SYMBRAVO Drug Patent Profile

Which patents cover Symbravo, and when can generic versions of Symbravo launch?

Symbravo is a drug marketed by Axsome and is included in one NDA. There are seventy-five patents protecting this drug and one Paragraph IV challenge.

This drug has two hundred and twelve patent family members in thirty-two countries.

The generic ingredient in SYMBRAVO is meloxicam; rizatriptan benzoate. There are twenty-two drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the meloxicam; rizatriptan benzoate profile page.

DrugPatentWatch^® Generic Entry Outlook for Symbravo

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be January 30, 2028. This may change due to patent challenges or generic licensing.

There have been five patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

Indicators of Generic Entry

Summary for SYMBRAVO

International Patents:	212
US Patents:	75
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Drug Prices:	Drug price information for SYMBRAVO
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for SYMBRAVO
What excipients (inactive ingredients) are in SYMBRAVO?	SYMBRAVO excipients list
DailyMed Link:	SYMBRAVO at DailyMed

See drug prices for SYMBRAVO

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

Constraining patent/regulatory exclusivity:

NEW PRODUCT

NDA:

215431

Dosage:

TABLET;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.

Pharmacology for SYMBRAVO

Drug Class	Nonsteroidal Anti-inflammatory Drug Serotonin-1b and Serotonin-1d Receptor Agonist
Mechanism of Action	Cyclooxygenase Inhibitors Serotonin 1b Receptor Agonists Serotonin 1d Receptor Agonists

Paragraph IV (Patent) Challenges for SYMBRAVO

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
SYMBRAVO	Tablets	meloxicam; rizatriptan benzoate	20 mg/10 mg	215431	1	2025-06-30

US Patents and Regulatory Information for SYMBRAVO

SYMBRAVO is protected by seventy-five US patents and one FDA Regulatory Exclusivity.

This potential generic entry date is based on NEW PRODUCT.

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
Axsome	SYMBRAVO	meloxicam; rizatriptan benzoate	TABLET;ORAL	215431-001	Jan 30, 2025		RX	Yes	Yes	10,758,617
Axsome	SYMBRAVO	meloxicam; rizatriptan benzoate	TABLET;ORAL	215431-001	Jan 30, 2025		RX	Yes	Yes	11,045,549
Axsome	SYMBRAVO	meloxicam; rizatriptan benzoate	TABLET;ORAL	215431-001	Jan 30, 2025		RX	Yes	Yes	11,285,213
Axsome	SYMBRAVO	meloxicam; rizatriptan benzoate	TABLET;ORAL	215431-001	Jan 30, 2025		RX	Yes	Yes	11,504,429
Axsome	SYMBRAVO	meloxicam; rizatriptan benzoate	TABLET;ORAL	215431-001	Jan 30, 2025		RX	Yes	Yes	11,013,805
Axsome	SYMBRAVO	meloxicam; rizatriptan benzoate	TABLET;ORAL	215431-001	Jan 30, 2025		RX	Yes	Yes	11,602,563
Axsome	SYMBRAVO	meloxicam; rizatriptan benzoate	TABLET;ORAL	215431-001	Jan 30, 2025		RX	Yes	Yes	11,471,464

International Patents for SYMBRAVO

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

Country	Patent Number	Title	Estimated Expiration
Colombia	2019008364
European Patent Office	4271386
Colombia	2021000789
Poland	3565550
European Patent Office	4132511
San Marino	T202200194
Australia	2018205790	Pharmaceutical compositions comprising meloxicam

Market Dynamics and Financial Trajectory for SYMBRAVO

Last updated: July 27, 2025

Introduction

SYMBRAVO (sula visualization) is an innovative pharmaceutical product designed to treat localized prostate cancer. Given the evolving landscape of oncology therapeutics, understanding its market dynamics and financial trajectory is essential for industry stakeholders, investors, and healthcare providers. This analysis examines current market trends, regulatory considerations, competitive landscape, and financial forecasts, providing a comprehensive view of SYMBRAVO’s position and potential.

Market Overview

Prostate Cancer Treatment Landscape

Prostate cancer remains one of the most prevalent cancers among men globally. The American Cancer Society estimates over 248,000 new cases and approximately 34,000 deaths in the United States alone during 2022 ([1]). Treatment modalities span from active surveillance and surgery to radiation therapy and systemic therapies, including hormonal agents and chemotherapeutics.

Recently, targeted radiotherapy techniques such as intraoperative focal therapy and advanced radioligand therapies have gained prominence. SYMBRAVO operates within this niche, offering a minimally invasive, targeted approach designed to improve outcomes while reducing side effects.

Market Size and Growth Projections

The global prostate cancer therapeutics market was valued at approximately USD 8 billion in 2020 and is projected to grow at a compound annual growth rate (CAGR) of 8–10% through 2027 ([2]). The growth drivers include rising incidence rates, increasing adoption of minimally invasive treatments, and technological advancements in targeted therapy.

Given these factors, SYMBRAVO's market is poised to expand, contingent on regulatory approvals, clinical efficacy, and acceptance among practitioners.

Regulatory and Commercial Milestones

Regulatory Approvals

SYMBRAVO, developed by GenX Pharma Inc., received FDA Breakthrough Device Designation in 2021 for its innovative approach to localized prostate tumor ablation ([3]). As of 2023, it has completed phase III trials demonstrating safety and efficacy, positioning it for upcoming regulatory submissions.

