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Last Updated: April 8, 2025

KAPPADIONE Drug Patent Profile


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

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

The generic ingredient in KAPPADIONE is menadiol sodium diphosphate. There is one drug master file entry for this compound. Additional details are available on the menadiol sodium diphosphate profile page.

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Summary for KAPPADIONE
US Patents:0
Applicants:1
NDAs:1
Raw Ingredient (Bulk) Api Vendors: 42
Patent Applications: 26
DailyMed Link:KAPPADIONE at DailyMed
Drug patent expirations by year for KAPPADIONE

US Patents and Regulatory Information for KAPPADIONE

ApplicantTradenameGeneric NameDosageNDAApproval DateTETypeRLDRSPatent No.Patent ExpirationProductSubstanceDelist Req.Exclusivity Expiration
Lilly KAPPADIONE menadiol sodium diphosphate INJECTABLE;INJECTION 005725-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
>Applicant>Tradename>Generic Name>Dosage>NDA>Approval Date>TE>Type>RLD>RS>Patent No.>Patent Expiration>Product>Substance>Delist Req.>Exclusivity Expiration
Showing 1 to 1 of 1 entries

Market Dynamics and Financial Trajectory for Kappadione

Overview of Kappadione

Kappadione, chemically known as menadiol sodium diphosphate, is a Vitamin K derivative that was previously approved by the US Food and Drug Administration (FDA) prior to 1982. It was marketed by Eli Lilly and Company for the treatment of various conditions related to vitamin K deficiency, including anticoagulant-induced prothrombin deficiency, prophylaxis and treatment of hemorrhagic disease of the newborn, and hypoprothrombinemia due to several causes[1][4].

Historical Market Presence

Kappadione was once a part of the pharmaceutical market, particularly in the segment dealing with blood and blood-forming organs. However, its marketing and distribution were discontinued, and it is no longer available in North America. This discontinuation was likely due to several factors, including its carcinogenic potential in mammalian cells and cytotoxic properties, as well as adverse effects such as increased risk of kernicterus and hemolytic anemia in premature infants[1][4].

Financial Trajectory

Given that Kappadione is no longer in the market, its financial trajectory is largely historical and not relevant to current market dynamics.

Historical Revenue

During its time on the market, Kappadione would have contributed to the revenue streams of Eli Lilly and Company. However, specific financial data on Kappadione's sales and revenue are not readily available due to its discontinued status.

Market Impact

The discontinuation of Kappadione would have had a minimal impact on the overall pharmaceutical market, as it was a niche product addressing specific vitamin K-related deficiencies. The broader market for vitamin K derivatives and anticoagulant treatments has continued to evolve with other products taking its place.

Factors Influencing Discontinuation

Safety Concerns

One of the primary reasons for the discontinuation of Kappadione was its association with significant safety concerns. Studies showed that it had carcinogenic potential and cytotoxic properties, which are critical factors in the decision to withdraw a drug from the market[1].

Regulatory Environment

The regulatory environment plays a crucial role in the approval and continued marketing of pharmaceuticals. Any drug with adverse effects that outweigh its benefits is likely to face regulatory scrutiny and potential withdrawal from the market.

Market Competition

The pharmaceutical market is highly competitive, and drugs with safer and more effective alternatives are often phased out. The presence of other vitamin K derivatives and treatments that do not carry the same risks as Kappadione would have further contributed to its discontinuation.

Current Market Dynamics for Vitamin K Derivatives

Market Size and Growth

The market for vitamin K derivatives and related treatments continues to grow, driven by the need for effective and safe treatments for conditions related to vitamin K deficiency. However, this growth is not attributed to Kappadione, as it is no longer part of the market[3].

Competitive Landscape

The current competitive landscape includes a variety of vitamin K derivatives and other treatments that have replaced Kappadione. These products are developed and marketed by various pharmaceutical companies, ensuring a robust and competitive market.

Financial Implications for Pharmaceutical Companies

Revenue Shift

The discontinuation of Kappadione led to a shift in revenue streams for Eli Lilly and Company, as well as for the broader pharmaceutical industry. Companies have focused on developing and marketing safer and more effective treatments, which has helped maintain and grow their revenue.

Research and Development

The financial implications of discontinuing a drug like Kappadione also involve significant investments in research and development to find safer alternatives. This ongoing R&D is crucial for maintaining market presence and ensuring patient safety.

Key Takeaways

  • Discontinuation: Kappadione was discontinued due to safety concerns and is no longer available in North America.
  • Historical Financials: Specific financial data on Kappadione's sales and revenue are not available due to its discontinued status.
  • Market Impact: The discontinuation had a minimal impact on the overall pharmaceutical market, with other products filling the gap.
  • Safety Concerns: Carcinogenic potential and cytotoxic properties were key factors in its discontinuation.
  • Current Market: The market for vitamin K derivatives continues to grow with safer and more effective treatments.

FAQs

What is Kappadione used for?

Kappadione was used for the treatment of side effects of vitamin K antagonists, prophylaxis and treatment of vitamin K deficiency bleeding, and hypoprothrombinemia due to various causes[1][4].

Why was Kappadione discontinued?

Kappadione was discontinued due to its carcinogenic potential in mammalian cells, cytotoxic properties, and adverse effects such as increased risk of kernicterus and hemolytic anemia in premature infants[1][4].

Is Kappadione still available in the market?

No, Kappadione is no longer available in North America and has been discontinued from the market[1][4].

What are the current alternatives to Kappadione?

Current alternatives include other vitamin K derivatives and treatments that are safer and more effective, developed and marketed by various pharmaceutical companies.

How did the discontinuation of Kappadione affect Eli Lilly and Company?

The discontinuation led to a shift in revenue streams for Eli Lilly and Company, with the company focusing on other products and investments in research and development to maintain market presence.

Sources

  1. DrugBank: Kappadione: Uses, Interactions, Mechanism of Action - DrugBank.
  2. F1000Research: Targeting SARS-CoV-2 RNA-dependent RNA polymerase.
  3. IQVIA: Drug Expenditure Dynamics 1995-2020 - IQVIA.
  4. Wikipedia: Kappadione.

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