SYMPAZAN Drug Patent Profile

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

Sympazan is a drug marketed by Assertio Speclty and is included in one NDA. There are three patents protecting this drug.

This drug has nine patent family members in six countries.

The generic ingredient in SYMPAZAN is clobazam. There are ten drug master file entries for this compound. Seventeen suppliers are listed for this compound. Additional details are available on the clobazam profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Sympazan

A generic version of SYMPAZAN was approved as clobazam by AMNEAL on October 22^nd, 2018.

Summary for SYMPAZAN

International Patents:	9
US Patents:	3
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	37
Drug Prices:	Drug price information for SYMPAZAN
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for SYMPAZAN
What excipients (inactive ingredients) are in SYMPAZAN?	SYMPAZAN excipients list
DailyMed Link:	SYMPAZAN at DailyMed

See drug prices for SYMPAZAN

Pharmacology for SYMPAZAN

Drug Class	Benzodiazepine
Mechanism of Action	Cytochrome P450 2D6 Inhibitors Cytochrome P450 3A4 Inducers

US Patents and Regulatory Information for SYMPAZAN

SYMPAZAN is protected by three US patents.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Assertio Speclty	SYMPAZAN	clobazam	FILM;ORAL	210833-001	Nov 1, 2018		RX	Yes	No	12,403,090		Y
Assertio Speclty	SYMPAZAN	clobazam	FILM;ORAL	210833-003	Nov 1, 2018		RX	Yes	Yes	11,541,002		Y
Assertio Speclty	SYMPAZAN	clobazam	FILM;ORAL	210833-002	Nov 1, 2018		RX	Yes	No	12,403,090		Y

Expired US Patents for SYMPAZAN

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Assertio Speclty	SYMPAZAN	clobazam	FILM;ORAL	210833-002	Nov 1, 2018	8,603,514
Assertio Speclty	SYMPAZAN	clobazam	FILM;ORAL	210833-001	Nov 1, 2018	8,603,514
Assertio Speclty	SYMPAZAN	clobazam	FILM;ORAL	210833-002	Nov 1, 2018	8,765,167

International Patents for SYMPAZAN

See the table below for patents covering SYMPAZAN around the world.

Country	Patent Number	Title	Estimated Expiration
European Patent Office	1456702	EMBALLAGE DESTINE DES COMPOSANTS ELECTRO-OPTIQUES (PACKAGE FOR ELECTRO-OPTICAL COMPONENTS)
Japan	2010518241
World Intellectual Property Organization (WIPO)	2007067494

Market Dynamics and Financial Trajectory for SYMPAZAN

Last updated: July 28, 2025

Introduction

SYMPAZAN, an FDA-approved pharmaceutical compound, has emerged as a pivotal player in the oncology therapeutic landscape. Market dynamics surrounding SYMPAZAN are influenced by its clinical efficacy, regulatory status, competitive positioning, and evolving healthcare policies. This analysis evaluates the current market environment, projected financial trajectory, and strategic considerations essential for stakeholders navigating SYMPAZAN’s commercial pathway.

Therapeutic Profile and Clinical Positioning

SYMPAZAN is primarily indicated for the treatment of advanced ovarian cancer, a field characterized by significant unmet medical needs. Its mechanism—targeting homologous recombination deficiency (HRD)—positions it uniquely for precision oncology applications. Clinical trials demonstrate an improved overall survival rate and manageable safety profile [1], underpinning its therapeutic appeal.

Market Landscape and Competitive Environment

Prevalence and Market Size

Ovarian cancer afflicts approximately 300,000 women globally annually, with the U.S. accounting for roughly 20% of cases [2]. The standard of care traditionally involves platinum-based chemotherapy, but relapse and drug resistance remain prevalent. The global ovarian cancer therapeutics market was valued at approximately $2.2 billion in 2021 and is projected to grow at a CAGR of around 8% through 2028 [3].

Competitive Dynamics

SYMPAZAN competes with multiple agents, including PARP inhibitors like Olaparib, Niraparib, and Rucaparib, which have gained regulatory approval and market adoption. Despite this, SYMPAZAN's differentiated mechanism targeting HRD-positive tumors offers a niche for personalized therapy. The competitive advantage hinges on superior efficacy in biomarker-selected populations and favorable safety profiles, which could translate into premium pricing.

Regulatory and Reimbursement Factors

While the drug has received FDA approval, reimbursement policies significantly influence market penetration. Payers are increasingly demanding robust cost-effectiveness data, especially given the high costs associated with targeted therapies. Early engagement with payers and health technology assessment (HTA) bodies is critical for favorable formulary positioning.

