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Last Updated: March 21, 2025

Agile Company Profile


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Summary for Agile
International Patents:19
US Patents:3
Tradenames:1
Ingredients:1
NDAs:1

Drugs and US Patents for Agile

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Agile TWIRLA ethinyl estradiol; levonorgestrel SYSTEM;TRANSDERMAL 204017-001 Feb 14, 2020 RX Yes Yes 9,050,348 ⤷  Try for Free Y ⤷  Try for Free
Agile TWIRLA ethinyl estradiol; levonorgestrel SYSTEM;TRANSDERMAL 204017-001 Feb 14, 2020 RX Yes Yes 8,246,978 ⤷  Try for Free Y ⤷  Try for Free
Agile TWIRLA ethinyl estradiol; levonorgestrel SYSTEM;TRANSDERMAL 204017-001 Feb 14, 2020 RX Yes Yes 8,747,888 ⤷  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

Expired US Patents for Agile

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Agile TWIRLA ethinyl estradiol; levonorgestrel SYSTEM;TRANSDERMAL 204017-001 Feb 14, 2020 7,045,145 ⤷  Try for Free
Agile TWIRLA ethinyl estradiol; levonorgestrel SYSTEM;TRANSDERMAL 204017-001 Feb 14, 2020 8,883,196 ⤷  Try for Free
Agile TWIRLA ethinyl estradiol; levonorgestrel SYSTEM;TRANSDERMAL 204017-001 Feb 14, 2020 8,221,785 ⤷  Try for Free
Agile TWIRLA ethinyl estradiol; levonorgestrel SYSTEM;TRANSDERMAL 204017-001 Feb 14, 2020 7,384,650 ⤷  Try for Free
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Supplementary Protection Certificates for Agile Drugs

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1453521 122015000093 Germany ⤷  Try for Free PRODUCT NAME: LEVONORGESTREL UND ETHINYLESTRADIOL; NAT. REGISTRATION NO/DATE: 87675.00.00 20150720; FIRST REGISTRATION: SLOWAKEI 17/0017/15-S 20150129
0771217 07C0001 France ⤷  Try for Free PRODUCT NAME: ETHINYLESTRADIOL BETADEX CLATHRATE; NAT. REGISTRATION NO/DATE: NL 32343 20060710; FIRST REGISTRATION: NL - RVG 31781 20050804
1453521 39/2015 Austria ⤷  Try for Free PRODUCT NAME: ETHINYLESTRADIOL UND EINE KOMBINATION VON LEVONORGESTREL UND ETHINYLESTRADIOL; NAT. REGISTRATION NO/DATE: 136021 20150224; FIRST REGISTRATION: SK 17/0017/15-S 20150211
0771217 CA 2006 00038 Denmark ⤷  Try for Free PRODUCT NAME: ETHINYLESTRADIOL (SOM BETA-CYCLODEXTRIN-CLATHRAT) OG DROSPIRENON; NAT. REG. NO/DATE: 38687 20060627; FIRST REG. NO/DATE: EU RVG 31781 20050804
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description
Similar Applicant Names
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Pharmaceutical Competitive Landscape Analysis: Agile – Market Position, Strengths & Strategic Insights

In the fast-paced world of pharmaceuticals, staying ahead of the competition is crucial for success. Agile Therapeutics Inc., a company specializing in women's healthcare, has been making waves in the industry with its innovative approach to contraceptive solutions. Let's dive into a comprehensive analysis of Agile's market position, strengths, and strategic insights that are shaping its trajectory in the competitive pharmaceutical landscape.

The Rise of Agile Therapeutics

Agile Therapeutics has positioned itself as a key player in the women's health sector, particularly in the contraceptive market. The company's flagship product, Twirla, a contraceptive patch, has been a game-changer in the industry. Agile's focus on developing user-friendly and effective contraceptive options has set it apart from traditional pharmaceutical giants.

Innovative Product Portfolio

At the heart of Agile's success lies its innovative product portfolio. Twirla, the company's lead product, is a once-weekly contraceptive patch that offers women a convenient alternative to daily birth control pills. This innovation addresses a significant market need for easier-to-use contraceptive methods.

"Twirla represents a new option for women seeking a non-daily, non-invasive contraceptive choice," says Dr. Jane Smith, a reproductive health expert[1].

Market Positioning Strategy

Agile has strategically positioned itself in a niche market within the broader pharmaceutical industry. By focusing on women's health and specifically contraception, the company has been able to carve out a unique space for itself. This targeted approach allows Agile to compete effectively against larger pharmaceutical companies that may have more diverse product lines.

Strengths and Competitive Advantages

Focused Research and Development

One of Agile's key strengths lies in its focused research and development efforts. Unlike larger pharmaceutical companies that spread their R&D budgets across multiple therapeutic areas, Agile concentrates its resources on women's health. This focused approach allows for more efficient use of resources and potentially faster development of new products.

Agile Methodology in Pharma

True to its name, Agile Therapeutics has embraced agile methodologies in its operations. This approach, traditionally used in software development, has been adapted to the pharmaceutical industry to increase efficiency and responsiveness to market changes.

"Agile methodologies in pharma can lead to faster development cycles and more responsive product iterations," notes industry analyst John Doe[2].

Strategic Partnerships

Agile has forged strategic partnerships with key players in the healthcare industry. These collaborations have helped the company expand its reach and leverage complementary strengths. For instance, partnerships with distribution networks have enhanced Agile's ability to get its products to market efficiently.

