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Last Updated: December 22, 2024

INDINAVIR SULFATE - Generic Drug Details


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What are the generic drug sources for indinavir sulfate and what is the scope of patent protection?

Indinavir sulfate is the generic ingredient in one branded drug marketed by Merck Sharp Dohme and is included in one NDA. Additional information is available in the individual branded drug profile pages.

There are two drug master file entries for indinavir sulfate.

Summary for INDINAVIR SULFATE
US Patents:0
Tradenames:1
Applicants:1
NDAs:1
Drug Master File Entries: 2
Raw Ingredient (Bulk) Api Vendors: 72
Clinical Trials: 81
Patent Applications: 6,029
What excipients (inactive ingredients) are in INDINAVIR SULFATE?INDINAVIR SULFATE excipients list
DailyMed Link:INDINAVIR SULFATE at DailyMed
Recent Clinical Trials for INDINAVIR SULFATE

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

SponsorPhase
Oncology Institute of Southern SwitzerlandPhase 2
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)N/A
PPDPhase 3

See all INDINAVIR SULFATE clinical trials

Medical Subject Heading (MeSH) Categories for INDINAVIR SULFATE
Anatomical Therapeutic Chemical (ATC) Classes for INDINAVIR SULFATE

US Patents and Regulatory Information for INDINAVIR SULFATE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Merck Sharp Dohme CRIXIVAN indinavir sulfate CAPSULE;ORAL 020685-001 Mar 13, 1996 DISCN Yes No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Merck Sharp Dohme CRIXIVAN indinavir sulfate CAPSULE;ORAL 020685-006 Apr 19, 2000 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Merck Sharp Dohme CRIXIVAN indinavir sulfate CAPSULE;ORAL 020685-005 Dec 17, 1998 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Merck Sharp Dohme CRIXIVAN indinavir sulfate CAPSULE;ORAL 020685-003 Mar 13, 1996 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 INDINAVIR SULFATE

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Merck Sharp Dohme CRIXIVAN indinavir sulfate CAPSULE;ORAL 020685-001 Mar 13, 1996 5,413,999 ⤷  Subscribe
Merck Sharp Dohme CRIXIVAN indinavir sulfate CAPSULE;ORAL 020685-003 Mar 13, 1996 6,645,961 ⤷  Subscribe
Merck Sharp Dohme CRIXIVAN indinavir sulfate CAPSULE;ORAL 020685-005 Dec 17, 1998 6,689,761 ⤷  Subscribe
Merck Sharp Dohme CRIXIVAN indinavir sulfate CAPSULE;ORAL 020685-006 Apr 19, 2000 5,413,999 ⤷  Subscribe
Merck Sharp Dohme CRIXIVAN indinavir sulfate CAPSULE;ORAL 020685-005 Dec 17, 1998 5,413,999 ⤷  Subscribe
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

INDINAVIR SULFATE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory of Indinavir Sulfate

Introduction to Indinavir Sulfate

Indinavir sulfate, marketed under the brand name CRIXIVAN, is a protease inhibitor used in the treatment of HIV-1 infection and AIDS in adults. It works by blocking the protease enzyme of the HIV virus, preventing the virus from replicating.

Market Size and Growth

The indinavir sulfate market has been valued at approximately USD 1.2 billion in 2023. This market is projected to grow significantly, reaching around USD 2.1 billion by 2032, with a notable growth rate over the forecast period[1].

Market Drivers

Several factors drive the growth of the indinavir sulfate market:

Increasing Prevalence of HIV

The global prevalence of HIV continues to be a significant health concern, driving the demand for effective antiretroviral therapies like indinavir sulfate.

Advancements in Treatment Protocols

Continuous advancements in HIV treatment protocols and the integration of protease inhibitors into combination therapies have enhanced the market for indinavir sulfate.

Regulatory Support

Regulatory approvals and guidelines supporting the use of protease inhibitors in HIV treatment contribute to the market's growth.

Market Challenges

Despite the growth potential, the indinavir sulfate market faces several challenges:

Side Effects and Adverse Reactions

Indinavir sulfate is associated with several adverse effects, including nephrolithiasis, which can impact patient compliance and market demand. The drug's administration requires careful management to minimize these risks[2][3].

Impact of Food on Pharmacokinetics

The absorption of indinavir sulfate is significantly affected by food intake, particularly high-fat meals, which can reduce its bioavailability. This necessitates strict dietary guidelines for patients, which can be a challenge[2][3].

