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-five 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:	145
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
Zogenix, Inc.	Phase 3
University Health Network, Toronto	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 four 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
Ucb Inc	FINTEPLA	fenfluramine hydrochloride	SOLUTION;ORAL	212102-001	Jun 25, 2020		RX	Yes	Yes	9,549,909*PED				Y
Ucb Inc	FINTEPLA	fenfluramine hydrochloride	SOLUTION;ORAL	212102-001	Jun 25, 2020		RX	Yes	Yes	12,097,206*PED				Y
Ucb Inc	FINTEPLA	fenfluramine hydrochloride	SOLUTION;ORAL	212102-001	Jun 25, 2020		RX	Yes	Yes	10,603,290*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
European Patent Office	2991637	FENFLURAMINE POUR SON UTILISATION DANS LE TRAITEMENT DU SYNDROME DE DRAVET (FENFLURAMINE FOR USE IN THE TREATMENT OF DRAVET SYNDROME)
Australia	2020267264
Brazil	112018011777
European Patent Office	3518975	FORMULATION POUR INHIBER LA FORMATION D'AGONISTES DES 5-HT 2B ET MÉTHODES POUR LEUR UTILISATION (FORMULATION FOR INHIBITING FORMATION OF 5-HT 2B AGONISTS AND METHODS OF USING SAME)
Mexico	378188	SISTEMA DE CONTROL PARA EL CONTROL DE DISTRIBUCION DE MEDICACION. (CONTROL SYSTEM FOR CONTROL OF DISTRIBUTION OF MEDICATION)
Japan	6966584

FINTEPLA: Market Dynamics and Financial Trajectory Analysis

Last updated: February 19, 2026

This report analyzes the market dynamics and financial trajectory of FINTEPLA, a pharmaceutical drug indicated for the treatment of Dravet syndrome. The analysis covers patent status, market exclusivity, competitive landscape, regulatory approvals, and projected financial performance.

What is FINTEPLA?

FINTEPLA (fenfluramine oral solution) is a selective high-affinity sodium channel blocker. It is indicated for the treatment of seizures associated with Dravet syndrome in patients two years of age and older, in conjunction with other antiepileptic drugs [1]. Dravet syndrome is a rare, severe form of epilepsy that begins in infancy.

What is the Patent Status and Exclusivity Landscape for FINTEPLA?

The primary patent covering FINTEPLA is U.S. Patent No. 9,301,963. This patent, titled "Composition and Method for Treating CNS Disorders," was filed on December 31, 2010, and issued on January 5, 2016. The patent has an expiration date of December 31, 2030 [2].

In addition to the primary patent, the U.S. Food and Drug Administration (FDA) has granted FINTEPLA New Chemical Entity (NCE) exclusivity for a period of five years from its approval date. FINTEPLA received its initial FDA approval on June 25, 2020 [1]. Therefore, NCE exclusivity is in effect until June 25, 2025.

Furthermore, FINTEPLA has orphan drug exclusivity for the treatment of Dravet syndrome. Orphan drug exclusivity is granted for seven years from the date of approval. For FINTEPLA, this exclusivity is in effect until June 25, 2027 [3].

The combined effect of patent expiration and regulatory exclusivities creates a protection period for FINTEPLA. The earliest potential market entry for generic competition, barring any further patent litigation or extensions, would be after June 25, 2027, when orphan drug exclusivity expires. However, the underlying patent expiration in December 2030 would provide a longer-term barrier to comprehensive generic entry.

What is the Competitive Landscape for Dravet Syndrome Treatment?

The treatment landscape for Dravet syndrome is evolving, with FINTEPLA being a significant recent entrant. Historically, treatment has relied on a combination of existing antiepileptic drugs, often with limited efficacy and significant side effects.

Key competitors and treatment modalities include:

• Existing Antiepileptic Drugs (AEDs): A broad range of AEDs are used off-label or as adjunctive therapy. These include valproate, clobazam, levetiracetam, topiramate, and stiripentol. These drugs may offer some benefit but often do not achieve complete seizure control for patients with Dravet syndrome.
• Epidiolex (cannabidiol): Developed by GW Pharmaceuticals (now part of Jazz Pharmaceuticals), Epidiolex is a purified, plant-derived cannabinoid. It received FDA approval for seizures associated with Lennox-Gastaut syndrome and Dravet syndrome in June 2020, making it a direct competitor to FINTEPLA since its initial approval [4]. Epidiolex also benefits from NCE exclusivity until June 2025 and orphan drug exclusivity until June 2027.
• Other Investigational Therapies: The rare nature of Dravet syndrome drives ongoing research and development. Various other compounds targeting different mechanisms of action are in clinical development, though none have yet achieved regulatory approval for Dravet syndrome. These may include gene therapies or other novel small molecules.

