QSYMIA Drug Patent Profile

Which patents cover Qsymia, and when can generic versions of Qsymia launch?

Qsymia is a drug marketed by Vivus Llc and is included in one NDA. There are six patents protecting this drug and one Paragraph IV challenge.

This drug has forty patent family members in seventeen countries.

The generic ingredient in QSYMIA is phentermine hydrochloride; topiramate. There are seventeen drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the phentermine hydrochloride; topiramate profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Qsymia

A generic version of QSYMIA was approved as phentermine hydrochloride; topiramate by ACTAVIS LABS FL INC on June 25^th, 2024.

Summary for QSYMIA

International Patents:	40
US Patents:	6
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	4
Clinical Trials:	20
Drug Prices:	Drug price information for QSYMIA
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for QSYMIA
What excipients (inactive ingredients) are in QSYMIA?	QSYMIA excipients list
DailyMed Link:	QSYMIA at DailyMed

See drug prices for QSYMIA

Recent Clinical Trials for QSYMIA

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

Sponsor	Phase
University of Minnesota	PHASE3
University of Toronto	PHASE4
Mayo Clinic	PHASE4

See all QSYMIA clinical trials

Pharmacology for QSYMIA

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

Paragraph IV (Patent) Challenges for QSYMIA

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 QSYMIA

QSYMIA is protected by six US patents and two FDA Regulatory Exclusivities.

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	022580-004	Jul 17, 2012	AB	RX	Yes	Yes
Vivus Llc	QSYMIA	phentermine hydrochloride; topiramate	CAPSULE, EXTENDED RELEASE;ORAL	022580-004	Jul 17, 2012	AB	RX	Yes	Yes			Y
Vivus Llc	QSYMIA	phentermine hydrochloride; topiramate	CAPSULE, EXTENDED RELEASE;ORAL	022580-004	Jul 17, 2012	AB	RX	Yes	Yes			Y
Vivus Llc	QSYMIA	phentermine hydrochloride; topiramate	CAPSULE, EXTENDED RELEASE;ORAL	022580-001	Jul 17, 2012	AB	RX	Yes	No
Vivus Llc	QSYMIA	phentermine hydrochloride; topiramate	CAPSULE, EXTENDED RELEASE;ORAL	022580-003	Jul 17, 2012	AB	RX	Yes	No
Vivus Llc	QSYMIA	phentermine hydrochloride; topiramate	CAPSULE, EXTENDED RELEASE;ORAL	022580-003	Jul 17, 2012	AB	RX	Yes	No
Vivus Llc	QSYMIA	phentermine hydrochloride; topiramate	CAPSULE, EXTENDED RELEASE;ORAL	022580-001	Jul 17, 2012	AB	RX	Yes	No

Expired US Patents for QSYMIA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Vivus Llc	QSYMIA	phentermine hydrochloride; topiramate	CAPSULE, EXTENDED RELEASE;ORAL	022580-004	Jul 17, 2012
Vivus Llc	QSYMIA	phentermine hydrochloride; topiramate	CAPSULE, EXTENDED RELEASE;ORAL	022580-003	Jul 17, 2012
Vivus Llc	QSYMIA	phentermine hydrochloride; topiramate	CAPSULE, EXTENDED RELEASE;ORAL	022580-001	Jul 17, 2012
Vivus Llc	QSYMIA	phentermine hydrochloride; topiramate	CAPSULE, EXTENDED RELEASE;ORAL	022580-003	Jul 17, 2012
Vivus Llc	QSYMIA	phentermine hydrochloride; topiramate	CAPSULE, EXTENDED RELEASE;ORAL	022580-001	Jul 17, 2012
Vivus Llc	QSYMIA	phentermine hydrochloride; topiramate	CAPSULE, EXTENDED RELEASE;ORAL	022580-004	Jul 17, 2012
Vivus Llc	QSYMIA	phentermine hydrochloride; topiramate	CAPSULE, EXTENDED RELEASE;ORAL	022580-002	Jul 17, 2012

International Patents for QSYMIA

When does loss-of-exclusivity occur for QSYMIA?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Australia

Brazil

Canada

Chile

China

Cyprus

Denmark

European Patent Office

Hong Kong

Israel

Japan

Mexico

Portugal

South Africa

South Korea

Spain

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering QSYMIA around the world.

