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Last Updated: December 15, 2025

Frovatriptan succinate - Generic Drug Details


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What are the generic sources for frovatriptan succinate and what is the scope of freedom to operate?

Frovatriptan succinate is the generic ingredient in two branded drugs marketed by Endo Operations, Amneal Pharms Co, Glenmark Pharms Ltd, Leading, Pharmobedient, and Renata, and is included in six NDAs. Additional information is available in the individual branded drug profile pages.

There are three drug master file entries for frovatriptan succinate. Four suppliers are listed for this compound.

Summary for frovatriptan succinate
US Patents:0
Tradenames:2
Applicants:6
NDAs:6
Drug Master File Entries: 3
Finished Product Suppliers / Packagers: 4
Raw Ingredient (Bulk) Api Vendors: 51
Patent Applications: 146
What excipients (inactive ingredients) are in frovatriptan succinate?frovatriptan succinate excipients list
DailyMed Link:frovatriptan succinate at DailyMed
Pharmacology for frovatriptan succinate
Anatomical Therapeutic Chemical (ATC) Classes for frovatriptan succinate
Paragraph IV (Patent) Challenges for FROVATRIPTAN SUCCINATE
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
FROVA Tablets frovatriptan succinate 2.5 mg 021006 1 2011-03-09

US Patents and Regulatory Information for frovatriptan succinate

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Endo Operations FROVA frovatriptan succinate TABLET;ORAL 021006-001 Nov 8, 2001 AB RX Yes Yes ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Glenmark Pharms Ltd FROVATRIPTAN SUCCINATE frovatriptan succinate TABLET;ORAL 204730-001 Mar 11, 2016 AB RX No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Pharmobedient FROVATRIPTAN SUCCINATE frovatriptan succinate TABLET;ORAL 202931-001 Aug 28, 2014 DISCN No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Renata FROVATRIPTAN SUCCINATE frovatriptan succinate TABLET;ORAL 213891-001 Apr 6, 2022 AB RX No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Amneal Pharms Co FROVATRIPTAN SUCCINATE frovatriptan succinate TABLET;ORAL 211292-001 Nov 6, 2018 AB RX No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Leading FROVATRIPTAN SUCCINATE frovatriptan succinate TABLET;ORAL 216998-001 Apr 16, 2025 AB RX No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for frovatriptan succinate

Market Dynamics and Financial Trajectory for Frovatriptan Succinate

Last updated: July 27, 2025

Introduction

Frovatriptan succinate stands as a notable entrant within the therapeutic class of triptans, widely utilized for acute migraine management. Its unique pharmacokinetic profile, competitive positioning, and evolving healthcare landscape significantly influence its market dynamics and financial prospects. This report provides a comprehensive analysis of the current market landscape, growth drivers, challenges, and future financial trajectories associated with frovatriptan succinate.

Pharmacological Profile and Clinical Positioning

Frovatriptan succinate is a selective serotonin receptor agonist (5-HT1B/1D) designed to relieve migraine symptoms by constricting cranial blood vessels and inhibiting inflammatory neuropeptide release. Its longer half-life (roughly 26 hours) compared to other triptans, such as sumatriptan, delivers sustained relief with a reduced recurrence rate, positioning it effectively for patients with frequent migraine episodes [1].

Clinicians favor frovatriptan for its favorable tolerability profile and lower recurrence rates, particularly in patients requiring prolonged analgesic coverage. However, its relatively slower onset—taking approximately 2–4 hours to achieve optimal relief—limits its use as an immediate-acting abortive therapy in acute settings. These pharmacokinetic nuances influence its market penetration among triptan options.

Current Market Landscape

Market Size and Revenue

The global migraine therapeutics market was valued at approximately USD 4.4 billion in 2022 and is projected to expand at a compound annual growth rate (CAGR) of 4.7% through 2030 [2]. While triptans constitute a significant component of this market, frovatriptan's specific contribution remains modest due to several factors, including limited formulary positioning and competitive alternatives.

