STIRIPENTOL - Generic Drug Details

What are the generic sources for stiripentol and what is the scope of freedom to operate?

Stiripentol is the generic ingredient in one branded drug marketed by Biocodex Sa and is included in two NDAs. Additional information is available in the individual branded drug profile pages.

One supplier is listed for this compound.

Summary for STIRIPENTOL

US Patents:	0
Tradenames:	1
Applicants:	1
NDAs:	2
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	74
Clinical Trials:	13
Patent Applications:	1,595
What excipients (inactive ingredients) are in STIRIPENTOL?	STIRIPENTOL excipients list
DailyMed Link:	STIRIPENTOL at DailyMed

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

Constraining patent/regulatory exclusivity:

TREATMENT OF SEIZURES ASSOCIATED WITH DRAVET SYNDROME (DS) IN PATIENTS TAKING CLOBAZAM WHO ARE 6 MONTHS TO LESS THAN 2 YEARS OF AGE AND WEIGHING 7 KG OR MORE

Dosage:

CAPSULE;ORAL

Constraining patent/regulatory exclusivity:

TREATMENT OF SEIZURES ASSOCIATED WITH DRAVET SYNDROME (DS) IN PATIENTS TAKING CLOBAZAM WHO ARE 6 MONTHS TO LESS THAN 2 YEARS OF AGE AND WEIGHING 7 KG OR MORE

Dosage:

FOR SUSPENSION;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 STIRIPENTOL

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

Sponsor	Phase
University Health Network, Toronto	Phase 3
Zogenix, Inc.	Phase 3
Biocodex	Phase 4

See all STIRIPENTOL clinical trials

Anatomical Therapeutic Chemical (ATC) Classes for STIRIPENTOL

N03AX	Other antiepileptics
N03A	ANTIEPILEPTICS
N03	ANTIEPILEPTICS
N	Nervous system

US Patents and Regulatory Information for STIRIPENTOL

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Biocodex Sa	DIACOMIT	stiripentol	CAPSULE;ORAL	206709-002	Aug 20, 2018		RX	Yes	Yes
Biocodex Sa	DIACOMIT	stiripentol	CAPSULE;ORAL	206709-002	Aug 20, 2018		RX	Yes	Yes
Biocodex Sa	DIACOMIT	stiripentol	CAPSULE;ORAL	206709-001	Aug 20, 2018		RX	Yes	No
Biocodex Sa	DIACOMIT	stiripentol	FOR SUSPENSION;ORAL	207223-001	Aug 20, 2018		RX	Yes	No
Biocodex Sa	DIACOMIT	stiripentol	FOR SUSPENSION;ORAL	207223-001	Aug 20, 2018		RX	Yes	No

EU/EMA Drug Approvals for STIRIPENTOL

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Biocodex	Diacomit	stiripentol	EMEA/H/C/000664 Diacomit is indicated for use in conjunction with clobazam and valproate as adjunctive therapy of refractory generalized tonic-clonic seizures in patients with severe myoclonic epilepsy in infancy (SMEI, Dravet's syndrome) whose seizures are not adequately controlled with clobazam and valproate.	Authorised	no	no	no	2007-01-03	2009-02-11

STIRIPENTOL Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Stiripentol

Introduction to Stiripentol

Stiripentol, marketed under the brand name Diacomit, is a medication specifically approved for the treatment of seizures associated with Dravet syndrome, a rare and severe form of epilepsy. Here, we will delve into the market dynamics and financial trajectory of stiripentol, highlighting its impact, growth drivers, and future prospects.

Regulatory Approvals and Market Impact

In 2018, the U.S. Food and Drug Administration (FDA) approved stiripentol for the treatment of seizures associated with Dravet syndrome, marking a significant milestone in the management of this disorder[1][4].

Clinical Efficacy

The approval was based on clinical trials, such as the STICLO France and STICLO Italy studies, which demonstrated the efficacy of stiripentol in reducing the frequency of seizures in patients with Dravet syndrome. These studies showed that stiripentol, when used adjunctively with clobazam and valproic acid, significantly reduced the number of tonic-clonic seizures[2].

Market Drivers

Several factors are driving the growth of the stiripentol market:

Increasing Awareness and Diagnosis

The increasing awareness and diagnosis of Dravet syndrome, particularly in regions like North America and Europe, have contributed to the growing demand for effective treatments. This awareness is driven by advances in diagnostic technologies and greater recognition of neurological disorders[4].

Recent Regulatory Approvals

The FDA approval of stiripentol, along with other drugs like epidiolex (cannabidiol), has expanded the treatment options for Dravet syndrome. These approvals have not only enhanced the market size but also attracted significant investment from major pharmaceutical companies[1][4].

