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Last Updated: December 22, 2024

RUBIVITE Drug Patent Profile


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

Rubivite is a drug marketed by Bel Mar and is included in one NDA.

The generic ingredient in RUBIVITE 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 Rubivite

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

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

US Patents and Regulatory Information for RUBIVITE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Bel Mar RUBIVITE cyanocobalamin INJECTABLE;INJECTION 010791-004 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Bel Mar RUBIVITE cyanocobalamin INJECTABLE;INJECTION 010791-005 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Bel Mar RUBIVITE cyanocobalamin INJECTABLE;INJECTION 010791-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Bel Mar RUBIVITE cyanocobalamin INJECTABLE;INJECTION 010791-002 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Bel Mar RUBIVITE cyanocobalamin INJECTABLE;INJECTION 010791-003 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

RUBIVITE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Rubius Therapeutics (RUBY)

Introduction

Rubius Therapeutics, Inc. (RUBY) operates in the highly competitive and dynamic pharmaceutical industry, particularly in the field of cell therapy. Understanding the market dynamics and financial trajectory of Rubius Therapeutics is crucial for investors, stakeholders, and industry analysts.

Market Overview

The global pharmaceutical market is projected to reach $1.15 trillion by 2024 and exceed $1.4 trillion by 2028, driven by the escalating global burden of chronic diseases[2].

Bargaining Power of Customers

Influence of Large Pharmaceutical Companies

The pharmaceutical landscape is dominated by a few large firms, which significantly influence pricing and demand. The top 10 pharmaceutical companies accounted for nearly 47% of global prescription sales in 2022. These companies, including Pfizer, Roche, and Novartis, have substantial bargaining power due to their large market share and financial resources[1].

Demand for Innovative Cell Therapy Solutions

The global cell therapy market is growing rapidly, projected to reach $18.8 billion by 2028 with a CAGR of approximately 20.7% from 2021 to 2028. This high demand for innovative solutions gives customers, particularly large pharmaceutical companies, significant bargaining power as they seek effective and cutting-edge treatments[1].

Competitive Rivalry

Established Biotech and Pharmaceutical Firms

The competitive landscape for Rubius Therapeutics includes well-established players such as Amgen, Gilead Sciences, and Novartis. These companies have robust financial resources and comprehensive portfolios, making the competition fierce. For instance, Amgen reported a revenue of $25.42 billion in 2022, while Gilead Sciences generated $27.30 billion the same year[1].

Rapid Advancements in Cell Therapy Technologies

The field of cell therapy is experiencing rapid innovation, which intensifies competition. The global cell therapy market was valued at approximately $8.75 billion in 2023 and is projected to reach $23.63 billion by 2026, growing at a CAGR of 22.7%. This rapid growth attracts new entrants and increases competitive pressure on Rubius Therapeutics[1].

Threat of Substitutes

Traditional Treatment Methods

Traditional treatment methods such as chemotherapy, radiation therapy, and conventional immunotherapy remain prevalent. For example, in 2022, approximately 1.9 million new cancer cases were diagnosed in the U.S., with around 600,000 cancer deaths expected. These established treatments pose a significant threat to cell-based therapies provided by Rubius Therapeutics[1].

Emerging Alternative Therapies

Emerging therapies like gene editing technologies (e.g., CRISPR) and small molecules are gaining traction. The global gene editing market size was estimated at $3.2 billion in 2022 and is projected to grow at a CAGR of 16.4% from 2023 to 2030. These advancements present a significant threat to Rubius's products[1].

Regulatory Hurdles for New Substitutes

The regulatory process for new therapies is challenging, with an average approval time exceeding 10 years and a success rate of only 15%. While this presents hurdles for emerging substitutes, it also underscores the demand for expedited and effective alternatives, intensifying competition[1].

Threat of New Entrants

High Barrier to Entry

Entering the pharmaceutical industry, especially in the cell therapy segment, is highly challenging due to significant capital requirements, stringent regulatory processes, and the need for specialized knowledge and intellectual property. For instance, R&D and manufacturing costs can range from $1 billion to $2.6 billion, and the time to market can exceed 10 years[1].

Funding Availability

Despite the high barriers, venture capital and funding availability can support new entrants. In 2020, the pharmaceutical sector raised $21 billion in venture capital, which can be leveraged by new companies to enter the market[1].

