Menadiol sodium diphosphate - Generic Drug Details

What are the generic drug sources for menadiol sodium diphosphate and what is the scope of patent protection?

Menadiol sodium diphosphate is the generic ingredient in two branded drugs marketed by Lilly and Roche, and is included in two NDAs. Additional information is available in the individual branded drug profile pages.

Summary for menadiol sodium diphosphate

US Patents:	0
Tradenames:	2
Applicants:	2
NDAs:	2
Raw Ingredient (Bulk) Api Vendors:	42
DailyMed Link:	menadiol sodium diphosphate at DailyMed

US Patents and Regulatory Information for menadiol sodium diphosphate

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Lilly	KAPPADIONE	menadiol sodium diphosphate	INJECTABLE;INJECTION	005725-001	Approved Prior to Jan 1, 1982		DISCN	No	No
Roche	SYNKAYVITE	menadiol sodium diphosphate	TABLET;ORAL	003718-010	Approved Prior to Jan 1, 1982		DISCN	No	No
Roche	SYNKAYVITE	menadiol sodium diphosphate	INJECTABLE;INJECTION	003718-008	Approved Prior to Jan 1, 1982		DISCN	No	No
Roche	SYNKAYVITE	menadiol sodium diphosphate	INJECTABLE;INJECTION	003718-006	Approved Prior to Jan 1, 1982		DISCN	No	No
Roche	SYNKAYVITE	menadiol sodium diphosphate	INJECTABLE;INJECTION	003718-004	Approved Prior to Jan 1, 1982		DISCN	No	No

Last updated: September 3, 2026

Menadiol sodium diphosphate is a legacy synthetic vitamin K product with limited and poorly disclosed commercial activity. Its market is driven by hospital and specialist demand rather than primary-care volume. The active ingredient is old, patent exclusivity has effectively expired, and no meaningful branded revenue, late-stage pipeline, or biosimilar risk is publicly identifiable. Commercial exposure depends on a small number of regional suppliers, regulatory maintenance, manufacturing continuity, and competition from phytonadione and other vitamin K products.

Menadiol Sodium Diphosphate Market Dynamics and Financial Trajectory

What is menadiol sodium diphosphate and how is it used?

Menadiol sodium diphosphate is a water-soluble synthetic vitamin K analogue. It is also described in some regulatory and pharmacological sources as menadiol sodium phosphate or a menadione derivative. Vitamin K compounds support hepatic production of clotting factors II, VII, IX and X.

Historically, menadiol sodium diphosphate has been used in products for:

• Vitamin K deficiency
• Hypoprothrombinemia
• Malabsorption-related bleeding risk
• Certain neonatal or pediatric deficiency settings
• Situations where an injectable or water-soluble vitamin K preparation is required

The product has been marketed in some jurisdictions under the Synkavit name and through regional generic or hospital channels. Its use is distinct from phytonadione, also known as vitamin K1, which is the principal vitamin K product used in many modern hospital protocols.

Attribute	Menadiol sodium diphosphate
Pharmacological class	Vitamin K analogue
Therapeutic area	Hematology, coagulation, nutritional deficiency
Typical dosage forms	Tablets and injectable preparations in selected markets
Primary users	Hospitals, specialists, pediatric and nutrition services
U.S. commercial position	No material current U.S. branded market identified
Patent position	Legacy compound with no meaningful unexpired composition-of-matter exclusivity
Biosimilar exposure	None
Commercial profile	Niche, mature, regional and supply-sensitive

What is the regulatory status of menadiol sodium diphosphate?

The regulatory position is fragmented by country. Menadiol sodium diphosphate is not a major contemporary FDA-approved product category in the United States. Public FDA product databases and the Orange Book do not show a significant current U.S. product franchise comparable with phytonadione products. The compound may appear in historical records, drug compendia, international formularies, or non-U.S. marketing authorizations without representing an active U.S. commercial product.[1][2]

In the United Kingdom and certain other markets, menadiol sodium diphosphate has been associated with legacy products such as Synkavit. The continuing commercial status of individual presentations has changed over time because of manufacturer transfers, discontinuations, supply constraints, and national marketing-authorization decisions.

FDA and Orange Book status

The U.S. commercial implications are limited for four reasons:

1. Menadiol sodium diphosphate is not a major current Orange Book product.
2. No active U.S. reference-product franchise comparable with vitamin K1 is evident.
3. No important U.S. Paragraph IV litigation campaign is associated with the ingredient.
4. No U.S. exclusivity period appears to support a modern branded launch strategy.

The absence of a substantial Orange Book position means that conventional U.S. generic-entry analysis has limited relevance. A potential U.S. entrant would face product-development, regulatory, formulation and manufacturing questions rather than a significant branded patent barrier.

European and international status

International regulatory activity is more relevant than the U.S. position. Older vitamin K products may remain available through national approvals, hospital procurement systems, or specialist suppliers. However, national availability does not establish a large or growing market. Products can remain licensed while experiencing limited distribution or intermittent supply.

