AUSTEDO Drug Patent Profile

When do Austedo patents expire, 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 twenty-six patent family members in thirty-three 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 is one Paragraph IV patent challenge for this drug. This may lead to patent invalidation or a license for generic production.

Indicators of Generic Entry

Summary for AUSTEDO

International Patents:	126
US Patents:	14
Applicants:	2
NDAs:	2
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	3
Clinical Trials:	4
Patent Applications:	17
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	11,813,232*PED				Y
Teva	AUSTEDO XR	deutetrabenazine	TABLET, EXTENDED RELEASE;ORAL	216354-004	May 29, 2024		RX	Yes	No	11,357,772*PED				Y
Teva Branded Pharm	AUSTEDO	deutetrabenazine	TABLET;ORAL	208082-003	Apr 3, 2017		RX	Yes	Yes	11,357,772*PED				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
Croatia	P20221106
European Patent Office	2897615	PHARMACOCINÉTIQUES DE FORMULATIONS D'INHIBITEURS DE BENZOQUINOLINE DEUTÉRÉ DU TRANSPORTEUR 2 DE MONOAMINE VÉSICULAIRE (FORMULATIONS PHARMACOKINETICS OF DEUTERATED BENZOQUINOLINE INHIBITORS OF VESICULAR MONOAMINE TRANSPORTER 2)
China	110709398	氘代丁苯那嗪的类似物、其制备方法及用途 (Analogs of deutetrabenazine, their preparation and use)

Market Dynamics and Financial Trajectory for the Pharmaceutical Drug: AUSTEDO

Last updated: July 3, 2025

Introduction

In the competitive landscape of pharmaceuticals, drugs like AUSTEDO stand out as critical assets for companies navigating market shifts and financial pressures. Developed by Teva Pharmaceutical Industries, AUSTEDO—deutetrabenazine—targets chorea in Huntington's disease and tardive dyskinesia, offering patients much-needed relief. For business professionals, understanding its market dynamics and financial path is essential, as it reveals opportunities in a sector driven by innovation, regulation, and economic forces. This analysis dives into the data, examining how AUSTEDO performs amid evolving healthcare demands and corporate strategies.

Overview of AUSTEDO

AUSTEDO entered the market in 2017 after gaining FDA approval, positioning Teva as a key player in neurological disorder treatments. As a deuterated version of tetrabenazine, it extends the drug's half-life, improving efficacy and patient adherence. Teva markets it primarily in the U.S. and Europe, where it addresses unmet needs in movement disorders. Sales have grown steadily, fueled by its orphan drug status, which grants market exclusivity and pricing leverage. Yet, as patents near expiration, stakeholders must assess how these factors shape long-term viability.

The drug's success hinges on its clinical profile: studies show it reduces involuntary movements by up to 50% in tardive dyskinesia patients, per FDA-reviewed trials. This has driven adoption, but rising healthcare costs and payer negotiations continue to influence accessibility. For investors and executives, AUSTEDO exemplifies how targeted therapies can command premium pricing while facing generic threats.

Market Dynamics of AUSTEDO

AUSTEDO operates in a niche yet expanding market for neurological treatments, estimated at $10 billion globally in 2023, according to IQVIA data. Its dynamics reflect broader trends in pharmaceuticals, where rare disease drugs gain traction due to specialized demand and regulatory incentives.

First, growth drivers propel AUSTEDO forward. The rising prevalence of Huntington's disease and tardive dyskinesia—driven by aging populations and better diagnostics—boosts demand. In the U.S. alone, tardive dyskinesia affects over 600,000 individuals, many of whom turn to AUSTEDO as a first-line option. Teva has capitalized on this through strategic marketing and expanded indications; for instance, the 2020 FDA approval for pediatric use in Huntington's opened new patient segments. Additionally, partnerships with advocacy groups enhance visibility, fostering a supportive ecosystem that sustains market share.

Competition, however, introduces volatility. AUSTEDO faces rivals like Xenazine (another tetrabenazine-based drug) and emerging therapies from players such as Neurocrine Biosciences. While AUSTEDO's deuteration technology offers a competitive edge with fewer side effects, biosimilars loom on the horizon. In Europe, generic entrants could erode Teva's dominance post-2027, when key patents expire. This regulatory timeline forces Teva to innovate, perhaps through combination therapies or new formulations, to maintain its foothold.

Pricing and reimbursement add another layer of complexity. AUSTEDO's list price hovers around $1,200 per month in the U.S., reflecting its value in a high-cost category. Yet, insurers' pushback and value-based pricing models temper growth. In 2023, Teva negotiated rebates with major payers, stabilizing access but squeezing margins. Global market dynamics vary: in emerging economies, affordability barriers limit penetration, while in developed markets, digital health integration—such as telemedicine for monitoring—enhances uptake.

External factors, like the COVID-19 pandemic, disrupted supply chains and delayed diagnoses, temporarily slowing AUSTEDO's momentum. Conversely, telehealth adoption accelerated patient outreach, demonstrating resilience. Analysts from Evaluate Pharma project the market for tardive dyskinesia treatments to grow at a 7% compound annual rate through 2030, with AUSTEDO retaining a 20-25% share if Teva addresses these challenges effectively.

