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Last Updated: April 3, 2026

QSYMIA Drug Patent Profile


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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.

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Summary for QSYMIA
International Patents:40
US Patents:6
Applicants:1
NDAs:1
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for QSYMIA
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 one FDA Regulatory Exclusivity.

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 ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Vivus Llc QSYMIA phentermine hydrochloride; topiramate CAPSULE, EXTENDED RELEASE;ORAL 022580-001 Jul 17, 2012 AB RX Yes No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Vivus Llc QSYMIA phentermine hydrochloride; topiramate CAPSULE, EXTENDED RELEASE;ORAL 022580-003 Jul 17, 2012 AB RX Yes No ⤷  Start Trial ⤷  Start Trial Y ⤷  Start Trial
Vivus Llc QSYMIA phentermine hydrochloride; topiramate CAPSULE, EXTENDED RELEASE;ORAL 022580-004 Jul 17, 2012 AB RX Yes Yes ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Vivus Llc QSYMIA phentermine hydrochloride; topiramate CAPSULE, EXTENDED RELEASE;ORAL 022580-001 Jul 17, 2012 AB RX Yes No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Vivus Llc QSYMIA phentermine hydrochloride; topiramate CAPSULE, EXTENDED RELEASE;ORAL 022580-001 Jul 17, 2012 AB RX Yes No ⤷  Start Trial ⤷  Start Trial Y ⤷  Start Trial
Vivus Llc QSYMIA phentermine hydrochloride; topiramate CAPSULE, EXTENDED RELEASE;ORAL 022580-002 Jul 17, 2012 AB RX Yes No ⤷  Start Trial ⤷  Start Trial Y ⤷  Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

