PHENTERMINE HYDROCHLORIDE; TOPIRAMATE - Generic Drug Details

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

Phentermine hydrochloride; topiramate is the generic ingredient in two branded drugs marketed by Actavis Labs Fl Inc and Vivus Llc, and is included in two 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.

One supplier is listed for this compound.

Summary for PHENTERMINE HYDROCHLORIDE; TOPIRAMATE

International Patents:	40
US Patents:	6
Tradenames:	2
Applicants:	2
NDAs:	2
Finished Product Suppliers / Packagers:	1
Clinical Trials:	25
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
University of Minnesota	Early Phase 1
University of Minnesota	Phase 3
University of Florida	Phase 3

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
Vivus Llc	QSYMIA	phentermine hydrochloride; topiramate	CAPSULE, EXTENDED RELEASE;ORAL	022580-002	Jul 17, 2012	AB	RX	Yes	No	8,580,299
Vivus Llc	QSYMIA	phentermine hydrochloride; topiramate	CAPSULE, EXTENDED RELEASE;ORAL	022580-002	Jul 17, 2012	AB	RX	Yes	No	8,895,057
Actavis Labs Fl Inc	PHENTERMINE HYDROCHLORIDE AND TOPIRAMATE	phentermine hydrochloride; topiramate	CAPSULE, EXTENDED RELEASE;ORAL	204982-004	Jun 25, 2024	AB	RX	No	No

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	7,674,776
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	022580-003	Jul 17, 2012	7,056,890

International Patents for PHENTERMINE HYDROCHLORIDE; TOPIRAMATE

Country	Patent Number	Title	Estimated Expiration
China	102112126	Low dose topiramate/phentermine compostion and methods of use thereof
Chile	2010001366	Composicion farmaceutica de liberacion controlada que comprende topiramato, celulosa microcristalina y metilcelulosa; preparado farmaceutico que la comprende, util para tratar la obesidad, diabetes o una afeccion relacionada.
Australia	2009257573	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	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	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	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

PHENTERMINE HYDROCHLORIDE; TOPIRAMATE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Phentermine Hydrochloride; Topiramate (QSYMIA)

Introduction

Phentermine hydrochloride and topiramate, combined as QSYMIA, is a prescription medication approved for the chronic treatment of obesity in adults. This article delves into the market dynamics, financial trajectory, and key aspects of QSYMIA, providing a comprehensive overview of its position in the obesity treatment market.

Mechanism of Action and Dosage

QSYMIA combines phentermine, an appetite suppressant, and topiramate, an anticonvulsant that also aids in weight loss. The recommended dosage starts with 3.75 mg/23 mg (phentermine/topiramate) daily for 14 days, increasing to 7.5 mg/46 mg daily, and can be escalated to 15 mg/92 mg if weight loss goals are not met[3].

Clinical Development and Efficacy

Clinical trials have demonstrated a dose-response relationship for weight loss with QSYMIA. The Phase 3 trials showed significant weight loss with the 7.5 mg/46 mg and 15 mg/92 mg doses, meeting efficacy criteria such as mean drug-associated weight loss exceeding placebo by at least 5% and a higher proportion of subjects achieving weight loss goals[2].

Regulatory Milestones

QSYMIA received FDA approval in 2012 for the treatment of obesity. The approval was based on extensive clinical trials and a thorough review of its safety and efficacy profile. Regulatory milestones include ongoing monitoring and post-marketing requirements to ensure continued safety and efficacy[2].

Market Outlook

The market for obesity treatments is expected to expand significantly due to increasing healthcare spending and extensive research. QSYMIA is positioned to benefit from this growth, although it faces competition from other emerging therapies.

Market Size and Forecast

The market size for QSYMIA in the seven major markets (7MM), including the United States, EU5 (Germany, France, Italy, Spain, and the United Kingdom), and Japan, is forecasted to grow from 2022 to 2032. Detailed market assessments and forecasted sales data indicate a steady increase in market size, driven by the growing need for effective obesity treatments[1][3].

Country-wise Market Analysis

• United States: The U.S. market is expected to be a significant contributor to QSYMIA's sales, driven by high obesity rates and a strong healthcare system.
• EU5: Countries like Germany, France, Italy, Spain, and the United Kingdom will also see substantial growth, influenced by increasing healthcare spending and regulatory approvals.
• Japan: The Japanese market is anticipated to grow, albeit at a slower pace, due to different regulatory and healthcare dynamics[3].

