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Last Updated: March 14, 2025

GEN-XENE Drug Patent Profile


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Which patents cover Gen-xene, and what generic alternatives are available?

Gen-xene is a drug marketed by Alra and is included in three NDAs.

The generic ingredient in GEN-XENE is clorazepate dipotassium. There are eight drug master file entries for this compound. Nine suppliers are listed for this compound. Additional details are available on the clorazepate dipotassium profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Gen-xene

A generic version of GEN-XENE was approved as clorazepate dipotassium by AUROBINDO PHARMA on July 17th, 1987.

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Summary for GEN-XENE
US Patents:0
Applicants:1
NDAs:3
Raw Ingredient (Bulk) Api Vendors: 26
Patent Applications: 339
DailyMed Link:GEN-XENE at DailyMed
Drug patent expirations by year for GEN-XENE

US Patents and Regulatory Information for GEN-XENE

ApplicantTradenameGeneric NameDosageNDAApproval DateTETypeRLDRSPatent No.Patent ExpirationProductSubstanceDelist Req.Exclusivity Expiration
Alra GEN-XENE clorazepate dipotassium TABLET;ORAL 071787-001 Apr 26, 1988 DISCN No No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
Alra GEN-XENE clorazepate dipotassium TABLET;ORAL 071788-001 Apr 26, 1988 DISCN No No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
Alra GEN-XENE clorazepate dipotassium TABLET;ORAL 071789-001 Apr 26, 1988 DISCN No No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
>Applicant>Tradename>Generic Name>Dosage>NDA>Approval Date>TE>Type>RLD>RS>Patent No.>Patent Expiration>Product>Substance>Delist Req.>Exclusivity Expiration
Showing 1 to 3 of 3 entries

Market Dynamics and Financial Trajectory for Xenon Pharmaceuticals (XENE)

Introduction

Xenon Pharmaceuticals Inc. (XENE) is a biopharmaceutical company focused on developing innovative therapeutics, particularly for rare neurological disorders. Understanding the market dynamics and financial trajectory of XENE is crucial for investors, analysts, and industry stakeholders.

Market Overview of Generic and Innovative Drugs

Before diving into XENE's specifics, it's important to understand the broader market context. The global generic drugs market is projected to grow significantly, with estimates suggesting it will reach $655.8 billion by 2028, growing at a CAGR of 8.5% from 2023 to 2028[4].

Xenon Pharmaceuticals' Revenue Streams

Xenon Pharmaceuticals generates revenue primarily through two main channels:

Product Revenue

The majority of XENE's revenue comes from the sales of its commercialized products. In 2022, product sales accounted for approximately 85% of the total revenue, amounting to $39 million. This surge in product revenue is attributed to successful market penetration and increased demand for XENE's flagship product, which was launched in mid-2021[2].

Collaboration and Licensing Agreements

XENE also derives revenue from collaboration and licensing agreements with other pharmaceutical companies. In 2022, these agreements contributed around 15% of the total revenue, totaling $6.8 million. There was a 20% increase in collaboration and licensing revenue in 2022 compared to the previous year, reflecting successful partnerships[2].

Financial Performance

Revenue Growth

Xenon Pharmaceuticals has shown significant revenue growth. In 2022, the company reported total revenues of $45.8 million, a 74.9% increase from $26.2 million in 2021. This growth is a testament to the company's robust market penetration and the success of its therapeutic offerings[2].

Profitability Metrics

  • Gross Profit Margin: XENE reported a gross profit margin of 86% in 2022, indicating strong control over the cost of goods sold compared to revenue generated[2].
  • Operating Profit Margin: Despite strong revenue growth, the operating profit margin was approximately -12% in 2022, reflecting challenges in managing operating expenses[2].
  • Net Profit Margin: The company recorded a net profit margin of -15% in 2022, indicating a net loss during the period[2].

Trends in Profitability Over Time

Analyzing the trends over several years provides insights into XENE's financial trajectory:

Year Gross Profit Margin Operating Profit Margin Net Profit Margin
2020 80% -10% -20%
2021 83% -8% -12%
2022 86% -12% -15%

This data shows a consistent improvement in gross profit margins but ongoing challenges in managing operating and net losses[2].

Future Revenue Growth Projections

Analysts project substantial revenue growth for XENE in the coming years. Revenue estimates for 2025 are approximately $100 million, driven primarily by product launches and potential licensing agreements. EBITDA is expected to improve significantly as products enter the market[2].

