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Last Updated: March 20, 2025

Acrotech Biopharma Company Profile


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Summary for Acrotech Biopharma
International Patents:179
US Patents:12
Tradenames:5
Ingredients:5
NDAs:5

Drugs and US Patents for Acrotech Biopharma

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Acrotech Biopharma FUSILEV levoleucovorin calcium POWDER;INTRAVENOUS 020140-001 Mar 7, 2008 DISCN Yes No ⤷  Try for Free ⤷  Try for Free
Acrotech Biopharma EVOMELA melphalan hydrochloride POWDER;INTRAVENOUS 207155-001 Mar 10, 2016 RX Yes Yes 8,410,077 ⤷  Try for Free Y ⤷  Try for Free
Acrotech Biopharma EVOMELA melphalan hydrochloride POWDER;INTRAVENOUS 207155-001 Mar 10, 2016 RX Yes Yes 9,493,582 ⤷  Try for Free Y ⤷  Try for Free
Acrotech Biopharma KHAPZORY levoleucovorin POWDER;INTRAVENOUS 211226-001 Oct 19, 2018 RX Yes Yes 11,541,012 ⤷  Try for Free Y ⤷  Try for Free
Acrotech Biopharma BELEODAQ belinostat POWDER;INTRAVENOUS 206256-001 Jul 3, 2014 RX Yes Yes 8,835,501 ⤷  Try for Free Y ⤷  Try for Free
Acrotech Biopharma FOLOTYN pralatrexate SOLUTION;INTRAVENOUS 022468-002 Sep 24, 2009 RX Yes Yes 8,299,078 ⤷  Try for Free ⤷  Try for Free
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for Acrotech Biopharma

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Acrotech Biopharma FUSILEV levoleucovorin calcium POWDER;INTRAVENOUS 020140-001 Mar 7, 2008 6,500,829 ⤷  Try for Free
Acrotech Biopharma FUSILEV levoleucovorin calcium SOLUTION;INTRAVENOUS 020140-002 Apr 29, 2011 6,500,829 ⤷  Try for Free
Acrotech Biopharma FUSILEV levoleucovorin calcium SOLUTION;INTRAVENOUS 020140-003 Apr 29, 2011 6,500,829 ⤷  Try for Free
Acrotech Biopharma FOLOTYN pralatrexate SOLUTION;INTRAVENOUS 022468-002 Sep 24, 2009 6,028,071 ⤷  Try for Free
Acrotech Biopharma FOLOTYN pralatrexate SOLUTION;INTRAVENOUS 022468-001 Sep 24, 2009 6,028,071 ⤷  Try for Free
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration
Paragraph IV (Patent) Challenges for ACROTECH BIOPHARMA drugs
Drugname Dosage Strength Tradename Submissiondate
➤ Subscribe Injection 500 mg/vial ➤ Subscribe 2018-07-03
➤ Subscribe Injection 10 mg/mL, 17.5 mL vial and 25 mL vial ➤ Subscribe 2011-10-26
➤ Subscribe Injection 20 mg/mL and 40 mg/2 mL ➤ Subscribe 2013-09-24
➤ Subscribe Injection 50 mg/vial ➤ Subscribe 2017-09-08
➤ Subscribe Injection 50 mg/vial ➤ Subscribe 2013-12-19

Supplementary Protection Certificates for Acrotech Biopharma Drugs

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2701720 3/2023 Austria ⤷  Try for Free PRODUCT NAME: MELPHALANFLUFENAMID-HYDROCHLORID; REGISTRATION NO/DATE: EU/1/22/1669 (MITTEILUNG) 20220818
2701720 CA 2022 00054 Denmark ⤷  Try for Free PRODUCT NAME: MELPHALAN FLUFENAMIDE HYDROCHLORIDE; REG. NO/DATE: EU/1/22/1669 20220818
2701720 23C1000 France ⤷  Try for Free PRODUCT NAME: MELPHALAN FLUFENAMIDE ET SES SELS PHARMACEUTIQUEMENT ACCEPTABLES, TELS QUE LE CHLORHYDRATE; REGISTRATION NO/DATE: EU/1/22/1669 20220818
2701720 CR 2022 00054 Denmark ⤷  Try for Free PRODUCT NAME: MELPHALAN FLUFENAMIDE HYDROCHLORIDE; REG. NO/DATE: EU/1/22/1669 20220818
2701720 122023000007 Germany ⤷  Try for Free PRODUCT NAME: MELPHALANFLUFENAMID HYDROCHLORID; REGISTRATION NO/DATE: EU/1/22/1669 20220817
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description
Similar Applicant Names
Applicants may be listed under multiple names.
Here is a list of applicants with similar names.