Competition from Newer Therapies

The HIV treatment landscape is evolving with newer, more effective, and potentially less side-effect-prone therapies. This competition can impact the market share of indinavir sulfate.

Financial Trajectory

Revenue Projections

The projected growth from USD 1.2 billion in 2023 to USD 2.1 billion by 2032 indicates a robust financial trajectory for the indinavir sulfate market. This growth is driven by increasing demand and the ongoing need for effective HIV treatments[1].

Cost and Pricing

The cost of indinavir sulfate can vary based on region, availability, and healthcare policies. However, the drug remains a significant component of HIV treatment regimens, ensuring a steady revenue stream.

Regional Market Analysis

The market for indinavir sulfate is not uniform across all regions:

Developed Markets

In developed countries, the market is more stable due to established healthcare systems and access to a wide range of antiretroviral therapies.

Emerging Markets

Emerging markets present significant growth opportunities due to increasing awareness and access to HIV treatments. However, these markets also face challenges related to affordability and healthcare infrastructure.

Competitive Landscape

The HIV treatment market is highly competitive, with several protease inhibitors and other antiretroviral drugs available. Key competitors include other protease inhibitors and combination therapies that offer improved efficacy and reduced side effects.

Regulatory Environment

The regulatory environment plays a crucial role in the market dynamics of indinavir sulfate:

Approvals and Guidelines

Regulatory approvals and treatment guidelines from health authorities such as the FDA influence the market. For instance, the FDA's approval of indinavir sulfate for HIV treatment has been a key factor in its market presence[2].

Safety and Efficacy Standards

Regulatory bodies enforce strict safety and efficacy standards, which indinavir sulfate must meet to remain a viable treatment option.

Patient Compliance and Adherence

Patient compliance is critical for the effectiveness of indinavir sulfate:

Dosage and Administration

The drug must be administered every 8 hours, and its absorption is significantly affected by food intake. This complexity can impact patient adherence and compliance[2][3].

Side Effect Management

Managing side effects, particularly nephrolithiasis, is essential to maintain patient compliance. This often involves careful monitoring and dietary adjustments.

Future Outlook

The future outlook for the indinavir sulfate market is influenced by several factors:

Research and Development

Ongoing research into new formulations and delivery methods could enhance the drug's efficacy and reduce side effects, potentially increasing its market share.

Market Expansion

Expanding into emerging markets and improving access to HIV treatments in these regions could further drive market growth.

Key Takeaways

  • Market Growth: The indinavir sulfate market is projected to grow from USD 1.2 billion in 2023 to USD 2.1 billion by 2032.
  • Market Drivers: Increasing HIV prevalence, advancements in treatment protocols, and regulatory support drive the market.
  • Challenges: Side effects, impact of food on pharmacokinetics, and competition from newer therapies are significant challenges.
  • Financial Trajectory: The market shows a robust financial trajectory with steady revenue projections.
  • Regional Analysis: Developed and emerging markets have different dynamics, with emerging markets offering significant growth opportunities.
  • Competitive Landscape: The market is highly competitive with several protease inhibitors and combination therapies available.

FAQs

  1. What is indinavir sulfate used for? Indinavir sulfate is used in the treatment of HIV-1 infection and AIDS in adults. It works by inhibiting the protease enzyme of the HIV virus.

  2. How does food affect the absorption of indinavir sulfate? High-fat meals significantly reduce the absorption of indinavir sulfate, while lighter meals have little or no effect on its bioavailability[2][3].

  3. What are the common side effects of indinavir sulfate? Common side effects include nephrolithiasis, and the drug requires careful management to minimize these risks[2][3].

  4. What is the projected market size of indinavir sulfate by 2032? The market is projected to reach around USD 2.1 billion by 2032[1].

  5. How is indinavir sulfate metabolized and eliminated? Indinavir sulfate is metabolized primarily by the liver, with cytochrome P-450 3A4 (CYP3A4) being the major enzyme involved. Less than 20% of the drug is excreted unchanged in the urine[2][5].

Sources

  1. Dataintelo: Indinavir Sulfate Market Research Report 2032.
  2. DailyMed: CRIXIVAN® (INDINAVIR SULFATE) CAPSULES.
  3. PubMed: Single-dose pharmacokinetics of indinavir and the effect of food.
  4. Market Research Intellect: Global Indinavir Sulfate Market Size, Scope And Forecast Report.
  5. DrugBank Online: Indinavir: Uses, Interactions, Mechanism of Action.

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