Competitive Landscape

QSYMIA operates in a competitive market with several other obesity treatments, both existing and emerging.

Marketed Therapies

Existing therapies include other prescription medications and lifestyle interventions. QSYMIA competes with these by offering a unique combination of phentermine and topiramate, which has shown efficacy in clinical trials[1].

Emerging Therapies

Late-stage emerging therapies are expected to challenge QSYMIA's market position. These new treatments focus on novel approaches to obesity, such as new drug targets and innovative delivery systems. The launch of these therapies will significantly impact the market dynamics and could pose a threat to QSYMIA's dominance[1][3].

Financial Trajectory

The financial trajectory of QSYMIA is closely tied to its market performance and the overall obesity treatment market.

Forecasted Sales

Forecasted sales data from 2022 to 2032 indicate a steady increase, reflecting the growing demand for effective obesity treatments. The sales are expected to rise across all major markets, with the U.S. and EU5 regions being the primary drivers[1][3].

Revenue Impact

The revenue generated by QSYMIA will be influenced by several factors, including market competition, regulatory environments, and the success of emerging therapies. Despite these challenges, QSYMIA is expected to maintain a significant market share due to its established efficacy and safety profile[1].

SWOT Analysis

A SWOT analysis highlights the strengths, weaknesses, opportunities, and threats for QSYMIA.

Strengths

• Efficacy and Safety: QSYMIA has a proven track record of efficacy and safety in clinical trials.
• Regulatory Approval: FDA approval in 2012 provides a strong regulatory foundation.
• Market Presence: Established presence in major markets.

Weaknesses

• Side Effects: Associated with side effects such as metabolic acidosis, psychiatric issues, and teratogenic effects[2].
• Competition: Faces competition from emerging therapies.

Opportunities

• Growing Market: Increasing demand for obesity treatments due to rising obesity rates and healthcare spending.
• Expanding Indications: Potential for approval in additional indications or patient populations.

Threats

• Emerging Therapies: Late-stage emerging therapies could challenge QSYMIA's market position.
• Regulatory Changes: Changes in regulatory environments could impact QSYMIA's approval status or market access[1][3].

Analyst Views

Analysts view QSYMIA as a significant player in the obesity treatment market, but one that must navigate the challenges posed by emerging therapies and changing market dynamics.

"The launch of late-stage emerging therapies in the near future will significantly impact the market, and QSYMIA will need to adapt to maintain its market share"[1].

Key Takeaways

• QSYMIA is a combination of phentermine and topiramate approved for chronic obesity treatment.
• The drug has a proven efficacy and safety profile but faces competition from emerging therapies.
• Market forecasts indicate steady growth in sales from 2022 to 2032 across major markets.
• Regulatory milestones and ongoing monitoring are crucial for QSYMIA's continued success.
• A SWOT analysis highlights the need for QSYMIA to adapt to changing market dynamics.

FAQs

What is the mechanism of action of QSYMIA?

QSYMIA combines phentermine, an appetite suppressant, and topiramate, which aids in weight loss through its anticonvulsant properties.

What are the recommended dosages for QSYMIA?

The recommended dosage starts with 3.75 mg/23 mg daily for 14 days, increasing to 7.5 mg/46 mg daily, and can be escalated to 15 mg/92 mg if weight loss goals are not met.

What are the key markets for QSYMIA?

The key markets include the United States, EU5 (Germany, France, Italy, Spain, and the United Kingdom), and Japan.

How does QSYMIA compete in the obesity treatment market?

QSYMIA competes through its unique combination of phentermine and topiramate, which has shown efficacy in clinical trials, but faces challenges from emerging therapies.

What are the potential threats to QSYMIA's market position?

Emerging therapies and changes in regulatory environments are significant threats to QSYMIA's market position.

Sources

1. QSYMIA (Phentermine-Topiramate) Drug Insights and Market Forecasts to 2032 - Research and Markets
2. QSYMIA (Phentermine-Topiramate) Clinical Pharmacology Review - FDA
3. QSYMIA (Phentermine-Topiramate), Drug Insight and Market Forecast - 2032 - Research and Markets
4. Cardiovascular effects of phentermine and topiramate - Lippincott Journals