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Last Updated: December 22, 2024

EVEX Drug Patent Profile


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Which patents cover Evex, and what generic alternatives are available?

Evex is a drug marketed by Roche Palo and is included in two NDAs.

The generic ingredient in EVEX is estrogens, esterified. There are three drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the estrogens, esterified profile page.

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Summary for EVEX
US Patents:0
Applicants:1
NDAs:2
Raw Ingredient (Bulk) Api Vendors: 57
Patent Applications: 3,276
DailyMed Link:EVEX at DailyMed
Drug patent expirations by year for EVEX

US Patents and Regulatory Information for EVEX

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Roche Palo EVEX estrogens, esterified TABLET;ORAL 084215-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Roche Palo EVEX estrogens, esterified TABLET;ORAL 083376-002 Approved Prior to Jan 1, 1982 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

EVEX Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for the Drug Industry: Lessons from Recent Trends

Introduction

The pharmaceutical industry is undergoing significant transformations, driven by a complex interplay of technological, economic, and regulatory factors. To understand the market dynamics and financial trajectory of drugs like EVEX, it is crucial to analyze recent trends and their implications.

Global Synthetic Drug Markets: A New Era

The global synthetic drug market has seen profound changes, particularly in the last two years. The rapid expansion of online platforms, especially on the dark web, has created new challenges for law enforcement and public health systems. This shift is driven by decentralized production models, technological advancements, and the globalization of supply chains[1].

Impact of Technological Advancements

Technological innovations have significantly influenced the drug market. Online platforms and cryptocurrencies have facilitated the sale and distribution of illicit substances, making it harder for authorities to track transactions. This trend highlights the need for pharmaceutical companies to adapt to technological changes to maintain market integrity[1].

Market Access Trends in 2024

In the legitimate pharmaceutical sector, market access trends are evolving. The Inflation Reduction Act (IRA) has pressured manufacturers to adjust their strategies. There is a growing emphasis on evidence throughout the product lifecycle, including Health Economic Outcomes Research (HEOR), Real World Evidence (RWE), and Patient Reported Outcomes (PRO). This shift is crucial for substantiating pricing decisions and speeding up payer adoption[3].

Pricing Pressure and Plateaus

Pricing dynamics have stabilized in recent years, with annual net price increases for drugs being at or below the rate of inflation since 2017. Manufacturers are now under pressure to launch products at higher prices to account for the inevitable net price decline over the product's lifecycle. This strategy is a response to the combination of price controls and the inability to adjust prices over time[3].

Role of Intermediaries in the Supply Chain

Intermediaries such as pharmacy benefit managers (PBMs) and group purchasing organizations (GPOs) play a significant role in the pharmaceutical supply chain. Their contractual relationships with manufacturers and health plan sponsors affect the prices consumers pay for prescription drugs. Understanding these dynamics is essential for navigating the complex pharmaceutical market[4].

Financial Performance of Pharmaceutical Companies

Companies like Blueprint Medicines provide insights into the financial trajectory of the industry. For instance, Blueprint Medicines reported significant revenue growth for their product AYVAKIT, with a 135% year-over-year increase in the first quarter of 2024. This growth is attributed to strong sales performance and strategic financial management, including a one-time non-cash debt extinguishment gain[5].

Revenue and Cost Structure

The revenue structure for pharmaceutical companies includes net product revenues, collaboration revenues, and other income. For Blueprint Medicines, the cost of sales has remained relatively flat despite increased sales, primarily due to the use of lower-cost dosages. Research and development expenses are also a significant component, reflecting the company's commitment to innovation[5].

Cash Position and Sustainability

A strong cash position is crucial for pharmaceutical companies to achieve self-sustainability. Blueprint Medicines, for example, had $735.6 million in cash, cash equivalents, and investments as of March 31, 2024. This financial stability enables the company to invest in research and development and navigate market challenges effectively[5].

Regulatory Frameworks

Regulatory frameworks such as the Hatch-Waxman Act and the Biologics Price Competition and Innovation Act have shaped the pharmaceutical market. These acts aim to expedite generic and biosimilar drug entry, thereby increasing competition and reducing drug prices. However, there are still obstacles to generic entry that policymakers are addressing[4].

Evidence-Based Strategies

The demonstration of value through evidence is becoming increasingly important. Pharmaceutical companies are investing heavily in generating evidence beyond clinical studies, including HEOR, RWE, and PRO. This approach helps in substantiating pricing decisions, counteracting third-party assessments, and speeding up payer adoption[3].

Persisting Challenges

Despite these strategies, the industry faces persisting challenges such as the 340B program, which continues to impact the supply chain and manufacturer net prices. The program's utilization has slowed in the retail channel but has accelerated in other areas, offsetting manufacturer mitigation efforts[3].

Market Adaptation and Innovation

The pharmaceutical industry is highly dynamic, with companies adapting to shifts in the market landscape. The emergence of new and novel psychoactive substances (NPS) and the exploitation of vulnerabilities in global transport and communications infrastructure are examples of these adaptations. Companies must innovate and leverage technological advancements to stay competitive[1].

Key Takeaways

  • Technological Advancements: Online platforms and cryptocurrencies are changing the drug market landscape.
  • Evidence-Based Strategies: Generating robust evidence is crucial for market success and pricing decisions.
  • Pricing Dynamics: Price controls and stabilization of price increases are influencing launch strategies.
  • Regulatory Frameworks: Acts like the Hatch-Waxman Act and Biologics Price Competition and Innovation Act shape market competition.
  • Financial Stability: A strong cash position is essential for self-sustainability and investment in R&D.

FAQs

What are the key factors driving the global synthetic drug market?

The global synthetic drug market is driven by decentralized production models, technological advancements, and the globalization of supply chains, including the proliferation of dark web marketplaces and the use of cryptocurrencies[1].

How are market access trends evolving in 2024?

Market access trends in 2024 are evolving with a greater emphasis on evidence throughout the product lifecycle, including HEOR, RWE, and PRO. This shift is driven by the Inflation Reduction Act and the need to substantiate pricing decisions[3].

What role do intermediaries play in the pharmaceutical supply chain?

Intermediaries such as PBMs and GPOs significantly affect the prices consumers pay for prescription drugs through their contractual relationships with manufacturers and health plan sponsors[4].

How has the financial performance of pharmaceutical companies like Blueprint Medicines been in recent quarters?

Blueprint Medicines has reported strong revenue growth, with a 135% year-over-year increase in the first quarter of 2024 for their product AYVAKIT. This growth is attributed to strong sales performance and strategic financial management[5].

What are the persisting challenges in the pharmaceutical industry?

The industry faces challenges such as the 340B program, which impacts the supply chain and manufacturer net prices, and the need to adapt to shifts in the market landscape, including the emergence of new psychoactive substances[3].

Sources

  1. Global Synthetic Drug Markets: The Present and Future - Global Initiative Against Transnational Organized Crime.
  2. Blueprint Medicines Reports Second Quarter 2024 Results and Raises AYVAKIT®/AYVAKYT® (avapritinib) Full Year Revenue Guidance - Blueprint Medicines.
  3. Top 10 U.S. Market Access Trends for 2024 - IQVIA.
  4. Understanding Competition in Prescription Drug Markets: Entry and Supply Chain Dynamics - Federal Trade Commission.
  5. Blueprint Medicines Reports Strong First Quarter 2024 Results and Raises AYVAKIT®/AYVAKYT® (avapritinib) Full Year Revenue Guidance - Blueprint Medicines.

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