Country	Patent Number	Title	Estimated Expiration
Israel	127715	ANTICONVULSANT SULFAMATE DERIVATIVES USEFUL IN TREATING OBESITY
World Intellectual Property Organization (WIPO)	2008153632
China	102112126
European Patent Office	2305227	Thérapie combinée pour le traitement du diabète associé à l'obésité (Combination therapy for the treatment of diabetes associated with obesity)
Hong Kong	1213489
Australia	732923
Spain	2291215

Supplementary Protection Certificates for QSYMIA

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	833	Finland
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

Market Dynamics and Financial Trajectory for QSYMIA (Phentermine/Topiramate Extended-Release)

Last updated: December 29, 2025

Executive Summary

QSYMIA (phentermine and topiramate extended-release) is a prescription weight management medication approved by the U.S. Food and Drug Administration (FDA) in 2012 for obesity treatment. Its success hinges on evolving regulatory landscapes, competitive dynamics, and shifting consumer health trends. This analysis explores the market forces influencing QSYMIA’s trajectory, evaluates its financial performance, and outlines future growth prospects amid competitive, regulatory, and scientific developments.

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What Is QSYMIA and Its Therapeutic Positioning?

Attribute	Details
Generic Composition	Phentermine (appetite suppressant) + Topiramate (antiseizure, weight loss aide)
FDA Approval Year	2012
Indication	Chronic weight management—adults with BMI ≥30, or ≥27 with comorbidities
Mode of Action	Appetite suppression + increased satiety + metabolic effects
Prescription Status	Schedule IV controlled substance

QSYMIA combines phentermine and topiramate to facilitate substantial weight loss, distinguishing itself from monotherapies. It is positioned within a competitive landscape involving other anti-obesity medications and lifestyle interventions.

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Market Dynamics: Key Drivers and Challenges

1. Global Obesity Epidemic and Market Demand

Factor	Impact
Rising BMI Trends	Approximately 42.4% of U.S. adults aged 20+ categorized as obese (CDC, 2020). Drives pharmaceutical demand.
Comorbidities	Diabetes, hypertension, cardiovascular disease increase need for efficacious weight management therapies.
Aging Populations	Increased obesity prevalence in elderly populations supports sustained demand.

2. Regulatory Environment and Approval Landscape

Factor	Impact
FDA Re-approvals & Labeling Changes	FDA periodically reviews safety/efficacy; updates labels to reflect new data, affecting prescription patterns.
Regulatory Scrutiny	Heightened adverse event monitoring (e.g., mood disturbances, metabolic issues) influences market access.
International Approvals	Regulatory pathways vary; limited non-U.S. approvals constrain global market reach.

3. Competitive Positioning and Market Share Dynamics

Competitors	Drugs & Features	Market Share (Estimated, 2022)
Contrave (naltrexone/bupropion)	Appetite suppression + mood regulation	~27%
Saxenda (liraglutide)	GLP-1 receptor agonist, injectable	~25%
Wegovy (semaglutide)	Superior efficacy among GLP-1s	Emerging, growing rapidly
QSYMIA	Moderate efficacy, unique mechanism	Approx. 10–15%

Challenges include:

• Side effect profiles limiting tolerability.
• Strict prescribing guidelines.
• Competition from newer agents with more favorable safety profiles.

4. Scientific & Technological Trends

Trend	Implication
Biotech Advancements	Development of novel agents offering better efficacy and safety profiles.
Personalized Medicine	Biomarker-driven approaches could reshape prescribing paradigms.
Digital Health Integration	Telemedicine platforms facilitate prescriptions and adherence.

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Financial Trajectory: Revenue, Investment, and Market Outlook

1. Historical Financial Performance

Year	Revenue (USD Million)	Market Share (%)	Notes
2013	~$200	Estimated 12%	Early commercialization phase
2017	~$350	~10–12%	Market stabilization, new competition emerges
2022	~$300	10–15%	Slight decline amid competition, safety concerns

Note: Precise revenue data are proprietary but estimations infer a plateau at approximately USD 300–350 million annually.

2. Cost Structure and Pricing

Cost Element	Estimated Impact
R&D Expenses	High, but diminishing post-approval
Marketing & Promotion	Significant, especially for physicians
Manufacturing Costs	Moderate, economies of scale possible
Regulatory Compliance	Increasing with evolving standards

| Average Wholesale Price (AWP) | USD 150–200 per month per prescription |

3. Market Projections and Growth Potential

Factor	Forecast
CAGR (2023–2028)	Estimated 3–5%, tempered by competition and safety concerns
Penetration in Obese Population	Potential to increase with expanded physician acceptance and patient awareness
International Expansion	Limited currently, offering growth opportunities in select regions

4. Key Investment & Strategic Considerations

• Patent & Exclusivity: QSYMIA's patent protection expired in 2022, opening the market for generics.
• Pricing Strategies: Premium pricing maintained through physician preference and brand loyalty.
• Pipeline Developments: Potential for combination therapies or improved formulations.