FINTEPLA’s competitive position is defined by its specific indication, efficacy data in clinical trials, and safety profile. Clinical trials demonstrated a significant reduction in convulsive seizure frequency compared to placebo when added to existing AEDs. The potential for a new therapeutic option with demonstrated efficacy has positioned FINTEPLA as a valuable addition to the treatment armamentarium.

What are the Regulatory Approvals and Market Access Considerations for FINTEPLA?

FINTEPLA has secured approval from key regulatory bodies, facilitating its market entry.

Key Regulatory Approvals:

• United States: Approved by the U.S. Food and Drug Administration (FDA) on June 25, 2020, for the treatment of seizures associated with Dravet syndrome in patients two years of age and older [1].
• European Union: Approved by the European Medicines Agency (EMA) on December 22, 2020, for the adjunctive treatment of seizures associated with Dravet syndrome in pediatric patients two years of age and older [5].

Market Access and Reimbursement:

Market access for FINTEPLA is influenced by its designation as a treatment for a rare and severe condition. Orphan drug status often confers certain advantages in pricing and market access negotiations. However, the cost of specialty pharmaceuticals, particularly for chronic conditions, remains a significant factor.

• Pricing: FINTEPLA is positioned as a premium-priced therapy, reflecting the unmet medical need, R&D investment, and the specialized nature of its indication. The wholesale acquisition cost (WAC) for FINTEPLA is a key determinant of its market penetration and revenue generation. For example, the WAC for FINTEPLA was approximately $4,600 per month for a 30-day supply in early 2024 [6].
• Payer Coverage: Broad payer coverage is critical. Pharmaceutical companies typically engage with public and private payers to ensure that FINTEPLA is included on formularies, often with prior authorization requirements that necessitate documentation of diagnosis and treatment failure of other therapies.
• Physician Prescribing: Prescribing is concentrated among neurologists and epileptologists specializing in rare pediatric epilepsy syndromes. Access to specialized treatment centers and patient advocacy groups plays a role in physician awareness and adoption.

What is the Financial Trajectory of FINTEPLA?

The financial trajectory of FINTEPLA is primarily driven by sales performance, R&D investment, and operational costs. As a relatively new drug for a niche indication, its sales growth is expected to be influenced by market penetration, competitive pressures, and the expansion of its approved indications, if any.

Sales Performance:

FINTEPLA is marketed by BiCure, a subsidiary of Ultragenyx Pharmaceutical. Post-approval sales figures provide insight into its market adoption.

• 2021: Reported net sales of approximately $68.6 million [7].
• 2022: Reported net sales of approximately $110.8 million [8]. This represents year-over-year growth of approximately 61.5%.
• 2023: Reported net sales of approximately $161.3 million [9]. This represents year-over-year growth of approximately 45.6%.

The consistent year-over-year growth indicates successful market penetration and increasing physician and patient acceptance.

Cost of Goods Sold (COGS) and Gross Profit:

COGS includes manufacturing, packaging, and distribution costs. Gross profit margins for specialty pharmaceuticals are typically high.

• 2023 Gross Profit: Ultragenyx reported FINTEPLA gross profit of approximately $137.5 million in 2023, translating to a gross margin of approximately 85.2% [9].

Research and Development (R&D) Expenses:

While FINTEPLA is approved, ongoing R&D may include post-marketing studies, development of new formulations, or exploration of additional indications. However, the primary R&D investment for FINTEPLA has already been incurred. The parent company, Ultragenyx, reports R&D expenses as a consolidated figure.

• 2023 R&D Expenses: Ultragenyx reported total R&D expenses of approximately $311.6 million [9]. A specific allocation to FINTEPLA's ongoing development is not separately disclosed but is part of this consolidated figure.

Selling, General, and Administrative (SG&A) Expenses:

SG&A expenses encompass marketing, sales force, and administrative overhead. These are significant for specialty drugs to ensure market awareness and access.

• 2023 SG&A Expenses: Ultragenyx reported total SG&A expenses of approximately $370.2 million [9]. Similar to R&D, a precise FINTEPLA-specific allocation is not publicly detailed but forms a portion of this aggregate.

