AUVELITY Drug Patent Profile

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

Auvelity is a drug marketed by Axsome and is included in one NDA. There are one hundred and twenty-two patents protecting this drug and one Paragraph IV challenge.

This drug has two hundred and six patent family members in thirty-three countries.

The generic ingredient in AUVELITY is bupropion hydrochloride; dextromethorphan hydrobromide. There are thirty-eight drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the bupropion hydrochloride; dextromethorphan hydrobromide profile page.

DrugPatentWatch^® Generic Entry Outlook for Auvelity

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be November 5, 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 AUVELITY

International Patents:	206
US Patents:	122
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Clinical Trials:	1
Drug Prices:	Drug price information for AUVELITY
What excipients (inactive ingredients) are in AUVELITY?	AUVELITY excipients list
DailyMed Link:	AUVELITY at DailyMed

See drug prices for AUVELITY

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

NDA:

215430

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 AUVELITY

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

Sponsor	Phase
National Institute on Drug Abuse (NIDA)	Phase 1/Phase 2
Virginia Commonwealth University	Phase 1/Phase 2

See all AUVELITY clinical trials

Pharmacology for AUVELITY

Drug Class	Aminoketone Sigma-1 Agonist Uncompetitive N-methyl-D-aspartate Receptor Antagonist
Mechanism of Action	Dopamine Uptake Inhibitors Norepinephrine Uptake Inhibitors Sigma-1 Receptor Agonists Uncompetitive NMDA Receptor Antagonists
Physiological Effect	Increased Dopamine Activity Increased Norepinephrine Activity

Paragraph IV (Patent) Challenges for AUVELITY

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
AUVELITY	Extended-release Tablet	bupropion hydrochloride; dextromethorphan hydrobromide	45 mg/105 mg	215430	1	2022-12-22

US Patents and Regulatory Information for AUVELITY

AUVELITY is protected by one hundred and twenty-two US patents and one FDA Regulatory Exclusivity.

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
Axsome	AUVELITY	bupropion hydrochloride; dextromethorphan hydrobromide	TABLET, EXTENDED RELEASE;ORAL	215430-001	Aug 18, 2022		RX	Yes	Yes
Axsome	AUVELITY	bupropion hydrochloride; dextromethorphan hydrobromide	TABLET, EXTENDED RELEASE;ORAL	215430-001	Aug 18, 2022		RX	Yes	Yes
Axsome	AUVELITY	bupropion hydrochloride; dextromethorphan hydrobromide	TABLET, EXTENDED RELEASE;ORAL	215430-001	Aug 18, 2022		RX	Yes	Yes
Axsome	AUVELITY	bupropion hydrochloride; dextromethorphan hydrobromide	TABLET, EXTENDED RELEASE;ORAL	215430-001	Aug 18, 2022		RX	Yes	Yes
Axsome	AUVELITY	bupropion hydrochloride; dextromethorphan hydrobromide	TABLET, EXTENDED RELEASE;ORAL	215430-001	Aug 18, 2022		RX	Yes	Yes
Axsome	AUVELITY	bupropion hydrochloride; dextromethorphan hydrobromide	TABLET, EXTENDED RELEASE;ORAL	215430-001	Aug 18, 2022		RX	Yes	Yes
Axsome	AUVELITY	bupropion hydrochloride; dextromethorphan hydrobromide	TABLET, EXTENDED RELEASE;ORAL	215430-001	Aug 18, 2022		RX	Yes	Yes

International Patents for AUVELITY

When does loss-of-exclusivity occur for AUVELITY?

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

Australia

Brazil

Canada

Chile

China

Colombia

Costa Rica

Croatia

Cyprus

Denmark

Ecuador

European Patent Office

Hong Kong

Hungary

Israel

Japan

Lithuania

Malaysia

Mexico

Morocco

New Zealand

Nicaragua

Peru

Poland

Portugal

San Marino

Serbia

Singapore

Slovenia

South Korea

Spain

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 AUVELITY around the world.

Country	Patent Number	Title	Estimated Expiration
South Korea	20240091043	거울상이성질체적으로 농후한 또는 순수한 부프로피온을 위한 투여 형태 및 방법 (DOSAGE FORMS AND METHODS FOR ENANTIOMERICALLY ENRICHED OR PURE BUPROPION)
South Korea	20240027872	에리트로히드록시부프로피온을 이용한 약물의 혈장 농도의 조절 방법 (METHODS OF MODULATING DRUG PLASMA LEVELS USING ERYTHROHYDROXYBUPROPION)
Japan	2024059812	鏡像異性体的に濃縮された、または純粋なブプロピオンの剤形および方法 (DOSAGE FORM AND METHOD FOR ENANTIOMERICALLY ENRICHED OR PURE BUPROPION)
China	111297860	使用赤式羟基安非他酮调节药物血浆水平的方法 (Methods of modulating drug plasma levels using erythrohydroxybupropion)
Taiwan	202408476	Bupropion dosage forms with reduced food and alcohol dosing effects
World Intellectual Property Organization (WIPO)	2019165379
South Korea	102603013

