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 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	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
Chile	2017002223
Denmark	3265085
Hong Kong	1249860

Market Dynamics and Financial Trajectory of Austedo (deutetrabenazine)

Last updated: December 25, 2025

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Executive Summary

Austedo (deutetrabenazine), developed by Teva Pharmaceutical Industries Ltd., is a prescription medication approved for tardive dyskinesia (TD) and chorea associated with Huntington’s disease. Since its approval by the FDA in 2017, Austedo has experienced notable market growth driven by an aging population, increasing prevalence of neurological disorders, and expanding indications. This analysis explores the current market landscape, competitive positioning, financial trajectories, key drivers, barriers, and future outlook for Austedo.

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Introduction: Overview of Austedo

Attribute	Details
Generic Name	Deutetrabenazine
Brand Name	Austedo
Manufacturer	Teva Pharmaceutical Industries Ltd.
Approved Indications	Tardive dyskinesia, chorea in Huntington’s disease
FDA Approval Date	April 2017 (Huntington’s chorea), August 2017 (tardive dyskinesia)
Pharmacological Class	Vesicular monoamine transporter 2 (VMAT2) inhibitor
Dosage Form	Tablets (6 mg, 9 mg, 12 mg)

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Market Dynamics: Key Drivers and Trends

1. Epidemiological Trends

Condition	Prevalence Estimates	Market Implication
Tardive Dyskinesia (TD)	~500,000-1,000,000 US adults (Approx.), with increased recognition	Growth driven by antipsychotic use in schizophrenia and bipolar disorder
Huntington’s Disease (HD)	~30,000 in the US, worldwide ~150,000	Limited but stagnant; unmet needs remain for symptomatic treatments

2. Therapeutic Landscape

Competitor Drugs	Mechanism	Market Share (2022)	Notes
Valbenazine (Ingrezza)	VMAT2 inhibitor	~60%	Approved 2017, leading in TD treatment
Deutetrabenazine (Austedo)	VMAT2 inhibitor	~30%	Differentiated by dosing flexibility and side-effect profile
Reserpine, other off-label agents	Various (older drugs, limited approvals)	~10%	Declining due to safety and efficacy concerns

3. Regulatory and Policy Influences

• Orphan Drug Designations: Both Austedo and Ingrezza have orphan status, incentivizing development but also affecting market exclusivities.
• Pricing and Reimbursement: High cost (~$7,000-$8,000/month), with coverage depending on payer policies and prior authorization requirements.

4. Market Penetration and Adoption

• Physician Awareness: Increasing, driven by growing publications and clinical guidelines.
• Patient Population Expansion: As awareness of TD increases, off-label use and early intervention strategies are emerging.
• Side-Effect Profile: Generally well-tolerated, with manageable adverse events aiding adherence.

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Financial Trajectory: Revenue and Market Forecast

1. Revenue Evolution (2017-2022)

Year	Estimated US Sales (USD millions)	Growth Rate	Key Factors
2017	$170	-	Launch year, initial adoption
2018	$280	64%	Increased awareness, expanded indications
2019	$430	53%	Competitive positioning strengthening
2020	$510	19%	COVID-19 impact, slower growth
2021	$520	2%	Market saturation, stabilizing sales
2022	$530	2%	Mature phase, steady demand

2. Market Forecast (2023-2028)

Year	Projected US Sales (USD millions)	CAGR (Compound Annual Growth Rate)	Assumptions and Drivers
2023	$550	3.8%	Incremental increase from new healthcare provider adoption
2024	$600	9.1%	Expansion in international markets, new indication trials, off-label use
2025	$650	8.3%	Growing awareness, improved reimbursement policies
2026	$700	7.7%	Market penetration into newly diagnosed populations
2027	$750	7.1%	Potential label expansion, pipeline developments
2028	$800	6.7%	Sustained steady growth

3. Key Revenue Drivers

Drivers	Impact
Growing prevalence of TD, especially in elderly	Aging population increases at-risk cohort
Physician and patient awareness	Leads to increased prescribing
New indications and label expansion	Potential growth avenues
Reimbursement landscape	Payer coverage persistence influences sales
Competition intensity	Affects market share and pricing dynamics

