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Last Updated: March 29, 2025

Mayne Pharma Company Profile


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Summary for Mayne Pharma
International Patents:476
US Patents:78
Tradenames:18
Ingredients:14
NDAs:15

Drugs and US Patents for Mayne Pharma

ApplicantTradenameGeneric NameDosageNDAApproval DateTETypeRLDRSPatent No.Patent ExpirationProductSubstanceDelist Req.Exclusivity Expiration
Mayne Pharma BIJUVA estradiol; progesterone CAPSULE;ORAL 210132-001 Oct 28, 2018 RX Yes Yes 10,206,932 ⤷  Try for Free ⤷  Try for Free
Mayne Pharma BIJUVA estradiol; progesterone CAPSULE;ORAL 210132-002 Dec 28, 2021 RX Yes No 8,633,178 ⤷  Try for Free Y ⤷  Try for Free
Mayne Pharma IMVEXXY estradiol INSERT;VAGINAL 208564-001 May 29, 2018 RX Yes No 10,806,697 ⤷  Try for Free Y ⤷  Try for Free
Mayne Pharma IMVEXXY estradiol INSERT;VAGINAL 208564-001 May 29, 2018 RX Yes No 9,289,382 ⤷  Try for Free Y ⤷  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
Showing 1 to 4 of 4 entries

Expired US Patents for Mayne Pharma

ApplicantTradenameGeneric NameDosageNDAApproval DatePatent No.Patent Expiration
Mayne Pharma DORYX doxycycline hyclate TABLET, DELAYED RELEASE;ORAL 050795-005 Apr 11, 2013 6,958,161 ⤷  Try for Free
Mayne Pharma DORYX doxycycline hyclate TABLET, DELAYED RELEASE;ORAL 050795-002 May 6, 2005 6,958,161 ⤷  Try for Free
Mayne Pharma DORYX MPC doxycycline hyclate TABLET, DELAYED RELEASE;ORAL 050795-008 May 20, 2016 6,958,161 ⤷  Try for Free
Mayne Pharma TOLSURA itraconazole CAPSULE;ORAL 208901-001 Dec 11, 2018 8,771,739 ⤷  Try for Free
>Applicant>Tradename>Generic Name>Dosage>NDA>Approval Date>Patent No.>Patent Expiration
Showing 1 to 4 of 4 entries
Paragraph IV (Patent) Challenges for MAYNE PHARMA drugs
Drugname Dosage Strength Tradename Submissiondate
➤ Subscribe Delayed-release Tablets 80 mg ➤ Subscribe 2015-07-01
➤ Subscribe Delayed-release Tablets 60 mg and 120 mg ➤ Subscribe 2017-09-28
➤ Subscribe Delayed-release Tablets 150 mg ➤ Subscribe 2008-12-19
➤ Subscribe Delayed-release Tablets 200 mg ➤ Subscribe 2014-05-19
➤ Subscribe Delayed-release Tablets 50 mg ➤ Subscribe 2015-11-05
➤ Subscribe Delayed-release Tablets 200 mg ➤ Subscribe 2013-08-12

Supplementary Protection Certificates for Mayne Pharma Drugs

Patent NumberSupplementary Protection CertificateSPC CountrySPC ExpirationSPC Description
0770388 09C0018 France ⤷  Try for Free PRODUCT NAME: ESTRADIOL VALERATE; DIENOGEST; NAT. REGISTRATION NO/DATE: NL35170 20081210; FIRST REGISTRATION: BE327792 20081103
2782584 122021000080 Germany ⤷  Try for Free PRODUCT NAME: ZUSAMMENSETZUNG, DIE SOWOHL ESTRADIOL (17SS-ESTRADIOL), GEGEBENENFALLS IN FORM EINES PHARMAZEUTISCH ANNEHMBAREN SALZES, HYDRATS ODER SOLVATS DAVON (EINSCHLIESSLICH IN FORM EINES HEMIHYDRATS), ALS AUCH PROGESTERON ENTHAELT; NAT. REGISTRATION NO/DATE: 2205034.00.00 20210924; FIRST REGISTRATION: BELGIEN BE582231 20210406
0770388 9/2009 Austria ⤷  Try for Free PRODUCT NAME: KOMBINATION AUS ESTRADIOLVALERAT UND DIENOGEST; NAT. REGISTRATION NO/DATE: 1-28003 20090203; FIRST REGISTRATION: BE BE 327792 20081103
0770388 PA2009004,C0770388 Lithuania ⤷  Try for Free PRODUCT NAME: ESTRADIOLI VALERAS + DIENOGESTUM; NAT. REGISTRATION NO/DATE: LT/1/09/1512/001, 2009 04 06 LT/1/09/1512/002, 2009 04 06 LT/1/09/1512/003 20090406; FIRST REGISTRATION: BE 327792 20081103
>Patent Number>Supplementary Protection Certificate>SPC Country>SPC Expiration>SPC Description
Showing 1 to 4 of 4 entries
Similar Applicant Names
Applicants may be listed under multiple names.
Here is a list of applicants with similar names.

