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Last Updated: December 22, 2024

CRYSTODIGIN Drug Patent Profile


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When do Crystodigin patents expire, and when can generic versions of Crystodigin launch?

Crystodigin is a drug marketed by Lilly and is included in one NDA.

The generic ingredient in CRYSTODIGIN is digitoxin. Additional details are available on the digitoxin profile page.

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Summary for CRYSTODIGIN
Drug patent expirations by year for CRYSTODIGIN

US Patents and Regulatory Information for CRYSTODIGIN

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Lilly CRYSTODIGIN digitoxin INJECTABLE;INJECTION 084100-005 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

CRYSTODIGIN Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Digitalis Medication (Crystodigin)

Introduction

Digitalis medication, commonly known by brand names such as Crystodigin, is a crucial treatment for certain heart conditions. Understanding the market dynamics and financial trajectory of this medication involves analyzing various factors, including competition, regulatory environments, and broader pharmaceutical market trends.

Market Overview of Digitalis Medication

Uses and Demand

Digitalis medication works directly on the heart muscle to strengthen and regulate the heartbeat, making it essential for treating conditions like atrial fibrillation and heart failure[4].

  • The demand for digitalis medication is relatively stable due to its specific therapeutic use, but it is not as high as for more common medications.

Generic Competition

The generic drug industry plays a significant role in the market dynamics of medications like Crystodigin. Generic versions of digitalis medications enter the market once the patent of the brand-name drug expires.

  • Studies have shown that generic drug prices fall with the number of competitors, but they remain above long-run marginal costs until there are 8 or more competitors[1].
  • This competition can significantly impact the pricing and profitability of brand-name and generic versions of digitalis medications.

Regulatory Environment

FDA Policies and Approval Process

The FDA's policies and approval processes can significantly affect the market dynamics of generic drugs, including digitalis medications.

  • Increased scrutiny of generic drug applications can raise the cost of obtaining approval, potentially delaying market entry and affecting prices[1].
  • The FDA's policy of approving multiple generic entrants simultaneously can lead to earlier competition, lower prices, but also reduced expected rents, which may deter some potential entrants[1].

Financial Trajectory

Revenue and Profitability

The financial performance of companies producing digitalis medications can be influenced by several factors:

  • Generic Competition: As more generic versions enter the market, the revenue and profitability of the original brand-name drug typically decline. This is because generic drugs are generally cheaper, attracting more price-sensitive consumers[1].
  • Market Size and Demand: The revenue from digitalis medications is relatively stable but can be affected by changes in the prevalence of heart conditions and the availability of alternative treatments.

Example: Broader Pharmaceutical Market Trends

While specific financial data for Crystodigin is not readily available, broader trends in the pharmaceutical industry can provide insights:

  • The global pharmaceutical drug delivery market is expected to grow from USD 1,949.4 billion in 2024 to USD 2,546.0 billion by 2029, driven by factors such as the rising incidence of chronic diseases and increased investment in R&D[3].
  • However, government pricing pressure and reimbursement policies can limit revenue potential for pharmaceutical companies, including those producing digitalis medications[3].

Impact of Government Pricing Pressure

Affordability and Revenue

Government agencies and insurers often impose price caps on medicines to increase affordability, which can reduce the revenue and profit margins for pharmaceutical companies.

  • This pressure is particularly significant in emerging economies where there is a large need for affordable therapies, but it also affects the bottom line for many pharmaceutical companies globally[3].

Case Study: Cryoport's Financial Performance

While Cryoport is not directly involved in the production of digitalis medications, its financial performance can illustrate broader industry trends:

  • Cryoport's revenue and profitability are influenced by factors such as demand for life sciences services and products, as well as cost reduction and capital realignment strategies[5].
  • The company's experience with government pricing pressure and the impact of regulatory changes can provide insights into how similar factors might affect the financial trajectory of companies producing digitalis medications.

Key Takeaways

  • Generic Competition: The entry of generic versions significantly impacts the pricing and profitability of digitalis medications.
  • Regulatory Environment: FDA policies and approval processes can affect market entry and competition.
  • Financial Trajectory: Revenue and profitability are influenced by generic competition, market size, and government pricing pressure.
  • Broader Trends: The pharmaceutical industry's growth and challenges, such as government pricing pressure, also impact the financial performance of companies producing digitalis medications.

FAQs

What is the primary use of digitalis medication like Crystodigin?

Digitalis medication is used to treat certain heart conditions by strengthening and regulating the heartbeat[4].

How does generic competition affect the pricing of digitalis medications?

Generic competition leads to lower prices as more competitors enter the market, with prices approaching long-run marginal costs when there are 8 or more competitors[1].

What role does the FDA play in the market dynamics of generic drugs?

The FDA's policies, such as increased scrutiny of applications and simultaneous approval of multiple generic entrants, can affect market entry, competition, and prices[1].

How does government pricing pressure impact pharmaceutical companies?

Government pricing pressure reduces revenue potential by imposing price caps, which can lower profit margins for pharmaceutical companies[3].

What are the broader trends affecting the pharmaceutical industry?

The industry is driven by factors such as the rising incidence of chronic diseases, increased investment in R&D, and government initiatives to provide affordable drug delivery products, but is also challenged by government pricing pressure and reimbursement policies[3].

More… ↓

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