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Last Updated: March 26, 2026

VITAMIN K1 Drug Patent Profile


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When do Vitamin K1 patents expire, and when can generic versions of Vitamin K1 launch?

Vitamin K1 is a drug marketed by Hospira and is included in three NDAs.

The generic ingredient in VITAMIN K1 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 Vitamin K1

A generic version of VITAMIN K1 was approved as phytonadione by AMNEAL PHARMS CO on May 11th, 2018.

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  • What is the 5 year forecast for VITAMIN K1?
  • What are the global sales for VITAMIN K1?
  • What is Average Wholesale Price for VITAMIN K1?
Drug patent expirations by year for VITAMIN K1

US Patents and Regulatory Information for VITAMIN K1

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Hospira VITAMIN K1 phytonadione INJECTABLE;INJECTION 087954-001 Jul 25, 1983 BP RX Yes Yes ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Hospira VITAMIN K1 phytonadione INJECTABLE;INJECTION 087955-001 Jul 25, 1983 AB1 RX Yes Yes ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Hospira VITAMIN K1 phytonadione INJECTABLE;INJECTION 087956-001 Jul 25, 1983 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

VITAMIN K1 Market Analysis and Financial Projection

Last updated: February 13, 2026

What Are the Current Market Dynamics for Vitamin K1?

The global Vitamin K1 (phytonadione) market is influenced by rising awareness of bone health and cardiovascular disease prevention, which drives demand. Key factors include increased use in dietary supplements, fortified foods, and medical treatments for bleeding disorders.

The market was valued at approximately $340 million in 2022, with compound annual growth rate (CAGR) projections around 6% from 2023 to 2030 [1]. Growth is further supported by expanding pharmaceutical formulations, bolstering Vitamin K1's application in clinical settings for coagulopathy treatment.

Supply chains are stable, with major producers in India, China, and Europe. Regulatory frameworks vary, but most countries require rigorous safety and efficacy testing for approval. Patent expiration on certain formulations has led to increased generics, intensifying price competition and affecting margins for branded products.

What Are Key Drivers and Barriers Impacting Market Growth?

Drivers

  • Rising Prevalence of Osteoporosis and Cardiovascular Diseases: Aging populations globally increase demand for Vitamin K1 in supplements aimed at improving bone density and arterial health.

  • Growing Use in Clinical Settings: Vitamin K1's role in reversing anticoagulant effects and treating bleeding disorders sustains steady demand among healthcare providers.

  • FDA and EMA Approvals: Regulatory approvals for new formulations or delivery methods can expand market reach.

Barriers

  • Limited Awareness: Consumer knowledge gaps about Vitamin K1's benefits hinder direct-to-consumer sales.

  • Competition from Vitamin K2: K2 variants sometimes considered more effective for bone health, may divert some demand, impacting market share.

  • Regulatory Challenges: Variability and stringency in approvals can delay product launches.

How Does the Financial Trajectory Look?

Revenue Trends

Since 2020, revenue growth has remained stable, with a compound annual growth rate approx. 6%, aligning with forecast projections [1]. The market's resilience owes to consistent demand in clinical settings and dietary supplement sectors.

Pricing Dynamics

Price points generally range from $10 to $50 per 100 capsules, depending on formulation and branding. Generics contribute to price erosion, maintaining high volume but lower margins.

Investment Trends

Pharmaceutical companies and nutraceutical firms invested approximately $25 million in R&D specifically targeting Vitamin K1 formulations and delivery systems from 2020 to 2022 [2]. The focus includes developing enhanced bioavailability and novel delivery systems (e.g., nanoencapsulation).

Future Outlook

Projections suggest a steady CAGR of 6% through 2030, with revenue potentially reaching $550 million by 2030, driven by increasing application scope and aging demographics. Market expansion into emerging economies and innovation in formulations are key growth avenues.

How Do Regulatory and Competitive Factors Shape Future Growth?

Regulatory bodies are updating guidelines to improve safety standards for dietary supplements, impacting manufacturing practices. Patent expirations are increasing, leading to a rise in generics and pressure on prices.

Competition from Vitamin K2 products, with claims of superior efficacy in bone health, may restrain growth unless marketed with clear clinical evidence. Innovation in delivery systems aims to differentiate products and address bioavailability limitations.

Key Players and Market Share

Major companies include:

  • Merck KGaA
  • EMSL Lipids Inc.
  • Shanghai Shyndec Pharmaceutical Co., Ltd.
  • Fenbur Pharmaceutical Co.
  • DSM Nutrition

Market share is fragmented, with top five players controlling approximately 45% of the market as of 2022. The remaining market shares distributed among regional manufacturers and generic producers.

What Are Future Opportunities and Risks?

Opportunities

  • Expanding into emerging markets with rising health awareness.
  • Development of novel delivery systems to improve bioavailability.
  • Incorporation into combination therapies for bone and cardiovascular health.

Risks

  • Regulatory delays or bans.
  • Market saturation in developed countries.
  • Competition from alternative formulations like Vitamin K2.

Key Takeaways

  • Market valued at $340 million (2022), projected to reach $550 million by 2030.
  • CAGR of approximately 6%, driven by health awareness and clinical use.
  • Price competition from generics is a defining feature.
  • Expansion opportunities exist in emerging economies and innovation.
  • Market growth faces regulatory and competitive challenges.

FAQs

1. What distinguishes Vitamin K1 from Vitamin K2 in the market?
Vitamin K2 is often promoted for bone health due to longer half-life and better distribution in tissues. Vitamin K1 is primarily used for coagulation disorders and certain deficiency treatments, leading to different market segments.

2. Are there any recent regulatory changes affecting Vitamin K1?
No major recent regulatory changes have occurred, but oversight nuances differ by region, impacting manufacturing and marketing practices.

3. How significant is the role of Vitamin K1 in pharmaceutical formulations?
It is critical for coagulation therapy, particularly in reversing anticoagulation effects. It has limited roles outside this scope.

4. What is the impact of patent expirations on market composition?
Patent expirations have increased generic availability, promoting price competition but reducing brand margins.

5. Which regions present the highest growth potential?
Emerging markets in Asia-Pacific and Latin America show strong growth prospects due to increasing health awareness and rising disposable incomes.


References

[1] MarketWatch, “Vitamin K1 Market Size, Share & Trends Analysis Report,” 2022.

[2] GlobalData, “Pharmaceutical R&D Spending Report,” 2022.

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