Pharmaceutical Competitive Landscape Analysis: Mayne Pharma – Market Position, Strengths & Strategic Insights

In the ever-evolving pharmaceutical industry, Mayne Pharma has emerged as a notable player, carving out its niche in specialty pharmaceuticals. This comprehensive analysis delves into Mayne Pharma's market position, strengths, and strategic insights, offering a detailed look at how the company navigates the competitive landscape.

Company Overview

Mayne Pharma is an ASX-listed specialty pharmaceutical company with a 40-year track record of innovation in oral drug delivery systems[1]. The company focuses on commercializing novel and generic pharmaceuticals, offering patients better, safe, and more accessible medicines[1]. With a global presence and a workforce of over 900 employees, including more than 200 scientists, Mayne Pharma has positioned itself as a technology-driven company with expertise in complex oral and topical dose forms[1].

Key Business Segments

Mayne Pharma operates across several key business segments:

  1. Women's Health
  2. Dermatology
  3. Contract Development and Manufacturing (CDMO)
  4. International Operations

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, coupled with its CDMO services and international operations, has allowed it to create a diversified portfolio that mitigates risks associated with any single market segment.

Women's Health

In the women's health segment, Mayne Pharma has made significant strides, particularly with the launch of NEXTSTELLIS®, a novel oral contraceptive. The company's strategy in this segment involves seeking out complementary products with strong growth potential that leverage its existing commercial infrastructure[6].

Dermatology

Mayne Pharma's dermatology segment has been a key focus area for growth. The company has adopted a unique channel strategy that aims to create a more seamless 'prescription to patient' experience[1]. This approach has attracted partnerships with leading generic companies, significantly strengthening Mayne Pharma's dermatology pipeline[1].

"Mayne Pharma has the unique opportunity to disintermediate a system rife with inefficiencies and pain points. The Dermatology segment is particularly well-suited for disruption given continuous demand (most dermatological conditions are not permanently cured), long cycle times, and ever-worsening insurance coverage."[6]

Contract Development and Manufacturing (CDMO)

Mayne Pharma's CDMO business, operated through Metrics Contract Services, has shown consistent growth over the years. The segment has delivered a 12% CAGR over eight years, operating in the attractive CDMO market that continues to grow above the broader pharmaceutical industry[1].

International Operations

Mayne Pharma International, based in Salisbury, South Australia, represents the company's international arm. The business has demonstrated a track record of growth with a 5% revenue CAGR over six years[1].

Competitive Strengths

Innovative Drug Delivery Systems

Mayne Pharma's 40-year track record in developing innovative oral drug delivery systems is a significant competitive advantage. These technologies have been successfully commercialized in numerous products that continue to be marketed worldwide[1].

Diversified Portfolio

The company's diversified portfolio across women's health, dermatology, CDMO services, and international operations provides resilience against market fluctuations in any single segment.

Strong R&D Capabilities

With over 200 scientists on its team, Mayne Pharma maintains robust research and development capabilities. In FY21, the company invested A$25 million in R&D, underscoring its commitment to innovation[1].

Strategic Partnerships

Mayne Pharma has successfully implemented strategic partnerships and alliances, adopting a flexible and pragmatic approach to licensing[8]. These partnerships have been crucial in expanding the company's product portfolio and market reach.

Strategic Insights

Focus on High-Growth Segments

Mayne Pharma's strategic focus on women's health and dermatology aligns with high-growth segments in the pharmaceutical industry. The company's efforts to expand its portfolio in these areas through both internal development and strategic acquisitions demonstrate a clear growth strategy.

Channel Strategy in Dermatology

The company's unique channel strategy in dermatology, which aims to create a more seamless 'prescription to patient' experience, represents a innovative approach to market disruption. This strategy has the potential to differentiate Mayne Pharma in a competitive market.

Expansion of CDMO Services

The consistent growth of Mayne Pharma's CDMO business suggests that further expansion of these services could be a key driver of future growth. The company's investment in new production facilities indicates a commitment to this strategy[1].

International Market Penetration

With a solid track record of growth in its international operations, Mayne Pharma is well-positioned to further penetrate international markets. The company's FDA-approved manufacturing facilities in Australia provide a strong foundation for this expansion[1].