Bargaining Power of Suppliers

Limited Numbers and Essential Technology

The bargaining power of suppliers in the cell therapy market is influenced by their limited numbers and the essential technology they provide. Suppliers of critical components and services can exert significant influence on pricing and supply chain dynamics[1].

Financial Trajectory

High Development Costs

The average cost of bringing a new drug to market is about $2.6 billion, with a development timeline spanning 10 to 15 years. The probability of success for a drug candidate entering clinical trials is only around 10%, highlighting the substantial risks and costs involved[2].

Declining ROI for R&D

The return on investment (ROI) for pharmaceutical R&D has been declining. Deloitte's annual R&D returns analysis for 2022 revealed a forecasted ROI of just 1.2%, a significant drop from the 1.9% reported in 2021. This decline is attributed to increasing costs, stricter regulatory hurdles, and short exclusivity periods[2].

Revenue Potential

Successful drugs can generate substantial revenue. For example, AbbVie's Humira generated over $20 billion in annual revenue at its peak before losing patent exclusivity in 2023. Similarly, Sanofi's Dupixent has emerged as a leading therapy for atopic dermatitis and asthma, generating over $8 billion in annual revenue in 2023[2].

Regulatory Environment

FDA Approval Process

The FDA approval process is lengthy and challenging, with an average time to approval exceeding 10 years and a success rate of only 15%. This regulatory landscape presents significant hurdles for new therapies but also underscores the demand for expedited and effective alternatives[1].

Technological Advancements

Precision Medicine and Next-Generation Sequencing

Technological advancements such as precision medicine and next-generation sequencing are transforming the pharmaceutical industry. These technologies enable faster and more affordable genomic analysis, guiding treatment decisions and optimizing treatment efficacy[2].

Market Analysis

Oncology and Rare Diseases

The oncology market represents a vast and expanding opportunity due to the rising incidence of cancer worldwide. By 2040, projections show there will be significant growth in cancer cases, stressing the need for innovative treatments. Rubius Therapeutics, focusing on cell therapy, is well-positioned to address these unmet medical needs[2].

Emerging Therapies

Emerging therapies like gene editing and small molecules are gaining traction. These advancements not only present competition but also opportunities for collaboration and innovation. For instance, the global gene editing market is projected to grow at a CAGR of 16.4% from 2023 to 2030[1].

Key Takeaways

  • High Demand for Innovative Therapies: The global cell therapy market is growing rapidly, driven by high demand for innovative solutions.
  • Fierce Competition: The presence of established biotech and pharmaceutical firms, along with rapid advancements in cell therapy technologies, intensifies competition.
  • Significant Regulatory Hurdles: The regulatory process for new therapies is challenging, affecting both new entrants and existing players.
  • High Development Costs: Bringing a new drug to market involves substantial costs and risks.
  • Declining ROI for R&D: The return on investment for pharmaceutical R&D is declining due to increasing costs and shorter exclusivity periods.
  • Technological Advancements: Precision medicine and next-generation sequencing are transforming treatment approaches and market dynamics.

FAQs

Q: What is the projected growth rate of the global cell therapy market? A: The global cell therapy market is projected to grow at a CAGR of approximately 20.7% from 2021 to 2028, reaching $18.8 billion by 2028[1].

Q: How does the bargaining power of customers affect Rubius Therapeutics? A: Large pharmaceutical companies have significant bargaining power due to their market share and financial resources, influencing pricing and demand for innovative therapies[1].

Q: What are the main challenges in bringing a new drug to market? A: The main challenges include high development costs (around $2.6 billion), a lengthy development timeline (10 to 15 years), and a low success rate (around 10%)[2].

Q: How does the regulatory environment impact new therapies? A: The FDA approval process is lengthy and challenging, with an average time to approval exceeding 10 years and a success rate of only 15%, presenting significant hurdles for new therapies[1].

Q: What role do technological advancements play in the pharmaceutical industry? A: Technological advancements such as precision medicine and next-generation sequencing are transforming treatment approaches, enabling faster and more affordable genomic analysis, and guiding treatment decisions[2].

Sources

  1. Porter's Five Forces of Rubius Therapeutics, Inc. (RUBY) - DCF.fm
  2. Investment Trends in Pharmaceutical Research - DrugBank Blog
  3. Psychedelic Drugs Market - GlobeNewswire
  4. Generic Drug Industry Dynamics - Federal Trade Commission

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