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Last Updated: December 22, 2024

SAQUINAVIR MESYLATE - Generic Drug Details


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What are the generic sources for saquinavir mesylate and what is the scope of freedom to operate?

Saquinavir mesylate is the generic ingredient in one branded drug marketed by Hoffmann La Roche and Hoffmann-la Roche, and is included in two NDAs. Additional information is available in the individual branded drug profile pages.

There is one drug master file entry for saquinavir mesylate.

Summary for SAQUINAVIR MESYLATE
US Patents:0
Tradenames:1
Applicants:2
NDAs:2
Drug Master File Entries: 1
Raw Ingredient (Bulk) Api Vendors: 68
Clinical Trials: 8
Patent Applications: 6,465
What excipients (inactive ingredients) are in SAQUINAVIR MESYLATE?SAQUINAVIR MESYLATE excipients list
DailyMed Link:SAQUINAVIR MESYLATE at DailyMed
Recent Clinical Trials for SAQUINAVIR MESYLATE

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
National Institute of Allergy and Infectious Diseases (NIAID)N/A
AIDS Clinical Trials GroupN/A
AbbottPhase 2

See all SAQUINAVIR MESYLATE clinical trials

Anatomical Therapeutic Chemical (ATC) Classes for SAQUINAVIR MESYLATE

US Patents and Regulatory Information for SAQUINAVIR MESYLATE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Hoffmann La Roche INVIRASE saquinavir mesylate CAPSULE;ORAL 020628-001 Dec 6, 1995 DISCN Yes No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Hoffmann-la Roche INVIRASE saquinavir mesylate TABLET;ORAL 021785-001 Dec 17, 2004 DISCN Yes No ⤷  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

Expired US Patents for SAQUINAVIR MESYLATE

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Hoffmann La Roche INVIRASE saquinavir mesylate CAPSULE;ORAL 020628-001 Dec 6, 1995 5,196,438*PED ⤷  Subscribe
Hoffmann-la Roche INVIRASE saquinavir mesylate TABLET;ORAL 021785-001 Dec 17, 2004 5,196,438*PED ⤷  Subscribe
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

SAQUINAVIR MESYLATE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory of Saquinavir Mesylate

Introduction to Saquinavir Mesylate

Saquinavir mesylate, known by its alternative name Ro 31-8959, is an HIV protease inhibitor used in the treatment of HIV-1 and HIV-2 infections. It works by inhibiting the HIV protease enzyme, which is essential for the maturation of the virus, thereby preventing the release of structurally defective and functionally inactive viral particles[3][5].

Market Overview

Global Market Value and Growth

The global saquinavir mesylate market has experienced significant fluctuations in recent years. As of 2022, the market value was estimated to be in the millions of USD, with projections indicating it will reach a higher value by 2029, exhibiting a CAGR of X.X% during the forecast period. This growth is driven by the ongoing need for effective antiretroviral therapies and advancements in drug formulations[1].

Regional Market Analysis

The market for saquinavir mesylate is distributed across various regions, including North America, Europe, Asia Pacific, Latin America, and the Middle East & Africa.

  • North America: The United States and Canada are key markets, with significant demand driven by advanced healthcare systems and high awareness of HIV treatments.
  • Europe: Countries such as Germany, the UK, France, Italy, and Spain contribute substantially to the market. The region's well-developed healthcare infrastructure supports the demand for saquinavir mesylate.
  • Asia Pacific: This region, including countries like China, Japan, South Korea, and India, is experiencing rapid growth due to increasing healthcare expenditure and a large patient population.
  • Latin America: Brazil, Mexico, and Argentina are the primary markets in this region, with growing demand due to improving healthcare access.
  • Middle East & Africa: Countries such as South Africa, the UAE, Egypt, and Saudi Arabia also contribute to the market, though at a slower pace compared to other regions[1].

Competitive Landscape

The competitive landscape of the saquinavir mesylate market is characterized by several prominent players. These companies are analyzed comprehensively in market reports, providing insights into their market shares, concentration ratios, and performance metrics. The competitive analysis helps stakeholders understand the market dynamics and the strategies employed by key players to maintain or gain market share[1].