Pharmaceutical Competitive Landscape Analysis: Acrotech Biopharma – Market Position, Strengths & Strategic Insights

In the ever-evolving pharmaceutical industry, Acrotech Biopharma has emerged as a notable player, carving out a unique niche for itself. This specialty pharmaceutical company, founded in 2018, has quickly made its mark in the oncology and dermatology sectors. Let's dive deep into Acrotech's market position, strengths, and strategic insights to understand how this relatively young company is navigating the competitive pharmaceutical landscape.

Acrotech Biopharma: A Brief Overview

Acrotech Biopharma Inc., a subsidiary of Aurobindo Pharma, was established with a clear mission: to develop and commercialize innovative proprietary medications, focusing initially on oncology and dermatology[1]. Since its inception, the company has made significant strides in the pharmaceutical industry, particularly in the U.S. market.

The Birth of a Specialty Pharma Company

Acrotech's journey began in earnest in March 2019 when it acquired a portfolio of FDA-approved hematology/oncology drugs along with a complete commercial and medical infrastructure[1]. This strategic move immediately positioned Acrotech as a serious contender in the oncology space.

Current Market Presence

Today, Acrotech markets five injectable oncology brands in the USA and has established itself as a leader in Peripheral T-Cell Lymphoma treatment[1]. The company's drugs are administered in clinical settings by healthcare providers, highlighting the specialized nature of its product portfolio.

Acrotech's Market Position

Acrotech has quickly carved out a significant position in the specialty pharmaceutical market, particularly in oncology. Let's examine the key factors contributing to its market standing.

Leadership in Niche Markets

Acrotech has strategically positioned itself as a leader in specific oncology niches, such as Peripheral T-Cell Lymphoma[1]. This focus on specialized areas allows the company to build expertise and establish a strong presence in markets that larger pharmaceutical companies might overlook.

Global Reach Through Partnerships

While Acrotech's primary focus is the U.S. market, the company has extended its reach globally through strategic partnerships. These collaborations cover major markets including the EU, Canada, Japan, China, and Latin America[1], allowing Acrotech to maximize the potential of its product portfolio on a global scale.

Expanding Portfolio

Acrotech continues to expand its portfolio in oncology and dermatology through creative licensing and internal R&D programs[1]. This ongoing expansion demonstrates the company's commitment to growth and innovation in its chosen therapeutic areas.

Acrotech's Strengths and Competitive Advantages

Acrotech's rapid rise in the pharmaceutical industry can be attributed to several key strengths and competitive advantages. Let's explore these in detail.

Focused Therapeutic Approach

Acrotech's laser focus on oncology and dermatology allows it to concentrate its resources and expertise in these specific areas. This specialized approach enables the company to develop deep knowledge and capabilities in its chosen fields, potentially giving it an edge over more diversified competitors.

Innovative Product Development Strategy

The company's strategy of developing "diamonds-in-the-rough" - drugs with improved efficacy and/or safety over currently available treatments - sets it apart in the market[4]. This approach allows Acrotech to identify and develop products that might be overlooked by larger pharmaceutical companies but have significant potential to improve patient outcomes.

Strong Commercial Infrastructure

Acrotech's acquisition of a complete commercial and medical infrastructure along with its initial product portfolio has provided the company with a solid foundation for growth[1]. This infrastructure enables Acrotech to effectively market and distribute its products, a crucial advantage in the competitive pharmaceutical landscape.

Strategic Partnerships

Acrotech's ability to forge strong partnerships, both for product development and global distribution, is a significant strength. These collaborations allow the company to leverage external expertise and resources, expanding its reach and capabilities beyond what it could achieve alone[1].

Acrotech's Strategic Insights

Acrotech's success thus far can be attributed to several key strategic insights that guide its operations and growth. Let's examine these insights and how they shape the company's approach to the market.

