Avanir Pharms Company Profile

What is the competitive landscape for AVANIR PHARMS

AVANIR PHARMS has one approved drug.

There is one US patent protecting AVANIR PHARMS drugs.

There are sixty-nine patent family members on AVANIR PHARMS drugs in twenty-one countries and sixteen supplementary protection certificates in fifteen countries.

Summary for Avanir Pharms

International Patents:	69
US Patents:	1
Tradenames:	1
Ingredients:	1
NDAs:	1

Drugs and US Patents for Avanir Pharms

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Avanir Pharms	NUEDEXTA	dextromethorphan hydrobromide; quinidine sulfate	CAPSULE;ORAL	021879-001	Oct 29, 2010	AB	RX	Yes	Yes	7,659,282

Expired US Patents for Avanir Pharms

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Avanir Pharms	NUEDEXTA	dextromethorphan hydrobromide; quinidine sulfate	CAPSULE;ORAL	021879-001	Oct 29, 2010	8,227,484
Avanir Pharms	NUEDEXTA	dextromethorphan hydrobromide; quinidine sulfate	CAPSULE;ORAL	021879-001	Oct 29, 2010	RE38115
Avanir Pharms	NUEDEXTA	dextromethorphan hydrobromide; quinidine sulfate	CAPSULE;ORAL	021879-001	Oct 29, 2010	5,166,207
Avanir Pharms	NUEDEXTA	dextromethorphan hydrobromide; quinidine sulfate	CAPSULE;ORAL	021879-001	Oct 29, 2010	5,206,248

Paragraph IV (Patent) Challenges for AVANIR PHARMS drugs

Drugname	Dosage	Strength	Tradename	Submissiondate
	Capsules	20 mg/10 mg		2011-03-07

International Patents for Avanir Pharms Drugs

Country	Patent Number	Estimated Expiration
Australia	2020270454
Denmark	1980252
Japan	2014129384
Norway	2013017
Portugal	1539166
Portugal	1980252

Supplementary Protection Certificates for Avanir Pharms Drugs

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1539166	122013000090	Germany		PRODUCT NAME: KOMBINATION AUS: (A) DEXTROMETHORPHAN ODER EINEM PHARMAZEUTISCH VERTRAEGLICHEN SALZ, Z.B. DEXTROMETHORPHAN-HYDROBROMID UND INSBESONDERE DEXTROMETHORPHAN-HYDROBROMID-MONOHYDRAT; UND (B) CHINIDIN ODER EINEM PHARMAZEUTISCH VERTRAEGLICHEN SALZ DAVON, Z.B.CHINIDIN-SULFAT UND INSBESONDERE CHINIDIN-SULFAT-DIHYDRAT; REGISTRATION NO/DATE: EU/1/13/833 20130624
1539166	132013902215214	Italy		PRODUCT NAME: ASSOCIAZIONE DI (A) DESTROMETORFANO O UN SUO SALE, PRECURSORE O DERIVATO FARMACEUTICAMENTE ACCETTABILE, INCLUSO IL DESTROMETORFANO BROMIDRATO E IN PARTICOLARE IL DESTROMETORFANO BROMIDRATO MONOIDRATO E (B) CHINIDINA O UN SUO SALE,PRECURSORE O DERIVATO FARMACEUTICAMENTE ACCETTABILE, INCLUSA LA CHINIDINA SOLFATO E IN PARTICOLARE LA CHINIDINA SOLFATO DIIDRATO(NUEDEXTA); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/13/833, 20130626
1539166	13C0062	France		PRODUCT NAME: (A) DEXTROMETHORPHAN OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE, PAR EXEMPLE LE BROMHYDRATE DE DEXTROMETHORPHAN ET EN PARTICULIER LE MONOHYDRATE DE BROMHYDRATE DE DEXTROMETHORPHAN (B) QUINIDINE OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE, PAR EXEMPLE LE SULFATE DE QUINIDINE EN PARTICULIER LE DIHYDRATE DE SULFATE DE QUINIDINE; REGISTRATION NO/DATE: EU/1/13/833/001-003 20130626
1539166	2013/055	Ireland		PRODUCT NAME: THE COMBINATION OF: (A) DEXTROMETHORPHAN OR A PHARMACEUTICALLY ACCEPTABLE SALT, PRECURSOR OR DERIVATIVE THEREOF, E.G. DEXTROMETHORPHAN HYDROBROMIDE AND IN PARTICULAR DEXTROMETHORPHAN HYDROBROMIDE MONOHYDRATE; AND (B) QUINIDINE OR A PHARMACEUTICALLY ACCEPTABLE SALT, PRECURSOR OR DERIVATIVE THEREOF, E.G. QUINIDINE SULPHATE AND IN PARTICULAR QUINIDINE SULPHATE DIHYDRATE, PROTECTED BY THE BASIC PATENT; REGISTRATION NO/DATE: EU/1/13/833 20130624
1539166	2013C/064	Belgium		PRODUCT NAME: DEXTROMETHORPHANE OU UN SEL, PRCURSEUR DE DERIVE PHARMACEUTIQUEMENT ACCEPTABLE, PAR EXEMPLE LE BROMHYDRURE DE DEXTROMETORPHANE ET EN PARTICULIER LE BROMHYDRURE DE DEXTROMETROPHANE MONHYDRATE ET QUINIDINE OU UN SEL,....; AUTHORISATION NUMBER AND DATE: EU/1/13/833 20130626
1539166	SPC/GB13/070	United Kingdom		PRODUCT NAME: THE COMBINATION OF: (A) DEXTROMETHORPHAN OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, E.G. DEXTROMETHORPHAN HYDROBROMIDE AND IN PARTICULAR DEXTROMETHORPHAN HYDROBROMIDE MONOHYDRATE; AND (B) QUINIDINE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, E.G. Q; REGISTERED: UK EU/1/13/833 20130626