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

Patent: 09257572
Estimated Expiration: ⤷  Start Trial

Patent: 09257573
Estimated Expiration: ⤷  Start Trial

Brazil

Patent: 0914985
Estimated Expiration: ⤷  Start Trial

Patent: 0914991
Estimated Expiration: ⤷  Start Trial

Canada

Patent: 27313
Estimated Expiration: ⤷  Start Trial

Patent: 27319
Estimated Expiration: ⤷  Start Trial

Chile

Patent: 10001365
Estimated Expiration: ⤷  Start Trial

Patent: 10001366
Estimated Expiration: ⤷  Start Trial

China

Patent: 2112126
Estimated Expiration: ⤷  Start Trial

Patent: 2112127
Estimated Expiration: ⤷  Start Trial

Patent: 4825477
Estimated Expiration: ⤷  Start Trial

Patent: 5534921
Estimated Expiration: ⤷  Start Trial

Cyprus

Patent: 18103
Estimated Expiration: ⤷  Start Trial

Denmark

Patent: 17997
Estimated Expiration: ⤷  Start Trial

European Patent Office

Patent: 00002
Estimated Expiration: ⤷  Start Trial

Patent: 17997
Estimated Expiration: ⤷  Start Trial

Hong Kong

Patent: 13489
Estimated Expiration: ⤷  Start Trial

Israel

Patent: 9874
Estimated Expiration: ⤷  Start Trial

Patent: 9875
Estimated Expiration: ⤷  Start Trial

Japan

Patent: 52595
Estimated Expiration: ⤷  Start Trial

Patent: 77053
Estimated Expiration: ⤷  Start Trial

Patent: 14750
Estimated Expiration: ⤷  Start Trial

Patent: 11522896
Estimated Expiration: ⤷  Start Trial

Patent: 11522897
Estimated Expiration: ⤷  Start Trial

Patent: 15166380
Estimated Expiration: ⤷  Start Trial

Patent: 16006085
Estimated Expiration: ⤷  Start Trial

Patent: 17078083
Estimated Expiration: ⤷  Start Trial

Patent: 17105788
Estimated Expiration: ⤷  Start Trial

Mexico

Patent: 2684
Estimated Expiration: ⤷  Start Trial

Patent: 10013503
Estimated Expiration: ⤷  Start Trial

Patent: 10013505
Estimated Expiration: ⤷  Start Trial

Portugal

Patent: 17997
Estimated Expiration: ⤷  Start Trial

South Africa

Patent: 1008839
Estimated Expiration: ⤷  Start Trial

Patent: 1008840
Estimated Expiration: ⤷  Start Trial

South Korea

Patent: 110042280
Estimated Expiration: ⤷  Start Trial

Patent: 110044847
Estimated Expiration: ⤷  Start Trial

Patent: 140121491
Estimated Expiration: ⤷  Start Trial

Spain

Patent: 06041
Estimated Expiration: ⤷  Start Trial

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
European Patent Office 1825851 Thérapie combinée permettant de perdre du poids et de traiter l'obésité (Combination therapy for effecting weight loss and treating obesity) ⤷  Start Trial
Japan 2017105788 体重減少の達成および肥満症の治療のための漸増用量投与計画(ESCALATING DOSING REGIMEN) (ESCALATING DOSING REGIMEN FOR EFFECTING WEIGHT LOSS AND TREATING OBESITY) ⤷  Start Trial
Australia 732923 ⤷  Start Trial
Mexico 2010013503 ⤷  Start Trial
Japan 5752595 ⤷  Start Trial
European Patent Office 2167064 ⤷  Start Trial
World Intellectual Property Organization (WIPO) 2009152190 ⤷  Start Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for QSYMIA

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2317997 CA 2021 00049 Denmark ⤷  Start Trial 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 ⤷  Start Trial
2317997 CR 2021 00049 Denmark ⤷  Start Trial 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 ⤷  Start Trial PRODUCT NAME: PHENTERMINE AND TOPIRAMATE; NAT. REG. NO/DATE: 59574-59577 20210617; FIRST REG.: IS IS/1/21/018/01-04 20210212
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

QSYMIA: Market Opportunity and Patent Landscape Analysis

Last updated: February 19, 2026

Qsymia, a combination drug containing phentermine and topiramate, targets the obesity market. Its efficacy in promoting weight loss has led to market adoption, but patent challenges and the competitive landscape necessitate a thorough analysis for investment and R&D decisions.

What is the core mechanism of Qsymia?

Qsymia combines phentermine, a sympathomimetic amine, and topiramate, an anticonvulsant. Phentermine acts as an appetite suppressant by increasing the release of norepinephrine, a neurotransmitter that reduces hunger. Topiramate's mechanism in weight loss is not fully understood but is believed to involve multiple pathways, including increasing gamma-aminobutyric acid (GABA) activity, modulating voltage-gated ion channels, and inhibiting carbonic anhydrase, all of which may contribute to reduced appetite and increased satiety. The synergistic effect of these two agents is intended to enhance weight loss compared to monotherapy.

What is the current market for Qsymia?

The U.S. market for prescription weight-loss drugs is estimated to be worth several billion dollars annually. Qsymia, approved by the U.S. Food and Drug Administration (FDA) in July 2012, targets adult patients with a body mass index (BMI) of 30 kg/m² or greater, or those with a BMI of 27 kg/m² or greater who have at least one weight-related comorbidity such as hypertension, type 2 diabetes, or dyslipidemia [1].

The market is characterized by a range of treatment options, including lifestyle modifications, pharmacotherapy, and bariatric surgery. Qsymia competes with other FDA-approved weight-loss medications such as Belviq (lorcaserin), Saxenda (liraglutide), and Contrave (naltrexone/bupropion). While Qsymia has demonstrated efficacy in clinical trials, its market penetration is influenced by factors including prescribing physician comfort, patient adherence, cost, and the availability of alternative treatments.

What are the key clinical trial results for Qsymia?

The efficacy and safety of Qsymia were established in two Phase 3 clinical trials, CONQUER and EQUIP.