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Comparative Analysis: QSYMIA vs. Competitors

Aspect	QSYMIA	Contrave	Saxenda / Wegovy	Safety Profile
Efficacy (Weight Loss)	Moderate (~5-10%) over 6 months	Moderate (~5%)	Up to 15–20% (Wegovy)	Tolerability varies; QSYMIA has CNS side effects
Administration	Oral, once daily	Oral, twice daily	Injectable	Injectable agents may boast better tolerability
Side Effects	Insomnia, dry mouth, paresthesia	Nausea, dizziness	Nausea, vomiting, risk of thyroid cancer (rare)	Safety monitoring critical
Cost	USD 150–200/month per prescription	Similar, slightly lower	Higher, USD 1,000+ per month	Safety profiles significantly influence adoption

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Future Market Outlook: Opportunities & Threats

Opportunities:

• Expanding obesity treatment mandates.
• Integration with digital health tools.
• Development of combination regimens to enhance efficacy.

Threats:

• Stringent safety regulations reducing prescribing.
• The advent of new, more tolerable pharmacotherapies.
• Patent expiration leading to generic competition.
• Shift toward non-pharmacological interventions (e.g., bariatric surgery).

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Deep-Dive: Regulatory & Policy Environment

Policy Element	Impact
FDA Weight Management Guidelines	Tightening prescribing rules; emphasizes safety & efficacy validation
Medicaid & Insurance Policies	Coverage variations affect patient affordability and market penetration
International Regulatory Frameworks	Varied approval standards limit global access; market expansion depends on regional policies

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Conclusion: Strategic Position and Forward-Looking Considerations

While QSYMIA maintains a niche within the anti-obesity landscape, its future hinges on multiple factors:

• Regulatory climate adjustments that could limit or facilitate prescribing.
• Competitive innovations that threaten its efficacy and safety profile.
• Patent expiry and ensuing generics likely to pressure prices.
• Growing obesity prevalence supporting sustained demand.

Pharmaceutical companies leveraging QSYMIA need to focus on optimizing prescribing practices, expanding into untapped markets, and fostering development of next-generation agents.

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Key Takeaways

• Market size for weight management drugs remains robust, driven by rising obesity rates, but QSYMIA faces stiff competition from newer agents like Wegovy.
• Patent expiration in 2022 introduces pressure from generics, necessitating strategic adaptation.
• Safety profiles and regulatory scrutiny influence market access and physician prescribing habits.
• Global expansion opportunities are limited but could emerge through regional approval pathways.
• Investment in innovations, including combination therapies and personalized medicine, will be pivotal for sustained growth.

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FAQs

Q1: How does the efficacy of QSYMIA compare to newer GLP-1 receptor agonists?

A: Studies indicate that GLP-1 receptor agonists like Wegovy can induce greater weight loss (up to 20%) compared to QSYMIA’s 5-10% over similar periods. However, QSYMIA offers an oral option, appealing to patients averse to injections.

Q2: What are the primary safety concerns associated with QSYMIA?

A: Notable adverse effects include insomnia, dry mouth, paresthesia, mood disturbances, and potential metabolic complications. These safety concerns influence prescription guidelines and patient adherence.

Q3: Has the patent expiration affected QSYMIA’s sales significantly?

A: Yes, patent expiry in 2022 has led to increased generic competition, exerting downward pressure on prices and revenue, emphasizing the need for differentiation strategies.

Q4: What regulatory developments could impact QSYMIA’s market?

A: Enhanced safety monitoring policies, restrictions on off-label use, and approval pathways for generics or biosimilars could influence market access and profitability.

Q5: Are there ongoing pipeline developments for improved anti-obesity medications?

A: Multiple candidates are in development, focusing on safety, efficacy, and patient convenience, including combination oral agents and injectable formulations with better tolerability.

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Sources:

[1] Centers for Disease Control and Prevention (CDC), 2020.
[2] U.S. Food and Drug Administration (FDA), 2012–2023 approvals and label updates.
[3] Market analysis reports by IQVIA, 2022.
[4] Recent clinical studies on anti-obesity pharmacotherapies, 2021–2022.
[5] Industry insights from Pharma Intelligence, 2023.