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DIACOMIT Drug Patent Profile

When do Diacomit patents expire, and when can generic versions of Diacomit launch?

Diacomit is a drug marketed by Biocodex Sa and is included in two NDAs.

The generic ingredient in DIACOMIT is stiripentol. One supplier is listed for this compound. Additional details are available on the stiripentol profile page.

Summary for DIACOMIT

US Patents:	0
Applicants:	1
NDAs:	2
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	74
Clinical Trials:	2
Patent Applications:	995
Drug Prices:	Drug price information for DIACOMIT
What excipients (inactive ingredients) are in DIACOMIT?	DIACOMIT excipients list
DailyMed Link:	DIACOMIT at DailyMed

See drug prices for DIACOMIT

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

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

NDA:

206709

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

NDA:

207223

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 DIACOMIT

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

Sponsor	Phase
Biocodex	Phase 4
Biocodex	Phase 2

See all DIACOMIT clinical trials

US Patents and Regulatory Information for DIACOMIT

DIACOMIT is protected by zero US patents and four FDA Regulatory Exclusivities.

This potential generic entry date is based on 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.

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
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	CAPSULE;ORAL	206709-002	Aug 20, 2018		RX	Yes	Yes
Biocodex Sa	DIACOMIT	stiripentol	FOR SUSPENSION;ORAL	207223-002	Aug 20, 2018		RX	Yes	Yes

EU/EMA Drug Approvals for DIACOMIT

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

DIACOMIT Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for DIACOMIT (Stiripentol)

Introduction to DIACOMIT

DIACOMIT, also known as stiripentol, is an FDA-approved antiseizure medication specifically developed for the treatment of seizures associated with Dravet syndrome, a rare and severe form of epilepsy. Here, we delve into the market dynamics and financial trajectory of this crucial medication.

Regulatory Milestones

The approval of DIACOMIT by the U.S. Food and Drug Administration (FDA) in August 2020 marked a significant milestone in the treatment of Dravet syndrome. This approval, along with that of other drugs like Epidiolex (cannabidiol), has been a key driver of market growth in the Dravet syndrome treatment sector[3].

Market Growth Drivers

Several factors are driving the growth of the DIACOMIT market:

Efficiency and Safety

DIACOMIT has shown higher efficiency and safety, providing prolonged relief from seizures. This has led to a significant increase in its market share post-2020[3].

Expanded Patient Access

DIACOMIT is approved for use in patients as young as 6 months old, weighing 15 pounds or more, and is typically used in conjunction with clobazam. This expanded patient access has broadened the market potential[4].

Insurance Coverage and Affordability

The medication is covered by most insurance plans, and patients often pay less than $3 for the treatment, making it more accessible and affordable[4].

Geographic Market Performance

North America

North America, particularly the United States and Canada, dominates the global market for Dravet syndrome treatments, including DIACOMIT. This is due to robust healthcare infrastructure, increasing healthcare expenditure, and higher awareness of neurological disorders[2][3].

Asia Pacific

The Asia Pacific region, especially Japan, is expected to grow significantly during the forecast period. This growth is driven by increasing awareness of Dravet syndrome and advancements in diagnostic technologies[1][3].

Financial Projections

Market Size and Growth Rate

The Dravet syndrome treatment market, which includes DIACOMIT, is projected to grow at a remarkable Compound Annual Growth Rate (CAGR) of 9.6% between 2022 and 2027, with the market size expected to increase by USD 575.14 million during this period[2].

Revenue Contribution

DIACOMIT, along with other approved drugs like Epidiolex, is expected to contribute significantly to the overall market growth. The market value for Dravet syndrome treatments was USD 258.1 million in 2020 and is projected to grow at a CAGR of 11.7% from 2021 to 2029[3].

Challenges and Limitations

Adverse Effects

Despite its efficacy, DIACOMIT and other Dravet syndrome treatments can have adverse effects such as increased drowsiness, agitation, impaired coordination, and depressive thoughts. These side effects can make the medications unsuitable for some patients and may inhibit market growth[1].

Economic Impact

The incremental cost-utility ratio (ICUR) for DIACOMIT, when added to valproate and clobazam, ranges from $51,160 to $120,419 per Quality-Adjusted Life Year (QALY) gained. This indicates a significant economic impact, which can be a challenge for widespread adoption[5].

Competitive Landscape

DIACOMIT competes in a market that includes other notable players such as GW Pharmaceuticals (Epidiolex), Zogenix (Fintepla), and other pharmaceutical companies. The competitive landscape is driven by ongoing research and development, regulatory approvals, and strategic collaborations[1][2].

Pipeline and Future Outlook

The future outlook for DIACOMIT is promising due to ongoing clinical trials and the submission of new drug applications. The strong drug pipeline and recent approvals are expected to continue driving market growth and improving treatment options for Dravet syndrome patients[1][2].

Key Takeaways

• Regulatory Approvals: DIACOMIT's FDA approval has been a significant driver of market growth.
• Efficiency and Safety: The drug's higher efficiency and safety have increased its market share.
• Geographic Performance: North America dominates the market, with Asia Pacific showing significant growth potential.
• Financial Projections: The market is expected to grow at a CAGR of 9.6% between 2022 and 2027.
• Challenges: Adverse effects and economic impact are key challenges to consider.

FAQs

1. What is DIACOMIT used for?

   • DIACOMIT (stiripentol) is used for the treatment of seizures associated with Dravet syndrome in patients 6 months and older, weighing 15 pounds or more, and typically in conjunction with clobazam[4].

2. When was DIACOMIT approved by the FDA?

   • DIACOMIT was approved by the FDA in August 2020[3].

3. How does DIACOMIT compare to other treatments in terms of cost?

   • Patients often pay less than $3 for DIACOMIT, making it relatively affordable. However, the ICUR for DIACOMIT ranges from $51,160 to $120,419 per QALY gained when added to valproate and clobazam[4][5].

4. What are the potential side effects of DIACOMIT?

   • Potential side effects include increased drowsiness, agitation, impaired coordination, loss of muscle tone, nausea, and depressive thoughts[1].

5. Which regions are expected to drive the growth of the DIACOMIT market?

   • North America is currently the largest market, but the Asia Pacific region, especially Japan, is expected to show significant growth during the forecast period[1][3].

Sources:

1. Fortune Business Insights: Dravet Syndrome Market Size, Industry Share and Forecast 2032
2. Technavio: Dravet Syndrome Treatment Market Size to Increase by USD 575.14 Million Between 2022-2027
3. Business Wire: Dravet Syndrome Treatment Market Report 2022-2029: Stiripentol and Cannabidiol to Contribute to Significant Growth
4. DIACOMIT HCP Site: DIACOMIT (stiripentol) Access and Affordability
5. CDR Pharmacoeconomic Review Report: CDR Pharmacoeconomic Review Report on Diacomit (stiripentol)