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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-four 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.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be March 18, 2034. This may change due to patent challenges or generic licensing.

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:	124
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

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

Constraining patent/regulatory exclusivity:

9,296,739*PED

NDA:

208082

Dosage:

TABLET;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 AUSTEDO

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

Sponsor	Phase
Teva Branded Pharmaceutical Products R&D, Inc.	Phase 2/Phase 3
Vanderbilt University Medical Center	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 and four FDA Regulatory Exclusivities.

This potential generic entry date is based on patent 9,296,739.

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

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	216354-002	Feb 17, 2023		RX	Yes	No	11,179,386*PED				Y
Teva	AUSTEDO XR	deutetrabenazine	TABLET, EXTENDED RELEASE;ORAL	216354-003	Feb 17, 2023		RX	Yes	Yes	11,357,772*PED				Y
Teva Branded Pharm	AUSTEDO	deutetrabenazine	TABLET;ORAL	208082-003	Apr 3, 2017		RX	Yes	Yes	9,814,708*PED				Y
Teva Branded Pharm	AUSTEDO	deutetrabenazine	TABLET;ORAL	208082-002	Apr 3, 2017		RX	Yes	No	12,016,858*PED				Y
Teva	AUSTEDO XR	deutetrabenazine	TABLET, EXTENDED RELEASE;ORAL	216354-008	Jul 1, 2024		RX	Yes	No	11,179,386*PED				Y
Teva	AUSTEDO XR	deutetrabenazine	TABLET, EXTENDED RELEASE;ORAL	216354-004	May 29, 2024		RX	Yes	No	12,016,858*PED				Y
Teva	AUSTEDO XR	deutetrabenazine	TABLET, EXTENDED RELEASE;ORAL	216354-007	May 29, 2024		RX	Yes	No	11,446,291*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
World Intellectual Property Organization (WIPO)	2010044981
Japan	6612420
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)
South Africa	201902108	METHODS FOR THE TREATMENT OF ABNORMAL INVOLUNTARY MOVEMENT DISORDERS
Spain	2425623
Japan	5970037
Lithuania	3061760

AUSTEDO Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Austedo

Introduction

Austedo, developed by Teva Pharmaceutical Industries, is a deuterated drug used primarily to treat tardive dyskinesia (TD) and chorea associated with Huntington's disease (HD). Here, we delve into the market dynamics and financial trajectory of Austedo, highlighting its performance, challenges, and future prospects.

Market Position and Dominance

Austedo has emerged as a market leader in the deuterated drugs segment. It holds a substantial market share, approximately 43% of the global deuterated drugs market, due to its exceptional effectiveness in treating specialized medical disorders like TD and HD[2][3].

Sales Performance

Despite facing challenges during the pandemic, Austedo has shown significant growth. In the third quarter of 2021, Austedo generated $201 million in sales, a 19% increase from the same period in 2020. By the end of 2021, its total sales for the year reached $520 million, although this was short of the projected $850 million target, requiring a substantial quarter-over-quarter increase to meet expectations[1].

In more recent times, Austedo has continued to contribute to Teva's financial growth. In the third quarter of 2023, revenues from Austedo in the North America segment were a key driver of Teva's overall revenue increase of 7% compared to the third quarter of 2022[4].

Market Growth Projections

The global deuterated drugs market, led by Austedo, is expected to experience robust growth. By 2031, the market is projected to reach a valuation of $780.7 million, growing at a CAGR of 11.25% from 2023 to 2031[2]. Another forecast indicates that the market will grow to $908.43 million by 2032, with a CAGR of 11.50% between 2024 and 2032[3].

Regional Dynamics

North America dominates the deuterated drugs market, driven by strong research infrastructure, advanced healthcare systems, and aggressive regulatory regimes. This region is expected to continue driving the market's growth due to the prevalence of rare diseases and the presence of regulatory agencies[2][3].

Competitive Landscape

Austedo faces competition from other VMAT2 inhibitors, such as Neurocrine’s Ingrezza. However, physicians are increasingly viewing Austedo and Ingrezza as similar in efficacy, with Austedo expected to capture 45% of the TD market at its peak[5].

Challenges and Opportunities

Pandemic Impact

The COVID-19 pandemic resulted in a drop in doctor visits, leading to fewer diagnoses and prescriptions of Austedo. However, Teva anticipates a rebound as psychiatrists return to their offices and the company's new ad campaigns take effect[1].

Regulatory Approvals

Recent regulatory approvals, such as the FDA approval of AUSTEDOXR (deutetrabenazine) extended-release tablets in February 2023, have bolstered Austedo's market position. These approvals expand the treatment options for patients and increase the drug's visibility among healthcare professionals[3].

Partnerships and Collaborations

Teva has entered into strategic partnerships to enhance the availability and reach of Austedo. For example, the collaboration with Jiangsu Nhwa Pharmaceutical Co., Ltd. aims to make Austedo more widely available in China's neuro-psychiatric healthcare market[3].

Financial Trajectory

Teva's financial results reflect the strong performance of Austedo. In the third quarter of 2023, Teva reported a 7% increase in revenues, largely driven by the solid performance of Austedo and other key products. The company has increased its revenue guidance for 2023 based on these strong results[4].

Revenue Growth

Austedo's revenue growth has been consistent, with significant contributions to Teva's overall revenue. The drug's success is a key component of Teva's "Pivot to Growth" strategy, which focuses on delivering growth through innovative products like Austedo[4].

Gross Profit Margin

The increase in revenues from Austedo has also positively impacted Teva's gross profit margin. In the third quarter of 2023, the gross profit margin was 48.1%, up from 46.4% in the third quarter of 2022, largely due to the favorable mix of products, including Austedo[4].

Key Takeaways

• Market Leadership: Austedo dominates the deuterated drugs market with a significant market share.
• Sales Growth: Despite pandemic challenges, Austedo has shown consistent sales growth and is expected to continue this trend.
• Regulatory Approvals: Recent approvals, such as AUSTEDOXR, have enhanced Austedo's market position.
• Partnerships: Strategic collaborations are expanding Austedo's reach and availability.
• Financial Performance: Austedo is a key driver of Teva's revenue growth and increased financial guidance.

FAQs

What is Austedo used for?

Austedo is used to treat tardive dyskinesia (TD) and chorea associated with Huntington's disease (HD).

How has the pandemic affected Austedo sales?

The pandemic led to a drop in doctor visits, resulting in fewer diagnoses and prescriptions of Austedo, but Teva anticipates a rebound as healthcare activities normalize.

What is the projected market size for deuterated drugs by 2031?

The global deuterated drugs market is projected to reach a valuation of $780.7 million by 2031, growing at a CAGR of 11.25% from 2023 to 2031[2].

How does Austedo compare to its competitors?

Physicians are increasingly viewing Austedo and Ingrezza as similar in efficacy, with Austedo expected to capture 45% of the TD market at its peak[5].

What are the key drivers of Austedo's market growth?

Key drivers include its exceptional effectiveness, strong support from the international medical community, and strategic partnerships to enhance its availability.

Sources

1. FiercePharma: Teva's Austedo, struggling from a pandemic slowdown, needs huge gains to meet company's 2021 target.
2. EIN Presswire: Deuterated Drugs Market to Present a Robust Growth of US$ 780.7 Million By 2031 | Astute Analytica.
3. Zion Market Research: Deuterated Drugs Market Size, Trends, Growth and Forecast 2032.
4. Teva Pharmaceutical Industries: Teva Reports Third Quarter 2023 Financial Results and Increases Revenue Guidance.
5. FiercePharma: Doctors are coming around to Teva's Austedo as TD drugs get more play.