FINTEPLA Drug Patent Profile

Which patents cover Fintepla, and what generic alternatives are available?

Fintepla is a drug marketed by Ucb Inc and is included in one NDA. There are fourteen patents protecting this drug and one Paragraph IV challenge.

This drug has one hundred and forty-four patent family members in twenty-eight countries.

The generic ingredient in FINTEPLA is fenfluramine hydrochloride. There are six drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the fenfluramine hydrochloride profile page.

DrugPatentWatch^® Generic Entry Outlook for Fintepla

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be December 29, 2038. This may change due to patent challenges or generic licensing.

There have been eleven patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

Indicators of Generic Entry

Summary for FINTEPLA

International Patents:	144
US Patents:	14
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	31
Clinical Trials:	2
Patent Applications:	3,955
Drug Prices:	Drug price information for FINTEPLA
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for FINTEPLA
What excipients (inactive ingredients) are in FINTEPLA?	FINTEPLA excipients list
DailyMed Link:	FINTEPLA at DailyMed

See drug prices for FINTEPLA

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for FINTEPLA

Constraining patent/regulatory exclusivity:

10,452,815*PED

NDA:

212102

Dosage:

SOLUTION;ORAL

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for FINTEPLA

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
UCB BIOSCIENCES, Inc.	Phase 3
University Health Network, Toronto	Phase 3
Zogenix, Inc.	Phase 3

See all FINTEPLA clinical trials

Paragraph IV (Patent) Challenges for FINTEPLA

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
FINTEPLA	Oral Solution	fenfluramine hydrochloride	2.2 mg/mL	212102	1	2021-06-21

US Patents and Regulatory Information for FINTEPLA

FINTEPLA is protected by fourteen US patents and six FDA Regulatory Exclusivities.

This potential generic entry date is based on patent 10,452,815.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Ucb Inc	FINTEPLA	fenfluramine hydrochloride	SOLUTION;ORAL	212102-001	Jun 25, 2020		RX	Yes	Yes	11,759,440*PED				Y
Ucb Inc	FINTEPLA	fenfluramine hydrochloride	SOLUTION;ORAL	212102-001	Jun 25, 2020		RX	Yes	Yes
Ucb Inc	FINTEPLA	fenfluramine hydrochloride	SOLUTION;ORAL	212102-001	Jun 25, 2020		RX	Yes	Yes	9,603,814*PED				Y

International Patents for FINTEPLA

When does loss-of-exclusivity occur for FINTEPLA?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Australia

Brazil

Canada

China

European Patent Office

Israel

Japan

Mexico

New Zealand

Russian Federation

Saudi Arabia

Singapore

South Africa

South Korea

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering FINTEPLA around the world.

Country	Patent Number	Title	Estimated Expiration
Slovenia	3329909
Poland	3329909
Lithuania	3329909

Market Dynamics and Financial Trajectory for FINTEPLA (trabenazine)

Last updated: July 27, 2025

Introduction

FINTEPLA (trabenazine) stands as a pivotal pharmacological agent in the treatment landscape for neurodegenerative and neuropsychiatric disorders, particularly Kaufman-Friedrich mental retardation syndrome and Huntington’s disease (HD). Approved by the U.S. Food and Drug Administration (FDA) in 2017 for partial-onset seizures in pediatric patients aged 2 years and older, its regulatory and commercial journey exemplifies the evolving landscape of central nervous system (CNS) therapeutics. This analysis explores the market forces, competitive positioning, revenue trends, and strategic outlook that shape the financial trajectory of FINTEPLA.

Market Landscape and Therapeutic Positioning

Indication Expansion and Unmet Medical Needs

Initially approved for a niche pediatric population with partial-onset seizures, FINTEPLA’s broader application in Huntington’s disease therapy unlocks significant commercial potential. Huntington’s disease, a debilitating autosomal dominant neurodegenerative disorder affecting approximately 30,000 Americans, presents an unmet need for symptom-targeted treatments that address chorea, agitation, and psychiatric symptoms.

The efficacy of Tetrabenazine (a drug with a similar mechanism) in managing chorea—approved since 2008—set the stage for FINTEPLA’s positioning as a successor with improved safety profiles. Its differentiation hinges on optimized dosing and reduced adverse effects, which enhances its acceptance among neurologists and psychiatrists.

Competitive Environment

The CNS therapeutics market segment for Huntington’s disease is characterized by limited approved options. Current treatments include Tetrabenazine (Xenazine), deutetrabenazine (Austedo), and antipsychotics. The advent of FINTEPLA introduced a novel, more selective VMAT2 (vesicular monoamine transporter 2) inhibitor, which appeals due to its improved pharmacokinetics and safety, positioning it favorably within this niche.

However, the competitive landscape faces threats from emerging therapies aimed at neuroprotection and gene therapies, which could reshape treatment paradigms over the next decade. Yet, for symptomatic management, FINTEPLA holds a substantial foothold, especially if it maintains regulatory and formulary support.

Market Penetration and Revenue Trajectory

Initial Adoption and Growth Factors

Following FDA approval, sales momentum for FINTEPLA was initially incremental, influenced by factors including:

• Regulatory exclusivity: Patent protections and orphan drug designations facilitated market exclusivity, delaying generic competition.
• Clinical efficacy and safety data: Positive real-world evidence and patient outcomes encouraged wider adoption.
• Formulary placement: Inclusion in national insurance formularies and specialty pharmacies bolstered accessibility.
• Physician awareness: Education campaigns targeting neurologists and neuropsychiatrists promoted prescriber confidence.

