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
Raw Ingredient (Bulk) Api Vendors:	1
Patent Applications:	2,668
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

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
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	5,827,871
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	5,618,947
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	5,618,948
Endo Operations	FROVA	frovatriptan succinate	TABLET;ORAL	021006-001	Nov 8, 2001	5,917,054

International Patents for FROVA

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

Country	Patent Number	Title	Estimated Expiration
African Regional IP Organization (ARIPO)	344	Tetrahydrocarbazole derivatives and their use as 5-HT1-like receptor
African Regional IP Organization (ARIPO)	9200403
Austria	170746
Australia	1977592
Australia	652842
Brazil	1100460

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

Last updated: June 23, 2026

FROVA (frovatriptan) market dynamics and financial trajectory: exclusivity, competitive pressure, and revenue outlook

FROVA (frovatriptan) sits in the triptan class for migraine treatment, with its core demand shaped by (1) aging originator exclusivity, (2) steady generic penetration in triptans, and (3) payer controls that favor lowest net-cost alternatives. The financial trajectory is therefore driven less by brand-level differentiation and more by (a) how much brand volume persists after generic entry and (b) whether wholesalers inventory drawdowns and payer formulary status sustain premium pricing versus therapeutically equivalent generics.

What is FROVA (frovatriptan) used for and how does class competition affect demand?

FROVA is a triptan indicated for acute treatment of migraine with or without aura in adults. Trip­tans compete on onset and tolerability, but prescribers routinely view the class as broadly interchangeable once efficacy is established for the individual patient.

Class-level demand drivers

• Payer substitution: Trip­tans are typically covered through tiering or preferred-agent lists, with brands facing rapid conversion to lower-cost generics.
• Clinical switching: Multiple triptans are used in sequence across lines of therapy for migraine sufferers, dampening the ability of a single agent to grow long-term.
• Formulary concentration: Many formularies consolidate access to a small set of triptans, accelerating generic-driven volume shifts.

Commercial implication for FROVA

• Brand performance is structurally tied to formulary position versus generic frovatriptan and comparator triptans (and to a lesser extent, non-triptan migraine acute options when payers broaden coverage).

How do specific competitor categories shift net sales for triptans like FROVA?

• Other triptans: Net sales for any single triptan brand tend to be capped once multiple generics and lower-priced triptans are accessible on preferred tiers.
• Newer acute migraine classes: CGRP antagonists and gepants can siphon patients who have intolerance to triptans or who have migraine recurrence patterns that drive usage outside triptans.

When did FROVA lose exclusivity and what generic entry risks exist for frovatriptan?

FROVA is an older, small-molecule product. In practice, frovatriptan’s market trajectory is dominated by the timing and depth of generic competition, including:

• initial ANDA launches for frovatriptan tablets,
• subsequent market-share shifts after multiple generic players,
• and ongoing erosion of wholesale acquisition cost through net-price concessions.

Key market dynamic

• For older branded triptans, the dominant “exclusivity event” is not a single patent. It is the combined effect of patent-to-generic conversion, payer switching, and ongoing generic price competition.

Generic entry risk

• For frovatriptan, entry risk is typically realized quickly once legal barriers fall and ANDA approval occurs. After multiple generic manufacturers are available, incremental demand capture by the brand is limited to subgroups with historical prescribing patterns or specific prescriber/patient preferences.

What patents or exclusivity timelines typically control frovatriptan’s commercial lifespan?

Brand triptan commercial life is usually governed by:

• composition-of-matter and first filing protection,
• regulatory exclusivity (where applicable),
• and later-life formulation or method-of-use patents.

For FROVA, the practical market effect is that any remaining barriers would have had to delay generic competition beyond the original compound protection window. The resulting financial trajectory, common for this category, is:

• early premium pricing post-launch,
• then step-down as first generics enter,
• then further step-down as price competition widens and formulary preference shifts.

How do settlement dynamics and ANDA litigation affect the timeline to generic share loss?

For triptans, settlement agreements often:

• define “first generic” launch dates,
• allocate market shares indirectly through “launch at-risk” or date-certain licensing,
• and can influence which generic competitors enter first, affecting price trajectories.

Financial implication: generic entry timing and number of entrants are the principal variables that determine the steepness of net-sales decline.

What is the competitive landscape for migraine acute therapies and how does it affect FROVA volume?

FROVA’s competitive set includes:

1. Other triptans (tablets and select delivery systems),
2. CGRP-pathway acute agents (including gepants and ditans depending on payer formulary strategy),
3. NSAIDs/combination strategies in patients who do not qualify for triptans or who discontinue due to side effects.

Payer-level effect

• As payers expand coverage for non-triptan acute migraine options, the addressable volume for triptans can compress, especially for patients who fail or do not tolerate triptans.

Utilization-level effect

• Trip­tan use is sensitive to:
  • frequency of migraine days,
  • refill patterns,
  • adherence,
  • and switching across attacks.

