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Last Updated: December 23, 2024

XENEISOL Drug Patent Profile


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When do Xeneisol patents expire, and what generic alternatives are available?

Xeneisol is a drug marketed by Mallinckrodt and is included in one NDA.

The generic ingredient in XENEISOL is xenon xe-133. There are twelve drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the xenon xe-133 profile page.

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Summary for XENEISOL
US Patents:0
Applicants:1
NDAs:1
Raw Ingredient (Bulk) Api Vendors: 7
Patent Applications: 262
DailyMed Link:XENEISOL at DailyMed
Drug patent expirations by year for XENEISOL

US Patents and Regulatory Information for XENEISOL

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Mallinckrodt XENEISOL xenon xe-133 SOLUTION;INHALATION, INJECTION 017262-002 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

XENEISOL Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory of Xenon Pharmaceuticals Inc. (XENE)

Introduction

Xenon Pharmaceuticals Inc. (XENE) is a biopharmaceutical company focused on developing innovative treatments for rare neurological disorders. Here, we delve into the market dynamics and financial trajectory of Xenon, highlighting its product portfolio, market strategies, financial performance, and future outlook.

Product Portfolio

Xenon's product pipeline is robust and focused on addressing critical unmet needs in neurology.

Innovative Pharmaceuticals

The company is developing several clinical candidates, including XEN901, a sodium channel blocker aimed at treating various forms of epilepsy. Another key candidate is azetukalner, which is in Phase III trials for focal onset seizures and is also being explored for major depressive disorder (MDD)[3].

Specialty Drugs

Xenon specializes in high-cost specialty drugs used to treat complex health issues, particularly rare diseases. This market is projected to reach $235 billion by 2025, positioning Xenon for significant growth[1].

Market Strategies

Global Distribution

Xenon operates globally, with its products available in over 21 countries. The company has a strong presence in the U.S. and European markets, particularly in countries like Germany, France, and the UK[1].

Distribution Channels

Xenon's products are distributed through various channels, including partnerships with hospitals, retail pharmacies, and online sales platforms. For instance, the company has partnerships with over 500 hospitals and more than 20,000 retail pharmacy locations[1].

Promotion Strategies

Xenon employs targeted promotion strategies such as medical conferences and digital outreach to engage with healthcare professionals and patients. These efforts are crucial for raising awareness and driving adoption of their innovative therapies[1].

Pricing Strategy

Premium Pricing

Xenon uses a premium pricing strategy for its innovative therapies, reflecting their unique value proposition. For example, the list price for XEN401 is approximately $300,000 per treatment course. This strategy helps the company recover research and development costs while capitalizing on its advanced therapeutic solutions[1].

Insurance Partnerships and Assistance Programs

To ensure patient accessibility, Xenon has established insurance partnerships that cover a significant portion of the treatment costs. As of 2022, over 80% of patients received coverage for their therapies, facilitating broader market adoption[1].

Competitive Pricing for Generics

For generic drugs, Xenon adopts a competitive pricing model to maintain market share in a cost-sensitive environment. The average wholesale price for generic equivalents is set at approximately 30% lower than branded versions[1].

Financial Performance

Cash Position

As of December 31, 2023, Xenon had $930.9 million in cash and marketable securities, indicating a strong financial position to support its ongoing clinical programs. This cash runway is expected to fund operations into 2027, reducing the immediate need for additional funding[2].

Operating Expenses and Net Loss

Despite the strong cash position, Xenon reported a net loss of $182.4 million for the year 2023, primarily due to high research and development costs. This is a common scenario for biopharmaceutical companies in the development stage[2].

Future Outlook and Catalysts

Phase III Trials and Regulatory Approvals

The Phase III X-TOLE2 study for azetukalner is a key catalyst for Xenon's future. Positive results could position azetukalner as a potential first-line treatment for focal onset seizures, significantly impacting Xenon's market valuation. The expansion into MDD treatment also represents a substantial opportunity, with the MDD market valued at approximately $700 million[3].

Market Potential and Commercial Outlook

Analysts project that if clinical data remains favorable, azetukalner could achieve blockbuster status within 3-5 years post-launch, generating over $1 billion in sales. The commercial prospects are further enhanced by comparisons with successful drugs like SK Life Science's Xcopri and AXSM's Auvelity[3].

Analyst Perspectives and Ratings

Analysts have maintained positive ratings for Xenon, with price targets ranging from $55 to $65. The consensus is that Xenon's current stock price may not fully reflect the quality of its pipeline or the relatively de-risked nature of its Phase III development program[3].

SWOT Analysis

Strengths

  • Robust pipeline with multiple Kv7-targeting candidates and efforts focused on Nav1.1 and Nav1.7 inhibitors.
  • Strong financial position with a significant cash runway.
  • Effective execution across operations and positive analyst ratings.

Weaknesses

  • High operating expenses and net losses associated with R&D efforts.
  • Dependence on successful clinical outcomes and regulatory approvals.

Opportunities

  • Expansion into the MDD market and potential entry into other CNS indications.
  • Synergies in marketing and sales efforts by targeting multiple indications with a single molecule.
  • Potential for partnership or acquisition interest from larger pharmaceutical companies.

Threats

  • Regulatory hurdles in the drug approval process.
  • Potential for unfavorable clinical trial results.
  • Competitive landscape in the neurological drug market[3].

Key Takeaways

  • Xenon Pharmaceuticals Inc. has a robust pipeline focused on innovative neurological treatments.
  • The company's global distribution strategy and premium pricing model support its market presence.
  • A strong cash position and positive analyst perspectives indicate a promising financial trajectory.
  • Success in Phase III trials and expansion into new indications could significantly boost Xenon's commercial opportunities.

Frequently Asked Questions (FAQs)

1. What is Xenon Pharmaceuticals Inc.'s primary focus in its product pipeline? Xenon Pharmaceuticals Inc. is primarily focused on developing innovative pharmacological solutions to address rare neurological disorders, such as epilepsy and other related syndromes.

2. How does Xenon's pricing strategy impact patient accessibility? Xenon employs a premium pricing strategy but also has insurance partnerships and assistance programs in place to ensure that over 80% of patients receive coverage for their therapies, facilitating broader market adoption.

3. What are the key catalysts for Xenon's future growth? Key catalysts include the Phase III X-TOLE2 study for azetukalner and the expansion into the major depressive disorder (MDD) market, both of which could significantly impact Xenon's market valuation and commercial prospects.

4. How does Xenon's financial position support its ongoing clinical programs? Xenon has a strong cash position of $930.9 million as of December 31, 2023, which is expected to fund operations into 2027, reducing the immediate need for additional funding.

5. What are the potential market implications of azetukalner's success in clinical trials? Success in clinical trials could position azetukalner as a potential first-line treatment for focal onset seizures and major depressive disorder, leading to significant revaluation of Xenon's stock and potential blockbuster sales.

Cited Sources:

  1. Marketing Mix Analysis of Xenon Pharmaceuticals Inc. (XENE) - dcf-fm
  2. Xenon Pharmaceuticals Reports Fourth Quarter and Full Year 2023 - Stock Titan
  3. Xenon Pharmaceuticals' SWOT analysis: stock poised for breakthrough in epilepsy - Investing.com

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