austedo Drug Patent Profile

Which patents cover Austedo, and when can generic versions of Austedo launch?

Austedo is a drug marketed by Teva Branded Pharm and Teva and is included in two NDAs. There are fifteen patents protecting this drug and one Paragraph IV challenge.

This drug has one hundred and thirty patent family members in thirty-four countries.

The generic ingredient in AUSTEDO is deutetrabenazine. One supplier is listed for this compound. Additional details are available on the deutetrabenazine profile page.

DrugPatentWatch^® Generic Entry Outlook for Austedo

Austedo was eligible for patent challenges on April 3, 2021.

There has been one patent litigation case involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

Indicators of Generic Entry

Summary for austedo

International Patents:	130
US Patents:	14
Applicants:	2
NDAs:	2
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	12
Clinical Trials:	4
Patent Applications:	18
Drug Prices:	Drug price information for austedo
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for austedo
What excipients (inactive ingredients) are in austedo?	austedo excipients list
DailyMed Link:	austedo at DailyMed

See drug prices for austedo

Recent Clinical Trials for austedo

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

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

See all austedo clinical trials

Paragraph IV (Patent) Challenges for AUSTEDO

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 austedo

austedo is protected by fourteen US patents.

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	216354-008	Jul 1, 2024		RX	Yes	No					Y
Teva	AUSTEDO XR	deutetrabenazine	TABLET, EXTENDED RELEASE;ORAL	216354-004	May 29, 2024		RX	Yes	No					Y
Teva Branded Pharm	AUSTEDO	deutetrabenazine	TABLET;ORAL	208082-003	Apr 3, 2017		RX	Yes	Yes					Y
Teva Branded Pharm	AUSTEDO	deutetrabenazine	TABLET;ORAL	208082-003	Apr 3, 2017		RX	Yes	Yes					Y
Teva	AUSTEDO XR	deutetrabenazine	TABLET, EXTENDED RELEASE;ORAL	216354-003	Feb 17, 2023		RX	Yes	No					Y
Teva	AUSTEDO XR	deutetrabenazine	TABLET, EXTENDED RELEASE;ORAL	216354-005	May 29, 2024		RX	Yes	No					Y

International Patents for austedo

When does loss-of-exclusivity occur for austedo?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Australia

Brazil

Canada

China

European Patent Office

Hong Kong

India

Japan

New Zealand

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering austedo around the world.

Country	Patent Number	Title	Estimated Expiration
South Korea	102528845
Japan	6932641
Eurasian Patent Organization	201992168
Israel	288712
Australia	2020205297
Australia	2021204740

Market Dynamics and Financial Trajectory for Austedo (Deutetrabenazine)

Last updated: July 27, 2025

Introduction

Austedo (deutetrabenazine), developed by Teva Pharmaceutical Industries, has established itself as a pivotal therapeutic agent in the management of chorea associated with Huntington’s disease and tardive dyskinesia. Since its FDA approval in 2017, Austedo has navigated complex market dynamics influenced by clinical efficacy, competitive landscape, patient population needs, and regulatory considerations. This report offers an in-depth analysis of the current market environment and the financial trajectory for Austedo, providing valuable insights for industry stakeholders, investors, and strategic partners.

Market Overview

Therapeutic Focus and Approved Indications

Austedo’s primary indications—Huntington’s disease chorea and tardive dyskinesia—are characterized by unmet clinical needs. Huntington's disease is a rare, hereditary neurodegenerative disorder with no curative treatments, making symptomatic management paramount. Tardive dyskinesia, often resulting from long-term antipsychotic use, affects a significant subset of psychiatric patients, with prevalence estimates between 20-50% among long-term medication users (1).

Market Size and Growth Potential

The global neuropsychiatric disorder market was valued at approximately $21 billion in 2022, with dyskinesia-related segments projected to grow at a CAGR of ~7% through 2030 (2). The specific market for drugs treating Huntington’s chorea and tardive dyskinesia, though smaller owing to rarity, remains a lucrative niche driven by increasing diagnoses, aging populations, and heightened awareness.

Current Competitive Landscape

Austedo competes primarily with older VMAT2 inhibitors such as tetrabenazine, valbenazine (Ingrezza), and emerging therapies under development. Valbenazine, approved in 2017 for tardive dyskinesia, has captured substantial market share due to its improved safety profile (3). Meanwhile, tetrabenazine remains a mainstay but is limited by side effects. The competitive advantage of Austedo lies in its twice-daily dosing and reduced side effect profile, mainly fewer symptoms of depression and sedation.

Market Dynamics Influencing Austedo

Regulatory Environment

The FDA’s approval of Austedo utilizing new drug application (NDA) pathways underscored its recognition of clinical need. The reduced dosing frequency and improved safety margin over tetrabenazine have facilitated market adoption. However, regulatory hurdles remain, especially concerning off-label use and long-term safety data, which could impact future access and reimbursement.

Pricing and Reimbursement Landscape

Austedo’s premium pricing, approximately $40,000–$50,000 annually per patient, relies heavily on reimbursement policies. Insurance coverage varies across regions, with payers scrutinizing cost-effectiveness and long-term benefits. The introduction of biosimilars or generics could exert downward pressure, though none currently threaten Austedo directly due to patent protections and formulation differences.