How does frovatriptan pricing move once generics dominate and what does that mean for margins?

Once generics dominate:

• Brand wholesalers reduce purchases or shift to generic sourcing.
• Net price for the brand drops as manufacturers add rebates and chargebacks to defend accounts.
• Marketing spend can remain, but brand revenue declines faster than fixed costs.

Margin trajectory (typical pattern for older branded triptans)

• Gross margin compresses as net price declines.
• Marketing and support expenses may not scale down proportionally.
• The result is a decline in operating profit and, for public companies, reduced strategic priority unless the brand retains a meaningful niche.

What is FROVA’s FDA status and how does labeling scope affect commercial resilience?

For a branded migraine product, commercial resilience depends on:

• whether the FDA-labeled indications remain current (adult acute migraine),
• whether safety warnings materially constrain use,
• and whether any label changes improved differentiation.

However, label scope generally does not prevent generic substitution once approvals exist. In practice, labeling keeps FROVA from becoming a niche due to clinical exclusion, but it does not protect against generic price competition.

How does FROVA compare with other triptans on market share dynamics?

Category structure

• Trip­tan brands typically lose share to generics, then stabilize at a reduced base.
• Some triptans retain niche use due to patient-specific tolerability or prescriber habits.

Comparison logic

• If a competing triptan has better formulary placement, lower patient copays, or a stronger reimbursement profile, it will draw volume away.
• Even with similar efficacy, “net cost per attack” becomes a deciding factor.

Which companies market frovatriptan and how does number of generic entrants affect the price curve?

In generic-dense markets:

• early entrants often capture a larger share before additional competitors add price pressure,
• subsequent entrants compress net prices further,
• and market share distribution becomes more fragmented.

Financial impact for FROVA

• A dense generic base usually accelerates the brand’s net-sales decline and limits any late-stage stabilization unless the brand can sustain a differentiated net-price position through payer contracts.

What manufacturing and IP barriers keep generics from fully replacing FROVA?

Even when legal barriers to market entry fall, operational constraints can influence speed and breadth of substitution:

• manufacturing scale-up and batch release capacity for ANDA-approved suppliers,
• quality and bioequivalence consistency,
• and supply chain continuity.

For many older small molecules, these barriers are usually surmountable, which supports rapid substitution and continued price erosion.

How do payer formularies and pharmacy benefit managers influence FROVA’s financial trajectory?

Formulary mechanics that determine outcome:

• placement on preferred tiers vs non-preferred tiers,
• generic substitution requirements,
• quantity limits,
• and step therapy policies.

Brand outcome

• Once frovatriptan generics are available, PBMs usually push acute migraine access toward the lowest-cost agents on the same tier strategy.
• Brand sales then rely on exception processes, patient continuity, and incremental preference contracts.

What Orange Book status would matter for FROVA’s late-life protection?

For a mature product, late-life listings usually fall into:

• patents tied to formulation,
• patents covering specific dosage and manufacturing approaches,
• and method-of-use patents.

Commercial relevance

• If any listing remained enforceable, it could delay certain ANDA filings for specific strengths or dosage forms. In practice, the broader market effect remains price erosion once generic tablets are available broadly.

What revenue exposure does FROVA face from therapeutic substitution and generic erosion?

FROVA faces dual substitution channels:

1. Generic erosion within frovatriptan once multiple manufacturers launch.
2. Therapeutic substitution across acute migraine as payer coverage expands for non-triptan acute treatments.

Revenue exposure drivers

• percentage of scripts shifted to generic frovatriptan,
• persistence of brand prescribing among existing patients,
• and changes in migraine acute formularies.

Key Takeaways

• FROVA’s market dynamics are dominated by generic substitution and payer tiering rather than by label-based differentiation.
• In triptans, revenue trajectories typically follow a step-down pattern after first generic entry, then further compression as the generic supplier base expands and net pricing converges toward the low-cost end.
• Long-term brand resilience depends on net-cost position in PBM contracts and any prescriber-patient continuity, but therapeutic substitution into newer acute migraine classes can further compress addressable volume.
• The principal financial variables are the timing of generic launches, the number of ANDA entrants, and the formulary outcomes governing copay and preferred placement.

FAQs

1. How fast do branded triptan sales typically decline after frovatriptan generic entry?
2. Do payer quantity limits on triptans accelerate switching to alternative acute migraine therapies?
3. Which migraine acute competitors most often displace triptans on commercial formularies?
4. How do settlement agreements in ANDA litigation shape the first generic launch date and price dynamics?
5. What manufacturing or supply chain constraints can delay generic replacement of an older small-molecule migraine drug?

References

1. FDA. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. U.S. Food and Drug Administration.
2. FDA. Drugs@FDA: FDA Approved Drug Products. U.S. Food and Drug Administration.
3. FDA. Guidance for Industry: Bioequivalence Studies Submitted in ANDA. U.S. Food and Drug Administration.