FROVATRIPTAN SUCCINATE - Generic Drug Details

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. Three 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:	3
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

Drug Class	Serotonin-1b and Serotonin-1d Receptor Agonist
Mechanism of Action	Serotonin 1b Receptor Agonists Serotonin 1d Receptor Agonists

Anatomical Therapeutic Chemical (ATC) Classes for FROVATRIPTAN SUCCINATE

N02CC	Selective serotonin (5HT1) agonists
N02C	ANTIMIGRAINE PREPARATIONS
N02	ANALGESICS
N	Nervous system

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
Renata	FROVATRIPTAN SUCCINATE	frovatriptan succinate	TABLET;ORAL	213891-001	Apr 6, 2022	AB	RX	No	No
Glenmark Pharms Ltd	FROVATRIPTAN SUCCINATE	frovatriptan succinate	TABLET;ORAL	204730-001	Mar 11, 2016	AB	RX	No	No
Amneal Pharms Co	FROVATRIPTAN SUCCINATE	frovatriptan succinate	TABLET;ORAL	211292-001	Nov 6, 2018	AB	RX	No	No
Pharmobedient	FROVATRIPTAN SUCCINATE	frovatriptan succinate	TABLET;ORAL	202931-001	Aug 28, 2014		DISCN	No	No
Leading	FROVATRIPTAN SUCCINATE	frovatriptan succinate	TABLET;ORAL	216998-001	Apr 16, 2025	AB	RX	No	No
Endo Operations	FROVA	frovatriptan succinate	TABLET;ORAL	021006-001	Nov 8, 2001	AB	RX	Yes	Yes

Expired US Patents for FROVATRIPTAN SUCCINATE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Endo Operations	FROVA	frovatriptan succinate	TABLET;ORAL	021006-001	Nov 8, 2001
Endo Operations	FROVA	frovatriptan succinate	TABLET;ORAL	021006-001	Nov 8, 2001
Endo Operations	FROVA	frovatriptan succinate	TABLET;ORAL	021006-001	Nov 8, 2001
Endo Operations	FROVA	frovatriptan succinate	TABLET;ORAL	021006-001	Nov 8, 2001
Endo Operations	FROVA	frovatriptan succinate	TABLET;ORAL	021006-001	Nov 8, 2001
Endo Operations	FROVA	frovatriptan succinate	TABLET;ORAL	021006-001	Nov 8, 2001

Market Dynamics and Financial Trajectory for Frovatriptan Succinate

Last updated: February 20, 2026

Frovatriptan succinate is a serotonin receptor agonist used in acute migraine treatment. It is marketed under brand names such as Frova. Its market is evolving amid broader trends in migraine therapeutics, with shifts driven by competitive drugs, regulatory approvals, and market demand. This analysis evaluates its current market position, growth factors, and financial outlook.

Market Size and Growth Drivers

Global Market Overview

The global migraine drugs market was valued at approximately $3.5 billion as of 2021, expected to grow at a compounded annual growth rate (CAGR) of around 3.5% through 2030 [1]. Frovatriptan accounts for a niche segment, estimated at $100 million in 2022, with growth potential as healthcare providers seek specific triptans for patients with cardiovascular risk factors.

Key Market Drivers

• Increased prevalence of migraines: Globally, migraine affects 15% of the population; in the U.S., around 39 million people [2].
• Prescription preferences for triptans: Triptans hold approximately 60% of acute migraine treatment prescriptions [3], with frovatriptan favored for its longer half-life and lower recurrence rates.
• Patient profile: Frovatriptan's safety profile suits patients with cardiovascular comorbidities, expanding its suitability.

Competitive Landscape

Major Competitors

• Sumatriptan
• Rizatriptan
• Zolmitriptan
• Naratriptan (closely related, similar pharmacokinetics)

Positioning of Frovatriptan

Frovatriptan has a half-life of approximately 26 hours, longer than other triptans like sumatriptan (~2 hours). It exhibits lower rates of migraine recurrence and fewer side effects related to vasoconstriction [4].

Regulatory Status and Approvals

Key Markets

• United States: Approved by the FDA in 2001.
• European Union: Approved under the European Medicines Agency (EMA), marketed since early 2000s.
• Emerging Markets: Approvals vary; some countries permit off-label use or license importation.

Patent Status

Patent expired in 2010 in the US, resulting in increased generic availability, which affects pricing and market share.

Revenue Trends and Financial Performance

Historical Data

• Estimated global sales peaked at $140 million in 2010.
• Market decline occurred post-patent expiry; sales dropped to approximately $80 million in 2015.
• Recent years show stabilization, with annual sales around $100 million.

Pricing and Market Penetration

• Brand-name frovatriptan: Average retail price approximately $60 per box (9 tablets of 2.5 mg).
• Generics: Price reduced by 50-70%, increasing accessibility but reducing revenue per prescription.

Patent and Market Entry Effects

The entrance of generics in 2010 caused a decline in revenue, but stable demand persists due to clinicians valuing its specific pharmacokinetic profile.

Forecasting Future Trajectory

Factors Influencing Growth

• Emerging markets: Greater acceptance of triptans and improvements in healthcare access could bolster sales.
• New formulations: Development of nasal and injectable formulations may expand use cases.
• Combination therapies: Potential integration with other migraine treatments, enhancing value.

Projected Revenue

Based on current trends, market is projected to stabilize at approximately $90-$110 million annually over the next five years. Growth opportunities hinge on:

• Adoption of new formulations.
• Strategic marketing in emerging markets.
• Increased awareness of its benefits in specific patient subsets.

Risks and Challenges

• Generic competition: Will continue to exert price pressure.
• Market saturation: In established markets, limited growth potential.
• Regulatory changes: Stringent controls could limit access or impose additional costs.

Key Takeaways

• Frovatriptan succinate maintains a niche market within oral triptans due to its pharmacokinetic profile.
• Revenues declined post-patent expiry but have stabilized, with potential for growth in emerging markets.
• Price competition from generics constrains profit margins.
• Opportunities reside in new delivery methods and expanded indications.

FAQs

Q1: What distinguishes frovatriptan from other triptans?
A1: Its longer half-life (~26 hours) results in lower migraine recurrence and a favorable safety profile for patients with cardiovascular risks.

Q2: How does patent expiry affect its market?
A2: The patent expiry in 2010 led to generic versions, reducing prices and revenue but maintaining steady demand due to therapeutic preferences.

Q3: What are the main growth opportunities?
A3: Developing alternative formulations (nasal, injectable), expanding into emerging markets, and targeted marketing are primary opportunities.

Q4: How does the competitive landscape influence its usage?
A4: The presence of other triptans and generics limits market share growth; frovatriptan's niche benefits are essential for continued demand.

Q5: What regulatory factors impact its future?
A5: Approval decisions, patent laws, and regulations on generics affect availability and pricing strategies worldwide.

References

[1] MarketWatch. (2022). Global migraine drugs market size and forecast.
[2] Centers for Disease Control and Prevention. (2021). Migraine prevalence report.
[3] IQVIA. (2022). Prescription data for triptans.
[4] Frovatriptan product monograph. (2001). U.S. FDA.

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Note: Data points and projections are based on publicly available market research reports and prescription data from leading analytics firms.