Supplementary Protection Certificates for AUVELITY

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2316456	65/2017	Austria		PRODUCT NAME: NALTREXON ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON, INSBESONDERE NALTREXONHYDROCHLORID, UND BUPROPION ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON, INSBESONDERE BUPROPIONHYDROCHLORID; REGISTRATION NO/DATE: EU/1/14/988 (MITTEILUNG) 20150330
2316456	CR 2017 00062	Denmark		PRODUCT NAME: NALTREXON ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF, ISAER NALTREXONHYDROCHLORID, OG BUPROPION ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF, ISAER BUPROPIONHYDROCHLORID; REG. NO/DATE: EU/1/14/988 20150330
2316456	300918	Netherlands		PRODUCT NAME: NALTREXON OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN, IN HET BIJZONDER NALTREXONHYDROCHLORIDE, EN BUPROPION OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN, IN HET BIJZONDER BUPROPIONHYDROCHLORIDE; REGISTRATION NO/DATE: EU/1/14/988 20150330
2316456	2017/059	Ireland		PRODUCT NAME: NALTREXONE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, IN PARTICULAR NALTREXONE HYDROCHLORIDE, AND BUPROPION OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, IN PARTICULAR BUPROPION HYDROCHLORIDE; REGISTRATION NO/DATE: EU/1/14/988 20150326
2316456	SPC/GB17/078	United Kingdom		PRODUCT NAME: NALTREXONE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, IN PARTICULAR NALTREXONE HYDROCHLORIDE, AND BUPROPION OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, IN PARTICULAR BUPROPION HYDROCHLORIDE.; REGISTERED: UK EU/1/14/988 20150330; UK PLGB 50742/0001 20150330
2316456	C 2017 047	Romania		PRODUCT NAME: COMBINATIE DE NALTREXONA SAU O SARE ACCEPTABILA FARMACEUTIC A ACESTEIA, IN PARTICULAR CLORHIDRAT DE NALTREXONA SI BUPROPION SAU O SARE ACCEPTABILA FARMACEUTIC A ACESTUIA, IN PARTICULAR CLORHIDRAT DE BUPROPION; NATIONAL AUTHORISATION NUMBER: EU/1/14/988; DATE OF NATIONAL AUTHORISATION: 20150326; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/14/988; DATE OF FIRST AUTHORISATION IN EEA: 20150326
2316456	1790064-8	Sweden		PRODUCT NAME: NALTREXONE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, IN PARTICULAR NALTREXONE HYDROCHLORIDE, AND BUPROPION OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, IN PARTICULAR BUPROPION HYDROCHLORIDE; REG. NO/DATE: EU/1/14/988 20150330

Market Dynamics and Financial Trajectory for Auvelity

Introduction

Auvelity, developed by Axsome Therapeutics, is a groundbreaking treatment for Major Depressive Disorder (MDD) that has been making significant waves in the pharmaceutical market. Here, we delve into the market dynamics and financial trajectory of this drug, highlighting its performance, challenges, and future prospects.

Market Context: Major Depressive Disorder

The MDD market is highly competitive and crowded, with a multitude of treatments available, many of which are generic and inexpensive. However, there is a persistent need for products with improved efficacy and safety profiles, as well as those that can show rapid antidepressant effects[1].

Launch and Initial Performance

Auvelity, a combination of dextromethorphan and bupropion, was launched with considerable success. In its first full year, Auvelity generated $130.1 million in sales, a remarkable achievement in a market dominated by established treatments like SSRIs and SNRIs[3][4].

Sales Growth and Market Penetration

Auvelity has demonstrated strong sales growth, with a 135% year-over-year increase in the second quarter of 2024, reaching $65.0 million in net product sales. This growth is indicative of effective market penetration and increasing acceptance among physicians and patients. The number of prescriptions for Auvelity has shown a 23% sequential increase, further highlighting its growing market presence[2][5].

Competitive Landscape

Despite the competitive nature of the MDD market, Auvelity is gaining traction. Its novel mechanism of action and rapid onset of action, with improvements in depressive symptoms seen as early as one week, position it favorably against existing treatments. GlobalData forecasts that Auvelity will be the top-selling drug in MDD in the US market by 2029, with projected sales of approximately $1.53 billion[1].