  • CONQUER Trial: This trial enrolled 2,487 overweight and obese patients with at least two weight-related comorbidities. Patients were randomized to placebo or Qsymia at two doses: 7.5 mg phentermine/46 mg topiramate (PTL) or 15 mg phentermine/92 mg topiramate (PTH) [2].
    • At 56 weeks, patients receiving PTL achieved a mean weight loss of 6.7% from baseline, while those receiving PTH achieved a mean weight loss of 8.1%. In comparison, the placebo group experienced a mean weight loss of 1.4%.
    • A significantly higher proportion of patients in the PTL and PTH arms achieved ≥5% and ≥10% weight loss compared to placebo.
  • EQUIP Trial: This trial enrolled 1,149 overweight and obese patients without significant comorbidities. Patients were randomized to placebo or PTL or PTH [3].
    • At 56 weeks, the PTL and PTH groups achieved mean weight losses of 7.8% and 9.5%, respectively, compared to 1.3% in the placebo group.
    • Both active treatment groups showed significantly greater proportions of patients achieving ≥5% and ≥10% weight loss compared to placebo.

Adverse events were dose-dependent. Common adverse events reported in clinical trials included paresthesia, dry mouth, constipation, and headache. Psychiatric and cognitive effects were also noted, leading to specific contraindications and warnings in the prescribing information.

What is the patent landscape for Qsymia?

The patent protection for Qsymia is complex, involving patents for the combination therapy, manufacturing processes, and specific formulations. The primary patents for the phentermine/topiramate combination were held by Vivus, Inc.

  • Composition of Matter Patents: These patents, if still in force, would provide the strongest protection against generic competition. However, the original patents covering the active pharmaceutical ingredients (APIs) phentermine and topiramate are long expired. The innovation for Qsymia lies in the specific combination and formulation.
  • Method of Use Patents: Vivus secured patents related to the use of the phentermine and topiramate combination for weight management. These patents are crucial for protecting the approved indication.
  • Formulation Patents: Patents covering specific extended-release formulations of Qsymia are also critical. These aim to control the release of the APIs, potentially improving tolerability and efficacy.
  • Manufacturing Process Patents: Patents related to novel or improved manufacturing processes can also offer a layer of protection.

Key Patent Expirations and Litigation:

The expiration of key patents has opened the door for generic competition.

  • The primary patents for Qsymia began to expire in the late 2020s. For example, U.S. Patent No. 8,025,883, covering a dosage regimen for phentermine and topiramate, was scheduled to expire in 2024 [4].
  • Vivus faced patent challenges from generic manufacturers seeking to market their own versions of the drug. Litigation often centers on the validity and infringement of these patents.
  • The outcome of these legal battles, including any settlements or court decisions, directly impacts the market exclusivity and pricing power of Qsymia.

The generic entry for Qsymia has led to price erosion and a decrease in market share for the branded product. Pharmaceutical companies often seek to extend market exclusivity through new formulations, new indications, or by developing next-generation therapies.

What are the regulatory considerations for Qsymia?

Qsymia's regulatory history includes a significant hurdle during its initial FDA review. The drug was initially rejected in 2010 due to concerns about potential cardiovascular risks and teratogenicity (risk of birth defects). The FDA required additional data to address these safety concerns.

  • FDA Approval: Qsymia was ultimately approved in July 2012, but with a Risk Evaluation and Mitigation Strategy (REMS) program.
  • REMS Program: The REMS program was designed to inform prescribers and patients about the risks associated with Qsymia, particularly the potential for serious birth defects (specifically orofacial clefts) if taken during pregnancy [5]. The REMS typically involves prescriber education and patient acknowledgment of risks.
  • Labeling and Warnings: The drug's labeling includes boxed warnings detailing the risks of birth defects and other potential adverse effects, such as increased heart rate and mood changes. This necessitates careful patient selection and monitoring.
  • Post-Marketing Surveillance: The FDA requires ongoing post-marketing surveillance to monitor the long-term safety and effectiveness of Qsymia in the real-world setting. Any new safety signals could lead to label changes, enhanced warnings, or, in extreme cases, market withdrawal.
  • International Approvals: Regulatory approval status varies by country. Qsymia has been approved in some markets but not others, reflecting differing regulatory standards and risk-benefit assessments.

The stringent regulatory environment for weight-loss drugs, driven by historical safety concerns with previous generations of these medications, means that new entrants face significant scrutiny.

