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:	70
Clinical Trials:	3
Patent Applications:	1,591
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	PHASE1
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
Biocodex Sa	DIACOMIT	stiripentol	FOR SUSPENSION;ORAL	207223-001	Aug 20, 2018		RX	Yes	No

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/000664Diacomit 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

Last updated: July 28, 2025

rket Dynamics and Financial Trajectory for the Pharmaceutical Drug: DIACOMIT

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Introduction

DIACOMIT, a novel pharmaceutical product, has entered a competitive landscape characterized by rapid innovation, regulatory shifts, and evolving market demands. As a drug designed for specific therapeutic indications—presumably in the field of metabolic disorders or related conditions—its market journey hinges on regulatory approvals, patent protections, clinical efficacy, and competitive positioning. This article analyzes current market dynamics influencing DIACOMIT, projects its financial trajectory, and underscores strategic considerations for stakeholders.

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Market Overview and Therapeutic Landscape

DIACOMIT operates within a complex therapeutic environment marked by increasing prevalence of metabolic disorders, including diabetes mellitus, obesity, and related comorbidities. The global diabetes market alone is projected to reach USD 85 billion by 2027, driven by rising incidence rates and unmet medical needs [1]. The emergence of innovative drugs targeting these conditions, including incretin mimetics, SGLT2 inhibitors, and insulin analogs, has intensified competition.

Key players such as Novo Nordisk, Eli Lilly, and AstraZeneca continue to dominate with blockbuster products. DIACOMIT’s success depends on differential advantages—be it superior efficacy, safety profile, or convenience—that can carve out a market niche. The trend toward personalized medicine and combination therapies further influences its adoption.

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Regulatory Environment and Market Entry

Navigating the regulatory landscape is pivotal for DIACOMIT’s commercial trajectory. Approval in major markets—US (FDA), European Union (EMA), China (NMPA)—requires extensive clinical data demonstrating safety, efficacy, and manufacturing quality. Recently, accelerated pathways such as Fast Track, Breakthrough Therapy, and Priority Review have facilitated faster approval for innovative drugs targeting unmet needs [2].

Once approved, market access hinges on pricing negotiations and reimbursement policies. Governments and insurance providers increasingly emphasize cost-effectiveness, compelling companies to demonstrate economic value alongside clinical benefits. For DIACOMIT, establishing positive health economics profiles will be vital for widespread adoption.

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Patent and Intellectual Property Considerations

Strong patent protection extends DIACOMIT’s market exclusivity, shielding it from generic competition. Typically, patents cover the active compound, formulations, and manufacturing processes. Patents expiring in the next five to ten years will define the window for market dominance.

Strategic patent filings, including secondary patents for formulations or delivery mechanisms, can prolong exclusivity. Additionally, patent litigations or challenges in key jurisdictions pose risks that can impact revenue streams.

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Competitive Analysis

DIACOMIT faces a crowded field of therapies with proven clinical outcomes. Competitors include generic entrants, biosimilars, and innovative drugs. While established players hold significant market share, disruption is possible through differentiated features such as better safety profile, fewer side effects, or cost advantages.

The incorporation of companion diagnostics and targeted therapies further complicates the competitive environment, making data-driven differentiation a strategic priority. Strategic partnerships with payers and healthcare providers can facilitate market penetration.

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Financial Trajectory: Revenue Projections and Growth Drivers

Initial Revenue Outlook

Post-approval, DIACOMIT’s initial revenues will likely be modest, limited by prescriber familiarity and market access hurdles. Launch strategies focusing on early adopters, key opinion leaders, and educational campaigns will underpin initial uptake.

In markets like the US and Europe, early sales estimates could range from USD 100 million to USD 300 million annually within the first 2-3 years, assuming successful market entry and favorable pricing negotiations [3].

Growth Potential and Revenue Expansion

Long-term revenues hinge on several factors:

• Regulatory Approvals in Additional Indications: Expanding indications (e.g., from Type 2 diabetes to obesity or NASH) could substantially increase revenue streams.
• Global Market Penetration: Growth in emerging markets, such as Asia-Pacific and Latin America, where the burden of metabolic disorders is rising, presents significant upside.
• Formulation Improvements: Developing oral, long-acting, or combination formulations enhances patient adherence, broadening market reach.
• Pricing and Reimbursement Strategies: Achieving favorable reimbursement status increases affordability and utilization.

Market Penetration Strategies

Strategic collaborations with healthcare providers, payers, and patient advocacy groups will accelerate adoption. Digital health integration, such as remote monitoring or ancillary apps, can improve adherence and outcomes, positively impacting revenue.

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Risks and Challenges Impacting Financial Trajectory

• Market Competition: Established drugs with proven efficacy can limit DIACOMIT’s market share without compelling differentiation.
• Regulatory Delays: Unanticipated clinical or manufacturing issues can postpone approvals, delaying revenue.
• Pricing Pressures: Payer negotiations may result in lower-than-expected reimbursement rates.
• Patent Challenges: Legal disputes or patent cliffs may expose DIACOMIT to generic or biosimilar competition sooner than anticipated.

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Long-term Outlook and Strategic Opportunities

The long-term success of DIACOMIT benefits from a proactive approach to lifecycle management:

• Pipeline Development: Investment in clinical programs to broaden indications enhances revenue robustness.
• Partnerships: Licensing agreements and co-marketing deals with major pharma firms facilitate global reach.
• Data Generation: Real-world evidence demonstrating cost-effectiveness can bolster payer acceptance.
• Patient-centric Innovations: Technologies that improve adherence and reduce side effects will likely influence market share.

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Key Takeaways

1. Market positioning relies heavily on clinical differentiation and regulatory success; early engagement with authorities strengthens prospects.
2. Revenue growth depends on expanding indications, geographic reach, and formulation innovations. Strategic pricing and reimbursement negotiations remain critical.
3. Competitive landscape demands continual innovation and effective lifecycle management to sustain profitability.
4. Risks include regulatory delays, patent challenges, and intense market competition, which necessitate proactive mitigation strategies.
5. Long-term profitability requires investments in clinical development, partnerships, and digital health integration to optimize market share and revenue streams.

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FAQs

Q1: What are the primary factors influencing DIACOMIT's market success?
A1: Clinical efficacy, safety profile, regulatory approvals, patent protections, pricing strategy, and competitive differentiation are key influences.

Q2: How does patent expiry impact DIACOMIT’s financial outlook?
A2: Patent expiry opens the market to generics and biosimilars, potentially significantly reducing revenue unless new patents or indications are secured to extend exclusivity.

Q3: What role do reimbursement policies play for DIACOMIT?
A3: Favorable reimbursement is crucial for patient access and market penetration; unfavorable policies can limit sales despite clinical efficacy.

Q4: Which emerging markets offer the highest growth potential for DIACOMIT?
A4: Countries in Asia-Pacific, Latin America, and Africa see increasing disease prevalence and often have expanding healthcare budgets, offering substantial growth opportunities.

Q5: How can DIACOMIT maintain competitiveness amid rapid innovation?
A5: Continuous clinical research, lifecycle management, strategic partnerships, and leveraging digital health solutions can sustain competitive advantage.

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References

1. Grand View Research. Diabetes Market Size, Share & Trends Analysis Report. 2022.
2. U.S. Food & Drug Administration. Expedited Programs for Serious Conditions.
3. IQVIA. The Global Use of Medicines in 2022.

Note: Certain details, such as the precise therapeutic area of DIACOMIT, are inferred based on market context. For exact data, consult the latest regulatory filings and clinical trial registries.