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Last Updated: June 14, 2025

Mayne Pharma Inc Company Profile


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What is the competitive landscape for MAYNE PHARMA INC

MAYNE PHARMA INC has two approved drugs.

There is one tentative approval on MAYNE PHARMA INC drugs.

Summary for Mayne Pharma Inc
US Patents:0
Tradenames:2
Ingredients:2
NDAs:2

Drugs and US Patents for Mayne Pharma Inc

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Mayne Pharma Inc HYDROCODONE BITARTRATE AND PSEUDOEPHEDRINE HYDROCHLORIDE hydrocodone bitartrate; pseudoephedrine hydrochloride SOLUTION;ORAL 205658-001 Nov 17, 2015 DISCN No No ⤷  Try for Free ⤷  Try for Free
Mayne Pharma Inc HYDROCODONE BITARTRATE, CHLORPHENIRAMINE MALEATE AND PSEUDOEPHEDRINE HYDROCHLORIDE chlorpheniramine maleate; hydrocodone bitartrate; pseudoephedrine hydrochloride SOLUTION;ORAL 205657-001 Aug 3, 2015 DISCN No No ⤷  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
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Pharmaceutical Competitive Landscape Analysis: Mayne Pharma Inc – Market Position, Strengths & Strategic Insights

In the ever-evolving pharmaceutical industry, Mayne Pharma Inc has established itself as a notable player with a focus on specialty pharmaceuticals. This comprehensive analysis delves into Mayne Pharma's market position, strengths, and strategic insights, providing valuable information for industry professionals and investors alike.

Company Overview

Mayne Pharma is an ASX-listed specialty pharmaceutical company with a 40-year track record of innovation and success in developing oral drug delivery systems[1]. The company focuses on commercializing novel and generic pharmaceuticals, offering patients better, safe, and more accessible medicines[2].

Key Business Segments

Mayne Pharma operates through three main segments:

  1. US Women's Health
  2. US Dermatology
  3. International

Global Presence

With a strong presence in the United States and Australia, Mayne Pharma has been expanding its international footprint. The company's Salisbury facility in South Australia is the largest Australian-owned full-service solid dose plant that manufactures TGA and FDA-registered pharmaceuticals[2].

Market Position

Mayne Pharma has strategically positioned itself in niche markets within the pharmaceutical industry. The company's focus on women's health and dermatology in the US, coupled with its international operations, has allowed it to carve out a unique space in the competitive landscape.

Women's Health

In the US women's health market, Mayne Pharma has made significant strides with its flagship product NEXTSTELLIS®, an oral contraceptive. The company is actively working to establish NEXTSTELLIS® as a leading brand in both the US and Australian contraceptive markets[7].

NEXTSTELLIS® remains the Company's most significant commercial opportunity participating in the US$3.2b short-acting combined hormonal contraceptive (CHC) market in the US and the A$60m CHC market in Australia[7].

Dermatology

Mayne Pharma has been strengthening its position in the US dermatology market through strategic partnerships and product acquisitions. The company has signed supply and distribution agreements with leading suppliers for multiple dermatology products, expanding its portfolio and leveraging its established commercial capabilities[2].

International Operations

The company's International segment, based in Salisbury, South Australia, has demonstrated consistent growth with a 5% revenue CAGR over six years[1]. This segment focuses on manufacturing and exporting products to more than a dozen countries, showcasing Mayne Pharma's global reach.

Strengths and Competitive Advantages

Innovative Drug Delivery Systems

Mayne Pharma's 40-year track record in developing oral drug delivery systems sets it apart from competitors. The company's expertise in complex oral and topical dose forms, including highly potent compounds and modified-release products, provides a strong foundation for product development and partnerships[1].

Diversified Business Model

The company's diverse business model, spanning women's health, dermatology, and international operations, provides multiple growth opportunities and potential for near-term value creation[7].

Strong Manufacturing Capabilities

Mayne Pharma's Salisbury facility is one of only two FDA-approved full-service solid oral dose manufacturers based in Australia. This capability, combined with its outstanding track record of regulatory compliance, positions the company as a reliable partner for contract manufacturing and development services[2].

Strategic Partnerships

The company has demonstrated a flexible and pragmatic approach to licensing and partnerships, which has been key to its success[3]. These collaborations have allowed Mayne Pharma to expand its product portfolio and market reach efficiently.

Strategic Insights

Focus on High-Value Markets

Mayne Pharma's strategic focus on women's health and dermatology in the US market aligns with high-value, growing segments of the pharmaceutical industry. This targeted approach allows the company to leverage its strengths and compete effectively against larger competitors.

Portfolio Optimization

The company has been actively rationalizing its generic portfolio to focus on more sustainable products and channels. This strategic move, while resulting in short-term adjustments, positions Mayne Pharma for improved long-term performance[7].

Direct-to-Consumer Marketing

In June 2022, Mayne Pharma launched a direct-to-consumer (DTC) campaign for NEXTSTELLIS® in the US. This strategic initiative is expected to accelerate sales and increase brand awareness among potential users[7].

End-to-End Market Solutions

Mayne Pharma is actively working to create a differentiated end-to-end market solution in the US that helps patients seek treatments with trusted healthcare professionals. This approach aims to provide a seamless, transparent, and cost-effective experience for patients[7].

Financial Performance

Recent Financial Results

While specific financial figures are not provided in the search results, it's important to note that Mayne Pharma has been undergoing a transition period. The company has been focusing on resetting the business for future growth, which has involved significant restructuring and repositioning efforts[1].

Revenue Streams

Mayne Pharma's revenue is primarily derived from its three main business segments:

  1. US Women's Health
  2. US Dermatology
  3. International operations

The company's International segment, in particular, has shown consistent growth, delivering $65 million in revenue during FY23, up 19% from the previous year[1].