Financial Performance

Mayne Pharma's financial performance has shown significant improvement in recent years. In FY23, the company generated positive operating cash flow of $14.1 million in the second half of the year[2]. The company also ended FY23 with a net cash position of $172.6 million, compared to net debt of $317 million at the end of FY22, representing a nearly half-billion net cash improvement[2].

Revenue Breakdown

While specific revenue figures for FY23 were not provided in the available search results, historical data shows that Mayne Pharma's revenue streams are diversified across its business segments. In FY21, the company reported revenue of A$400 million, with 85% of revenue coming from the US market[1].

Market Challenges

Competitive Pressure

The pharmaceutical industry is highly competitive, with numerous players vying for market share. Mayne Pharma faces competition from both large pharmaceutical companies and specialized players in its key segments.

Regulatory Environment

As with all pharmaceutical companies, Mayne Pharma operates in a heavily regulated environment. Changes in regulations or delays in product approvals can significantly impact the company's performance.

Pricing Pressures

The pharmaceutical industry continues to face pricing pressures, particularly in the generic drug market. Mayne Pharma's strategy to focus on specialty pharmaceuticals and novel drug delivery systems helps mitigate some of these pressures.

Future Outlook

Mayne Pharma's future outlook appears positive, with the company well-positioned for sustainable long-term growth. The company's focus on women's health and dermatology, coupled with its strong CDMO services and international operations, provides a solid foundation for future growth.

Growth Drivers

  1. Expansion of women's health portfolio
  2. Continued innovation in dermatology products and channel strategy
  3. Growth in CDMO services
  4. International market expansion

Strategic Priorities for FY24

Mayne Pharma has outlined several strategic priorities for FY24, including:

  1. Driving organic growth across all business segments
  2. Completing the integration of the licensed women's health portfolio
  3. Continuing to drive NEXTSTELLIS® unit growth
  4. Launching low strength BIJUVA® in the second half of FY24
  5. Refining the dermatology channel strategy
  6. Improving operational efficiency[6]

Sustainability Initiatives

Mayne Pharma has demonstrated a commitment to sustainability, particularly in packaging. The company is working to reduce its environmental footprint by reviewing new and existing packaging against APCO Sustainable Packaging Guidelines[9]. This focus on sustainability aligns with growing consumer and investor expectations for environmentally responsible business practices.

Key Takeaways

  1. Mayne Pharma has strategically positioned itself in high-growth segments of women's health and dermatology.
  2. The company's innovative channel strategy in dermatology represents a potential market disruptor.
  3. Mayne Pharma's CDMO services and international operations provide diversification and growth opportunities.
  4. The company has significantly improved its financial position, moving from a net debt to a net cash position.
  5. Future growth is expected to be driven by portfolio expansion, particularly in women's health and dermatology.
  6. Sustainability initiatives, particularly in packaging, demonstrate the company's commitment to responsible business practices.

FAQs

  1. Q: What are Mayne Pharma's key business segments? A: Mayne Pharma's key business segments include Women's Health, Dermatology, Contract Development and Manufacturing (CDMO), and International Operations.

  2. Q: How has Mayne Pharma's financial position changed recently? A: Mayne Pharma has significantly improved its financial position, moving from a net debt of $317 million at the end of FY22 to a net cash position of $172.6 million at the end of FY23.

  3. Q: What is Mayne Pharma's strategy in the dermatology segment? A: Mayne Pharma has adopted a unique channel strategy in dermatology that aims to create a more seamless 'prescription to patient' experience, potentially disrupting the traditional market approach.

  4. Q: How is Mayne Pharma addressing sustainability? A: Mayne Pharma is committed to reducing its environmental footprint, particularly by reviewing new and existing packaging against APCO Sustainable Packaging Guidelines.

  5. Q: What are some of Mayne Pharma's strategic priorities for FY24? A: Some of Mayne Pharma's strategic priorities for FY24 include driving organic growth across all business segments, completing the integration of the licensed women's health portfolio, and refining the dermatology channel strategy.

Sources cited: [1] https://www.maynepharma.com/wp-content/uploads/2022/04/mayne-pharma-annual-report-2021-web.pdf [2] https://www.maynepharma.com/wp-content/uploads/2023/09/FY23-MYX-ASX-Media-Release-FINAL.pdf [6] https://www.maynepharma.com/wp-content/uploads/2023/11/MPG-AR-2023-artwork-FINAL.pdf [8] https://www.maynepharma.com/partnering-philosophy/ [9] https://www.maynepharma.com/our-operations/packaging-sustainability/

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