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Last Updated: December 23, 2024

XENAZINE Drug Patent Profile


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

Xenazine is a drug marketed by Bausch and is included in one NDA.

The generic ingredient in XENAZINE is tetrabenazine. There are twelve drug master file entries for this compound. Twelve suppliers are listed for this compound. Additional details are available on the tetrabenazine profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Xenazine

A generic version of XENAZINE was approved as tetrabenazine by HETERO LABS LTD V on February 3rd, 2016.

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Summary for XENAZINE
Drug patent expirations by year for XENAZINE
Drug Prices for XENAZINE

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Recent Clinical Trials for XENAZINE

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SponsorPhase
The University of Texas Health Science Center, HoustonPhase 4
H. Lundbeck A/SPhase 4
William Ondo, MDPhase 4

See all XENAZINE clinical trials

Pharmacology for XENAZINE

US Patents and Regulatory Information for XENAZINE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Bausch XENAZINE tetrabenazine TABLET;ORAL 021894-001 Aug 15, 2008 AB RX Yes No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Bausch XENAZINE tetrabenazine TABLET;ORAL 021894-002 Aug 15, 2008 AB RX Yes Yes ⤷  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

XENAZINE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Xenazine (Tetrabenazine)

Introduction to Xenazine

Xenazine, also known as tetrabenazine, is a medication specifically designed to manage chorea, a common symptom of Huntington's disease (HD). It is the first FDA-approved drug for this purpose and has been a cornerstone in the treatment of HD since its approval.

Market Share and Dominance

In the Huntington's disease treatment market, the tetrabenazine segment, which includes Xenazine, held a significant market share in 2023. This segment accounted for the highest market share, with approximately 53.6% of the market in 2024, due to its effectiveness in managing chorea[4].

Mechanism of Action

Xenazine works by reducing excessive dopamine activity in the brain, which helps in managing the involuntary movements associated with Huntington's disease. This mechanism has solidified Xenazine as a go-to drug for symptom management in HD patients[4].

Financial Performance

Revenue Trends

Historically, Xenazine has been a key revenue generator for its marketing rights holder, Lundbeck. However, the introduction of generic versions of tetrabenazine has impacted its sales. For instance, by the third quarter of 2015, the first generic introduction of tetrabenazine led to a significant decline in Xenazine's revenue. In 2018, revenue from Xenazine reached DKK 333 million, a decline of 59% compared to DKK 820 million in 2017[3].

Current Market Position

Despite the generic competition, Xenazine remains a significant player in the market. The branded segment, which includes Xenazine and other drugs like Austedo (deutetrabenazine), continues to see steady growth. This growth is attributed to the safety profiles and efficacy of these branded drugs, as well as increasing awareness and research activities[4].

Competitive Landscape

The competitive landscape for Huntington's disease treatments is dynamic, with several key players involved. Teva Pharmaceutical Industries Ltd., with its drug Austedo (deutetrabenazine), is a major competitor to Xenazine. Austedo has seen steady adoption since its FDA approval in 2017, and the increasing launches of new formulations have boosted its market share[1].

Geographical Performance

The market for Xenazine and other HD treatments is predominantly driven by North America, where the prevalence of Huntington's disease is higher. In 2023, the North America market for HD treatments stood at USD 0.95 billion, with a significant portion attributed to drugs like Xenazine and Austedo[1].

Research and Development

The growth of the Xenazine segment is also driven by ongoing research and development activities. Companies are investing heavily in developing new drug formulations with lesser side effects, which is expected to open new opportunities and increase the revenue share of the tetrabenazine segment[4].

Insurance Coverage and Distribution

Insurance coverage provided by hospital pharmacies has been a crucial factor in fostering the growth of the HD treatment market, including Xenazine. Hospital pharmacies, along with drug stores and retail pharmacies, play a significant role in the distribution of these medications, ensuring better accessibility for patients[1].

Future Outlook

The Huntington's disease treatment market, including the segment dominated by Xenazine, is poised for significant growth. The market is expected to grow at a CAGR of around 21.5% between 2025 and 2037, driven by advancements in gene therapies and emerging treatments aimed at slowing the disease's progression. The tetrabenazine segment is expected to continue its dominance due to its effectiveness and the ongoing development of new formulations with improved safety profiles[4].

Challenges and Opportunities

Despite the positive outlook, the market faces challenges such as generic competition and the need for continuous innovation to maintain market share. However, the growing awareness of Huntington's disease and the increasing demand for effective treatments present significant opportunities for growth. As research and development activities continue to advance, the market is likely to see the introduction of new and more effective treatments, further driving the growth of the tetrabenazine segment[4].

Key Takeaways

  • Market Dominance: Xenazine holds a significant market share in the Huntington's disease treatment market due to its effectiveness in managing chorea.
  • Financial Impact: Despite generic competition, Xenazine remains a key revenue generator, though its sales have declined since the introduction of generics.
  • Research and Development: Ongoing R&D activities are expected to drive the growth of the tetrabenazine segment with new formulations and improved safety profiles.
  • Geographical Performance: North America is the primary market for Xenazine and other HD treatments.
  • Future Outlook: The market is expected to grow significantly, driven by advancements in treatments and increasing awareness of Huntington's disease.

Frequently Asked Questions (FAQs)

1. What is Xenazine used for? Xenazine, or tetrabenazine, is used to manage chorea, a common symptom of Huntington's disease.

2. How does Xenazine work? Xenazine works by reducing excessive dopamine activity in the brain, which helps in managing the involuntary movements associated with Huntington's disease.

3. What is the current market share of Xenazine? The tetrabenazine segment, which includes Xenazine, held approximately 53.6% of the market share in 2024.

4. How has generic competition affected Xenazine's sales? The introduction of generic versions of tetrabenazine has significantly impacted Xenazine's sales, leading to a decline in revenue since 2015.

5. What are the future prospects for Xenazine in the HD treatment market? The market for Xenazine is expected to grow as new formulations with improved safety profiles are developed, and awareness of Huntington's disease treatments increases.

Cited Sources:

  1. Fortune Business Insights - Huntington's Disease Treatment Market Size, Share [2032]
  2. Lundbeck - Q3 2023 Corporate Release
  3. Lundbeck - Q3 2018 Release
  4. Research Nester - Huntington's Disease Treatment Market Size & Share, Forecast

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