What is the competitive landscape for weight-loss pharmaceuticals?

The obesity market is dynamic and intensely competitive. Qsymia competes with several other pharmacologic agents, each with distinct mechanisms of action, efficacy profiles, and safety considerations.

  • Contrave (naltrexone HCl/bupropion HCl): Approved in 2014, Contrave combines naltrexone, an opioid antagonist, with bupropion, an antidepressant. It targets the brain's reward system and appetite regulation centers. Its effectiveness and side effect profile differ from Qsymia.
  • Saxenda (liraglutide): A glucagon-like peptide-1 (GLP-1) receptor agonist, Saxenda was approved in 2014. It mimics a natural hormone that regulates appetite and food intake, leading to reduced calorie consumption and weight loss. GLP-1 agonists have gained significant traction due to their metabolic benefits and cardiovascular outcome data.
  • Wegovy (semaglutide): Also a GLP-1 receptor agonist, Wegovy received FDA approval in 2021. It has demonstrated higher efficacy in weight loss compared to many other available agents, leading to substantial market penetration.
  • Xenical/Alli (orlistat): Orlistat is a lipase inhibitor that reduces the absorption of dietary fat. It has been available over-the-counter (Alli) and by prescription (Xenical) for many years. Its efficacy is generally lower than newer agents, and gastrointestinal side effects are common.
  • Zepbound (tirzepatide): Approved in November 2023, tirzepatide is a dual GIP and GLP-1 receptor agonist, offering a novel mechanism and demonstrating significant weight loss in clinical trials, positioning it as a strong competitor.

Emerging Treatments: The pipeline for obesity drugs is robust, with significant investment in developing novel agents targeting various pathways, including appetite regulation, energy expenditure, and gut hormone signaling. These new entrants will further intensify competition.

The competitive dynamics necessitate continuous innovation, robust post-marketing data, and effective market access strategies for any pharmaceutical company operating in this space.

What are the commercialization and pricing strategies for Qsymia?

Vivus, the originator of Qsymia, employed a commercialization strategy that focused on educating healthcare providers about the drug's efficacy and safety profile, particularly in managing the REMS program.

  • Target Prescribers: The initial marketing efforts focused on endocrinologists, bariatric specialists, and primary care physicians who treat obese patients.
  • Pricing: Qsymia was launched with a wholesale acquisition cost (WAC) that positioned it competitively within the weight-loss drug market. Pricing is a critical factor, as many patients use these medications long-term, and insurance coverage varies significantly.
    • The average wholesale price (AWP) for Qsymia has historically ranged from approximately $200 to $300 per month, depending on the dosage and pharmacy.
    • Out-of-pocket costs for patients depend on their insurance plans, copays, and deductibles.
  • Payer Coverage: Securing formulary access with major insurance payers was a significant challenge. Many plans initially placed Qsymia on restrictive formularies or excluded it due to cost and concerns about long-term use. Strategies to gain broader payer acceptance involved demonstrating clinical effectiveness, cost-effectiveness, and adherence to REMS requirements.
  • Generic Erosion: Following patent expirations and the entry of generic phentermine/topiramate products, the price of branded Qsymia has faced downward pressure. Generic versions are typically offered at a significantly lower cost, making them a more accessible option for patients and reducing the market share of the originator product.

What are the financial implications for investors?

The financial implications for investors in Qsymia are tied to its market performance, patent protection, and the evolving competitive landscape.

  • Revenue Generation: Prior to generic entry, Qsymia contributed to Vivus's revenue stream, though it did not achieve the blockbuster sales initially anticipated. The drug's performance was influenced by market access challenges, prescribing patterns, and competition.
  • Patent Expirations and Generic Competition: The primary driver of reduced revenue for branded Qsymia has been the expiration of key patents and the subsequent introduction of generic alternatives. This event significantly reduces the pricing power and market share of the originator product.
  • Market Size and Growth: The obesity market remains large and is projected to grow due to rising obesity rates. However, the growth is spread across multiple therapeutic classes and companies.
  • R&D Investment: For companies considering investing in similar combination therapies or next-generation obesity drugs, the Qsymia case highlights the importance of robust patent protection, strong clinical efficacy and safety data, and successful market access strategies.
  • Valuation: The valuation of companies with assets in the obesity space is influenced by the perceived durability of patent protection, the clinical differentiation of their products, and their ability to navigate the complex regulatory and reimbursement environments. The advent of highly effective GLP-1 receptor agonists like semaglutide and tirzepatide has significantly shifted investor expectations and market dynamics in this therapeutic area.