Clinical Adoption and Prescriber Dynamics

Physician familiarity and clinical guidelines significantly influence Austedo’s prescribing patterns. Increased awareness, education campaigns, and post-marketing surveillance data demonstrating tolerability expand its uptake. Off-label use in other hyperkinetic movement disorders remains a potential growth avenue, albeit with regulatory caution.

Patient Demographics and Disease Epidemiology

The prevalence of Huntington’s disease remains steady, approximately 6-10 cases per 100,000 globally (4). Tardive dyskinesia affects a broader patient base, especially among older adults on neuroleptics. An aging population and increased antipsychotic utilization may elevate the latter’s market size, potentially amplifying Austedo’s demand.

Financial Trajectory and Sales Projections

Historical Sales Performance

Austedo’s initial launch in 2017 faced slow uptake, limited by provider familiarity and reimbursement hurdles. Nonetheless, sales growth accelerated post-2018, reaching approximately $250 million globally in 2022 (5). Growth was notably driven by expanded indications and improved market access strategies.

Forecasting Future Revenue

Projections indicate steady growth with a CAGR of 10-12% through 2030, driven by:

• Expansion in Tardive Dyskinesia Treatment: As awareness increases, prescriptions are expected to rise, especially given the expanding use of antipsychotics among aging populations.

• Geographical Expansion: Entry into emerging markets such as Asia-Pacific, Latin America, and parts of Europe will broaden revenue streams. Regulatory approvals in these regions are pivotal.

• Pipeline Development and Label Expansion: Ongoing clinical trials and potential new indications (e.g., Parkinson’s disease dyskinesia) could intensify market penetration.

Risks to Financial Growth

Key risks include:

• Patent Expiry and Generic Competition: The patent for Austedo is expected to expire around 2030. Entry of generic deutetrabenazine formulations would significantly undercut pricing and sales.

• Regulatory or Clinical Setbacks: Future safety concerns or failure to demonstrate superiority or equivalence could hinder uptake.

• Competitive Innovations: Development of novel therapies with superior safety or efficacy profiles could reduce Austedo’s market share.

Emerging Trends Impacting Future Trajectory

Personalized Medicine and Biomarker Development

Advances in genetic and biomarker research might enable tailored treatments, improving patient outcomes. Such developments could influence prescribing practices and market segmentation.

Digital Health Solutions

Integration of digital monitoring devices to assess movement disorders could enhance treatment adherence and efficacy assessments, indirectly benefiting Austedo’s market position.

Policy and Reimbursement Fluctuations

Healthcare policies favoring cost-effective treatments could apply pressure on Austedo prices, particularly when generics become available. Negotiation and value-based agreements will be crucial to sustain revenue.

Conclusion

Austedo is positioned within a niche but expanding segment of neurodegenerative and movement disorder therapeutics. Its market dynamics are shaped by clinical efficacy, safety profiles, regulatory pathways, and reimbursement landscapes. While current financial growth appears promising, long-term success will depend on innovative market strategies, pipeline development, and navigating patent exclusivity. Investors and industry players must monitor evolving regulatory policies, competitive developments, and demographic trends to optimize fiscal planning.

Key Takeaways

• Austedo’s revenue is driven by its unique position in treating chorea associated with Huntington’s disease and tardive dyskinesia, with steady growth projected through 2030.
• Market expansion is contingent upon increased prescriber awareness, geographic entry, and evolving reimbursement policies.
• Patent expiry and generic formulations pose significant future risks to fiscal performance.
• Competitive landscape evolution, especially by valbenazine, influences market share and pricing power.
• Emerging trends in personalized medicine and digital health could complement Austedo’s market presence, optimizing patient outcomes and potentially expanding indications.

FAQs

1. What are the primary drivers behind Austedo's market growth?
   Increasing prevalence of movement disorders, greater physician awareness, expanded indications, and geographic market expansion primarily drive growth.

2. When is patent expiration expected for Austedo, and how might it impact sales?
   Patent protection is anticipated to expire around 2030, potentially leading to generic competition that could significantly reduce sales unless mitigated by alternative revenue strategies.

3. How does Austedo compare to valbenazine in clinical efficacy and safety?
   Both drugs target VMAT2 and are effective for tardive dyskinesia, but Austedo offers a more convenient dosing schedule with a potentially better side-effect profile, influencing prescriber preference.

4. What are the major risks facing Austedo’s future financial trajectory?
   Patent expirations, high price sensitivity among payers, emergence of competitive therapies, and regulatory setbacks pose substantial risks.

5. Are there prospects for additional indications or expanded uses for Austedo?
   Clinical trials exploring its efficacy in other hyperkinetic disorders and Parkinsonian dyskinesia may open new markets, contingent upon successful outcomes and regulatory review.

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References

[1] American Psychiatric Association. (2021). Diagnostic and Statistical Manual of Mental Disorders (DSM-5®).
[2] Market Research Future. (2023). Neuropsychiatric Disorders Market Analysis.
[3] Ingrezza (valbenazine) FDA label.
[4] Walker, F. O. (2007). Huntington’s disease. Lancet, 369(9559), 218-228.
[5] Teva Pharmaceuticals Annual Report, 2022.