Similar Applicant Names

Applicants may be listed under multiple names.
Here is a list of applicants with similar names.

• Avanir Pharms
• Avanthi Inc

Pharmaceutical Competitive Landscape Analysis: Avanir Pharmaceuticals – Market Position, Strengths & Strategic Insights

In the dynamic world of pharmaceuticals, understanding the competitive landscape is crucial for success. Avanir Pharmaceuticals, a subsidiary of Otsuka Pharmaceutical Co., Ltd., has carved out a unique position in the market, focusing on central nervous system (CNS) disorders. This analysis delves into Avanir's market position, strengths, and strategic insights, providing a comprehensive view of the company's standing in the pharmaceutical industry.

Company Overview

Avanir Pharmaceuticals, founded in 1988 and headquartered in Aliso Viejo, California, specializes in developing and commercializing innovative treatments for CNS disorders[1]. The company's flagship product, NUEDEXTA, has positioned Avanir as a leader in treating pseudobulbar affect (PBA), a neurological condition characterized by involuntary, sudden, and frequent episodes of laughing and/or crying[2].

Market Position

Niche Focus on CNS Disorders

Avanir has strategically positioned itself in the CNS disorder market, a sector with significant unmet medical needs. This focus has allowed the company to develop expertise and build a strong reputation in treating conditions like PBA, which were previously underserved[1].

NUEDEXTA: A Game-Changer

NUEDEXTA, the world's first and only approved treatment for PBA, has been a significant driver of Avanir's market position. Launched in 2011, the drug has seen impressive growth, with sales reaching $94 million in the twelve-month period from July 2013 through June 2014, representing a 50% increase over the prior year[2].

Expanding Portfolio

While NUEDEXTA remains Avanir's primary revenue generator, the company is actively expanding its portfolio. The promising new chemical entity AVP-786, targeting agitation associated with Alzheimer's disease, is being prepared for Phase III clinical trials[2]. This expansion demonstrates Avanir's commitment to growth and diversification within the CNS market.

Strengths and Competitive Advantages

Innovative Research and Development

Avanir's strength lies in its robust R&D capabilities, focusing on novel therapies for CNS disorders. The company's success with NUEDEXTA showcases its ability to identify unmet needs and develop effective treatments[1].

Strategic Partnerships

Avanir has formed strategic partnerships to enhance its research capabilities and market reach. These collaborations, including its relationship with parent company Otsuka Pharmaceutical, provide access to additional resources and expertise[3].

Specialized Sales Force

The company has invested in a specialized sales force of over 300 representatives, with 150 recently hired to accelerate NUEDEXTA's growth[2]. This dedicated team enhances Avanir's ability to educate healthcare providers about PBA and promote its treatments effectively.

Financial Backing

As a subsidiary of Otsuka Pharmaceutical, Avanir benefits from the financial stability and resources of a larger pharmaceutical company. This backing provides a competitive advantage in terms of funding for R&D and market expansion[2].

Strategic Insights

Focus on Unmet Needs

Avanir's strategy of targeting underserved CNS disorders has proven successful. By identifying and addressing unmet medical needs, the company has created a niche market with less competition from larger pharmaceutical companies[1].

Pipeline Development

The company's focus on developing its pipeline, particularly AVP-786, demonstrates a forward-thinking approach to sustaining growth. This strategy aims to reduce reliance on a single product and expand Avanir's presence in the CNS market[2].

Leveraging Otsuka's Resources

Avanir's acquisition by Otsuka Pharmaceutical in 2014 for $3.5 billion was a strategic move that provided access to greater resources and a global network[2]. This relationship allows Avanir to leverage Otsuka's expertise in psychiatric diseases, complementing its own strengths in neurological disorders.