Estimates suggest that frovatriptan succinate accounts for roughly 3-5% of the total triptan market, translating into estimated revenues in the low hundreds of millions annually. These figures are influenced by regional availability, prescribing practices, and formulary inclusions.

Regional Adoption and Market Penetration

Europe and North America dominate the triptan market, with strong approval, extensive prescribing, and broader insurance coverage. In Europe, resulting from guidelines favoring triptans with longer durations of action for recurrent migraines, frovatriptan benefits from sustained use [3]. However, regulatory restrictions, such as prior authorization requirements in certain markets (e.g., the US), restrain rapid adoption compared to more established triptans like sumatriptan and rizatriptan.

Emerging markets, notably Asia-Pacific, show increasing acceptance as migraine prevalence rises and healthcare systems expand access. Nonetheless, limited awareness and economic barriers affect potential growth in these regions.

Competitive Landscape

Frovatriptan faces stiff competition from multiple triptans with faster onset profiles—sumatriptan, zolmitriptan, eletriptan—each with broader brand recognition. Major pharmaceutical players such as Novartis (Imitrex/ Sumatriptan), Teva, and Genentech (rizatriptan) dominate the market.

The presence of generics—frovatriptan has been available as a generic for several years—has bolstered price competitiveness and expanded accessibility. However, the emergence of newer therapies, including gepants (ubrogepant, rimegepant) and ditans (lasmiditan), poses challenges to traditional triptan utilization [4].

Market Drivers

Growing Migraine Prevalence

Migraine affects approximately 15% of the global adult population, with significant socioeconomic impacts, including missed workdays and reduced productivity [5]. Rising awareness and improved diagnosis contribute to increased treatment demand, potentially benefitting frovatriptan’s market share.

Preference for Long-Acting Tripans

Clinicians increasingly prioritize triptans with sustained action to minimize recurrence. Frovatriptan's pharmacokinetic properties, yielding fewer relapse episodes, align with this trend, bolstering its appeal in specific patient subsets.

Advances in Pharmacovigilance and Tolerability

Frovatriptan exhibits a favorable side-effect profile, with lower rates of chest tightness and paresthesia compared to some triptans. Its safety profile enhances its positioning among patients contraindicated for other vasoconstrictors.

Regulatory and Reimbursement Environment

Regulatory approvals and positive reimbursement policies in developed markets facilitate access. In Europe, reimbursements under national health schemes have increased prescriptions, especially for recurrent migraine sufferers.

Market Challenges

Competitive Alternatives

The advent of newer, non-vasoconstrictive agents (gepants and ditans) offers effective alternatives with rapid onset and fewer cardiovascular contraindications. For example, ubrogepant and lasmiditan provide rapid relief, targeting unmet needs, which could constrain frovatriptan's growth [6].

Limited Awareness and Prescriber Preference

Despite its clinical advantages, frovatriptan's slower onset and regional availability limit widespread prescriber awareness. Physicians often opt for faster-acting triptans in acute scenarios, especially in emergency or urgent care settings.

Pricing and Generic Competition

While availability of generic frovatriptan enhances affordability, it compresses margins for pharmaceutical companies and may reduce investments in promotional activities or research.

Therapeutic Positioning

Frovatriptan's niche utility in recurrent migraines may constrain market expansion unless supported by targeted educational initiatives, formulary inclusion, and evidence-based positioning among healthcare providers.

Future Financial Trajectory

Growth Opportunities

Expanded Indications

Potential approval for prophylactic use remains unlikely due to pharmacokinetics and current indications; however, research exploring its efficacy in menstrual migraine could open niche markets.

Developments in Formulation and Delivery

Innovations such as rapid-dissolving tablets or combination therapies could improve onset times, enhancing appeal among acute migraine sufferers.

Strategic Positioning in Specialty Markets

Targeted marketing focusing on patients experiencing high recurrence rates, or those contraindicated for other triptans, could foster loyalty and repeat prescriptions.

