Deutetrabenazine - Generic Drug Details

What are the generic sources for deutetrabenazine and what is the scope of freedom to operate?

Deutetrabenazine is the generic ingredient in two branded drugs marketed by Teva and Teva Branded Pharm, and is included in two NDAs. There are fifteen patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Deutetrabenazine has one hundred and forty-eight patent family members in thirty-four countries.

One supplier is listed for this compound.

Summary for deutetrabenazine

International Patents:	148
US Patents:	15
Tradenames:	2
Applicants:	2
NDAs:	2
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	164
Clinical Trials:	15
Patent Applications:	3,861
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for deutetrabenazine
What excipients (inactive ingredients) are in deutetrabenazine?	deutetrabenazine excipients list
DailyMed Link:	deutetrabenazine at DailyMed

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

Dosage:

TABLET;ORAL

Dosage:

TABLET, EXTENDED RELEASE;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.

Recent Clinical Trials for deutetrabenazine

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

Sponsor	Phase
Vanderbilt University Medical Center	Phase 2/Phase 3
Fundacion Huntington Puerto Rico	Phase 1
Teva Branded Pharmaceutical Products, R&D Inc.	Phase 1/Phase 2

See all deutetrabenazine clinical trials

Anatomical Therapeutic Chemical (ATC) Classes for deutetrabenazine

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

Paragraph IV (Patent) Challenges for DEUTETRABENAZINE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
AUSTEDO	Tablets	deutetrabenazine	6 mg, 9 mg and 12 mg	208082	2	2021-04-05

US Patents and Regulatory Information for deutetrabenazine

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Teva	AUSTEDO XR	deutetrabenazine	TABLET, EXTENDED RELEASE;ORAL	216354-006	May 29, 2024		RX	Yes	No					Y
Teva Branded Pharm	AUSTEDO	deutetrabenazine	TABLET;ORAL	208082-003	Apr 3, 2017		RX	Yes	Yes
Teva Branded Pharm	AUSTEDO	deutetrabenazine	TABLET;ORAL	208082-002	Apr 3, 2017		RX	Yes	No					Y
Teva	AUSTEDO XR	deutetrabenazine	TABLET, EXTENDED RELEASE;ORAL	216354-001	Feb 17, 2023		RX	Yes	No					Y
Teva	AUSTEDO XR	deutetrabenazine	TABLET, EXTENDED RELEASE;ORAL	216354-004	May 29, 2024		RX	Yes	No			Y
Teva	AUSTEDO XR	deutetrabenazine	TABLET, EXTENDED RELEASE;ORAL	216354-006	May 29, 2024		RX	Yes	No					Y
Teva Branded Pharm	AUSTEDO	deutetrabenazine	TABLET;ORAL	208082-001	Apr 3, 2017		RX	Yes	No					Y

International Patents for deutetrabenazine

Country	Patent Number	Title	Estimated Expiration
Chile	2022003512	Formas farmacéuticas osmóticas que comprenden deutetrabenazina y métodos de uso de las mismas
European Patent Office	2610254	DÉRIVÉS DEUTÉRÉS DE BENZOQUINOLINE EN TANT QU'INHIBITEURS DU TRANSPORTEUR DE MONOAMINE VÉSICULAIRE 2 (DEUTERATED BENZOQUINOLINE DERIVATIVES AS INHIBITORS OF VESICULAR MONOAMINE TRANSPORTER 2)
China	114767672	氘代丁苯那嗪或包含氘代丁苯那嗪的组合物 (Deuterated tetrabenazine or composition containing deuterated tetrabenazine)
Spain	2425623
South Africa	201902108	METHODS FOR THE TREATMENT OF ABNORMAL INVOLUNTARY MOVEMENT DISORDERS
Cyprus	1120060
Croatia	P20221106

Deutetrabenazine Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Deutetrabenazine

Introduction to Deutetrabenazine

Deutetrabenazine, marketed under the brand name AUSTEDO®, is a drug approved by the FDA for the treatment of chorea associated with Huntington’s disease and tardive dyskinesia in adults. Here, we delve into the market dynamics and financial trajectory of this significant pharmaceutical product.

Market Size and Growth Projections

The deutetrabenazine market is poised for substantial growth. By 2030, the market size is projected to reach USD 419.58 million, growing at a Compound Annual Growth Rate (CAGR) of 21.4% during the forecast period of 2024-2030[1].

Driving Factors

Growing Prevalence of Huntington’s Disease

The increasing prevalence of Huntington’s disease, a neurodegenerative illness characterized by involuntary movements, is a key driver of the deutetrabenazine market. This condition has a growing need for effective treatments, making deutetrabenazine a highly sought-after drug[1].

Unmet Medical Need

The scarcity of specific therapies for chorea linked to Huntington’s disease creates an unmet medical need that deutetrabenazine can fill. This gap in the medical field contributes significantly to the drug's market demand[1].

Clinical Efficacy and Safety Profile

Favorable clinical trial results showcasing the safety and efficacy of deutetrabenazine in treating chorea symptoms further fuel its market demand. The drug's positive clinical profile is a crucial factor in its adoption[1].

Challenges and Limitations

Restricted Indications and Patient Population

The primary indication for deutetrabenazine is the treatment of chorea associated with Huntington’s disease, which limits its market to a relatively small patient base. This narrow range of indications can hamper market growth[1].