Focus on Late-Stage and Commercialized Products

Acrotech's current strategy prioritizes commercialized or late Phase III drugs[4]. This approach allows the company to leverage its existing infrastructure effectively while bringing therapies to market that might otherwise not have been commercialized. It's a strategy that balances risk and reward, providing a solid foundation for growth.

"Focusing on later-stage products now will allow us to leverage our current infrastructure, and at the same time, make it accessible to patients for therapies which otherwise may not have been commercialized," Dr. Anvekar said[4].

Exploration of New Indications for Existing Drugs

Acrotech is actively exploring new indications for its existing drugs, a strategy that aligns perfectly with its business model. This approach allows the company to maximize the potential of its drug portfolio and make treatments formally accessible to patient populations that could benefit from them[4].

Building Towards Full Biopharma Capabilities

While currently focused on later-stage products, Acrotech has its sights set on becoming a fully operational biopharmaceutical company. The company is gradually building its R&D capabilities, with plans to look at early-stage products in the future[4]. This long-term vision guides Acrotech's current strategies and investments.

Emphasis on Accessibility and Affordability

Acrotech's mission includes providing effective treatments in an accessible and affordable manner[4]. This focus on accessibility aligns with growing concerns about drug pricing and healthcare costs, potentially positioning Acrotech favorably in the eyes of patients, healthcare providers, and payers.

Acrotech's Product Portfolio and Pipeline

Acrotech's current product portfolio and pipeline are crucial elements of its competitive position. Let's take a closer look at what the company offers and what's in development.

Current Product Offerings

Acrotech currently markets five injectable oncology brands in the USA[1]. While specific product names aren't provided in the available information, we know that these drugs are administered in clinical settings by healthcare providers, indicating their specialized nature.

Leadership in Peripheral T-Cell Lymphoma

Acrotech has established itself as a leader in Peripheral T-Cell Lymphoma treatment[1]. This positioning in a specific oncology niche demonstrates the company's strategy of focusing on areas where it can build significant expertise and market share.

Pipeline Development

Acrotech is actively working to expand its portfolio in both oncology and dermatology through creative licensing and internal R&D programs[1]. While specific details of pipeline products aren't provided, this ongoing development is crucial for the company's future growth and competitive position.

Biosimilar Pipeline

In the near term, Acrotech is preparing to commercialize a biosimilar pipeline in the immuno-oncology space through its sister company CuraTeq[1]. This move into biosimilars represents a significant expansion of Acrotech's capabilities and market reach.

Acrotech's Approach to Innovation

Innovation is at the heart of Acrotech's strategy, driving its growth and competitive position. Let's explore how the company approaches innovation in its operations and product development.

Focus on "Scientifically Advanced" Products

Acrotech aims to bring "scientifically advanced" products to market, particularly in areas where others might see less potential[4]. This approach allows the company to identify and develop innovative treatments that could significantly impact patient care.

Leveraging Partnerships for Innovation

Acrotech recognizes that partnerships can play a crucial role in bringing innovative products to market. The company actively seeks to forge strong relationships with partners to help bring scientifically advanced products to market where others might see less potential[4].

Investigator-Initiated Trials

Acrotech supports multiple investigator-initiated trials exploring potential new applications for its established drugs[4]. This approach not only helps to maximize the potential of existing products but also fosters innovation by exploring new uses for proven treatments.

Acrotech's Market Challenges and Opportunities

Like any pharmaceutical company, Acrotech faces both challenges and opportunities in its chosen markets. Understanding these can provide insight into the company's future prospects.

Challenges

  1. Competitive Landscape: The pharmaceutical industry is highly competitive, with both established giants and innovative startups vying for market share. Acrotech must continually innovate and differentiate itself to maintain its position.

  2. Regulatory Environment: The pharmaceutical industry is heavily regulated, and navigating this complex landscape can be challenging, particularly for a relatively young company like Acrotech.

  3. Drug Development Risks: The process of developing new drugs is inherently risky and expensive. Acrotech's focus on later-stage products helps mitigate some of this risk, but it remains a significant challenge.

Opportunities

  1. Expanding Oncology Market: The global oncology market is growing rapidly, providing significant opportunities for companies like Acrotech that specialize in this area.

  2. Potential in Dermatology: Acrotech's focus on dermatology alongside oncology provides diversification and additional growth opportunities.

  3. Biosimilar Market: Acrotech's move into biosimilars through CuraTeq opens up new market opportunities in the growing biosimilar sector.

