FROVA Drug Patent Profile

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

Frova is a drug marketed by Endo Operations, Amneal Pharms Co, Glenmark Pharms Ltd, Leading, Pharmobedient, and Renata. and is included in six NDAs.

The generic ingredient in FROVA is frovatriptan succinate. There are three drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the frovatriptan succinate profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Frova

A generic version of FROVA was approved as frovatriptan succinate by GLENMARK PHARMS LTD on March 11^th, 2016.

Summary for FROVA

US Patents:	0
Applicants:	6
NDAs:	6
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	1
Patent Applications:	2,571
Drug Prices:	Drug price information for FROVA
What excipients (inactive ingredients) are in FROVA?	FROVA excipients list
DailyMed Link:	FROVA at DailyMed

See drug prices for FROVA

Pharmacology for FROVA

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

Paragraph IV (Patent) Challenges for FROVA

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 FROVA

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

Expired US Patents for FROVA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Endo Operations	FROVA	frovatriptan succinate	TABLET;ORAL	021006-001	Nov 8, 2001	5,637,611
Endo Operations	FROVA	frovatriptan succinate	TABLET;ORAL	021006-001	Nov 8, 2001	5,464,864
Endo Operations	FROVA	frovatriptan succinate	TABLET;ORAL	021006-001	Nov 8, 2001	5,917,054
Endo Operations	FROVA	frovatriptan succinate	TABLET;ORAL	021006-001	Nov 8, 2001	5,827,871
Endo Operations	FROVA	frovatriptan succinate	TABLET;ORAL	021006-001	Nov 8, 2001	5,618,948
Endo Operations	FROVA	frovatriptan succinate	TABLET;ORAL	021006-001	Nov 8, 2001	5,618,947
Endo Operations	FROVA	frovatriptan succinate	TABLET;ORAL	021006-001	Nov 8, 2001	5,616,603

International Patents for FROVA

See the table below for patents covering FROVA around the world.

Country	Patent Number	Title	Estimated Expiration
Slovakia	131993	AGONISTS 5 HT-1 RECEPTORS
Singapore	47877	Use of tetrahydrocarbazone derivatives as 5HT receptor agonists
Czech Republic	282083	Použití tetrahydrokarbazonových derivátů jako agonistů 5HT1-receptorů (THE USE OF TETRAHYDROCARBAZONE DERIVATIVES AS 5HT1-RECEPTOR AGONISTS)
Portugal	100620	DERIVADOS DE TETRA-HIDROCARBAZOL, SEU USO E PREPARACAO E COMPOSICOES FARMACEUTICAS QUE OS CONTEM
Czech Republic	9302861
Australia	2851797
China	1069726

Supplementary Protection Certificates for FROVA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0591280	SPC/GB03/014	United Kingdom		PRODUCT NAME: 3 METHYLAMINO-6-CARBOXAMIDO-1, 2, 3, 4-TETRAHYDROCARBAZOLE ("FROVATRIPTAN") INCLUDING A SALT, SOLVATE OR HYDRATE THEREOF; REGISTERED: FR NL 24548 20001212; UK PL 16239/0017 20021007; UK PL 16239/0018 20021007
0591280	C300103	Netherlands		PRODUCT NAME: FROVATRIPTAN EN FARMACEUTISCH AANVAARDBARE ZOUTEN DAARVAN; NAT. REGISTRATION NO/DATE: RVG 27211RVG 27212 2002190419; FIRST REGISTRATION: NL 24548 20001212
0591280	37/2002	Austria		PRODUCT NAME: FROVATRIPAN; NAT. REGISTRATION NO/DATE: 1-24487 20020424; FIRST REGISTRATION: FR NL 24548 20001212
0591280	C00591280/01	Switzerland		FORMER REPRESENTANTIVE: E. BLUM AND CO. PATENTANWAELTE, CH
0591280	01C0019	France		PRODUCT NAME: FROVATRIPTAN SUCCINATE MONOHYDRATE; NAT. REGISTRATION NO/DATE: NL 24548 20001212; FIRST REGISTRATION: FR - NL 24548 20001212

Market Dynamics and Financial Trajectory for the Pharmaceutical Drug: FROVA

Last updated: July 27, 2025

Introduction

FROVA (generic name: Frovatriptan) is a selective serotonin receptor agonist, classified within the triptan class, primarily indicated for the acute treatment of migraine attacks with or without aura in adult patients. Since its approval, FROVA has maintained a niche but significant position within the migraine therapeutics landscape. This analysis delves into the market dynamics influencing FROVA's performance and its projected financial trajectory, considering competitive forces, regulatory factors, demographic shifts, and therapeutic trends.

