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Last Updated: December 22, 2024

VIVIMUSTA Drug Patent Profile


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

Vivimusta is a drug marketed by Azurity and is included in one NDA. There is one patent protecting this drug.

The generic ingredient in VIVIMUSTA is bendamustine hydrochloride. There are twenty-three drug master file entries for this compound. Eleven suppliers are listed for this compound. Additional details are available on the bendamustine hydrochloride profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Vivimusta

A generic version of VIVIMUSTA was approved as bendamustine hydrochloride by ACCORD HLTHCARE on December 7th, 2022.

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Summary for VIVIMUSTA
Drug patent expirations by year for VIVIMUSTA
Drug Prices for VIVIMUSTA

See drug prices for VIVIMUSTA

Pharmacology for VIVIMUSTA
Drug ClassAlkylating Drug
Mechanism of ActionAlkylating Activity

US Patents and Regulatory Information for VIVIMUSTA

VIVIMUSTA is protected by one US patents.

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Azurity VIVIMUSTA bendamustine hydrochloride SOLUTION;INTRAVENOUS 212209-001 Dec 7, 2022 RX Yes Yes ⤷  Subscribe ⤷  Subscribe Y ⤷  Subscribe
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

VIVIMUSTA Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for VIVIMUSTA

Introduction

VIVIMUSTA, a bendamustine hydrochloride injection, is a significant player in the treatment of chronic lymphocytic leukemia (CLL) and indolent B-cell non-Hodgkin lymphoma (NHL). To understand its market dynamics and financial trajectory, it is crucial to analyze various factors including market trends, competition, and the impact of major health events.

Indications and Usage

VIVIMUSTA is indicated for the treatment of adult patients with CLL and indolent B-cell NHL that has progressed during or within six months of treatment with rituximab or a rituximab-containing regimen[4][5].

Market Context: Pharmaceutical Spending

The pharmaceutical market has seen significant growth over the past two decades. In Canada, for example, total drug purchases increased from $10.5 billion in 2001 to $29.9 billion in 2021 in the retail sector, and from $1.3 billion to $5.5 billion in the hospital sector during the same period. This growth is expected to continue, with forecasts indicating moderate to high levels of growth in both retail and hospital sectors[1].

Competitive Landscape

VIVIMUSTA operates in a competitive market dominated by high-spending drugs. The top 25 drugs in Canada account for a significant portion of total spending, with drugs like Infliximab, Adalimumab, and Ustekinumab leading the pack. While VIVIMUSTA is not among the top 25, its niche in treating specific types of leukemia and lymphoma positions it as a valuable asset in the oncology segment[1].

Pricing and Formulary Status

The pricing and formulary status of VIVIMUSTA can significantly impact its market dynamics. In some regions, VIVIMUSTA is classified as a non-preferred brand-specialty drug, which may affect its prescription rates and reimbursement levels. For instance, in Vermont, it is listed under the non-preferred category in the Blue Cross Formulary, which could influence its adoption rates compared to preferred alternatives[2].

Impact of Major Health Events

Major health events, such as pandemics and epidemics, can have profound effects on the pharmaceutical sector. The COVID-19 pandemic, for example, led to unprecedented volatility in pharmaceutical stocks, with companies involved in vaccine development and production experiencing substantial gains. However, this volatility also extended to other segments, including oncology drugs like VIVIMUSTA. The pandemic's impact on healthcare systems and patient access to treatments could have both short-term and long-term effects on the financial trajectory of such drugs[3].

Macroeconomic and Market Indicators

Macroeconomic variables such as GDP, inflation rates, and unemployment rates play a critical role in determining stock market dynamics and, by extension, the financial performance of pharmaceutical companies. Positive consumer sentiment and lower interest rates generally lead to higher stock prices, signaling economic stability and growth prospects. During economic downturns, however, the impact on pharmaceutical stocks can be exacerbated, especially if coupled with health emergencies[3].

Financial Performance and Projections

While specific financial data for VIVIMUSTA is not readily available, its performance can be inferred from broader trends in the pharmaceutical sector. The growth in pharmaceutical spending, particularly in the oncology segment, suggests a favorable market environment. However, the drug's non-preferred status in some formularies and the competitive landscape may temper its financial performance.

Historical Context

The pharmaceutical sector has experienced steady growth over the past two decades, with an average annual growth rate of 5.4% in the retail sector and 7.4% in the hospital sector in Canada. This growth is expected to continue, albeit at moderate levels in the retail sector and higher rates in the hospital sector[1].

Future Projections

Given the ongoing demand for oncology treatments and the expected growth in pharmaceutical spending, VIVIMUSTA is likely to maintain a stable market presence. However, its financial trajectory will depend on factors such as formulary status, competition from other treatments, and the overall economic and health landscape.

Key Takeaways

  • Market Growth: The pharmaceutical market, particularly the oncology segment, is expected to continue growing.
  • Competitive Landscape: VIVIMUSTA operates in a competitive market but has a niche in treating specific types of leukemia and lymphoma.
  • Impact of Health Events: Major health events can significantly impact the financial trajectory of pharmaceutical companies.
  • Macroeconomic Factors: Economic indicators such as GDP, inflation, and unemployment rates influence stock market dynamics.
  • Formulary Status: The non-preferred status of VIVIMUSTA in some formularies may affect its adoption and financial performance.

FAQs

What is VIVIMUSTA used for?

VIVIMUSTA is used for the treatment of adult patients with chronic lymphocytic leukemia (CLL) and indolent B-cell non-Hodgkin lymphoma (NHL) that has progressed during or within six months of treatment with rituximab or a rituximab-containing regimen[4][5].

How does the competitive landscape affect VIVIMUSTA?

The competitive landscape, dominated by high-spending drugs, positions VIVIMUSTA as a valuable asset in the oncology segment but also subjects it to competition from other treatments.

What impact do major health events have on VIVIMUSTA?

Major health events, such as pandemics, can lead to volatility in pharmaceutical stocks and affect the financial trajectory of drugs like VIVIMUSTA by influencing healthcare systems and patient access to treatments[3].

How do macroeconomic indicators influence VIVIMUSTA's financial performance?

Macroeconomic indicators such as GDP, inflation rates, and unemployment rates can influence stock market dynamics and, by extension, the financial performance of pharmaceutical companies, including those producing VIVIMUSTA[3].

What is the expected growth in the pharmaceutical sector for VIVIMUSTA?

The pharmaceutical sector, particularly the oncology segment, is expected to continue growing, which could support a stable market presence for VIVIMUSTA. However, specific growth projections for VIVIMUSTA would depend on various market and economic factors[1].

Sources

  1. Canadian Trends in Estimated Pharmaceutical Drug Purchases and Spending - Canadian Journal of Health Technology.
  2. BCVT-133971481 - Rate Review - Vermont.gov.
  3. Impact of Major Health Events on Pharmaceutical Stocks - arXiv.
  4. VIVIMUSTA- bendamustine hydrochloride injection - DailyMed.
  5. VIVIMUSTA (bendamustine hydrochloride injection) - FDA.

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