Market Risks

Emergence of Novel Therapies

Gepants and ditans, supported by extensive clinical trial data and aggressive marketing, threaten to displace traditional triptans, including frovatriptan.

Market Saturation and Cost Pressures

Pricing pressures, especially in competitive segments with generics, could constrain revenue growth. Payers demanding cost-effective alternatives might favor newer agents with broader indications.

Forecasts and Financial Outlook

By 2030, the global migraine drug market is expected to surpass USD 6 billion, with triptans maintaining a significant share. Frovatriptan's niche positioning suggests low to moderate growth potential, primarily driven by regional market expansion and formulation innovations. Estimated revenues could approach USD 250-400 million by 2030 in a best-case scenario, assuming favorable formulary inclusion and physician adoption [2].

Regulatory and Patent Landscape

Frovatriptan's patent protections have expired in key markets, paving the way for generics and intensified price competition. Companies seeking to extend exclusivity explore novel delivery mechanisms or combination formulations. Regulatory agencies' evolving stance on migraine therapies, especially concerning reimbursement criteria, influences market access.

Concluding Remarks

Frovatriptan succinate occupies a specialized position within the migraine therapeutics landscape, leveraged by its sustained action and tolerability. Its financial trajectory hinges on regional market growth, formulary access, and the evolving competitive arena. Despite challenges from novel agents, strategic clinical positioning and potential formulation innovation could sustain or modestly grow its market share over the coming decade.


Key Takeaways

  • Niche but Valuable: Frovatriptan's long-acting profile suits recurrent migraine management but limits its appeal in acute, rapid-onset scenarios.
  • Market Growth Constrained by Competition: Emerging therapies like gepants and ditans threaten to overshadow traditional triptans, including frovatriptan.
  • Regional Variations Critical: Licensing, reimbursement policies, and prescriber familiarity significantly influence market penetration.
  • Opportunities in Formulation Innovation: Advanced delivery systems could mitigate onset limitations and expand patient appeal.
  • Generic Competition Limits Margins: Patent expiration and generic availability require strategic differentiation to sustain revenues.

FAQs

1. How does frovatriptan compare to other triptans in terms of efficacy?
Frovatriptan offers similar effectiveness in migraine relief but is distinguished by its longer half-life, resulting in lower recurrence rates. However, its slower onset may limit its use in rapidly progressing migraines compared to agents like sumatriptan.

2. What are the primary markets driving frovatriptan sales?
Europe and North America generate the majority of frovatriptan sales due to established prescribing habits, higher reimbursement levels, and regulatory approval, with emerging markets showing growing potential.

3. Are there prospects for expanding frovatriptan's indications?
Currently, no. Its profile suggests limited utility for prophylactic use; research into specific migraine subtypes or combination formulations remains experimental.

4. How might the rise of gepants and ditans impact frovatriptan’s market?
These newer agents, offering rapid relief with fewer cardiovascular restrictions, are likely to reduce triptan utilization, especially among high-risk populations, constraining frovatriptan’s growth prospects.

5. What strategies can pharmaceutical companies employ to sustain frovatriptan’s market share?
Investing in formulation innovations, targeted educational initiatives, and expanding regional access can help maintain relevance amid competitive pressures.


References

[1] Goadsby PJ, et al. Frovatriptan: Pharmacology, efficacy, and tolerability in migraine. Expert Opin Pharmacother. 2010.
[2] Grand View Research. Migraine Drugs Market Size, Share & Trends Analysis Report. 2022.
[3] European Medicines Agency (EMA). Frovatriptan summary. 2016.
[4] Miller ST, et al. The impact of novel migraine therapies on traditional triptan markets. J Headache Pain. 2021.
[5] Vos T, et al. Global, regional, and national incidence, prevalence, and years lived with disability for 310 diseases and injuries, 1990–2019. The Lancet. 2020.
[6] Food and Drug Administration (FDA). Ubrogepant and Lasmiditan Approvals. 2020.

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