Market Overview of Migraine Therapeutics

Migraine affects over 1 billion individuals globally, representing a substantial market opportunity for specialized treatments like FROVA. The migraine drug market is characterized by a mix of branded medications, including topiramate, propranolol, and newer CGRP (calcitonin gene-related peptide) antagonists such as erenumab and fremanezumab. These agents have diversified treatment options, impacting the sales and positioning of triptans like FROVA.

While triptans remained the mainstay for acute migraine relief for decades, the advent of CGRP inhibitors shifted some market share from traditional options. Nevertheless, triptans retain appeal due to rapid onset, established safety profiles, and cost-effectiveness—factors critical for broad healthcare system integration.

Market Dynamics Affecting FROVA

1. Competition from Newer Therapeutics

The expanding landscape of migraine treatments includes CGRP-based therapies. These monoclonal antibodies outperform triptans like FROVA in preventing attacks, but their higher costs and subcutaneous administration limit widespread adoption. Conversely, FROVA offers oral convenience, making it attractive for patients seeking immediate relief without injectable therapies.

However, the presence of multiple triptan options, including sumatriptan and rizatriptan, intensifies price competition. FROVA’s unique position relies on its pharmacokinetic profile—longer half-life (26 hours)—which reduces recurrence, offering an advantage over some triptans.

2. Regulatory Environment and Patent Status

FROVA was approved by the FDA in 2000. Its patent protections have long expired, positioning it as a generic product. The generic status enables significant price reductions and widespread market penetration but also diminishes exclusive revenue potential. Manufacturers now focus on manufacturing efficiencies and market expansion efforts to sustain profitability.

3. Pricing and Reimbursement Dynamics

Price sensitivity remains a pivotal factor. Health insurers and pharmacy benefit managers (PBMs) favor generics like FROVA due to cost savings. Reimbursement policies influence prescribing patterns, especially as healthcare systems prioritize cost-effective migraine management.

4. Demographic and Epidemiologic Factors

The global migraine epidemic underscores increasing demand for effective treatments. Aging populations in developed nations and rising awareness contribute to steady demand. Notably, women aged 18–44 have the highest migraine prevalence, which influences regional market potential.

5. Prescribing Trends and Clinical Acceptance

Physician preferences favor proven, safety-verified agents like FROVA. Its distinct pharmacokinetic profile fosters clinical adoption, especially among patients with frequent migraines or those experiencing high recurrence. However, the emergence of triptan contraindications and side-effect profiles continues to shape prescription patterns.

6. Geographical Expansion

Markets in North America and Europe remain dominant due to established healthcare infrastructure and regulatory approval. Emerging markets, including Asia-Pacific and Latin America, present growth opportunities as they increasingly adopt migraine-specific therapies amid rising health awareness.

Financial Trajectory and Revenue Forecasts

Historical Performance

FROVA, being a generic, historically achieved steady sales driven by affordability and licensing agreements. In the early 2010s, annual revenues for the brand declined due to market saturation and competition, but overall revenue stability persisted in core markets.

Current Market Position

With patent expiration, manufacturer focus has shifted toward operational efficiencies and expanding regional footprints. Sales volumes are influenced by pricing strategies, prescriber acceptance, and formulary placements.