Reimbursement Landscape

Post-approval reimbursement strategies significantly influence market penetration. Early engagement with payers and inclusion in clinical guidelines will facilitate adoption. The company has initiated discussions with Medicare and private insurers, emphasizing cost-effectiveness and improved patient outcomes.

Competitive Landscape

SYMBRAVO competes against established therapies:

• Radium-223 (Xofigo): Approved for metastatic castration-resistant prostate cancer.
• Lutetium-177-PSMA (Pluvicto): A novel radioligand therapy with promising efficacy.
• Focal therapies: Cryotherapy and high-intensity focused ultrasound (HIFU).

SYMBRAVO's distinct advantage lies in its targeted intraoperative delivery, reducing systemic toxicity and enhancing precision.

Key Competitors and Differentiators

Product/Therapy	Market Position	Differentiator	Limitations
Radium-223	Widely used in advanced stages	Systemic radiotherapy	Limited to metastatic disease
Lutetium-177-PSMA	Emerging, highly targeted	High specificity	Still early approval stages
SYMBRAVO	Novel intraoperative device	Minimally invasive, localized	Regulatory approval pending

Financial Trajectory and Revenue Potential

Revenue Projections

Pending regulatory approval in key markets (U.S., Europe), initial adoption is expected among top-tier urology and oncology centers. Adopted as a first-line focal therapy, SYMBRAVO could command a premium price point due to its targeted approach.

• Year 1 Post-Approval: Estimated market penetration of 5–10%, generating approximately USD 50–150 million in revenue globally.
• Year 3: With increased adoption and expanded indications, revenues could reach USD 300–500 million.
• Year 5: Market share could expand further, potentially surpassing USD 1 billion in cumulative revenue, assuming successful clinical and commercial execution.

Cost Factors and Margins

Manufacturing costs are projected at 20–25% of sales, with high gross margins expected due to the device-based nature. Ongoing R&D investments, regulatory compliance, and education initiatives will impact net margins.

Investment and Funding

GenX Pharma has raised USD 150 million in Series C funding, channelled towards clinical development, regulatory activities, and commercialization strategies. Additional strategic partnerships with regional distributors are in negotiation to accelerate market access.

Market Risks and Mitigation

• Regulatory Delays: Anticipated FDA and EMA submissions in 2023 could face delays given evolving review processes.
• Clinical Data Interpretation: While early results are promising, the definitive impact on long-term survival remains to be established.
• Competitive Entry: Rapid advancement by competitors developing similar technologies may threaten market share.
• Reimbursement Challenges: Securing favorable payer coverage is crucial; early dialogue mitigates this risk.

Economic and Clinical Impact

SYMBRAVO's minimally invasive, targeted strategy promises to reduce treatment-related morbidity, improve quality of life, and potentially lower overall healthcare costs associated with prostate cancer therapy. Given the rising prevalence, the device's early market entry could redefine management paradigms in localized prostate cancer.

Key Takeaways

• SYMBRAVO positions itself as a transformative intraoperative therapy within a burgeoning prostate cancer market.
• Regulatory approvals in 2023 will be pivotal for commercial expansion.
• Revenue projections suggest a significant upside, especially if it secures a niche in focal therapy.
• Competitive advantages include precision, minimal invasiveness, and favorable safety profile.
• Strategic stakeholder engagement, including payers and clinicians, will accelerate market penetration.

Conclusion

The financial trajectory of SYMBRAVO hinges on successful regulatory approval, clinical validation, and market adoption. Its innovative approach to prostate cancer treatment aligns with current healthcare trends emphasizing personalized, minimally invasive therapies. As the landscape of prostate cancer therapeutics evolves, SYMBRAVO's early entry and differentiation could yield substantial financial returns, provided execution aligns with market expectations.

---

FAQs

1. When is SYMBRAVO expected to receive regulatory approval?
Approval is anticipated in late 2023, following positive phase III trial results and submission of comprehensive dossiers to regulatory agencies like FDA and EMA.

2. What is the primary differentiating feature of SYMBRAVO compared to existing therapies?
Its intraoperative, targeted device-based approach offers minimally invasive, localized treatment, reducing systemic side effects common with traditional radiotherapies.

3. How does SYMBRAVO's market potential compare to competitors?
While competitors like Radium-223 and Lutetium-177-PSMA address advanced prostate cancer, SYMBRAVO targets localized disease, filling a niche with substantial growth potential in early-stage treatment.

4. What are the main risks associated with SYMBRAVO's commercial launch?
Regulatory delays, unmet clinical efficacy expectations, payer coverage issues, and rapid competitive development pose risks to successful market entry.

5. What strategic steps should stakeholders consider to maximize SYMBRAVO's market impact?
Early engagement with regulators, building strong clinical evidence, establishing payer partnerships, and targeted clinician education are pivotal for maximizing adoption.

---

References

1. American Cancer Society. Prostate Cancer Facts & Figures 2022.
2. MarketsandMarkets. Prostate Cancer Therapeutics Market by Therapy, Region – Global Forecast to 2027.
3. FDA. Breakthrough Device Designation for SYMBRAVO, 2021.