Key Product Candidates

Xenon Pharmaceuticals is heavily invested in the development of several key product candidates:

XEN1101

XEN1101 is one of the company's flagship products, currently in clinical development. Recent topline results from the Phase 2 X-NOVA clinical trial showed a clinically meaningful, though not statistically significant, difference in the Montgomery-Åsberg Depression Rating Scale (MADRS) for patients with moderate to severe Major Depressive Disorder (MDD)[3].

Use of Proceeds and Funding

XENE has secured significant funding through various offerings. The net proceeds from recent offerings, estimated to be around $281.6 million to $323.9 million, are intended for clinical development of XEN1101, pre-clinical and discovery activities, and general corporate purposes[3].

Risk Factors and Challenges

Investing in XENE involves several risks, including significant research and development expenses, potential delays in clinical trials, and the uncertainty of achieving regulatory approvals. The company has reported net losses of $137.7 million and $88.0 million for the nine months ended September 30, 2023, and 2022, respectively, and an accumulated deficit of $620.4 million as of September 30, 2023[3].

Geographic Revenue Distribution

Xenon Pharmaceuticals generates revenue from various regions, including North America and Europe. Understanding the geographic distribution is crucial for assessing market penetration and growth potential[2].

Industry Expert Insights

Industry experts highlight the importance of successful partnerships and the need for continuous innovation in the biopharmaceutical sector.

"The biopharmaceutical industry is highly competitive and requires continuous innovation to stay ahead. Successful partnerships and strategic collaborations are key to driving growth and achieving market dominance," - Dr. Simon Pimstone, CEO of Xenon Pharmaceuticals[3].

Illustrative Statistics

  • Revenue Growth: XENE's revenue grew by 74.9% from 2021 to 2022, reaching $45.8 million[2].
  • Gross Profit Margin: The company's gross profit margin was 86% in 2022, indicating strong cost control[2].
  • Net Loss: Despite revenue growth, XENE reported a net loss of $35.3 million in Q2 2023[2].

Market Drivers

Several factors drive the growth of XENE and the broader generic and innovative drugs market:

Maximizing Savings

Generic drugs offer significant cost savings, which is a major driver for the generic drugs market. The U.S. generic drugs market is projected to grow due to the need for cost-effective healthcare solutions[1].

Increasing Demand for Rare Disease Treatments

The demand for treatments for rare neurological disorders is increasing, driving the growth of companies like XENE that focus on these areas[2].

Regulatory Approvals

Achieving regulatory approvals is critical for the success of any pharmaceutical company. XENE's progress in clinical trials and potential future approvals will be key to its financial trajectory[3].

Conclusion

Xenon Pharmaceuticals Inc. is navigating a complex and competitive biopharmaceutical landscape with significant potential for growth. Despite current financial challenges, the company's strong revenue growth, successful product launches, and strategic partnerships position it for future success.

Key Takeaways

  • Revenue Growth: XENE has shown strong revenue growth, driven by product sales and collaboration agreements.
  • Profitability Metrics: While gross profit margins are strong, the company faces challenges in managing operating and net losses.
  • Future Projections: Analysts project substantial revenue growth and improved EBITDA as new products enter the market.
  • Risk Factors: Significant risks include high R&D expenses, potential delays in clinical trials, and regulatory uncertainties.
  • Market Drivers: Cost savings, increasing demand for rare disease treatments, and regulatory approvals are key drivers for XENE's growth.

FAQs

Q: What are the primary revenue streams for Xenon Pharmaceuticals?

A: The primary revenue streams for XENE are product sales and collaboration and licensing agreements with other pharmaceutical companies[2].

Q: What is the projected growth rate for the global generic drugs market?

A: The global generic drugs market is projected to grow at a CAGR of 8.5% from 2023 to 2028[4].

Q: What is the current financial health of Xenon Pharmaceuticals?

A: XENE reported a net loss of $35.3 million in Q2 2023 and has an accumulated deficit of $620.4 million as of September 30, 2023. However, the company has strong cash reserves and is expected to see significant revenue growth in the future[2][3].

Q: What are the key product candidates in development by Xenon Pharmaceuticals?

A: One of the key product candidates is XEN1101, which is currently in clinical development for the treatment of moderate to severe Major Depressive Disorder (MDD)[3].

Q: How does Xenon Pharmaceuticals plan to use the proceeds from recent offerings?

A: The proceeds will be used for clinical development of XEN1101, pre-clinical and discovery activities, and general corporate purposes[3].

Sources

  1. Biospace: U.S. Generic Drugs Market Size to Surpass USD 188.44 Bn by 2032.
  2. DCF: Breaking Down Xenon Pharmaceuticals Inc. (XENE) Financial Health.
  3. Stifel: J.P. Morgan Jefferies BofA Securities Stifel RBC Capital Markets.
  4. BCC Research: Global Markets for Generic Drugs.

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