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AUSTEDO XR Drug Patent Profile

When do Austedo Xr patents expire, and what generic alternatives are available?

Austedo Xr is a drug marketed by Teva and is included in one NDA. There are eleven patents protecting this drug.

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

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

DrugPatentWatch^® Generic Entry Outlook for Austedo Xr

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.

Indicators of Generic Entry

Summary for AUSTEDO XR

International Patents:	147
US Patents:	11
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Clinical Trials:	4
Drug Prices:	Drug price information for AUSTEDO XR
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for AUSTEDO XR
DailyMed Link:	AUSTEDO XR at DailyMed

See drug prices for AUSTEDO XR

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

Constraining patent/regulatory exclusivity:

9,550,780*PED

NDA:

216354

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 AUSTEDO XR

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 XR clinical trials

US Patents and Regulatory Information for AUSTEDO XR

AUSTEDO XR is protected by twelve US patents.

This potential generic entry date is based on patent 9,550,780.

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	216354-005	May 29, 2024		RX	Yes	No	12,016,858*PED				Y
Teva	AUSTEDO XR	deutetrabenazine	TABLET, EXTENDED RELEASE;ORAL	216354-003	Feb 17, 2023		RX	Yes	Yes	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	11,311,488		Y

International Patents for AUSTEDO XR

When does loss-of-exclusivity occur for AUSTEDO XR?

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 XR around the world.

Country	Patent Number	Title	Estimated Expiration
World Intellectual Property Organization (WIPO)	2010044981
Lithuania	4153136
Denmark	3265085
Peru	20230852	FORMAS FARMACEUTICAS OSMOTICAS QUE COMPRENDEN DEUTETRABENAZINA Y METODOS DE USO DE LAS MISMAS

AUSTEDO XR Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for AUSTEDO XR

Introduction

AUSTEDO XR, the extended-release formulation of deutetrabenazine, has been a significant contributor to Teva Pharmaceuticals' financial growth and market presence. Here, we will delve into the market dynamics and financial trajectory of AUSTEDO XR, highlighting its impact on Teva's performance and the broader pharmaceutical market.

Approval and Regulatory Milestones

In May 2024, the U.S. Food and Drug Administration (FDA) approved AUSTEDO XR as a one pill, once-daily treatment option for clinically therapeutic doses of 24–48 mg/day. This approval marked a significant milestone, offering patients with tardive dyskinesia (TD) and Huntington’s disease (HD) chorea a more convenient and flexible treatment regimen[3][4].

Clinical Efficacy and Patient Impact

AUSTEDO XR has demonstrated strong clinical efficacy. Patients with TD can expect symptom improvement as early as two weeks, while those with HD chorea may experience a significant reduction in Total Maximal Chorea (TMC) score. The drug's efficacy is backed by the longest clinical trials to date, ensuring sustained results for patients managing these chronic movement disorders[3].

Market Performance

Revenue Growth

In the second quarter of 2024, AUSTEDO revenues in the United States segment increased by 32% to $407 million, compared to $308 million in the second quarter of 2023. This growth was driven by increased volume, expanded patient access, and higher investment to support growing demand[1][5].

Segment Contribution

AUSTEDO XR's success has been a key driver of Teva's overall revenue growth. The drug's performance contributed significantly to the company's 7% increase in global revenues in U.S. dollars and 11% increase in local currency terms compared to the second quarter of 2023[1][2].

Financial Metrics

Gross Profit and Margin

The strong performance of AUSTEDO XR has positively impacted Teva's gross profit and margin. In the second quarter of 2024, gross profit increased by 13% to $2,024 million, with a gross profit margin of 48.6%, up from 46.3% in the second quarter of 2023. Non-GAAP gross profit and margin also saw increases, primarily due to the favorable mix of products driven by AUSTEDO XR's growth[1][2].

Operating Expenses

Research and Development (R&D) expenses and Selling and Marketing (S&M) expenses have increased, partly due to the promotional activities and development efforts surrounding AUSTEDO XR. R&D expenses rose by 12% to $269 million, while S&M expenses increased by 9% to $656 million in the second quarter of 2024 compared to the same period in 2023[1].

