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Last Updated: January 5, 2025

CIMDUO Drug Patent Profile


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Summary for CIMDUO
US Patents:0
Applicants:1
NDAs:1
Finished Product Suppliers / Packagers: 1
Drug Prices: Drug price information for CIMDUO
What excipients (inactive ingredients) are in CIMDUO?CIMDUO excipients list
DailyMed Link:CIMDUO at DailyMed
Drug patent expirations by year for CIMDUO
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US Patents and Regulatory Information for CIMDUO

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Mylan Labs Ltd CIMDUO lamivudine; tenofovir disoproxil fumarate TABLET;ORAL 022141-001 Feb 28, 2018 RX Yes Yes ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

CIMDUO Market Analysis and Financial Projection

Market Dynamics and Financial Trajectory for Cimduo

Introduction to Cimduo

Cimduo, a fixed-dose combination of lamivudine and tenofovir disoproxil fumarate, is an antiretroviral medication used in the treatment of HIV-1 infection. Developed by Mylan, Cimduo is part of a broader landscape of HIV treatments that have transformed the management of the disease from a terminal condition to a chronic, manageable illness.

Global HIV Market Overview

The global HIV market is characterized by a large and growing patient population. As of 2016, there were approximately 36.7 million people living with HIV worldwide, with 1.8 million new infections and 1 million deaths attributed to the disease that year[1].

Market Growth and Projections

The HIV treatment market is expected to grow significantly, reaching $22.5 billion by 2025, driven by an increasing patient population and advancements in treatment options. This growth is fueled by factors such as changing lifestyles, injection drug use, and unprotected sex[1].

Competitive Landscape

The HIV market is highly competitive, with several major players vying for market share. Gilead Sciences dominates the market with three of the top four best-selling HIV drugs, including Truvada, Atripla, and Stribild. However, other companies like ViiV Healthcare and Mylan are also making significant strides.

Mylan's Position in the HIV Market

Mylan, with its approval of Cimduo, has strengthened its presence in the HIV treatment market. Cimduo is one of three HIV drugs approved by the FDA for Mylan, the others being Symfi and Symvi Lo. Heather Bresch, Mylan’s CEO, emphasized the company's commitment to expanding affordable access to HIV treatments, which is crucial in a market where affordability and accessibility are key factors[1].

Financial Performance and Revenue

While specific financial data for Cimduo alone is not readily available, Mylan's overall revenue from its HIV pipeline is significant. The approval and subsequent market entry of Cimduo contribute to Mylan's growing share in the HIV market. The company's commitment to affordability and its strategic approach to pricing, particularly in developing and middle-income countries, helps in capturing a broader market segment[1].

Pricing and Accessibility

Pricing strategies play a critical role in the HIV market, especially in regions with varying economic conditions. Companies like ViiV Healthcare adopt a tiered pricing model, offering voluntary free licenses in developing countries, high-volume lower-cost tenders in middle-income countries, and standard pricing in developed markets. This approach ensures that medicines are accessible to a wide range of patients, which can positively impact the financial trajectory of drugs like Cimduo[3].

Clinical Significance and Patient Impact

Cimduo, as a fixed-dose combination, offers convenience and adherence benefits to patients. The combination of lamivudine and tenofovir disoproxil fumarate is well-tolerated and effective, making it a viable option for patients who require a simpler treatment regimen. This can lead to better patient outcomes and higher patient satisfaction, which in turn can drive market demand and financial performance[2].

Regulatory Approvals and Market Expansion

The FDA approval of Cimduo marked a significant milestone for Mylan, enabling the company to expand its offerings in the U.S. and other markets. Regulatory approvals are crucial for market entry and expansion, and Mylan's success in this area has helped the company to gain a foothold in the competitive HIV treatment market[1].

Market Share and Competition

In a market dominated by Gilead Sciences, Mylan's Cimduo faces stiff competition. However, the drug's approval and Mylan's strategic pricing and distribution strategies have helped the company to carve out a niche. ViiV Healthcare's two-drug regimen, Juluca, is another competitor in this space, but Cimduo's unique combination and affordability make it an attractive option for many patients[1][3].

Future Outlook and Innovations

The future of the HIV treatment market is marked by innovation, with a focus on two-drug regimens and long-acting treatments. Companies are investing heavily in research and development to bring new and more effective treatments to the market. Mylan's continued commitment to innovation and accessibility will be key to the long-term success of Cimduo and its other HIV treatments[3].

Key Takeaways

  • Growing Market: The global HIV treatment market is expected to reach $22.5 billion by 2025.
  • Competitive Landscape: The market is dominated by Gilead Sciences, but Mylan and ViiV Healthcare are significant players.
  • Affordability: Tiered pricing models and affordable access strategies are crucial for market success.
  • Regulatory Approvals: FDA approvals are vital for market entry and expansion.
  • Innovation: Two-drug regimens and long-acting treatments are the future of HIV management.
  • Patient Impact: Fixed-dose combinations like Cimduo improve patient adherence and outcomes.

FAQs

Q: What is Cimduo used for? A: Cimduo is a fixed-dose combination of lamivudine and tenofovir disoproxil fumarate used in the treatment of HIV-1 infection.

Q: Who developed Cimduo? A: Cimduo was developed by Mylan.

Q: What is the expected growth of the HIV treatment market? A: The HIV treatment market is expected to grow to $22.5 billion by 2025.

Q: How does Mylan's pricing strategy impact Cimduo's market performance? A: Mylan's tiered pricing model, offering affordable access in various regions, helps in capturing a broader market segment and improving the drug's financial trajectory.

Q: What are the key competitors to Cimduo in the HIV market? A: Key competitors include Gilead Sciences' drugs like Truvada and ViiV Healthcare's Juluca.

Sources

  1. BioSpace: Companies Fight for Growing Share of HIV Market.
  2. ResearchGate: A Review and Clinical Understanding of Tenofovir.
  3. GSK: ViiV Meet The Management - transcript.

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