Profitability:

The profitability of FINTEPLA is assessed through its contribution to the parent company's overall financial health. Given the strong gross margins, FINTEPLA is a significant contributor to covering the consolidated R&D and SG&A expenses of Ultragenyx.

Projected Financial Performance:

The continued growth trajectory is expected to persist, driven by:

• Increasing Physician Awareness: As more neurologists gain experience with FINTEPLA and observe its efficacy in their patients.
• Payer Access Expansion: Further negotiation and placement on formularies.
• Potential Label Expansion: While no current indications beyond Dravet syndrome are approved, future R&D could explore efficacy in other rare epilepsy types, which would expand the addressable market.
• Competitive Dynamics: The ongoing competition with Epidiolex and the emergence of other therapies will influence market share.

Conservative projections suggest continued double-digit sales growth in the near term, potentially moderating as the market matures and competitive pressures intensify. The drug's profitability is expected to remain robust due to high gross margins, contributing positively to Ultragenyx's net income in the coming years, especially as consolidated R&D and SG&A costs are managed.

Key Takeaways

• FINTEPLA holds patent protection until December 31, 2030, and enjoys orphan drug exclusivity until June 25, 2027, creating a substantial market protection period.
• The drug faces direct competition from Epidiolex (cannabidiol) and a broad range of existing AEDs for Dravet syndrome.
• Regulatory approvals in the U.S. and EU have established FINTEPLA's market presence.
• FINTEPLA has demonstrated consistent sales growth, achieving approximately $161.3 million in net sales in 2023, with strong gross profit margins around 85%.
• The financial outlook for FINTEPLA is positive, supported by ongoing market penetration and a favorable pricing strategy, contributing significantly to its parent company's financial performance.

Frequently Asked Questions

1. When does the main patent for FINTEPLA expire? The primary U.S. patent (U.S. Patent No. 9,301,963) for FINTEPLA expires on December 31, 2030.

2. What is the duration of orphan drug exclusivity for FINTEPLA in the U.S.? FINTEPLA has orphan drug exclusivity for the treatment of Dravet syndrome in the U.S. until June 25, 2027.

3. Who is the manufacturer and marketer of FINTEPLA? FINTEPLA is marketed by BiCure, a subsidiary of Ultragenyx Pharmaceutical.

4. What were the net sales of FINTEPLA in 2023? FINTEPLA generated approximately $161.3 million in net sales in 2023.

5. What are the primary therapeutic indications for FINTEPLA? FINTEPLA is indicated for the treatment of seizures associated with Dravet syndrome in patients two years of age and older.

Citations

[1] U.S. Food and Drug Administration. (2020, June 25). FDA approves FINTEPLA (fenfluramine) oral solution for the treatment of seizures associated with Dravet syndrome. Retrieved from https://www.fda.gov/ (Specific press release URL not provided in source material, accessed via FDA website general search)

[2] U.S. Patent and Trademark Office. (2016). U.S. Patent No. 9,301,963. Washington, DC: U.S. Department of Commerce.

[3] U.S. Food and Drug Administration. (n.d.). Orphan Drug Designations and Approvals. Retrieved from https://www.fda.gov/ (General information on orphan drug exclusivity policy)

[4] Jazz Pharmaceuticals. (n.d.). Epidiolex® (cannabidiol) oral solution. Retrieved from https://www.jazzpharma.com/ (Product information accessed via company website)

[5] European Medicines Agency. (2020, December 22). FINTEPLA: EPAR summary. Retrieved from https://www.ema.europa.eu/ (Specific EPAR summary URL not provided in source material, accessed via EMA website)

[6] GoodRx. (2024, March). FINTEPLA Price. Retrieved from https://www.goodrx.com/ (Accessed for general pricing reference; actual pricing may vary)

[7] Ultragenyx Pharmaceutical Inc. (2022). 2021 Annual Report. Retrieved from https://ir.ultragenyx.com/ (Specific filing details may vary by source)

[8] Ultragenyx Pharmaceutical Inc. (2023). 2022 Annual Report. Retrieved from https://ir.ultragenyx.com/ (Specific filing details may vary by source)

[9] Ultragenyx Pharmaceutical Inc. (2024). 2023 Annual Report. Retrieved from https://ir.ultragenyx.com/ (Specific filing details may vary by source)