Avyxa Holdings Company Profile

What is the competitive landscape for AVYXA HOLDINGS

AVYXA HOLDINGS has five approved drugs.

There are three US patents protecting AVYXA HOLDINGS drugs.

There are eight patent family members on AVYXA HOLDINGS drugs in five countries and fourteen supplementary protection certificates in seven countries.

Summary for Avyxa Holdings

International Patents:	8
US Patents:	3
Tradenames:	5
Ingredients:	5
NDAs:	5

Drugs and US Patents for Avyxa Holdings

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Avyxa Holdings	AXTLE	pemetrexed dipotassium	POWDER;INTRAVENOUS	210661-002	Jun 28, 2024		RX	Yes	Yes
Avyxa Holdings	CYCLOPHOSPHAMIDE	cyclophosphamide	SOLUTION;INTRAVENOUS	210852-003	Jun 7, 2023		RX	Yes	Yes	11,382,923		Y
Avyxa Holdings	DOCIVYX	docetaxel	SOLUTION;INTRAVENOUS	215813-001	Nov 22, 2022		RX	Yes	Yes	10,398,785		Y
Avyxa Holdings	FULVESTRANT	fulvestrant	SOLUTION;INTRAMUSCULAR	210063-001	Aug 19, 2019		DISCN	No	No
Avyxa Holdings	POSFREA	palonosetron hydrochloride	SOLUTION;INTRAVENOUS	203050-001	Mar 1, 2016		DISCN	Yes	No
Avyxa Holdings	POSFREA	palonosetron hydrochloride	SOLUTION;INTRAVENOUS	203050-002	Mar 1, 2016		RX	Yes	Yes

International Patents for Avyxa Holdings Drugs

Country	Patent Number	Estimated Expiration
China	111714449
China	111728940
European Patent Office	3270912
Japan	2018512395
Poland	3270912
World Intellectual Property Organization (WIPO)	2016005962

Supplementary Protection Certificates for Avyxa Holdings Drugs

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2785706	122020000046	Germany		PRODUCT NAME: FOSNETUPITANT MIT PALONOSETRON; REGISTRATION NO/DATE: C(2020)1804(FINAL) 20200316
0430190	18/2005	Austria		PRODUCT NAME: PALONOSETRON, DESSEN SALZE UND STEREOISOMERE; REGISTRATION NO/DATE: EU/1/04/306/001 20050322
1667986	28/2013	Austria		PRODUCT NAME: DIMETHOXYDOCETAXEL-ACETONSOLVAT (CABAZITAXEL-ACETONSOLVAT); REGISTRATION NO/DATE: EU/1/11/676/001 20110317
1667986	92172	Luxembourg		PRODUCT NAME: SOLVAT ACETONIQUE DU CABAZITAXEL, OU DESIGNE SOLVAT ACETONIQUE DU DIMETHOXY DOCETAXEL OU SOLVAT ACETONIQUE DU (2R,3S)-3-TERT-BUTOXYCARBONYLAMINO-2-HYDROXY-3-PHENYLPROPIONATE DE 4-ACETOXY-2A-BENZOYLOXY-5BETA,20-EPOXY-1-HYDROXY-7BETA,10A-DIMETHOXY-9-OXO-TAX-11-ENE-13A-YLE(ACETONATE DU CABAZITAXEL)
2785706	C02785706/01	Switzerland		PRODUCT NAME: FOSNETUPITANT, PALONOSETRON.; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 68290 01.09.2022
0253738	C960002	Netherlands		PRODUCT NAME: DOCETAXEL, DESGEWENST IN DE VORM VAN EEN TRIHYDRAAT; REGISTRATION NO/DATE: EU/1/95/002/001 - EU/1/95/002/002 19951127

Similar Applicant Names

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

• Avyxa Holdings

Pharmaceutical Competitive Landscape Analysis: Avyxa Holdings – Market Position, Strengths & Strategic Insights

Introduction

In the ever-evolving pharmaceutical industry, companies must constantly innovate and adapt to maintain a competitive edge. Avyxa Holdings, LLC has emerged as a notable player in this landscape, focusing on the development and marketing of complex therapies for cancer patients. This comprehensive analysis will delve into Avyxa's market position, strengths, and strategic insights, providing valuable information for industry professionals and investors alike.

Company Overview

Avyxa Holdings, LLC is a specialty pharmaceutical company dedicated to making a difference in the lives of cancer patients, healthcare providers, and the broader healthcare system[1]. The company's core focus lies in developing and marketing complex therapies, with a particular emphasis on oncology treatments.

"AVYXA is a specialty pharmaceutical company that is focused on the development and marketing of complex therapies that make a difference for cancer patients, providers and the healthcare system." - Avyxa Holdings, LLC[1]

Product Portfolio

Key Products

1. DOCIVYX (docetaxel) injection: Approved by the FDA on November 22, 2022, under a 505(b)(2) New Drug Application (NDA)[4]. This product is a microtubule inhibitor used in the treatment of various cancers, including breast cancer and non-small cell lung cancer.

2. Pemetrexed for Injection: Approved by the FDA on June 28, 2024, also under a 505(b)(2) NDA[3]. This folate analog metabolic inhibitor is indicated for the treatment of non-squamous non-small cell lung cancer (NSCLC) in various stages and combinations.

Product Strengths

1. Innovative Formulations: Avyxa's products, such as DOCIVYX, demonstrate the company's ability to develop innovative formulations of existing drugs, potentially offering improved efficacy or reduced side effects.

2. Diverse Pipeline: The company's focus on both solid tumors (e.g., NSCLC) and hematological malignancies showcases a diverse and strategically balanced product pipeline.