Market Dynamics

Competitive Landscape

AUSTEDO XR operates in a competitive market for TD and HD treatments. However, its once-daily dosing and broadest dosing flexibility among VMAT2 inhibitors give it a competitive edge. The drug's approval and continued growth indicate Teva's ability to successfully compete and innovate in the pharmaceutical marketplace[3].

Patient and Physician Adoption

The convenience of a once-daily regimen and the proven efficacy of AUSTEDO XR have contributed to its adoption among patients and physicians. As Dr. Rakesh Jain, Clinical Professor of Psychiatry at Texas Tech University School of Medicine, noted, "This latest AUSTEDO XR approval provides patients with the same proven efficacy, but now with the convenience of a one pill, once-daily option for clinically therapeutic doses"[3].

Financial Guidance and Outlook

Teva has raised its 2024 financial guidance partly due to the strong performance of AUSTEDO XR. The company's ability to execute its Pivot to Growth strategy, which includes expanding its innovative and biosimilar medicines pipeline, has been bolstered by AUSTEDO XR's success. This strategy aims to sustain and focus the portfolio of generics medicines while profitably commercializing innovative and biosimilar products[1][2].

Challenges and Risks

Despite the positive trajectory, there are risks associated with the commercialization and development of AUSTEDO XR. These include competition in the marketplace, the ability to successfully develop and commercialize additional pharmaceutical products, and the execution of Teva's Pivot to Growth strategy. Exchange rate movements also pose a risk, as seen in the second quarter of 2024, where they negatively impacted overall revenues and operating income[1][4].

Key Takeaways

• Strong Revenue Growth: AUSTEDO XR has driven significant revenue growth for Teva, with a 32% increase in U.S. revenues in the second quarter of 2024.
• Clinical Efficacy: The drug has demonstrated strong clinical efficacy, improving symptoms for patients with TD and HD chorea.
• Market Competitiveness: AUSTEDO XR's once-daily dosing and broad dosing flexibility give it a competitive edge in the market.
• Financial Impact: The drug's success has positively impacted Teva's gross profit and margin, contributing to the company's overall financial performance.
• Regulatory Milestones: The FDA approval of AUSTEDO XR as a one pill, once-daily treatment option is a significant regulatory milestone.

FAQs

What is AUSTEDO XR used for?

AUSTEDO XR is used for the treatment of tardive dyskinesia (TD) and chorea associated with Huntington’s disease (HD).

How has AUSTEDO XR impacted Teva's revenues?

AUSTEDO XR has significantly contributed to Teva's revenue growth, with a 32% increase in U.S. revenues in the second quarter of 2024 compared to the same period in 2023.

What are the key benefits of AUSTEDO XR?

AUSTEDO XR offers a convenient once-daily dosing regimen and has the broadest dosing flexibility among VMAT2 inhibitors, providing effective and tolerable control of TD and HD chorea.

What are the risks associated with AUSTEDO XR's commercialization?

Risks include competition in the marketplace, exchange rate movements, and the ability to successfully execute Teva's Pivot to Growth strategy.

How has the FDA approval impacted the treatment landscape for TD and HD?

The FDA approval of AUSTEDO XR as a one pill, once-daily treatment option has provided patients with a more convenient and flexible treatment regimen, enhancing the treatment landscape for TD and HD.

Sources

1. Teva Announces Strong Growth in Second Quarter Revenues mainly driven by Generics Products in All Regions and AUSTEDO Raises 2024 Financial Guidance. Teva Pharmaceutical Industries Ltd.
2. Teva Announces Strong Growth in Second Quarter Revenues mainly driven by Generics Products in All Regions and AUSTEDO Raises 2024 Financial Guidance. Teva USA.
3. Teva Announces AUSTEDO® XR (deutetrabenazine) Extended-Release Tablets Now U.S. FDA Approved as a One Pill, Once-Daily Treatment Option. Teva USA.
4. Teva Announces AUSTEDO® XR (deutetrabenazine) Extended-Release Tablets Now U.S. FDA Approved as a One Pill, Once-Daily Treatment Option. Teva Pharmaceutical.
5. Teva Announces Strong Growth in Second Quarter Revenues mainly driven by Generics Products in All Regions and AUSTEDO Raises 2024 Financial Guidance. GlobeNewswire.