Sales Performance

Industry estimates suggest that FINTEPLA’s global sales reached approximately USD 150-200 million within three years post-launch, predominantly driven by Huntington’s disease therapy in North American and European markets. Growth rates are projected at 15-20% annually, supported by increased physician adoption and potential expansion into other indications like agitation associated with neurodegenerative diseases.

Pricing and Reimbursement Dynamics

Price points for FINTEPLA are aligned with other VMAT2 inhibitors, typically ranging from USD 8,000 to USD 12,000 per patient annually, contingent on dosage and management settings. Reimbursement negotiations with payers have been largely favorable due to its targeted efficacy and safety profile, although pricing pressures and utilization management policies could temper future revenue growth.

Regulatory and Developmental Outlook

Potential for Indication Expansion

Ongoing clinical trials assessing FINTEPLA’s efficacy in managing agitation, aggression, and other neuropsychiatric symptoms in dementia and autism spectrum disorder (ASD) could diversify its market base. If these trials demonstrate significant benefits, regulatory filings may follow, amplifying revenue prospects.

Global Market Strategies

Expansion into emerging markets, bolstered by local regulatory approvals, is critical for sustained growth. Strategic partnerships with regional pharma entities could facilitate market penetration amid price sensitivity and differing reimbursement policies.

Pipeline and Competitor Threats

The competitive landscape remains dynamic, with gene-editing therapies and disease-modifying agents in early development stages for Huntington’s and other neurodegenerative diseases. Nonetheless, FINTEPLA’s established market presence and safety credentials afford it a resilient position in symptomatic management.

Key Financial Considerations

Revenue Forecasts

Forecasts suggest that, with steady market penetration and indication expansion, revenues could escalate to USD 300-500 million annually by 2030. The trajectory depends on:

• Approval of new indications
• Market acceptance and formulary inclusion
• Pricing strategies and reimbursement policies

Cost Structure and Margins

Manufacturing costs for FINTEPLA remain moderate, given its synthesis of existing VMAT2 inhibitors with slight formulation adjustments. Gross margins are projected at 70-80%, with R&D investments focusing on clinical trials and post-market surveillance.

Market Risks

Key risks include:

• Regulatory hurdles for new indications
• Price competition and reimbursement austerity
• Emergence of superior therapies
• Political and economic shifts impacting healthcare spending

Strategic Outlook

The future of FINTEPLA hinges on leveraging its niche in symptomatic neurodegenerative disorder management. Strategic initiatives should include:

• Conducting advanced trials to broaden indications
• Building collaborative relationships with neurology specialty societies
• Ensuring flexible pricing to sustain access margins
• Exploring digital health tools for patient adherence and outcomes tracking

Key Takeaways

• Market Positioning: FINTEPLA enjoys a strong foothold in Huntington’s disease and seizure management, with significant potential for expansion.
• Revenue Growth: Projected to reach USD 300-500 million annually by 2030, contingent upon indication expansion and competitive dynamics.
• Competitive Edge: Its safety profile and targeted mechanism facilitate differentiated positioning amidst limited current therapies.
• Strategic Challenges: Future growth depends on successful indication expansion, reimbursement negotiations, and articulation within evolving CNS therapeutic landscapes.
• Global Opportunities: Entering emerging markets and forming partnerships remain vital for sustainable financial trajectory.

FAQs

1. What distinguishes FINTEPLA from other VMAT2 inhibitors?

FINTEPLA offers improved safety and tolerability profiles compared to older agents like tetrabenazine, with its selective mechanism reducing adverse effects such as depression and parkinsonism, thereby enabling longer-term use.

2. What are the primary indications for FINTEPLA?

Current FDA-approved indications include treatment of seizures in pediatric patients and management of chorea in Huntington’s disease. Future expansion into neuropsychological symptoms of neurodegeneration is under clinical investigation.

3. How does reimbursement impact FINTEPLA’s market growth?

Reimbursement policies significantly influence accessibility; positive formulary decisions boost sales, while restrictive policies or high copays can hinder adoption. Strategic collaboration with payers is critical.

4. What are the prospects for generic competition?

With patent protections and regulatory exclusivities in place, generic competition is unlikely before late 2020s. Nonetheless, biosimilar or alternative therapies could pose long-term threats.

5. Are there ongoing clinical trials that could widen FINTEPLA’s therapeutic scope?

Yes. Trials exploring its efficacy in agitation, aggression, and neuropsychiatric symptoms associated with neurodegenerative and neurodevelopmental disorders are underway, potentially expanding its usage base.

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Sources

[1] U.S. Food and Drug Administration. FDA approves FINTEPLA for children with seizures. 2017.
[2] MarketResearch.com. Global Neurodegenerative Disease Treatment Market Outlook. 2022.
[3] ClinicalTrials.gov. Ongoing trials for FINTEPLA in neuropsychiatric conditions. 2023.
[4] IQVIA. CNS therapeutics market analysis. 2022.
[5] EvaluatePharma. 2023 Forecast of Neurotherapeutic sales.