Tetrabenazine - Generic Drug Details

What are the generic sources for tetrabenazine and what is the scope of patent protection?

Tetrabenazine is the generic ingredient in two branded drugs marketed by Actavis Labs Fl Inc, Ajanta Pharma Ltd, Apotex, Bionpharma, Chartwell Rx, Dr Reddys, Hetero Labs Ltd V, Hikma, Mylan, Slate Run Pharma, Sun Pharm, and Bausch, and is included in twelve NDAs. Additional information is available in the individual branded drug profile pages.

There are twelve drug master file entries for tetrabenazine. Twelve suppliers are listed for this compound.

Summary for tetrabenazine

US Patents:	0
Tradenames:	2
Applicants:	12
NDAs:	12
Drug Master File Entries:	12
Finished Product Suppliers / Packagers:	12
Raw Ingredient (Bulk) Api Vendors:	134
Clinical Trials:	13
Patent Applications:	3,993
Drug Prices:	Drug price trends for tetrabenazine
What excipients (inactive ingredients) are in tetrabenazine?	tetrabenazine excipients list
DailyMed Link:	tetrabenazine at DailyMed

See drug prices for tetrabenazine

Recent Clinical Trials for tetrabenazine

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
William Ondo, MD	Phase 4
The University of Texas Health Science Center, Houston	Phase 4
H. Lundbeck A/S	Phase 4

See all tetrabenazine clinical trials

Pharmacology for tetrabenazine

Drug Class	Vesicular Monoamine Transporter 2 Inhibitor
Mechanism of Action	Vesicular Monoamine Transporter 2 Inhibitors

Medical Subject Heading (MeSH) Categories for tetrabenazine

Adrenergic Uptake Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for tetrabenazine

N07XX	Other nervous system drugs
N07X	OTHER NERVOUS SYSTEM DRUGS
N07	OTHER NERVOUS SYSTEM DRUGS
N	Nervous system

US Patents and Regulatory Information for tetrabenazine

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Bionpharma	TETRABENAZINE	tetrabenazine	TABLET;ORAL	208826-001	Dec 18, 2017	AB	RX	No	No
Hetero Labs Ltd V	TETRABENAZINE	tetrabenazine	TABLET;ORAL	204574-002	Feb 3, 2016	AB	RX	No	No
Slate Run Pharma	TETRABENAZINE	tetrabenazine	TABLET;ORAL	213316-002	Jan 22, 2020	AB	RX	No	No

Tetrabenazine Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Tetrabenazine

Introduction to Tetrabenazine

Tetrabenazine, marketed under the brand name Xenazine, is a medication specifically approved by the FDA for the treatment of chorea associated with Huntington's disease (HD), a neurodegenerative disorder characterized by involuntary movements.

Market Size and Growth

The global Huntington's disease treatment market, in which tetrabenazine plays a significant role, is projected to experience substantial growth. As of 2023, the global market size was valued at USD 1.14 billion and is expected to grow to USD 3.06 billion by 2032, with a Compound Annual Growth Rate (CAGR) of 11.7% during the forecast period from 2024 to 2032[1].

Segment Dominance

Tetrabenazine has historically held the largest share in the global Huntington’s disease treatment market. In 2023, the tetrabenazine segment led the market, driven by its effectiveness in managing chorea, a common symptom of HD. It is the first FDA-approved drug specifically designed to manage chorea, making it a go-to treatment for HD patients[1][4].

Factors Driving Growth

Several factors contribute to the growth of the tetrabenazine market:

Increasing Prevalence of Huntington’s Disease

The growing prevalence of Huntington’s disease globally is a significant driver. As awareness and diagnosis rates increase, so does the demand for effective treatments like tetrabenazine[1][4].

Regulatory Approvals and Generic Versions

The availability of generic versions of tetrabenazine has boosted its adoption. Additionally, regulatory approvals and the launch of new formulations by key players further propel the market growth[1].

Government Support and Awareness

Active support from government authorities to increase awareness of HD treatment measures also drives market growth. This includes initiatives to educate healthcare providers and patients about available treatments[1].

Distribution Channels

The market is segmented into hospital pharmacies, drug stores & retail pharmacies, and online pharmacies. Hospital pharmacies play a crucial role in the distribution of tetrabenazine, with insurance coverage provided by these pharmacies fostering segment growth[1].