Drug Pipeline and R&D

The ongoing research and development efforts, including new drug applications and clinical trials, are expected to further boost the market. For instance, the submission of new drug applications like ZX008 (Fintepla) by Zogenix is anticipated to contribute to the market's accelerated growth[1].

Geographical Market Segmentation

The global market for stiripentol is segmented into several regions:

North America

North America, particularly the United States, dominates the market due to early adoption of new treatments, high awareness of neurological disorders, and advanced diagnostic technologies. The region is expected to maintain its dominance throughout the forecast period[1][4].

Europe

Europe is the second-largest market for stiripentol, with countries like France and the UK contributing significantly. The approval of stiripentol in these regions has led to increased market share and revenue growth[1][4].

Asia Pacific

The Asia Pacific region, especially Japan, is expected to provide significant market opportunities. Japan's growing awareness of Dravet syndrome, coupled with ongoing R&D efforts, makes it a key market for stiripentol[1].

Financial Trajectory

The financial performance of stiripentol is closely tied to its market dynamics:

Market Size and Growth

The Dravet syndrome treatment market, which includes stiripentol, was valued at US$ 288.2 million in 2021 and is projected to grow at a CAGR of 11.7% from 2022 to 2030. Stiripentol's market share is growing significantly due to its higher efficiency, safety, and prolonged relief from seizures[4].

Revenue Growth

The approval and subsequent market entry of stiripentol have led to substantial revenue growth. For instance, the approval of stiripentol in 2020 saw its market share grow at a significant rate, contributing to the overall growth of the Dravet syndrome treatment market[4].

Competitive Landscape

Stiripentol operates in a competitive landscape with other approved drugs for Dravet syndrome:

Epidiolex (Cannabidiol)

Epidiolex, approved in June 2020, is another key player in the market. It is the first FDA-approved drug containing a purified drug substance derived from marijuana. The competition between stiripentol and epidiolex drives innovation and market growth[1][4].

Fintepla (ZX008)

Fintepla, currently under approval process in the U.S. and Europe, is expected to further diversify the treatment options for Dravet syndrome. This diversification is likely to attract more patients and increase market size[4].

Cost-Utility Analysis

A cost-utility analysis comparing stiripentol with other treatments like cannabidiol highlights the economic viability of stiripentol. Such analyses are crucial for healthcare providers and payers, as they help in making informed decisions about treatment options[5].

Challenges and Opportunities

Despite the positive market dynamics, there are challenges and opportunities to consider:

Unmet Needs in Emerging Markets

In regions like Latin America and the Middle East & Africa, there is a significant unmet need for Dravet syndrome treatment. Addressing these needs could provide substantial growth opportunities for stiripentol[1].

Ongoing R&D and Clinical Trials

Continued research and development, along with ongoing clinical trials, offer opportunities for further market expansion and the development of more effective treatment regimens[1].

Key Takeaways

• Stiripentol's FDA approval in 2018 marked a significant milestone in the treatment of Dravet syndrome.
• The drug's market growth is driven by increasing awareness, recent regulatory approvals, and ongoing R&D efforts.
• North America and Europe are the largest markets, with the Asia Pacific region, especially Japan, offering significant growth opportunities.
• The competitive landscape includes other approved drugs like epidiolex and upcoming treatments like Fintepla.
• Cost-utility analyses highlight the economic viability of stiripentol.

FAQs

1. What is stiripentol used for? Stiripentol is used for the treatment of seizures associated with Dravet syndrome, a rare and severe form of epilepsy.

2. When was stiripentol approved by the FDA? Stiripentol was approved by the FDA in 2018 for the treatment of seizures associated with Dravet syndrome.

3. How does stiripentol compare to other treatments like epidiolex? Stiripentol and epidiolex are both approved for Dravet syndrome but have different mechanisms of action. Stiripentol is often used adjunctively with clobazam and valproic acid, while epidiolex is a purified drug substance derived from marijuana.

4. What regions dominate the market for stiripentol? North America and Europe are the dominant markets for stiripentol, with the Asia Pacific region, particularly Japan, showing significant growth potential.

5. What are the future prospects for stiripentol in the market? The future prospects for stiripentol are positive, driven by increasing awareness, ongoing R&D, and the unmet needs in emerging markets.

Cited Sources

1. Fortune Business Insights: Dravet Syndrome Market Size, Industry Share and Forecast 2032.
2. FDA: Clinical Review of Stiripentol (Diacomit).
3. Jazz Pharmaceuticals: 2021 Annual Report.
4. Research and Markets: Dravet Syndrome Treatment Market Size, Market Share, Application.
5. ISPOR: Cost-Utility Analysis of Add-on Stiripentol Vs Cannabidiol.