  4. Global Expansion: While currently focused on the U.S. market, Acrotech's global partnerships provide potential for further international expansion.

Acrotech's Leadership and Corporate Culture

The leadership and corporate culture of a company can significantly impact its success and competitive position. Let's examine these aspects of Acrotech.

Leadership Team

Acrotech's leadership team is described as diverse and experienced, with a track record of success prior to joining the company[8]. This blend of experience and fresh perspectives can be a significant asset in navigating the competitive pharmaceutical landscape.

Focus on People and Culture

Acrotech's culture is centered around the care of its business, people, and customers[8]. This people-centric approach can be a significant differentiator in attracting and retaining talent, as well as in building strong relationships with healthcare providers and patients.

Emphasis on Customer Satisfaction

Acrotech states that "Customer satisfaction is paramount to our success"[1]. This focus on customer satisfaction can be a key differentiator in the pharmaceutical industry, where relationships with healthcare providers and patients are crucial.

Acrotech's Future Outlook

Based on its current position, strengths, and strategies, what might the future hold for Acrotech? Let's explore some potential scenarios.

Continued Growth in Oncology

Given Acrotech's strong position in oncology, particularly in niche areas like Peripheral T-Cell Lymphoma, we can expect continued growth and expansion in this therapeutic area. The company's strategy of exploring new indications for existing drugs could lead to further opportunities in oncology.

Expansion in Dermatology

While less prominent in the available information, Acrotech's focus on dermatology alongside oncology suggests potential for growth in this area. As the company builds its R&D capabilities, we might see more dermatology products in its pipeline.

Move into Earlier-Stage Drug Development

As Acrotech builds towards becoming a fully operational biopharmaceutical company, we might see a gradual shift towards earlier-stage drug development. This could open up new opportunities for innovation and growth, but would also come with increased risks.

International Expansion

While currently focused on the U.S. market, Acrotech's global partnerships provide a foundation for potential international expansion. As the company grows, we might see increased efforts to establish a direct presence in key international markets.

Key Takeaways

  1. Acrotech Biopharma, founded in 2018, has quickly established itself as a significant player in the specialty pharmaceutical market, particularly in oncology.

  2. The company's focus on niche areas like Peripheral T-Cell Lymphoma has allowed it to build expertise and market leadership in specific segments.

  3. Acrotech's strategy of developing "diamonds-in-the-rough" - drugs with improved efficacy or safety over existing treatments - sets it apart in the market.

  4. The company's emphasis on late-stage and commercialized products allows it to leverage its infrastructure effectively while minimizing development risks.

  5. Acrotech's global partnerships and plans for biosimilar development through CuraTeq provide avenues for future growth and expansion.

  6. The company's focus on innovation, customer satisfaction, and a people-centric culture could be key differentiators in the competitive pharmaceutical landscape.

  7. As Acrotech builds towards becoming a fully operational biopharmaceutical company, we may see a gradual shift towards earlier-stage drug development and increased R&D capabilities.

FAQs

  1. Q: What are Acrotech Biopharma's main therapeutic areas of focus? A: Acrotech Biopharma primarily focuses on oncology and dermatology, with a particular strength in oncology products.

  2. Q: How does Acrotech differentiate itself in the competitive pharmaceutical market? A: Acrotech differentiates itself through its focus on niche areas, development of "diamonds-in-the-rough" drugs, and emphasis on customer satisfaction and accessibility.

  3. Q: What is Acrotech's approach to drug development? A: Acrotech currently prioritizes late-stage and commercialized products, while also exploring new indications for existing drugs. The company is gradually building its R&D capabilities for future early-stage development.

  4. Q: How does Acrotech approach global markets? A: While primarily focused on the U.S. market, Acrotech has established global partnerships covering major markets like the EU, Canada, Japan, China, and Latin America.

  5. Q: What are some potential future directions for Acrotech? A: Potential future directions include continued growth in oncology, expansion in dermatology, movement into earlier-stage drug development, and increased international expansion.

Sources cited: [1] https://www.aurobindo.com/our-business/acrotech [4] https://www.biospace.com/a-platform-for-hope-in-the-face-of-rare-and-uncommon-diseases [8] https://acrotechbiopharma.com/about-us/executive-leadership-2/

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.