Geographical Performance

North America dominates the market for Huntington’s disease treatments, including tetrabenazine. This region is expected to continue its dominance due to the high prevalence of HD and strong research and development investments[1][4].

Competitive Landscape

Teva Pharmaceutical Industries Ltd., H. Lundbeck A/S, and Bausch Health Companies Inc. are among the leading players in the tetrabenazine market. These companies are involved in the development and distribution of both branded and generic versions of tetrabenazine[1].

Adherence and Patient Outcomes

Real-world adherence data indicate that while tetrabenazine is effective, patients treated with deutetrabenazine (a related drug) show higher adherence rates and lower discontinuation rates. However, tetrabenazine remains a preferred choice due to its established efficacy and safety profile[2].

Safety and Side Effects

Tetrabenazine can cause serious side effects, including depression, suicidal thoughts, and suicidal actions. Patients with untreated or poorly controlled depression are advised against starting tetrabenazine, and close monitoring is recommended for any changes in mood or behavior[5].

Financial Trajectory

The financial trajectory for tetrabenazine is positive, driven by its market dominance and growing demand. Here are some key financial highlights:

• Revenue Share: In 2024, the tetrabenazine segment registered the highest revenue share in the global market, with a 53.6% market share[4].
• Market Growth: The segment is expected to continue growing, driven by its effectiveness in managing HD symptoms and the increasing awareness of HD treatments[1][4].
• Generic Competition: While generic versions of tetrabenazine are available, the branded segment, including Xenazine, continues to grow due to its safety profile and buyer confidence[4].

Challenges and Opportunities

High Treatment Costs

One of the challenges facing the tetrabenazine market is the high treatment cost, which can be a financial hardship for individuals and healthcare systems, particularly in areas with constrained funding[3].

Competition from Alternative Therapies

The market may face competition from currently available drugs or new treatments for the symptomatic treatment of HD. However, tetrabenazine’s established efficacy and safety profile help it maintain its market position[3].

Research and Development

The ongoing research and development in HD treatments, including novel formulations and gene therapies, present opportunities for growth. New drug formulations with lesser side effects could further increase the revenue share of tetrabenazine and related treatments[1][4].

Key Takeaways

• Tetrabenazine dominates the Huntington’s disease treatment market due to its effectiveness in managing chorea.
• The global market for HD treatments is projected to grow significantly, driven by increasing prevalence and awareness.
• North America is the leading region for tetrabenazine sales, supported by strong R&D investments.
• Despite challenges such as high treatment costs and competition, tetrabenazine’s established safety and efficacy profile ensure its continued market growth.
• Ongoing R&D activities and the launch of new formulations are expected to fuel further growth.

FAQs

1. What is tetrabenazine used for? Tetrabenazine is used to treat the involuntary movements (chorea) associated with Huntington's disease.

2. What are the potential side effects of tetrabenazine? Tetrabenazine can cause serious side effects including depression, suicidal thoughts, and suicidal actions. It is also associated with other side effects like drowsiness and sedation.

3. Which region dominates the market for tetrabenazine? North America dominates the market for Huntington’s disease treatments, including tetrabenazine, due to the high prevalence of HD and strong R&D investments.

4. What are the key drivers of the tetrabenazine market? The key drivers include the increasing prevalence of Huntington’s disease, regulatory approvals, availability of generic versions, and government support for awareness and treatment measures.

5. How does tetrabenazine compare to deutetrabenazine in terms of patient adherence? Patients treated with deutetrabenazine show higher adherence rates and lower discontinuation rates compared to those treated with tetrabenazine, although tetrabenazine remains a preferred choice due to its established efficacy and safety profile.

Cited Sources

1. Fortune Business Insights: Huntington's Disease Treatment Market Size, Share [2032]
2. Analysis Group: Real-World Adherence to Tetrabenazine or Deutetrabenazine Among Patients With Huntington's Disease: A Retrospective Database Analysis
3. Verified Market Research: Deutetrabenazine Market Size, Share, Scope & Forecast
4. Research Nester: Huntington's Disease Treatment Market Size & Share, Forecast
5. Xenazine USA: Treatment for Chorea Associated with Huntington's Disease