Projected Growth Factors

• Market Penetration in Emerging Economies: As healthcare access expands, demand for affordable migraine treatments like FROVA is expected to rise, especially where newer, expensive options face cost barriers.
• Integration into Combination Therapies: Research into combination formulations and adjunct therapies may influence prescribing trends.
• Expanded Indications: While currently specific to acute migraine, ongoing research may broaden FROVA’s application scope, augmenting revenue potential.
• Digital and Pharmacovigilance Enhancements: Improved marketing channels and pharmacovigilance data can reinforce FROVA's safety profile, bolstering prescriber confidence.

Risks and Challenges

• Market Share Erosion: Continued proliferation of generic triptan options dilutes the market share.
• Pricing Pressures: Payers and PBMs’ emphasis on cost containment threaten profit margins.
• Therapeutic Shifts: The ascendancy of CGRP inhibitors for both preventive and acute therapy may cannibalize triptan sales.
• Regulatory Adversities: Any adverse regulatory actions or updates could impact manufacturing or marketing.

Forecast Summary

Based on current trends, FROVA’s global sales are projected to experience moderate decline or plateau in mature markets, driven by competitive pricing and therapeutic shifts. However, in regions with limited access to newer treatments, demand remains stable or increasing. Overall, a compound annual growth rate (CAGR) of approximately -2% to 0% over the next five years is plausible, driven by regional expansion and incremental market share gains in emerging markets.

Strategic Considerations

Organizations manufacturing or marketing FROVA should focus on:

• Enhancing regional distribution and local formulary acceptance.
• Investing in pharmacovigilance to reinforce safety credentials.
• Exploring potential combination therapies or new indications.
• Pricing strategies aligned with healthcare affordability targets.
• Building awareness among healthcare providers about FROVA's pharmacokinetic advantages.

Key Takeaways

• Competitive Landscape: While FROVA faces stiff competition from both generics and CGRP therapies, its oral administration and longer half-life sustain niche appeal.
• Market Expansion: Emerging markets present promising growth avenues driven by cost sensitivity and increasing migraine prevalence.
• Pricing and Reimbursement: Cost advantages due to generic status bolster FROVA’s market position, but pricing pressures continue to challenge profitability.
• Therapeutic Trends: The rise of preventive migraine therapies may influence short-to-medium-term sales, with acute treatment preferences remaining key.
• Innovation and Differentiation: Opportunities to develop combination formulations or identify new indications could stabilize or enhance revenue streams.

Conclusion

FROVA maintains a noteworthy position in the migraine treatment landscape, supported by its pharmacological profile and affordability. Its financial trajectory over the next five years will hinge on regional market expansion, competition management, and evolving therapeutic paradigms. Strategic engagement with healthcare providers, payers, and regulators remains essential to sustain its market relevance and financial performance.

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FAQs

1. How does FROVA compare to other triptans in terms of efficacy?
FROVA’s longer half-life offers reduced recurrence rates compared to some other triptans like sumatriptan, making it suitable for patients with frequent migraine attacks. Clinical trials support comparable immediate efficacy among triptans, with pharmacokinetic differences influencing relapse prevention.

2. What are the primary factors influencing FROVA’s pricing strategy?
As a generic, FROVA’s price is primarily driven by manufacturing costs, regional healthcare reimbursement policies, and competitive pricing among triptans. Market demand and payer negotiation also significantly impact pricing.

3. Are there any new formulations or indications for FROVA on the horizon?
Currently, FROVA’s indications remain limited to acute migraine treatment. No new formulations or expanded indications have been officially announced, but ongoing research into migraine management may influence future development.

4. How significant is the impact of CGRP therapies on FROVA’s sales?
CGRP therapies primarily target migraine prevention, but their emergence influences acute treatment choices indirectly. While they may reduce overall migraine frequency, triptans like FROVA retain importance for immediate relief, especially where CGRP therapies are inaccessible or contraindicated.

5. What regions offer the highest growth potential for FROVA?
Emerging markets such as Asia-Pacific, Latin America, and parts of Africa present significant growth opportunities due to increasing healthcare infrastructure, rising awareness, and cost-effective treatment demands.

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Sources:
[1] IMS Health Data, 2022.
[2] FDA Drug Approvals, 2000.
[3] Global Migraine Market Report, 2023.
[4] Healthcare reimbursement and policy updates, OECD, 2023.