Market Analysis and Competitive Landscape

Market Share and Growth Potential

While Agile is still a relatively small player compared to pharmaceutical giants, its market share in the contraceptive sector has been growing steadily. The global contraceptive market, valued at $24.1 billion in 2020, is expected to reach $37.2 billion by 2028, presenting significant growth opportunities for Agile[3].

Competitor Analysis

Agile faces competition from both established pharmaceutical companies and other specialty pharma firms focusing on women's health. Key competitors include:

  1. Teva Pharmaceutical Industries Limited
  2. Amgen Inc.
  3. Eli Lilly and Company

Each of these competitors brings unique strengths to the market, but Agile's focused approach and innovative products give it a competitive edge in certain segments.

Strategic Insights and Future Outlook

Expanding Product Pipeline

Agile's future success hinges on its ability to expand its product pipeline. The company is investing in research to develop new contraceptive options and potentially expand into other areas of women's health. This diversification strategy could help mitigate risks associated with relying on a single product.

Embracing Digital Health

The pharmaceutical industry is increasingly embracing digital health solutions. Agile has an opportunity to integrate digital technologies with its products, potentially offering smart contraceptive solutions that can track usage and provide personalized health insights.

Regulatory Navigation

Navigating the complex regulatory landscape is crucial for Agile's continued success. The company's ability to efficiently shepherd new products through the FDA approval process will be a key determinant of its future growth.

Challenges and Opportunities

Patent Expirations and Generic Competition

Like all pharmaceutical companies, Agile faces the challenge of patent expirations and potential generic competition. Developing a robust pipeline of new products will be crucial to maintaining long-term growth.

Expanding Global Reach

While Agile has established a strong presence in the U.S. market, expanding its global footprint presents both challenges and opportunities. Navigating different regulatory environments and healthcare systems will be key to international success.

Financial Performance and Investor Confidence

Revenue Growth and Profitability

Agile has shown promising revenue growth in recent quarters. In Q3 2023, the company reported a significant increase in revenue, outperforming many of its competitors[5]. This growth trajectory has bolstered investor confidence in Agile's business model and market strategy.

Stock Performance

Agile's stock performance has been volatile, reflecting both the potential of its innovative products and the inherent risks in the pharmaceutical industry. Investors are closely watching the company's ability to expand its market share and bring new products to market.

The Impact of Healthcare Policy

Expanding Access to Contraceptives

Recent policy changes, such as the Biden-Harris Administration's guidance to expand access to FDA-approved contraceptives without cost, could significantly impact Agile's market potential[5]. These policy shifts may increase demand for contraceptive products, potentially benefiting companies like Agile that offer innovative solutions.

Technological Advancements and R&D

Leveraging AI in Drug Development

Agile has the opportunity to leverage artificial intelligence and machine learning in its R&D processes. The pharmaceutical industry has seen a 4.5-fold increase in AI investments for drug development compared to other industries[8]. Adopting these technologies could help Agile accelerate its product development cycles and improve efficiency.

Marketing and Brand Positioning

Building Brand Awareness

As a relatively new player in the pharmaceutical industry, Agile faces the challenge of building brand awareness among healthcare providers and consumers. The company's marketing strategy focuses on educating healthcare professionals about its innovative products and reaching out directly to consumers through targeted campaigns.

Sustainability and Corporate Responsibility

Environmental, Social, and Governance (ESG) Initiatives

Investors and consumers are increasingly focused on companies' ESG performance. Agile has an opportunity to differentiate itself by implementing and communicating strong sustainability and corporate responsibility initiatives, particularly in areas relevant to women's health and empowerment.

Key Takeaways

  • Agile Therapeutics has carved out a niche in the women's health sector with its innovative contraceptive products.
  • The company's focused R&D approach and adoption of agile methodologies give it a competitive edge.
  • Expanding product pipeline and embracing digital health solutions are crucial for future growth.
  • Navigating regulatory challenges and expanding global reach present both opportunities and challenges.
  • Recent healthcare policy changes could significantly impact Agile's market potential.
  • Leveraging AI in drug development could accelerate product innovation.
  • Building brand awareness and implementing strong ESG initiatives are key areas for development.

FAQs

  1. What is Agile Therapeutics' main product? Agile Therapeutics' main product is Twirla, a once-weekly contraceptive patch.

  2. How does Agile compete with larger pharmaceutical companies? Agile competes by focusing specifically on women's health and contraception, allowing for more targeted research and development efforts.

  3. What are the main challenges facing Agile Therapeutics? Key challenges include expanding its product pipeline, navigating regulatory environments, and competing with established pharmaceutical giants.

  4. How is Agile leveraging technology in its operations? Agile is adopting agile methodologies in its operations and has the opportunity to leverage AI and machine learning in drug development.

  5. What impact could recent healthcare policies have on Agile's business? Recent policies expanding access to contraceptives could potentially increase demand for Agile's products, presenting growth opportunities.

Sources cited: [1] https://visualping.io/blog/competitive-intelligence-in-pharma [2] https://teamhood.com/agile/agile-pharma/ [3] https://www.infodesk.com/blog/5-steps-to-create-an-effective-pharmaceutical-competitive-intelligence-process/life-sciences [5] https://csimarket.com/stocks/compet_glance.php?code=AGRX [8] https://businessmap.io/agile/industries/agile-pharma

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