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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 seventeen patent family members in twenty-seven 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 is one Paragraph IV patent challenge for this drug. This may lead to patent invalidation or a license for generic production.

Indicators of Generic Entry

Summary for FINTEPLA

International Patents:	117
US Patents:	14
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	31
Clinical Trials:	2
Patent Applications:	4,892
Drug Prices:	Drug price information 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
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

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	3393655	COMPOSITIONS DE FENFLURAMINE ET PROCÉDÉS DE PRÉPARATION DE CELLES-CI (FENFLURAMINE COMPOSITIONS AND METHODS OF PREPARING THE SAME)
Japan	2022180461	５－ＨＴ２Ｂアゴニストの形成を阻害するための製剤およびその使用方法
Spain	2863929
Brazil	112015027282
Japan	7412320
World Intellectual Property Organization (WIPO)	2018037306

FINTEPLA Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for FINTEPLA

Introduction

FINTEPLA, developed by Zogenix and now part of the UCB portfolio, is a significant player in the treatment of rare epileptic conditions, particularly Dravet syndrome and Lennox-Gastaut Syndrome (LGS). Here, we delve into the market dynamics and financial trajectory of FINTEPLA, highlighting its approvals, market performance, and future prospects.

FDA Approvals and Indications

FINTEPLA, an oral solution of fenfluramine, received FDA approval for the treatment of seizures associated with Dravet syndrome in mid-2020. This was a crucial milestone, as Dravet syndrome is a rare and severe form of epilepsy. In March 2022, FINTEPLA gained FDA approval for the treatment of seizures associated with LGS, significantly expanding its addressable patient pool[1][4].

Market Performance

Initial Challenges

The initial launch of FINTEPLA in July 2020 was impacted by the COVID-19 pandemic, which affected its sales. Additionally, FINTEPLA is available through a restricted distribution program, requiring prescribers to complete REMS (Risk Evaluation and Mitigation Strategy) certification before prescribing, further influencing its sales[1].

Sales Figures

In 2021, FINTEPLA generated approximately $74.7 million in sales, which is significantly lower than its competitor, Epidiolex, which clocked over $650 million in the same period. However, with the recent FDA approval for LGS, FINTEPLA's sales trajectory is expected to improve[1].

Growth Prospects

Following the acquisition of Zogenix by UCB in March 2022, FINTEPLA has seen a boost in its market presence. UCB's financial reports indicate that FINTEPLA showed strong growth, with a 94% increase in net sales in 2023 compared to the previous year. This growth is attributed to the expanded indications and aggressive marketing efforts by UCB[3].

Addressable Patient Pool

The approval for LGS has significantly expanded FINTEPLA's addressable patient pool. While Dravet syndrome affects approximately 20,000 patients in the US, LGS affects around 45-50,000 patients. This broader patient base is expected to drive higher sales for FINTEPLA[1].

Global Rollout

FINTEPLA is not only gaining traction in the US but also in European markets. It has been launched in countries such as Spain, Italy, Germany, and France, with an anticipated launch in the UK pending NICE technology appraisal. In Japan, Zogenix has filed a J-NDA in collaboration with Nippon Shinyaku, further expanding its global reach[1][4].

Financial Impact on UCB

The inclusion of FINTEPLA in UCB's portfolio has contributed to the company's revenue growth. In the first six months of 2022, UCB's revenue reached €2.925 billion, with net sales increasing by 2% to €2.705 billion, partly driven by the addition of FINTEPLA. The strong performance of FINTEPLA, along with other growth drivers like EVENITY and BIMZELX, has been instrumental in UCB's financial growth[2][5].

Future Development and Pipeline

UCB is advancing FINTEPLA for additional indications, including seizures due to CDKL5 deficiency. Zogenix, now part of UCB, is also collaborating with Tevard Biosciences to develop next-generation gene therapies for Dravet syndrome and other genetic epilepsies. These ongoing and future development programs indicate a robust pipeline for FINTEPLA, promising continued growth and innovation[1][4].

Regulatory and Clinical Updates

UCB's clinical pipeline is robust, with 12 clinical development programs ongoing, spanning 10 different medicines. The company has obtained 14 approvals across six patient populations since January 2023, further solidifying its position in the market. The regulatory acceptance and ongoing studies for FINTEPLA in additional rare epilepsies are key to its future success[3].

Competitive Landscape

FINTEPLA operates in a competitive landscape dominated by Epidiolex, which has a first-mover advantage and broader indications, including TSC-associated seizures. However, FINTEPLA's recent approvals and expanding patient pool are positioning it as a strong competitor. Other companies like Epygenix, Neurocrine Biosciences, and Takeda are also developing treatments for developmental and epileptic encephalopathies, making the market increasingly competitive[1].

Conclusion

FINTEPLA's market dynamics and financial trajectory are marked by significant milestones and challenges. Despite initial hurdles, the drug has shown promising growth following its approval for LGS and the acquisition by UCB. With an expanding addressable patient pool, global rollout, and a robust development pipeline, FINTEPLA is poised to play a substantial role in the treatment of rare epileptic conditions.

Key Takeaways

• FDA Approvals: FINTEPLA is approved for Dravet syndrome and LGS, with ongoing development for CDKL5 deficiency.
• Market Performance: Initial sales were impacted by the pandemic and REMS certification, but recent approvals have boosted growth.
• Addressable Patient Pool: Expanded to include approximately 45-50,000 LGS patients in the US.
• Global Rollout: Launched in several European countries and pending launch in the UK and Japan.
• Financial Impact: Contributed to UCB's revenue growth, with strong net sales increases.
• Future Development: Ongoing and future development programs, including gene therapies, promise continued innovation.

FAQs

Q: What are the approved indications for FINTEPLA? A: FINTEPLA is approved for the treatment of seizures associated with Dravet syndrome and Lennox-Gastaut Syndrome (LGS).

Q: How has the COVID-19 pandemic affected FINTEPLA's sales? A: The pandemic impacted the initial launch period of FINTEPLA, affecting its sales in 2020.

Q: What is the current market performance of FINTEPLA compared to its competitor, Epidiolex? A: While Epidiolex has higher sales due to its first-mover advantage and broader indications, FINTEPLA has shown significant growth following its approval for LGS.

Q: What is the addressable patient pool for FINTEPLA in the US? A: The addressable patient pool includes approximately 20,000 Dravet syndrome patients and 45-50,000 LGS patients in the US.

Q: What are the future development plans for FINTEPLA? A: UCB is advancing FINTEPLA for seizures due to CDKL5 deficiency and collaborating on next-generation gene therapies for Dravet syndrome and other genetic epilepsies.

Sources

1. DelveInsight: Epidiolex vs Fintepla: Fight in Rare Epilepsies
2. UCB: 2022 Half-Year Financial Report
3. UCB: UCB on Growth Path for a Decade Plus
4. Biospace: Zogenix To Present New FINTEPLA Data at AES 2021
5. UCB: Strong first six months – UCB with continued delivery and strong resilience