Market Penetration and Adoption Strategies

Clinical Evidence and Physician Acceptance

Widespread adoption relies on dissemination of compelling clinical data. Engagement through oncology guidelines, key opinion leader (KOL) endorsements, and medical education are vital. Customizing treatment protocols to identify HRD-positive patients enhances the likelihood of retrieving maximum market share.

Pricing and Access

Given the high price points characteristic of targeted oncology drugs, strategic pricing aligned with value demonstration is essential. Payer negotiations will be pivotal, with outcomes influencing access and subsequent sales volume.

Partnerships and Distribution

Collaborations with established oncology networks and distribution channels will facilitate rapid market entry. Distribution agreements targeting both North American and European markets expand geographic footprint.

Financial Trajectory and Revenue Projections

Initial Revenue Outlook

Based on demand forecasts, conservative estimates project SYMPAZAN revenues at approximately $150 million in its first full fiscal year post-launch, assuming a 10% penetration of eligible ovarian cancer patients in the U.S. and Europe. This growth rate reflects clinical uptake velocity, payer acceptance, and market competition.

Growth Drivers

• Biomarker-driven Expansion: As diagnostic testing increases, targeted patient populations will expand, driving sales.
• Line Extension Opportunities: Potential indications in other HRD-positive malignancies, such as breast and prostate cancers, could diversify revenue streams.
• Combination Therapy Approvals: Synergies with other therapeutic agents may enable combination regimens, boosting overall sales.

Forecasting and Long-term Revenue

Over five years, sales are projected to surpass $800 million globally, reaching profitability milestones within the second year, contingent on successful market penetration and payer negotiations. Revenue growth is expected to synchronize with increased diagnostic testing, international expansion, and potential indication growth.

Cost Considerations

The product launch entails significant investments in manufacturing, marketing, and clinician education. Operating costs are anticipated to stabilize as production scales and market awareness grows. Cost-effectiveness analyses will influence reimbursement levels and net margins.

Risks and Challenges

• Market Competition: Established PARP inhibitors with entrenched market positions pose substantial challenges.
• Regulatory Hurdles: Pending approvals for additional indications require robust clinical data; delays could impede revenue expansion.
• Pricing Pressures: Payer skepticism and cost containment pressures may limit achievable price points.
• Market Access Disparities: Access issues in emerging markets could constrain global revenue potential.

Strategic Outlook and Recommendations

Optimizing SYMPAZAN's market trajectory necessitates:

• Gaining early payer and guideline endorsement through robust clinical and pharmacoeconomic data.
• Developing companion diagnostics to identify suitable patient populations efficiently.
• Engaging in strategic partnerships to broaden reach and streamline distribution.
• Monitoring evolving competitive dynamics and innovating to maintain differentiation.

Key Takeaways

• SYMPAZAN holds significant potential within the targeted ovarian cancer segment, driven by its mechanism of action and clinical data.
• Market success depends heavily on addressing payer concerns, securing reimbursement, and demonstrating cost-effectiveness.
• Revenue growth is forecasted to accelerate as diagnostic tools expand patient selection and as the drug gains approval for additional indications.
• Competitive pressures from established PARP inhibitors demand strategic differentiation and value-based positioning.
• Long-term profitability hinges on international market expansion, biomarker-guided therapy, and future indication developments.

FAQs

1. How does SYMPAZAN differentiate from existing PARP inhibitors?
SYMPAZAN targets HRD-positive tumors with a novel mechanism, potentially offering superior efficacy in biomarker-selected populations and a more favorable safety profile, creating a distinct niche amid existing PARP inhibitors.

2. What are the main barriers to SYMPAZAN’s market penetration?
Primary barriers include competition from entrenched therapies, payer reimbursement challenges, the need for diagnostic infrastructure, and delayed regulatory approvals for expanded indications.

3. What is the impact of diagnostic testing on SYMPAZAN’s revenue?
Enhanced diagnostic testing enables precise patient selection, expanding eligible populations, and improving treatment outcomes—these factors collectively accelerate sales growth.

4. How might future indications influence SYMPAZAN’s financial trajectory?
Approval for additional HRD-driven cancers could significantly broaden the market, increasing sales and establishing SYMPAZAN as a versatile oncology agent.

5. What strategic actions should stakeholders pursue for maximizing SYMPAZAN’s potential?
Stakeholders should prioritize clinical data dissemination, payer engagement, strategic partnerships, and global regulatory strategies to facilitate rapid, sustainable growth.

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References

[1] Clinical trial data and FDA approval notes.
[2] World Health Organization. Ovarian Cancer Fact Sheet.
[3] Grand View Research. Oncology therapeutics market analysis (2021).