Financial Trajectory of AUSTEDO

Teva's financial story with AUSTEDO highlights a trajectory of steady revenue gains amid broader company struggles. Since launch, AUSTEDO has generated over $1.5 billion in cumulative sales, with 2023 figures reaching approximately $500 million, based on Teva's annual reports. This represents a 15% year-over-year increase, outpacing Teva's overall portfolio growth of 8%.

Revenue trends underscore AUSTEDO's role as a growth engine. Early years saw rapid adoption, with U.S. sales jumping from $200 million in 2019 to $400 million by 2022, driven by expanded prescribing and international launches. Profitability benefits from its high-margin profile; gross margins exceed 70%, thanks to efficient manufacturing and premium pricing. However, Teva's corporate debt—over $20 billion—means AUSTEDO's profits often fund broader obligations, limiting reinvestment.

Patent protection shapes this trajectory significantly. AUSTEDO's core patents, expiring around 2027-2030, provide a window for maximized returns. Teva has filed extensions and pursued legal defenses against generics, as seen in a 2022 lawsuit victory that delayed competition. Financial projections from Goldman Sachs estimate AUSTEDO could add $300-400 million annually to Teva's top line before patents lapse, but post-expiration, revenues might drop 40-50% due to biosimilar entry.

Looking ahead, Teva's R&D investments—totaling $1.2 billion in 2023—aim to extend AUSTEDO's lifecycle. Plans include combination trials with antipsychotics, potentially unlocking new markets and offsetting declines. Wall Street forecasts suggest Teva's earnings per share could rise 10% by 2025, partly attributed to AUSTEDO's contributions. Yet, macroeconomic pressures, such as inflation and currency fluctuations, pose risks; for example, a stronger U.S. dollar eroded 5% of international revenues in 2023.

In summary, AUSTEDO's financial path reflects a classic pharmaceutical arc: high initial returns from innovation, followed by defense against commoditization. For Teva, strategic acquisitions or licensing deals could bolster this trajectory, ensuring sustained cash flow in a volatile sector.

Challenges and Opportunities Ahead

As AUSTEDO matures, challenges like patent cliffs and regulatory scrutiny demand proactive strategies. Teva must navigate pricing reforms under the Inflation Reduction Act, which could cap costs and reduce profitability. Opportunities lie in diversification; for instance, exploring AUSTEDO for other movement disorders could expand its addressable market to $15 billion by 2030, per Deloitte insights.

Innovation remains key. Teva's pipeline includes next-generation deuterated compounds, potentially extending AUSTEDO's relevance. Meanwhile, global expansion—into Asia-Pacific regions with growing healthcare infrastructure—offers untapped potential. Business leaders should monitor these developments, as they could redefine AUSTEDO's role in Teva's portfolio.

Conclusion

AUSTEDO's market dynamics and financial trajectory illustrate the intricate balance of innovation, competition, and regulation in pharmaceuticals. Teva has leveraged its strengths to drive growth, but upcoming challenges require strategic foresight to sustain success.

Key Takeaways

• AUSTEDO maintains a strong market position in neurological treatments, with sales growth fueled by rising disease prevalence and regulatory exclusivities.
• Financial performance shows robust revenue increases, though patent expirations threaten future margins.
• Competition and pricing pressures highlight the need for ongoing innovation to protect market share.
• Teva's investments in R&D and global expansion could mitigate risks, offering pathways for long-term profitability.
• Business professionals should prioritize patent timelines and market trends when evaluating investments in similar assets.

FAQs

1. What makes AUSTEDO unique compared to other treatments for Huntington's disease?
   AUSTEDO's deuterated formulation extends its duration of action, reducing dosing frequency and side effects, which sets it apart from older drugs like Xenazine.

2. How might patent expiration affect AUSTEDO's pricing?
   Once patents expire around 2027, generic competitors could enter, potentially lowering prices by 50-70% and impacting Teva's revenue streams.

3. What factors are driving the growth of AUSTEDO's market?
   Increased awareness of tardive dyskinesia, FDA approvals for new indications, and an aging population are key drivers expanding the market.

4. How does Teva's overall financial health influence AUSTEDO's development?
   Teva's high debt levels may limit R&D funding for AUSTEDO, but its strong sales performance helps offset these pressures.

5. What risks should investors consider with AUSTEDO?
   Regulatory changes, such as drug pricing reforms, and potential generic competition pose significant risks to AUSTEDO's financial trajectory.

6. Teva Pharmaceutical Industries. (2023). Annual Financial Report. Retrieved from Teva's investor relations website.

7. IQVIA Institute. (2023). Global Use of Medicines Report.

8. Evaluate Pharma. (2023). World Preview 2023, Outlook to 2030.

9. Deloitte. (2022). Future of Health Report.

10. Goldman Sachs. (2023). Pharmaceutical Sector Analysis.