Financial Performance

Axsome Therapeutics has reported significant revenue growth driven by Auvelity and another product, Sunosi. In the second quarter of 2024, total net product revenue increased by 87% year-over-year to $87.2 million. However, this growth has been accompanied by increased operating expenses, particularly in research and development (R&D) and sales, general, and administrative (SG&A) costs. The company reported a net loss of $79.3 million in the second quarter of 2024, up from $67.2 million in the same period in 2023[2][5].

Research and Development Expenses

The increase in R&D expenses is primarily due to the initiation and continuation of Phase 3 trials for various indications, including major depressive disorder, ADHD, and binge eating disorder. These investments are crucial for the long-term growth and diversification of Axsome's product portfolio[2][5].

Payer Coverage and Market Access

Broad payer coverage has been a significant factor in Auvelity's success. Payer coverage for Auvelity in the commercial channel increased from 48% to 60% of lives covered, enhancing its market access and potential for sustained sales growth[2].

Future Prospects

GlobalData forecasts that the MDD market across the eight major markets (US, France, Germany, Italy, Spain, UK, Japan, and Canada) will grow at a CAGR of 7.4% from $4.7 billion in 2019 to $9.6 billion in 2029. Auvelity is expected to play a significant role in this growth, particularly in the US market, where it is forecast to dominate the MDD treatment landscape by 2029[1].

Challenges and Barriers

Despite the positive outlook, the MDD market faces challenges such as generic erosion, particularly in Japan, where patent expiries of key drugs will lead to significant sales erosion. Additionally, the decreasing prevalent MDD population in Japan is expected to negatively impact the market growth in that region[1].

Strategic Initiatives

Axsome Therapeutics is employing strategic initiatives to enhance its market position. The expansion of the Auvelity sales force and the initiation of new Phase 3 trials reflect a balanced approach to immediate revenue generation and long-term pipeline development. The company's Digital Centric Commercialization (DCC™) platform is an innovative strategy aimed at enhancing the reach and efficiency of its marketing efforts[3].

Key Takeaways

• Strong Sales Growth: Auvelity has shown significant year-over-year sales growth, driven by its effective market penetration and acceptance.
• Competitive Advantage: Its novel mechanism of action and rapid onset of action position it favorably in the competitive MDD market.
• Financial Performance: While revenue has surged, increased operating expenses have resulted in net losses, highlighting the need for balanced financial management.
• Future Prospects: Auvelity is forecast to be a top-selling drug in the US MDD market by 2029, with significant sales projections.
• Challenges: Generic erosion and decreasing prevalent MDD populations in certain markets pose challenges to sustained growth.

FAQs

What is Auvelity and how does it work?

Auvelity is a combination of dextromethorphan and bupropion, designed to treat Major Depressive Disorder (MDD). It works by a novel mechanism of action that leads to rapid improvements in depressive symptoms, often seen within one week of treatment.

How has Auvelity performed in the market since its launch?

Auvelity has shown strong sales growth since its launch, with a 135% year-over-year increase in the second quarter of 2024, reaching $65.0 million in net product sales. It has also demonstrated effective market penetration with a 23% sequential increase in prescriptions.

What are the key drivers of Auvelity's success?

The key drivers include its novel mechanism of action, rapid onset of action, and broad payer coverage, which have enhanced its market access and acceptance among physicians and patients.

What challenges does the MDD market face, and how might they impact Auvelity?

The MDD market faces challenges such as generic erosion, particularly in Japan, and a decreasing prevalent MDD population in Japan. These factors could impact the overall market growth but are not expected to significantly hinder Auvelity's dominance in the US market.

What are Axsome Therapeutics' strategic initiatives to support Auvelity's growth?

Axsome Therapeutics is expanding the Auvelity sales force, initiating new Phase 3 trials, and using its Digital Centric Commercialization (DCC™) platform to enhance marketing efficiency and reach.

How does Auvelity's financial performance impact Axsome Therapeutics' overall financial health?

While Auvelity's sales have driven significant revenue growth for Axsome Therapeutics, the company has also incurred increased operating expenses, leading to net losses. This highlights the need for balanced financial management to sustain long-term growth.

Sources

1. GlobalData, "Major depressive disorder market to reach $9.6bn across 8MM by 2029," Clinical Trials Arena.
2. StockTitan, "Axsome Therapeutics Reports Second Quarter 2024 Financial Results," StockTitan.
3. StockTitan, "Axsome Therapeutics Reports Fourth Quarter and Full Year 2023," StockTitan.
4. Seeking Alpha, "Axsome: Unpacking Auvelity's First-Year Market Dynamics And Economic Challenges," Seeking Alpha.
5. Axsome Therapeutics, "Axsome Therapeutics Reports Second Quarter 2024 Financial Results," Axsome Therapeutics.

Last updated: 2024-12-16