You're using a free limited version of DrugPatentWatch: Upgrade for Complete Access

Last Updated: April 5, 2026

KONAKION Drug Patent Profile


✉ Email this page to a colleague

« Back to Dashboard


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

Konakion is a drug marketed by Roche and is included in one NDA.

The generic ingredient in KONAKION is phytonadione. There are ten drug master file entries for this compound. Twenty-seven suppliers are listed for this compound. Additional details are available on the phytonadione profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Konakion

A generic version of KONAKION was approved as phytonadione by AMNEAL PHARMS CO on May 11th, 2018.

  Start Trial

AI Deep Research
Questions you can ask:
  • What is the 5 year forecast for KONAKION?
  • What are the global sales for KONAKION?
  • What is Average Wholesale Price for KONAKION?
Summary for KONAKION
Drug patent expirations by year for KONAKION
Recent Clinical Trials for KONAKION

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Ain Shams UniversityPHASE3

See all KONAKION clinical trials

US Patents and Regulatory Information for KONAKION

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Roche KONAKION phytonadione INJECTABLE;INJECTION 011745-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Roche KONAKION phytonadione INJECTABLE;INJECTION 011745-003 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Market Dynamics and Financial Trajectory for KONAKION (Vitamin K1)

Last updated: February 16, 2026

KONAKION, the brand name for vitamin K1, is used primarily to treat and prevent vitamin K deficiency. It is essential in blood clotting and bone metabolism. The drug’s market presence is influenced by clinical indications, regulatory factors, and industry trends.

Market Overview

KONAKION is marketed globally by pharmaceutical companies, with notable markets in the US, Europe, and Asia. The drug's revenue depends heavily on its applications in neonatal care, bleeding disorders, and surgical prophylaxis.

Historical Revenue and Sales Data

Year Estimated Global Sales (USD Millions) Key Drivers
2020 200 Neonatal deficiency management, bleeding disorders
2021 220 Increased neonatal screening, surgical use
2022 250 Expansion into emerging markets, new formulations
2023 280 Regulatory approvals, increased awareness

Note: These figures are estimates based on industry reports and market analyses.

Market Drivers

  1. Neonatal Prophylaxis:
    Neonatal vitamin K deficiency bleeding (VKDB) remains a primary indication, especially in developed countries with routine screening programs. The rising birth rates in emerging markets expand the patient population.

  2. Bleeding Management:
    Patients on anticoagulant therapy or those with bleeding disorders (e.g., hemorrhagic disease) receive vitamin K1 for reversal or management. Increased awareness improves demand.

  3. Surgical and Trauma Applications:
    Preoperative administration to reduce bleeding risk continues to sustain sales.

  4. Regulatory Environment:
    Approval of new formulations and indications in certain markets can boost revenue. For example, recent approvals of injectable vs. oral forms influence procurement patterns.

Competitive Landscape

  • Major Manufacturers:
    Sanofi, Novo Nordisk, and local generic producers.
  • Generics:
    Constitute a significant share due to the drug’s essential and low-cost nature.
  • Innovation:
    Limited, but interest exists in developing long-acting formulations and novel delivery systems to enhance compliance.

Pricing Trends

Prices for vitamin K1 formulations remain stable across regions, but generic competition has driven slight reductions, especially in mature markets such as North America and Europe.

Market Challenges

  • Regulatory Hurdles:
    Variations in approvals across countries can delay entry into certain markets.

  • Supply Chain Disruptions:
    Manufacturing constraints, especially amid global logistical issues, impact supply.

  • Market Saturation:
    The essential nature of vitamin K1 limits exponential growth; market expansion hinges on demographic and procedural increases.

Financial Trajectory Projection

Forecast (2024–2028)

Year Expected Global Sales (USD Millions) Growth Rate Key Factors
2024 300 7% Increased neonatal births, emerging market growth
2025 330 10% Regulatory approvals, new formulations
2026 365 10.6% Expansion of indications, supply reliability
2027 400 9.6% Market penetration in Asia, hospital procurement
2028 440 10% Aging populations, increased surgical procedures

Note: Compound annual growth rate (CAGR) approximately 9.8% from 2024 to 2028.

Key Drivers for Growth

  • Rising birth rates in countries like India, Nigeria, and Indonesia.
  • Growing use of vitamin K1 in managing bleeding disorders.
  • Development of new formulations optimizing delivery and dosing.

Limitations and Risks

  • Market saturation in mature markets reduces growth potential.
  • Price competition with generics limits profit margins.
  • Regulatory delays and healthcare policy changes could slow expansion.

Key Takeaways

  • The global KONAKION market is stable, with steady growth driven by demographic trends and clinical application expansion.
  • Revenue projections suggest an annual growth rate approaching 10%, fueled chiefly by emerging markets and new formulations.
  • Competition from generics constrains pricing power, but innovation and indication expansion could offer growth opportunities.
  • Supply chain issues and regulatory hurdles pose ongoing risks to market stability.
  • Long-term growth relies on demographic shifts and increasing awareness of vitamin K deficiency management.

FAQs

1. What are the main indications for KONAKION?
Treatment and prevention of vitamin K deficiency, especially in neonates, patients with bleeding disorders, and preoperative settings.

2. How does the market for KONAKION compare to other vitamin K derivatives?
KONAKION is a leading branded form, but the market is also served by multiple generics, which supply the essential vitamin at lower costs. Its market share remains significant due to clinical familiarity.

3. What factors could influence future demand?
Increased birth rates in emerging markets, new indications, approval of novel formulations, and widespread neonatal screening contribute to demand.

4. What challenges hinder market expansion?
Regulatory delays, supply chain disruptions, market saturation, and price competition from generics.

5. Are there innovations in vitamin K1 formulations?
Research focuses on sustained-release options, oral vs. injectable formulations, and combination therapies, which may influence market dynamics.


Sources

[1] Industry Market Research, "Global Vitamin K Market Report," 2022.
[2] IQVIA Data, "Pharmaceutical Sales and Market Share," 2023.
[3] FDA and EMA Regulatory Directives, 2023.

More… ↓

⤷  Start Trial

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. We do not provide individual investment advice. This service is not registered with any financial regulatory agency. The information we publish is educational only and based on our opinions plus our models. By using DrugPatentWatch you acknowledge that we do not provide personalized recommendations or advice. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.