FROVA Drug Patent Profile

When do Frova patents expire, 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. Three 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

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		DISCN	Yes	No
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	Yes

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
Israel	102322	TETRAHYDROCARBAZOLE DERIVATIVES FOR USE AS 5-HT1-LIKE AGONIST MEDICAMENTS
European Patent Office	0591280	UTILISATION DE DERIVES DE TETRAHYDROCARBAZOLE COMME AGONISTES DE RECEPTEURS DU TYPE 5-HT1 (USE OF TETRAHYDROCARBAZOLE DERIVATIVES AS 5HT1-RECEPTOR AGONISTS)
Portugal	100620	DERIVADOS DE TETRA-HIDROCARBAZOL, SEU USO E PREPARACAO E COMPOSICOES FARMACEUTICAS QUE OS CONTEM
Poland	171034

Supplementary Protection Certificates for FROVA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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	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	37/2002	Austria		PRODUCT NAME: FROVATRIPAN; NAT. REGISTRATION NO/DATE: 1-24487 20020424; FIRST REGISTRATION: FR NL 24548 20001212
0591280	01C0019	France		PRODUCT NAME: FROVATRIPTAN SUCCINATE MONOHYDRATE; NAT. REGISTRATION NO/DATE: NL 24548 20001212; FIRST REGISTRATION: FR - NL 24548 20001212
0591280	C00591280/01	Switzerland		FORMER REPRESENTANTIVE: E. BLUM AND CO. PATENTANWAELTE, CH

Last updated: February 3, 2026

What Is the Market Standout for FROVA?

FROVA, the brand name for Frovatriptan, is prescribed for acute migraines. It is marketed by Endo Pharmaceuticals. Its primary competitive advantage is a long half-life of approximately 26 hours, which allows sustained relief and reduced recurrence, differentiating it from other triptans with shorter durations.

How Does the Global Market for Migraine Treatments Shape FROVA’s Outlook?

The global migraine therapeutics market exceeds $4 billion in annual sales and is projected to grow at a compound annual growth rate (CAGR) of about 4-5% over the next five years [1]. This growth is driven by increased prevalence, greater awareness, and new formulations. Specifically, triptans account for roughly 30-40% of migraine drug sales.

Key market segments include:

• Prescription Drugs: Estimated at $1.5 billion.
• Generic Versions: Increasing competition impacts pricing.
• Emerging Biologics: Targeted therapies under development.

FROVA maintains a niche due to its unique pharmacokinetics but faces pricing pressure from generics for other triptans.

What Are The Product-Focused Fundamentals of FROVA?

Market Share & Positioning:
FROVA commands approximately a 5-10% share within triptan prescriptions, primarily prescribed for patients with recurrent migraines or those who benefit from prolonged relief.

Pricing & Reimbursement:
Pricing varies regionally, with costs approximately $15–$25 per dose in the U.S. market. Reimbursement depends on insurance policies; in some cases, prior authorization is required, which may limit access.

Formulation & Dosing:
Available as 2.5 mg tablets. Typically, a single dose is prescribed, with a maximum of two doses in 24 hours.

Generic Competition:
While Frovatriptan was patent-eligible until around 2012, patent challenges and generic entries have reduced exclusivity. Presently, several generics exist, exerting downward pressure on prices.

Clinical Efficacy & Safety:
FROVA’s long half-life means fewer recurrences post-treatment. Clinical trials show comparable efficacy with other triptans, with a favorable safety profile, particularly for patients with cardiovascular risk factors.

What Are the Investment Drivers and Challenges?

Drivers:

• Growing migraine prevalence, especially in aging populations.
• Specialty-formulation appeal for recurrent migraines.
• Prescriber preference for medications with fewer relapse rates.

Challenges:

• Patent expiration and generics reduce exclusivity.
• Competition from other triptans offering faster onset.
• Biosimilar and alternative therapies (e.g., CGRP antagonists) threatening triptan market share.
• Price sensitivity and insurance barriers.

How Do Competitive and Regulatory Trends Impact FROVA?

While triptans face market saturation, innovative delivery methods—such as nasal sprays—are emerging. FROVA does not have a nasal spray formulation; development investments could be constrained.

Regulatory trends favor fast approval pathways for new drugs but also impose stricter cost-effectiveness standards, especially under payer plans. The shift toward biologic migraine preventives, such as monoclonal antibodies targeting CGRP, reduces reliance on acute treatments like FROVA.

What Are the R&D and Pipeline Considerations?

Endo Pharmaceuticals has not announced significant pipeline developments for FROVA. The company mainly focuses R&D resources on other therapeutic areas, marking FROVA as a mature asset.

Potential innovations include:

• New formulations for improved onset or convenience.
• Combination therapies to extend efficacy.

However, high R&D costs with uncertain returns in a mature market limit investment attractiveness.

What Is the Financial Outlook and Valuation Perspective?

FROVA derives revenues primarily from existing prescriptions. Market share erosion due to generics and competition constrains growth. Potential revenue decline is anticipated as patent protections lapse and new entrants capture market share.

Valuation models must consider revenue declines, patent expiry timelines (patents likely expired around 2012 with some market exclusivity remaining for certain formulations), and price erosion.

Key Takeaways

• FROVA is a long-acting triptan with niche appeal, mainly used for recurrent migraines.
• The global migraine market is growing, but FROVA faces intense competition from generics and new therapies.
• Revenue streams are declining due to patent expiry and competition.
• Limited pipeline development reduces future growth prospects.
• Market dynamics favor biologics and preventive treatments, posing long-term threats to triptan sales.

FAQs

1. What is the primary differentiator of FROVA compared to other triptans?
Its long half-life (26 hours) allows for sustained relief and reduces migraine recurrence.

2. Are there generic versions of FROVA, and how do they impact its market share?
Yes, generics are available since around 2012, leading to significant price competition and reduced market share for branded FROVA.

3. How does the rise of CGRP inhibitors affect FROVA?
CGRP inhibitors serve as migraine preventives and have begun to replace some acute treatments, diminishing the necessity for triptans like FROVA.

4. What are the prospects for future growth of FROVA?
Limited, due to patent expirations, market saturation, and competition from newer biologics.

5. Can FROVA's long half-life be leveraged for new indications?
Currently unlikely; no significant pipeline developments or new formulations are announced.

References

[1] MarketsandMarkets, "Migraine Drugs Market," 2022.