imminent patent expiry of branded formulations has catalyzed shift toward generics, impacting overall profitability. Nonetheless, combination therapies like Qsymia maintain moderate sales, buoyed by continued clinical use and expanded indications.

Market Interplay and Competitive Landscape

Synergistic Use and Market Expansion

The combination of phentermine and topiramate represents a strategic convergence, leveraging synergistic weight loss efficacy. The approval of Qsymia catalyzed growth in this segment, with sales steadily ascending prior to patent expiration.

Emerging Competitors and Alternative Therapies

• Novel Pharmacotherapies: GLP-1 receptor agonists such as semaglutide and liraglutide are increasingly favored for weight management, posing nascent competition to phentermine/topiramate.

• Device and Surgical Options: Rising popularity of minimally invasive procedures further influence the market landscape.

Regulatory Evolution and Future Outlook

Regulatory agencies' evolving stance on controlled substances and safety profiles influences product availability and market expansion. The potential reclassification or withdrawal of certain formulations could reshape market shares.

Impacts of COVID-19

The pandemic accelerated telemedicine adoption and heightened focus on metabolic health, leading to increased prescriptions for weight loss drugs. Nonetheless, economic downturns and healthcare resource reallocation may temper growth.

Financial Trajectory: Summary and Projections

• Short to Medium Term: Moderate growth for phentermine, driven by obesity trends, with revenue stabilization primarily through generics.

• Long Term: Potential shifts toward novel agents and combination therapies may reduce reliance on phentermine/topiramate, but existing formulations will maintain steady cash flows due to entrenched prescriber habits.

• Emerging Opportunities: The development of safer, more effective agents targeting metabolic pathways offers prospective avenues for growth, though regulatory hurdles remain significant.

Key Drivers Influencing Market Dynamics

• Demographic Shifts: Rising obesity prevalence across developed and emerging markets sustains demand.

• Regulatory and Safety Concerns: Stricter guidelines may impede sales but can also create opportunities for safer alternatives.

• Innovation and Competitive Entry: Advancements in pharmacotherapy targeting obesity and metabolic syndrome diversify the market.

Conclusion

The pharmaceutical markets for phentermine hydrochloride and topiramate face a landscape characterized by steady demand aligned with global obesity trends, but also challenged by regulatory constraints, safety concerns, and increasing competition from innovative therapies. While their current financial trajectories suggest modest growth, evolving healthcare paradigms and pipeline developments will significantly influence their long-term positioning.

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Key Takeaways

• The market for phentermine hydrochloride remains stable but faces headwinds from safety alerts and regulatory scrutiny.

• Topiramate's revenue is declining in the face of generic competition, with growth largely confined to combination therapies like Qsymia.

• Emerging therapies, especially GLP-1 receptor agonists, represent significant competitive pressure, prompting strategic adaptations.

• Regulatory environments and safety profiles significantly influence market access, sales volume, and future product development.

• Continuous innovation and safety improvement are vital for sustaining long-term profitability and market relevance.

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FAQs

1. What factors are driving growth in the phentermine hydrochloride market?
The primary drivers include increasing global obesity prevalence, limited alternative pharmacological options for short-term weight loss, and growing awareness of obesity's health risks, all supported by broad accessibility due to generic formulations.

2. How does the safety profile of topiramate impact its market?
Concerns over cognitive side effects, metabolic issues, and teratogenicity have curtailed its use and limited new indications. These safety concerns, coupled with patent expirations, diminish revenue potential, especially in the face of emerging competitors.

3. What role do regulatory bodies play in shaping the future of these drugs?
Regulators influence market dynamics through scheduling, safety mandates, and approval of new formulations. Stricter controls may limit prescriptions, while approvals of safer alternatives can diminish market shares for existing drugs.

4. How is the competitive landscape evolving for weight management pharmacotherapy?
Innovations such as GLP-1 receptor agonists and minimally invasive devices are increasingly favored, challenging traditional drugs like phentermine and topiramate, driving a shift toward more effective, safer options.

5. What are the prospects for new formulations or combination therapies involving these drugs?
Development of safer, more effective combination therapies, possibly with novel agents, holds promise for expanding indications and improving patient adherence, but regulatory approval remains a significant hurdle.

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References

[1] World Health Organization. Obesity and Overweight. 2022.

[2] MarketWatch. Phentermine Market Analysis. 2022.

[3] GlobalData. Topiramate Market Report. 2022.