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Last Updated: December 25, 2024

RUVITE Drug Patent Profile


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When do Ruvite patents expire, and what generic alternatives are available?

Ruvite is a drug marketed by Savage Labs and is included in one NDA.

The generic ingredient in RUVITE is cyanocobalamin. There are nine drug master file entries for this compound. Twenty-four suppliers are listed for this compound. Additional details are available on the cyanocobalamin profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Ruvite

A generic version of RUVITE was approved as cyanocobalamin by PADAGIS ISRAEL on September 9th, 2020.

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Summary for RUVITE
US Patents:0
Applicants:1
NDAs:1
Raw Ingredient (Bulk) Api Vendors: 92
DailyMed Link:RUVITE at DailyMed
Drug patent expirations by year for RUVITE

US Patents and Regulatory Information for RUVITE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Savage Labs RUVITE cyanocobalamin INJECTABLE;INJECTION 080570-002 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

RUVITE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Hematology-Oncology Drugs: A Case Study on RUVITE and Similar Therapeutics

Introduction

The hematology-oncology drug market has been undergoing significant transformations with the introduction of new therapeutic drugs. This article will delve into the market dynamics and financial trajectory of drugs in this sector, using examples like RUVITE and other recent market entrants to illustrate key trends and insights.

Market Adoption and Competition

The entry of new drugs into the hematology-oncology market has led to a competitive landscape where market shares are constantly shifting. For instance, drugs like BRUKINSA®, IMBRUVICA®, VENCLEXTA®, ICLUSIG®, and CALQUENCE® have shown significant market movements in recent years.

  • BRUKINSA®, approved for chronic lymphocytic leukemia in January 2023, saw a remarkable 149% growth in patient counts from 2022 to 2023. This rapid adoption underscores the potential for new drugs to quickly gain market traction[1].
  • IMBRUVICA®, on the other hand, experienced a 51% decline in patient counts from its peak in 2019, highlighting the competitive nature of the market and shifting clinical preferences[1].

Market Share and Dominance

By 2023, VENCLEXTA® emerged as the leading therapeutic among the five drugs analyzed, capturing 42% of the market basket share. This dominance is a result of its efficacy and the strategic positioning by its manufacturers[1].

Payers and Demographics

Understanding the payer landscape and demographic trends is crucial for market analysis.

  • Medicare was found to be the dominant payer across most prescriptions, indicating a significant role of government-funded healthcare in the adoption of these drugs[1].
  • Demographic Analysis revealed that non-Hispanic Whites made up the largest percentage of the treated population (76%), and treated patients were more likely to be male (61%). These findings align with existing literature on the higher incidence rates of blood cancers among White patients and males[1].

Financial Trajectory of Hematology-Oncology Drugs

The financial performance of these drugs is influenced by several factors, including market adoption, competition, and regulatory approvals.

Revenue Growth

The global market for biologic therapeutic drugs, which includes many hematology-oncology treatments, is expected to grow significantly. For example:

  • The market is projected to increase from $452.9 billion in 2023 to $823.4 billion by 2028, with a compound annual growth rate (CAGR) of 12.7% during the forecast period[4].

Cost and Investment

The development and launch of new pharmaceuticals are costly and risky endeavors. Pharmaceutical companies often face a pipeline gap due to the economic burden and uncertainty associated with internal research and development. To mitigate this, companies increasingly rely on in-licensing opportunities and strategic partnerships[3].

Patent and Intellectual Property

The patent life of a successful new molecular entity (NME) is a critical factor in the financial trajectory. Companies often rush to recoup their investment before the patent expires, which can lead to aggressive marketing and pricing strategies. A proposed royalty-based system after patent expiration could help companies continue research without the pressure of the patent clock[3].

Case Study: RUVITE and Similar Therapeutics

While specific data on RUVITE is not provided, we can infer its potential market dynamics and financial trajectory from similar drugs.

Market Entry and Adoption

New drugs entering the market, like RUVITE, would need to compete with established therapeutics. The success of such drugs depends on their efficacy, safety profile, and the ability to secure favorable reimbursement policies.

Competitive Landscape

RUVITE would face competition from drugs like VENCLEXTA®, BRUKINSA®, and others. The competitive landscape is dynamic, with market shares shifting based on clinical preferences, patient outcomes, and payer policies[1].

Financial Projections

Given the growth trends in the biologic therapeutic drugs market, a new drug like RUVITE could potentially capture a significant market share if it demonstrates superior efficacy and safety. The financial trajectory would be influenced by its adoption rate, pricing strategy, and the ability to secure long-term reimbursement agreements.

Strategic Use of Data and Analytics

To navigate the competitive hematology-oncology market, pharmaceutical companies must leverage detailed, real-time insights. Tools like Komodo Health’s Healthcare Map™, MapLab™, and MapView™ solutions provide high-fidelity tracking of new therapeutic entries, demographic variations, and payer dynamics. This data helps in refining market positioning, adjusting marketing tactics, and tailoring patient outreach to align with healthcare provider preferences and patient needs[1].

Addressing Equity in Healthcare Access

The demographic findings highlight disparities in healthcare access, with non-Hispanic Whites and males being overrepresented among treated patients. Addressing these disparities requires targeted strategies to ensure equitable access to cutting-edge treatments. This includes leveraging data analytics to identify gaps in care and developing outreach programs that cater to underserved populations[1].

Key Takeaways

  • The hematology-oncology drug market is highly competitive, with new drugs rapidly gaining market traction.
  • Market share shifts significantly based on clinical preferences and payer policies.
  • Demographic trends show disparities in healthcare access, necessitating targeted strategies for equity.
  • The financial trajectory of new drugs is influenced by market adoption, competition, and regulatory factors.
  • Leveraging data analytics is crucial for refining market strategies and ensuring equitable patient care.

FAQs

What are the key factors influencing the market adoption of new hematology-oncology drugs?

The key factors include the drug's efficacy, safety profile, clinical preferences, payer policies, and the ability to secure favorable reimbursement agreements.

How does the demographic makeup of treated patients impact market strategies?

The demographic makeup, which often shows higher treatment rates among non-Hispanic Whites and males, highlights the need for targeted outreach programs to ensure equitable access to care.

What role do data analytics play in the hematology-oncology market?

Data analytics tools help in tracking market entries, understanding demographic variations, and refining market positioning to align with healthcare provider preferences and patient needs.

How does the patent life of a drug impact its financial trajectory?

The patent life is critical as companies often rush to recoup their investment before the patent expires, leading to aggressive marketing and pricing strategies.

What is the projected growth rate for the biologic therapeutic drugs market?

The market is expected to grow from $452.9 billion in 2023 to $823.4 billion by 2028, with a CAGR of 12.7% during the forecast period[4].

Sources

  1. Komodo Health, "Drug Snapshot: Shifting Paradigms in Hematology-Oncology," May 23, 2024.
  2. City of Bethlehem, "2023 OPERATING & CAPITAL BUDGETS," 2023.
  3. Science.gov, "Pharmaceutical product development: Topics by Science.gov."
  4. BCC Research, "Biologic Therapeutic Drugs: Technologies and Global Markets."

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