High Treatment Costs

Deutetrabenazine, like other specialized drugs, can be expensive. This high cost presents a financial hardship for individuals and healthcare systems, particularly in regions with constrained medical funding[1].

Competition from Alternative Therapies

The market share of deutetrabenazine may be impacted by competition from other available drugs or new treatments for the symptomatic treatment of Huntington’s disease and tardive dyskinesia[1].

Adverse Effects and Safety Concerns

While deutetrabenazine has a generally favorable safety profile, it does come with potential adverse effects such as hyperprolactinemia and binding to melanin-containing tissues. These safety concerns need to be carefully managed[2].

Distribution Channels

Hospital Pharmacies

Deutetrabenazine is widely distributed through hospital pharmacies, especially for patients receiving care in a hospital setting. This channel ensures timely and controlled access to the medication[1].

Retail Pharmacies

The drug is also available in retail pharmacies for outpatient use and prescription refills, making it more accessible to a broader patient population[1].

Online Pharmacies

The emerging trend of online pharmacies is expected to increase market penetration by providing convenient access to deutetrabenazine for patients[1].

Geographical Market Dynamics

North America

North America, including the United States and Canada, is a significant market for deutetrabenazine due to the high prevalence of Huntington’s disease and well-established healthcare infrastructure. The region is expected to dominate the market during the forecast period[1][3].

Europe

Europe is another key market, with regional differences in disease prevalence, healthcare practices, and regulatory environments influencing the uptake of deutetrabenazine. The region is expected to grow at a high CAGR due to rising disease prevalence[1][4].

Asia-Pacific and Other Regions

The Asia-Pacific region and other areas such as Latin America and the Middle East & Africa also show potential for growth, driven by increasing awareness and improvements in healthcare infrastructure. However, these regions face challenges such as limited healthcare expenditure and lack of awareness about the disease[1][4].

Key Players

Major players in the deutetrabenazine market include Viatris Inc., Glenmark Pharmaceuticals Ltd., Alembic Pharmaceuticals Ltd., Teva Pharmaceutical Industries Ltd., and others. These companies are driving market growth through regulatory approvals, product launches, and strategic partnerships[1].

Financial Assistance and Affordability

To address the high treatment costs, various financial assistance programs are available. For example, ~90% of patients pay $10 or less out of pocket for deutetrabenazine, with some patients paying nothing due to preferred positioning on healthcare plans and copay cards[5].

Clinical Trials and Expansion

Teva Pharmaceutical Industries Ltd. has conducted clinical trials to evaluate deutetrabenazine for the treatment of tics in pediatric patients with Tourette Syndrome, although these trials did not meet their primary endpoints. Such efforts indicate ongoing research and potential future expansions of deutetrabenazine's indications[2].

Market Segments

Huntington’s Disease Treatment Market

Deutetrabenazine holds a significant portion of the global Huntington’s disease treatment market, driven by its strong potency and regulatory approvals. The global Huntington’s disease treatment market is projected to grow from $1.26 billion in 2024 to $3.06 billion by 2032, at a CAGR of 11.7%[3].

Tardive Dyskinesia Therapeutics Market

In the tardive dyskinesia therapeutics market, deutetrabenazine holds the second largest market share. The global market size for tardive dyskinesia therapeutics is projected to reach USD 5.09 billion by 2030, growing at a CAGR of 9.1% from 2023 to 2030[4].

Key Takeaways

• Market Growth: The deutetrabenazine market is expected to grow significantly, reaching USD 419.58 million by 2030.
• Driving Factors: Growing prevalence of Huntington’s disease, unmet medical need, and favorable clinical efficacy and safety profile.
• Challenges: Restricted indications, high treatment costs, competition from alternative therapies, and adverse effects.
• Distribution Channels: Hospital pharmacies, retail pharmacies, and online pharmacies.
• Geographical Dynamics: North America and Europe are key markets, with Asia-Pacific and other regions showing potential growth.
• Financial Assistance: Various programs make deutetrabenazine more affordable for patients.

Frequently Asked Questions

1. What is deutetrabenazine used for?

Deutetrabenazine is used for the treatment of chorea associated with Huntington’s disease and tardive dyskinesia in adults.

2. What is the projected market size of deutetrabenazine by 2030?

The deutetrabenazine market is projected to reach USD 419.58 million by 2030, growing at a CAGR of 21.4% during the forecast period of 2024-2030[1].

3. What are the main challenges facing the deutetrabenazine market?

The main challenges include restricted indications, high treatment costs, competition from alternative therapies, and potential adverse effects[1].

4. How is deutetrabenazine distributed?

Deutetrabenazine is distributed through hospital pharmacies, retail pharmacies, and online pharmacies[1].

5. What financial assistance is available for deutetrabenazine?

Various financial assistance programs are available, making deutetrabenazine affordable for most patients, with ~90% paying $10 or less out of pocket[5].

Cited Sources:

1. Verified Market Research - Deutetrabenazine Market Size, Share, Scope & Forecast
2. Teva Pharmaceutical Industries Ltd. - Teva Announces Registration Trials of Deutetrabenazine in Pediatric Patients with Tourette Syndrome
3. Fortune Business Insights - Huntington's Disease Treatment Market Size, Share
4. Fortune Business Insights - Tardive Dyskinesia Therapeutics Market Share & Growth
5. AUSTEDO HCP - Access & Affordability | Huntington's Disease Chorea