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Last Updated: December 22, 2024

E-Z PREP Drug Patent Profile


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When do E-z Prep patents expire, and what generic alternatives are available?

E-z Prep is a drug marketed by Clinipad and is included in one NDA.

The generic ingredient in E-Z PREP is povidone-iodine. There are four drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the povidone-iodine profile page.

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Summary for E-Z PREP
US Patents:0
Applicants:1
NDAs:1
Raw Ingredient (Bulk) Api Vendors: 60
DailyMed Link:E-Z PREP at DailyMed
Drug patent expirations by year for E-Z PREP

US Patents and Regulatory Information for E-Z PREP

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Clinipad E-Z PREP povidone-iodine SOLUTION;TOPICAL 019382-001 Jul 25, 1989 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Clinipad E-Z PREP povidone-iodine SPONGE;TOPICAL 019382-002 Jul 25, 1989 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Clinipad E-Z PREP 220 povidone-iodine SPONGE;TOPICAL 019382-003 Jul 25, 1989 DISCN No 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

E-Z PREP Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Pre-Exposure Prophylaxis (PrEP) Drugs like E-Z PREP

Introduction to PrEP

Pre-Exposure Prophylaxis (PrEP) is a crucial component in the prevention of HIV infections. Drugs like E-Z PREP, which are part of the PrEP regimen, have shown significant effectiveness in reducing the risk of HIV acquisition. Here, we delve into the market dynamics and financial trajectory of PrEP drugs.

Market Size and Growth

The global HIV drugs market, which includes PrEP, is projected to grow significantly. As of 2023, the global HIV drugs market size was $34.13 billion, and it is expected to reach $58.24 billion by 2032, growing at a CAGR of 6.2% during the forecast period[1].

Key Drivers of Market Growth

Several factors are driving the growth of the PrEP market:

Increasing Prevalence of HIV

The rising number of individuals living with HIV, particularly in regions like North America and Europe, is a significant driver. For instance, in the U.S., approximately 1.2 million individuals were living with HIV as of 2018[1].

New Product Launches and R&D

The development of new and more effective PrEP products, such as long-acting antiretroviral therapies, is expected to boost market growth. Increased research and development initiatives are focusing on improving the efficacy and convenience of PrEP drugs[1].

Government Awareness Programs

Government-run awareness programs and public health initiatives are increasing the adoption of PrEP. These programs aim to educate high-risk populations about the benefits of PrEP and improve access to these medications[1].

Challenges in PrEP Access

Despite the effectiveness of PrEP, several challenges hinder its widespread adoption:

Under-Utilization

Fewer than 25% of individuals who are indicated for PrEP actually receive a prescription. This under-utilization is exacerbated by disparities in access across different racial, ethnic, and geographic groups[2].

High Costs and Complexity

The high list prices of branded PrEP products, such as Truvada and Descovy, make them inaccessible to many. The complexity of obtaining PrEP through various assistance programs also acts as a barrier. For example, the Ready, Set, PrEP program, while helpful, is limited to specific branded products and involves multiple steps and forms of identification[2].

Financial Trajectory

Cost-Effectiveness

PrEP is cost-effective in many scenarios. Studies have shown that PrEP can be cost-effective in 71% of all setting-scenarios, particularly in areas with high HIV prevalence. The introduction of generic PrEP has significantly reduced costs, making it more affordable and sustainable for healthcare systems[4][5].

Generic PrEP

The availability of generic PrEP has been a game-changer. Generic versions of TDF/FTC, for instance, can be as low as $40 per month, compared to the approximately $1,800 list price for branded products. This reduction in cost is expected to increase access and drive market growth[2].

Pricing Pressures

The pharmaceutical industry is facing pricing pressures, particularly with the implementation of the Inflation Reduction Act. This has led to a stabilization of price increases, and manufacturers are now focusing on launching products at higher prices to account for the inevitable net price decline over the product's lifecycle[3].

Distribution Channels

Hospital Pharmacies

The hospital pharmacies segment is expected to hold the dominant share in the distribution of PrEP drugs. This is due to the increasing patient visits to hospitals for HIV treatment and the higher sales of prescribed antiretroviral drugs through these channels[1].

Regional Market Dynamics

North America

North America, particularly the U.S., dominates the market due to the high prevalence of HIV and the presence of key players offering innovative HIV drugs. The region's market size was $24.09 billion in 2023 and is expected to continue growing[1].

Europe

Europe is the second-largest market, driven by increasing cases of HIV infections and strategic collaborations among European companies to improve drug availability[1].

Asia Pacific

The Asia Pacific region is anticipated to be the fastest-growing market, driven by highly populated countries like China and India, along with increasing treatment programs and funding from the private sector and healthcare companies[1].

Market Access Trends

Evidence-Based Value

The industry is shifting towards generating more evidence throughout the product lifecycle, including Health Economic Outcomes Research (HEOR), Real World Evidence (RWE), and Patient Reported Outcomes (PRO). This evidence is crucial for substantiating pricing decisions, speeding up payer adoption, and expanding audiences beyond the traditional medical community[3].

Transition Assistance Programs

Manufacturers are increasingly using transition assistance programs to subsidize patient demand and smooth the prescriber experience by removing payer hurdles. These programs have become significant, with over 50% of year-one demand now being fully subsidized by manufacturers[3].

Key Takeaways

  • The global HIV drugs market, including PrEP, is expected to grow significantly, driven by increasing prevalence, new product launches, and government awareness programs.
  • Despite its effectiveness, PrEP faces challenges such as under-utilization, high costs, and complexity in access.
  • Generic PrEP has made the treatment more affordable and sustainable.
  • Hospital pharmacies are expected to dominate the distribution channels.
  • North America, Europe, and the Asia Pacific are key regions driving market growth.
  • The industry is focusing on evidence-based value and transition assistance programs to improve market access.

FAQs

Q: What is the current market size of the global HIV drugs market? A: The global HIV drugs market size was $34.13 billion in 2023[1].

Q: How is the COVID-19 pandemic impacting the HIV drugs market? A: The COVID-19 pandemic had an adverse impact on the market due to disruptions in drug supply and reduced new patient prescriptions. However, the market has seen strong growth post-pandemic[1].

Q: What are the main challenges in accessing PrEP? A: The main challenges include under-utilization, high costs of branded products, and the complexity of obtaining PrEP through various assistance programs[2].

Q: How cost-effective is PrEP? A: PrEP is cost-effective in many scenarios, particularly in areas with high HIV prevalence. Generic PrEP has significantly reduced costs, making it more affordable[4][5].

Q: What role do hospital pharmacies play in the distribution of PrEP drugs? A: Hospital pharmacies are expected to hold the dominant share in the distribution of PrEP drugs due to increasing patient visits and higher sales of prescribed antiretroviral drugs[1].

Cited Sources

  1. Fortune Business Insights: HIV Drugs Market Size & Growth | Global Report [2024-2032]
  2. Johns Hopkins Bloomberg School of Public Health: Financing and Delivering Pre-Exposure Prophylaxis (PrEP) to End the HIV Epidemic
  3. IQVIA: Top 10 U.S. Market Access Trends for 2024
  4. The Lancet: Cost-effectiveness of easy-access, risk-informed oral pre-exposure prophylaxis
  5. NCBI: Effectiveness, cost effectiveness, acceptability and unintended consequences of pre-exposure prophylaxis (PrEP) for HIV

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