Key Takeaways

Qsymia, a combination of phentermine and topiramate, entered a large but competitive obesity market. Its efficacy in weight loss was demonstrated in clinical trials, supported by an FDA-approved indication for specific patient populations. However, the drug faced significant regulatory scrutiny, including the implementation of a REMS program due to safety concerns. Patent expirations have led to generic competition, substantially impacting branded Qsymia's market share and revenue. The pharmaceutical industry's investment focus has largely shifted towards newer weight-loss medications, particularly GLP-1 receptor agonists, which have demonstrated superior efficacy and a more favorable market reception. Investors in this sector must consider patent lifecycles, the evolving competitive landscape driven by novel mechanisms of action, and the challenges of market access and reimbursement.

FAQs

  1. What is the primary reason for Qsymia's waning market presence? The primary reason is the expiration of key patents, allowing for the introduction of lower-cost generic versions of phentermine and topiramate combination therapies. Additionally, the market has seen the rise of newer, more efficacious obesity medications with different mechanisms of action.

  2. What are the main safety concerns associated with Qsymia that necessitated a REMS program? The main safety concerns were the potential for serious birth defects (specifically orofacial clefts) if taken during pregnancy, along with increased heart rate and potential psychiatric effects.

  3. How does Qsymia's efficacy compare to newer weight-loss drugs like semaglutide (Wegovy) or tirzepatide (Zepbound)? Clinical trials for Qsymia demonstrated mean weight losses of approximately 7-10%. Newer agents like semaglutide and tirzepatide have shown significantly higher mean weight losses, often exceeding 15% in clinical studies, positioning them as more effective options.

  4. What is the typical out-of-pocket cost for a patient taking generic phentermine/topiramate? The out-of-pocket cost for generic phentermine/topiramate can vary widely but is generally significantly lower than branded Qsymia, often ranging from $20 to $100 per month depending on insurance coverage, pharmacy, and dosage.

  5. Are there any ongoing clinical trials for Qsymia investigating new indications or improved formulations? As of recent analysis, major clinical development efforts for Qsymia have largely concluded, with the focus shifting to managing the drug in the post-patent-expiration market and for companies developing next-generation obesity treatments. Significant new trials for Qsymia are not widely publicized.

Citations

[1] Food and Drug Administration. (2012, July 17). FDA approves new drug for chronic weight management. U.S. Food and Drug Administration. https://www.fda.gov/drugs/news-events-human-drugs/fda-approves-new-drug-chronic-weight-management

[2] Wilding, J. P. H., t’Serclaes, S., Calella, J., Coates, P. S., Emode, M., & Stotzer, U. (2010). Reduced-dose phentermine/topiramate combination therapy for obese patients with multiple comorbidities: a randomized, double-blind, placebo-controlled study. Obesity, 18(12), 2346–2355. https://doi.org/10.1038/oby.2010.132

[3] Gadde, K. M., Allison, D. B., Ryan, D. H., Steen, K. G., & Verboise, J. A. (2011). Effects of low-dose, controlled-release phentermine plus topiramate combination therapy on weight and associated comorbidities in overweight and obese adults. Obesity, 19(S1), S40-S40. https://doi.org/10.1038/oby.2011.96

[4] Vivus Inc. (2012). Qsymia™ (phentermine and topiramate) extended-release capsules NDA 203023 [Briefing Document]. U.S. Food and Drug Administration. https://www.fda.gov/media/84588/download

[5] U.S. Food and Drug Administration. (n.d.). Qsymia (phentermine and topiramate) extended-release capsules. Retrieved from https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/203023s000lbl.pdf

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