Impact of External Factors

COVID-19 Pandemic

The COVID-19 pandemic has had a significant impact on the saquinavir mesylate market. The report highlights changes in consumer behavior, demand, transport capacity, and trade flow during and post-pandemic. The pandemic disrupted supply chains and affected the availability of raw materials, leading to fluctuations in the market[1].

Regional Conflicts

Regional conflicts, such as the Russia-Ukraine war, have also influenced the market. These conflicts can disrupt supply chains, affect production, and alter market dynamics, making it essential for stakeholders to understand these impacts to navigate the market effectively[1].

Challenges and Opportunities

Low Bioavailability and Metabolic Interference

One of the significant challenges with saquinavir mesylate is its low bioavailability, which is further reduced in the fasting state. This issue is addressed by combining the drug with CYP3A4 inhibitors like ritonavir or ketoconazole to enhance plasma drug concentrations. However, this also introduces metabolic interference, limiting its coadministration with certain drugs[3][4].

Resistance and Cross-Resistance

Resistance to saquinavir mesylate has been observed both in vitro and in vivo, with a specific mutation profile. This necessitates the use of combination therapies to mitigate resistance and cross-resistance issues. Ongoing studies aim to clarify the optimal sequence and combination strategies for saquinavir mesylate within protease inhibitor regimens[3].

New Formulations and Therapeutic Guidelines

Advancements in drug formulations have led to the introduction of new saquinavir mesylate formulations with higher bioavailability. Current therapeutic guidelines recommend the use of other protease inhibitors with higher in vivo activity, but ongoing studies may redefine the role of saquinavir mesylate in treatment strategies[3].

Financial Performance

Revenue and Sales

The financial performance of the saquinavir mesylate market is reflected in its revenue and sales figures. The market achieved significant revenue in 2022 and is expected to grow further by 2029. Sales data by country and region provide a detailed picture of the market's financial trajectory[1].

Gross Margin and Pricing

The gross margin and pricing strategies of saquinavir mesylate vary by region and are influenced by factors such as production costs, regulatory environments, and market competition. The report provides a gross analysis from 2018 to 2023, helping stakeholders understand the financial health of the market[1].

Key Takeaways

  • Global Market Growth: The saquinavir mesylate market is projected to grow at a CAGR of X.X% from 2022 to 2029.
  • Regional Dynamics: The market is distributed across various regions, with North America and Europe being significant contributors.
  • Competitive Landscape: Prominent players dominate the market, with comprehensive analyses available in market reports.
  • External Factors: The COVID-19 pandemic and regional conflicts have impacted the market, affecting supply chains and demand.
  • Challenges and Opportunities: Low bioavailability and metabolic interference are key challenges, while new formulations and combination therapies offer opportunities for growth.
  • Financial Performance: The market has achieved significant revenue and is expected to continue growing, with detailed financial analyses available by region.

FAQs

What is saquinavir mesylate used for?

Saquinavir mesylate is used as an HIV protease inhibitor in the treatment of HIV-1 and HIV-2 infections.

What are the challenges associated with saquinavir mesylate?

The primary challenges include low bioavailability, metabolic interference, and the potential for resistance and cross-resistance.

How does the COVID-19 pandemic affect the saquinavir mesylate market?

The pandemic has disrupted supply chains, affected consumer behavior, and altered trade flows, impacting the market's dynamics.

What are the regional markets for saquinavir mesylate?

The key regional markets include North America, Europe, Asia Pacific, Latin America, and the Middle East & Africa.

How is saquinavir mesylate metabolized?

Saquinavir mesylate is metabolized mainly through the cytochrome P450 (CYP) 3A4 system, both hepatically and intestinally.

Sources

  1. Global SAQUINAVIR MESYLATE Industry Market Competitive Landscape and Trends - Maiaresearch
  2. Saquinavir mesylate | HIV Protease - Tocris Bioscience
  3. Saquinavir. Clinical pharmacology and efficacy - PubMed
  4. INVIRASE (saquinavir mesylate) CAPSULES and TABLETS Product Label - FDA
  5. Saquinavir mesylate | HIV Protease Inhibitors - R&D Systems

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