Market Education

A key part of Avanir's strategy involves educating healthcare providers and patients about PBA and other CNS disorders. This approach not only drives sales of NUEDEXTA but also positions Avanir as a thought leader in the field[2].

Competitive Landscape

Major Competitors

While Avanir has a unique position in the PBA market, it faces competition from larger pharmaceutical companies in the broader CNS disorder space. Companies like Pfizer, Novartis, and Roche have significant resources and established presence in neurological and psychiatric treatments[5].

Emerging Threats

As the CNS market grows, Avanir may face increased competition from both established players and emerging biotech companies. Staying ahead will require continued innovation and strategic partnerships[3].

Market Trends and Opportunities

Growing CNS Market

The global market for CNS disorder treatments is expanding, driven by an aging population and increased awareness of mental health issues. This trend presents opportunities for Avanir to expand its product offerings and market reach[5].

Personalized Medicine

Advancements in genomics and personalized medicine are creating opportunities for more targeted CNS treatments. Avanir could leverage its expertise to develop precision therapies for specific patient populations[10].

Digital Health Integration

The integration of digital health technologies in CNS disorder management presents new opportunities. Avanir could explore partnerships or in-house development of digital tools to complement its pharmaceutical offerings[5].

Challenges and Risks

Product Concentration

Avanir's heavy reliance on NUEDEXTA for revenue poses a risk. Diversifying the product portfolio is crucial for long-term stability and growth[3].

Regulatory Environment

The pharmaceutical industry faces ongoing regulatory challenges. Avanir must navigate complex approval processes and potential policy changes that could impact drug pricing and market access[10].

Market Access and Reimbursement

Ensuring favorable reimbursement policies for CNS treatments, particularly for novel therapies, remains a challenge. Avanir needs to demonstrate the value of its treatments to payers and healthcare systems[10].

Future Outlook

Avanir Pharmaceuticals is well-positioned to capitalize on its strengths in the CNS disorder market. The company's focus on innovation, strategic partnerships, and market education provides a solid foundation for future growth. However, success will depend on effectively managing risks, diversifying the product portfolio, and adapting to evolving market trends.

"The acquisition of Avanir will bring Otsuka three distinct values: 1) NUEDEXTA, created to treat the under-recognized, neurologic disease PBA; 2) the late-stage investigational compound AVP-786 in clinical development to treat agitation associated with Alzheimer's disease and; 3) Avanir's clinical development and commercial expertise in neurologic diseases, which complements Otsuka's capabilities in psychiatric diseases." - Otsuka Pharmaceutical Co., Ltd.[2]

Key Takeaways

• Avanir Pharmaceuticals has established a strong position in the CNS disorder market, particularly with its flagship product NUEDEXTA for PBA treatment.
• The company's focus on unmet medical needs and innovative R&D has been key to its success.
• Strategic partnerships, including its acquisition by Otsuka Pharmaceutical, provide Avanir with significant resources and expertise.
• Challenges include product concentration risk and navigating a complex regulatory environment.
• Future growth opportunities lie in pipeline development, market expansion, and leveraging advancements in personalized medicine and digital health.

FAQs

1. What is Avanir Pharmaceuticals' primary focus? Avanir Pharmaceuticals primarily focuses on developing and commercializing innovative treatments for central nervous system (CNS) disorders.

2. Who owns Avanir Pharmaceuticals? Avanir Pharmaceuticals is a subsidiary of Otsuka Pharmaceutical Co., Ltd., which acquired the company in 2014 for $3.5 billion.

3. What is NUEDEXTA, and why is it significant for Avanir? NUEDEXTA is Avanir's flagship product and the world's first and only approved treatment for pseudobulbar affect (PBA). It has been a significant driver of the company's market position and revenue growth.

4. How is Avanir expanding beyond NUEDEXTA? Avanir is developing new compounds like AVP-786, which is being prepared for Phase III clinical trials to treat agitation associated with Alzheimer's disease.

5. What are the main challenges facing Avanir Pharmaceuticals? Key challenges include product concentration risk (reliance on NUEDEXTA), navigating regulatory environments, and ensuring market access and favorable reimbursement policies for its treatments.

Sources cited:

1. https://www.investing.com/equities/avanir-pharmaceuticals
2. https://www.fiercepharma.com/m-a/otsuka-pharmaceutical-to-acquire-avanir-pharmaceuticals
3. https://pitchgrade.com/companies/adamas-pharmaceuticals-inc
4. https://visualping.io/blog/competitive-intelligence-in-pharma
5. https://www.infinitiresearch.com/thoughts/steps-competitor-analysis-pharma-companies/