Investment in R&D

Mayne Pharma invested A$25 million in R&D according to its FY21 key metrics[2]. This commitment to research and development underscores the company's focus on innovation and future growth.

Market Challenges and Opportunities

Challenges

  1. Competitive US Market: The US pharmaceutical market is highly competitive, particularly in the generic space. Mayne Pharma has had to strategically reposition itself to compete effectively.

  2. Regulatory Environment: As with all pharmaceutical companies, Mayne Pharma must navigate complex regulatory landscapes across multiple jurisdictions.

  3. Product Performance: The company has faced challenges in meeting initial forecasts for some products, such as NEXTSTELLIS®, due to factors like COVID-19 and longer physician and patient activation times[7].

Opportunities

  1. Growing Women's Health Market: The global women's health market is expanding, providing significant opportunities for products like NEXTSTELLIS®.

  2. Dermatology Partnerships: Mayne Pharma's strategic partnerships in dermatology offer potential for portfolio expansion and revenue growth.

  3. International Expansion: The company's strong manufacturing capabilities and international segment provide a platform for further global expansion.

Future Outlook and Strategic Priorities

Mayne Pharma's future outlook is focused on consolidation and execution. The company has outlined several strategic priorities for FY24 and beyond:

  1. Driving growth in existing businesses without significant capital for acquisitions
  2. Completing the integration of the licensed women's health portfolio
  3. Continuing to drive NEXTSTELLIS® unit growth while improving net selling price
  4. Launching low-strength BIJUVA® in the second half of FY24
  5. Refining the Dermatology channel strategy
  6. Improving the performance of the International segment
  7. Enhancing operational efficiency[1]

Competitive Positioning

Market Share

While specific market share data is not provided in the search results, Mayne Pharma has positioned itself as a significant player in niche markets. In women's health, for example, the company has become one of the top women's health companies in the US based on its commercial footprint[1].

Differentiation Strategy

Mayne Pharma differentiates itself through:

  1. Expertise in complex oral and topical dose forms
  2. Focus on high-value therapeutic areas like women's health and dermatology
  3. Strong manufacturing capabilities and regulatory compliance track record
  4. Strategic partnerships and licensing agreements

Competitor Analysis

While detailed competitor information is not provided in the search results, it's important to note that Mayne Pharma competes with both large pharmaceutical companies and specialty pharma players in its key markets. The company's strategy of focusing on niche areas and leveraging partnerships allows it to compete effectively against larger competitors.

Innovation and Product Pipeline

R&D Focus

Mayne Pharma has shifted its R&D focus towards business development activities in dermatology and women's health, moving away from internal R&D[1]. This strategic pivot allows the company to leverage external innovation while focusing on its core strengths in commercialization and manufacturing.

Product Pipeline

While specific details of the product pipeline are not provided in the search results, Mayne Pharma has mentioned having 15+ pipeline products in its FY21 key metrics[2]. The company's focus on women's health and dermatology suggests that many of these pipeline products are likely in these therapeutic areas.

Sustainability and Corporate Responsibility

Mayne Pharma has demonstrated a commitment to sustainability and corporate responsibility. The company's approach includes strategies and initiatives designed to provide more affordable pharmaceutical pricing and accessibility to products for patients[8]. This focus on affordability and accessibility aligns with broader industry trends towards more sustainable and socially responsible business practices.

Key Takeaways

  1. Mayne Pharma has strategically positioned itself in niche markets, focusing on women's health and dermatology in the US, along with international operations.

  2. The company's strengths lie in its innovative drug delivery systems, diversified business model, strong manufacturing capabilities, and strategic partnerships.

  3. NEXTSTELLIS®, an oral contraceptive, represents Mayne Pharma's most significant commercial opportunity in the US and Australian markets.

  4. The company is actively working on creating end-to-end market solutions and optimizing its product portfolio for sustainable growth.

  5. Mayne Pharma faces challenges in the competitive US market but has opportunities for growth in expanding therapeutic areas and international markets.

  6. Future strategic priorities include driving growth in existing businesses, improving operational efficiency, and refining channel strategies.

  7. The company's focus on affordability and accessibility aligns with industry trends towards more sustainable and socially responsible practices.

FAQs

  1. Q: What are Mayne Pharma's main business segments? A: Mayne Pharma operates through three main segments: US Women's Health, US Dermatology, and International.

  2. Q: What is Mayne Pharma's flagship product? A: NEXTSTELLIS®, an oral contraceptive, is Mayne Pharma's flagship product and most significant commercial opportunity.

  3. Q: How has Mayne Pharma strengthened its position in the US dermatology market? A: Mayne Pharma has signed supply and distribution agreements with leading suppliers for multiple dermatology products, expanding its portfolio and leveraging its established commercial capabilities.

  4. Q: What sets Mayne Pharma apart from its competitors? A: Mayne Pharma differentiates itself through its expertise in complex oral and topical dose forms, focus on high-value therapeutic areas, strong manufacturing capabilities, and strategic partnerships.

  5. Q: What are Mayne Pharma's key strategic priorities for the future? A: Mayne Pharma's strategic priorities include driving growth in existing businesses, completing the integration of licensed women's health products, improving operational efficiency, and refining its dermatology channel strategy.

Sources cited: [1] https://www.maynepharma.com/wp-content/uploads/2023/11/MPG-AR-2023-artwork-FINAL.pdf [2] https://www.maynepharma.com/wp-content/uploads/2022/04/mayne-pharma-annual-report-2021-web.pdf [3] https://www.maynepharma.com/partnering-philosophy/ [7] https://www.maynepharma.com/wp-content/uploads/2022/10/MPG-AR-2022-web.pdf [8] https://www.maynepharma.com/sustainability/our-approach/

Last updated: 2025-02-12

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