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Competitive Landscape

Company / Drug	Status	Key Attributes	Market Share (2022)	Regulatory Status
Teva (Austedo)	Leading VMAT2 inhibitor	Dosing flexibility, established safety profile	~30%	Strong commercial presence
Neurocrine (Ingrezza)	Leading TD therapy	Higher market share due to earlier approval	~60%	Market leader
Others	Reserpine, off-label use	Outdated, less favored	~10%	Declining reliance

Barriers to Growth

Barrier	Description
High cost and reimbursement hurdles	Limits access for some patients; necessitates prior authorization
Competition from Ingrezza	Higher market penetration and brand recognition for competitor
Off-label limitations	Restricted use outside approved indications
Market saturation	Plateauing of sales in mature markets
Regulatory challenges	Potential restrictions on off-label use, label expansion hurdles

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Future Outlook: Opportunities and Risks

Opportunities

• Label Expansion: Investigating Austedo for additional indications such as tardive dystonia, Tourette syndrome, or other hyperkinetic movement disorders.
• International Expansion: Growing markets in Europe, Asia, where neurological disorder burdens are rising.
• Combination Therapies: Potential for synergistic treatments with other neurologics.
• Pipeline Development: Teva and competitors exploring next-gen VMAT2 inhibitors or alternative mechanisms.

Risks

• Market Competition: Ingrezza’s dominance as market leader, potential for upcoming generics.
• Patent and Exclusivity: Patent expirations could erode revenue.
• Pricing Pressures: Growing focus on drug affordability might impact pricing strategies.
• Clinical Efficacy and Safety: Any emerging safety concern could affect prescriptions.

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Policy and Regulatory Environment

Year	Key Policy/Regulation	Impact on Austedo
2017	FDA Fast Track and Orphan Drug Designation	Accelerated approval; incentives for development
2018	CMS Coverage and Coding updates	Reimbursement clarity for US providers
2020+	Increasing emphasis on drug price transparency	Potential impact on pricing strategies

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Comparison of Austedo and Ingrezza

Feature	Austedo (deutetrabenazine)	Ingrezza (valbenazine)
Approval Year	2017	2017
Indications	TD, Huntington’s chorea	TD
Dosage Flexibility	Yes (multiple dosing options)	Yes
Side Effect Profile	Lower sedation, manageable adverse events	Slightly higher sedation incidents
Market Share (2022)	~30%	~60%
Pricing	~$7,000/month	~$8,000/month

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Key Takeaways

• Market Maturity: Austedo has established itself as a significant player in TD treatment, yet faces stiff competition from Ingrezza and potential generics.
• Growth Potential: Opportunities lie in label expansion, international markets, and off-label use, with a projected CAGR of near 4-10% over the next five years.
• Pricing and Reimbursements: High costs influence access; efficient reimbursement strategies remain crucial.
• Competitive Dynamics: Dominance of Ingrezza necessitates differentiation through dosing, safety profile, and clinical evidence.
• Innovation & Pipeline: Continued research into broader neurological indications could sustain long-term growth.

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FAQs

1. What factors influence Austedo’s market share in the US?
Market share is driven by physician prescribing habits, patient awareness, reimbursement policies, and competition mainly from Ingrezza.

2. How does Austedo's safety profile compare with competitors?
Austedo generally exhibits a favorable safety profile with fewer sedative effects, making it suitable for long-term management.

3. Are there upcoming regulatory approvals that could impact Austedo?
Potential label expansions for other movement disorders and international approvals could diversify revenue streams.

4. What market strategies can Teva pursue for growth?
Developing new indications, optimizing reimbursement, international expansion, and differentiation through clinical data are key.

5. How does the cost of Austedo influence patient access?
High monthly costs necessitate prior authorization and impact affordability, prompting reliance on insurance coverage.

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References

[1] FDA Official Website — Austedo (deutetrabenazine) approvals. (2017).
[2] IQVIA Data — US pharmaceutical sales data, 2017-2022.
[3] Teva Annual Reports — Financials and strategic initiatives. (2017-2022).
[4] MarketResearch.com — Isolated movement disorder markets. (2022).
[5] CMS Policies & Reimbursements — Coverage for movement disorder drugs. (2022).

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This comprehensive review offers a strategic perspective for stakeholders evaluating Austedo’s market position and financial outlook within evolving neurological therapeutics landscape.