3. Regulatory Success: Obtaining FDA approvals for multiple products within a relatively short timeframe indicates Avyxa's regulatory expertise and ability to navigate the complex approval process efficiently.

Market Position

Oncology Focus

Avyxa has positioned itself firmly in the oncology market, a sector with high growth potential due to increasing cancer incidence rates globally. By focusing on complex therapies for cancer, the company has carved out a niche in a highly competitive but lucrative market segment.

Generic Competition

As a developer of products approved under the 505(b)(2) pathway, Avyxa competes in the branded generic space. This strategy allows the company to leverage existing safety and efficacy data while potentially offering improvements or differentiation from the original products.

Manufacturing Capabilities

While specific details about Avyxa's manufacturing capabilities are not provided in the search results, the company's ability to produce complex pharmaceutical products suggests robust manufacturing processes and quality control measures.

Strategic Insights

1. Focus on Unmet Medical Needs

Avyxa's commitment to developing therapies that "make a difference for cancer patients" suggests a strategy focused on addressing unmet medical needs in oncology. This approach can lead to higher market acceptance and potentially faster regulatory pathways.

2. Leveraging Regulatory Pathways

The company's use of the 505(b)(2) NDA pathway for product approvals demonstrates a strategic approach to drug development. This pathway can result in faster time-to-market and reduced development costs compared to traditional NDAs.

3. Patient-Centric Approach

Avyxa's emphasis on patient assistance programs[1] indicates a patient-centric strategy, which can enhance brand loyalty and market penetration, especially in the competitive oncology space.

4. Strategic Partnerships and Acquisitions

The transfer of the NDA for DOCIVYX from Ingenus Pharmaceuticals to Avyxa[4] suggests that the company is open to strategic partnerships or acquisitions to expand its product portfolio and market presence.

Competitive Advantages

1. Specialized Expertise: Avyxa's focus on complex therapies in oncology allows for the development of specialized expertise, potentially giving the company an edge in R&D and market understanding.

2. Efficient Drug Development: The successful use of the 505(b)(2) pathway demonstrates Avyxa's ability to bring products to market efficiently, potentially resulting in cost savings and faster revenue generation.

3. Patient Support Programs: By offering patient assistance programs, Avyxa can differentiate itself from competitors and build stronger relationships with patients and healthcare providers.

4. Agile Business Model: The company's ability to acquire and integrate new products (e.g., DOCIVYX) suggests an agile business model that can quickly respond to market opportunities.

Challenges and Opportunities

Challenges

1. Generic Competition: As a player in the branded generic space, Avyxa faces intense competition from other generic manufacturers and must continually innovate to maintain market share.

2. Pricing Pressures: The pharmaceutical industry, especially in oncology, faces increasing pressure to reduce drug prices, which could impact Avyxa's profit margins.

3. Regulatory Hurdles: Ongoing changes in healthcare regulations and drug approval processes could pose challenges to Avyxa's product development and marketing strategies.

Opportunities

1. Expansion into New Therapeutic Areas: While currently focused on oncology, Avyxa could leverage its expertise in complex therapies to expand into other high-need therapeutic areas.

2. Global Market Expansion: The search results do not provide information on Avyxa's global presence, suggesting potential opportunities for international expansion.

3. Technological Advancements: Investing in cutting-edge technologies, such as AI-driven drug discovery or personalized medicine approaches, could further strengthen Avyxa's competitive position.

Conclusion

Avyxa Holdings, LLC has established itself as a notable player in the specialty pharmaceutical industry, with a strong focus on oncology and complex therapies. The company's strategic use of regulatory pathways, patient-centric approach, and ability to bring innovative products to market quickly are key strengths that position it well for future growth.

However, Avyxa must navigate challenges such as intense generic competition and pricing pressures while capitalizing on opportunities for expansion and technological advancement. By continuing to focus on unmet medical needs and leveraging its expertise in complex therapies, Avyxa has the potential to further strengthen its market position and make significant contributions to cancer treatment.

Key Takeaways

1. Avyxa Holdings specializes in complex therapies for cancer patients, with a strong focus on oncology treatments.
2. The company has successfully leveraged the 505(b)(2) NDA pathway for efficient drug development and approval.
3. Avyxa's patient-centric approach, including assistance programs, enhances its market position and brand loyalty.
4. Strategic partnerships and acquisitions play a role in Avyxa's growth strategy.
5. The company faces challenges from generic competition and pricing pressures but has opportunities for expansion and technological innovation.

FAQs

1. What is Avyxa Holdings' primary focus in the pharmaceutical industry? Avyxa Holdings primarily focuses on developing and marketing complex therapies for cancer patients, with a strong emphasis on oncology treatments.

2. How does Avyxa differentiate itself from other pharmaceutical companies? Avyxa differentiates itself through its specialization in complex therapies, efficient use of regulatory pathways, patient-centric approach, and focus on addressing unmet medical needs in oncology.

3. What are some of Avyxa's key products? Key products include DOCIVYX (docetaxel) injection and Pemetrexed for Injection, both approved by the FDA for cancer treatment.

4. How does Avyxa approach drug development and approval? Avyxa strategically uses the 505(b)(2) NDA pathway for efficient drug development and faster time-to-market for its products.

5. What potential growth opportunities exist for Avyxa in the future? Potential growth opportunities include expansion into new therapeutic areas, global market expansion, and investment in cutting-edge technologies for drug discovery and development.

Sources:

1. https://avyxa.com
2. https://www.fda.gov/media/72973/download
3. https://www.cms.gov/files/document/2024-hcpcs-application-summary-quarter-3-2024-drugs-and-biologicals.pdf
4. https://www.cms.gov/files/document/2024-hcpcs-application-summary-quarter-2-2024-drugs-and-biologicals.pdf
5. https://www.drugs.com/availability/generic-docivyx.html