Menadiol sodium diphosphate should therefore be analyzed as a regional legacy medicine rather than as a globally coordinated pharmaceutical brand.

When does menadiol sodium diphosphate lose exclusivity?

Menadiol sodium diphosphate has no commercially meaningful remaining exclusivity based on the age of the molecule and the historical nature of its products. The compound was developed decades ago, making expiration of any original composition-of-matter patent unavoidable.

Exclusivity category	Position
Composition-of-matter patent	Expired or commercially irrelevant
Basic formulation patents	Any original rights are expected to have expired
Regulatory data exclusivity	Not a meaningful current barrier
Orphan-drug exclusivity	No material current designation identified
Pediatric exclusivity	No material current U.S. exclusivity identified
Patent-term extension	No relevant modern extension identified
Biosimilar exclusivity	Not applicable

The relevant commercial protection is not patent exclusivity. It is the combination of:

• Existing manufacturing know-how
• Regulatory files and product history
• Access to qualified active-pharmaceutical-ingredient suppliers
• Sterile manufacturing capability for injectable presentations
• Hospital formulary relationships
• Distribution reliability
• Ability to maintain older products at acceptable margins

What patents protect menadiol sodium diphosphate?

No material unexpired patent estate covering the basic menadiol sodium diphosphate molecule has been identified in public drug-patent sources. The molecule is too old for a current composition-of-matter patent to support market exclusivity.

Potential historical rights may have covered:

• Salt selection
• Water-soluble formulations
• Injectable preparation methods
• Stabilization systems
• Packaging
• Dosing methods
• Specific therapeutic uses

Those categories do not create a meaningful modern barrier unless a jurisdiction still recognizes a live patent with enforceable claims and a relevant remaining term. There is no prominent patent family, litigation record or marketed proprietary delivery system associated with menadiol sodium diphosphate comparable with newer specialty medicines.

The practical patent-strength assessment is therefore low.

Patent factor	Assessment
Core molecule protection	Expired
Modern formulation estate	Limited or absent
Method-of-use protection	Not commercially significant
Manufacturing patent barrier	Possible process know-how, not visible market exclusivity
Patent litigation risk	Low
Freedom-to-operate risk	Primarily regulatory and technical rather than patent-based

How large is the menadiol sodium diphosphate market?

Public sources do not provide a reliable standalone global market size or product-level revenue figure for menadiol sodium diphosphate. The ingredient is generally grouped into broader categories such as vitamin K, antihemorrhagic agents, nutritional products, or hospital injectable medicines.

The market is likely small relative to:

• Phytonadione and other vitamin K1 products
• Direct oral anticoagulant reversal agents
• Prothrombin complex concentrates
• Recombinant and plasma-derived coagulation products
• General nutritional supplements

The absence of standalone revenue disclosure is itself commercially relevant. Menadiol sodium diphosphate is not generally reported as a material revenue driver by diversified pharmaceutical companies. Where it is sold, revenue is more likely embedded in a broader hospital, generic, specialty or legacy-products portfolio.

Revenue exposure and financial visibility

No public company-level reporting has been identified that isolates menadiol sodium diphosphate revenue. The financial trajectory is therefore best characterized as mature, low-growth and opaque.

Financial indicator	Market assessment
Standalone global sales	Not publicly disclosed
Branded-product revenue	Limited and regional
Growth profile	Flat to declining in mature markets
Pricing power	Low to moderate
Gross-margin potential	Dependent on shortage status and presentation
Volume driver	Hospital procurement and specialist demand
Investment profile	Maintenance product, not platform asset
Revenue risk	Discontinuation, substitution and supply interruption

A small product can generate temporary pricing gains if only one or two suppliers remain. That does not necessarily indicate durable market expansion. In legacy injectables, price increases can reflect manufacturing scarcity, batch failures, quality remediation or low-volume economics.

What drives demand for menadiol sodium diphosphate?

Demand is determined by clinical substitution, hospital protocols and product availability. The principal demand drivers are:

Clinical need for vitamin K replacement

Patients with vitamin K deficiency may require replacement because of malabsorption, prolonged antibiotic use, liver-related dysfunction, inadequate nutrition or other medical conditions. In many settings, clinicians use vitamin K1 rather than menadiol sodium diphosphate.

Product presentation

Injectable products can retain demand where oral administration is unsuitable or rapid intervention is required. Sterile injectable manufacturing raises technical and regulatory barriers, but it also increases production cost.

Pediatric and specialist use

Historical use in pediatric and neonatal settings supports a specialist niche. Current protocols and preferred products vary by country and institution, limiting global standardization.

Hospital shortages

Legacy medicines can experience demand spikes during shortages of substitute products. Those spikes are episodic. They do not establish sustained volume growth unless the product becomes a preferred substitute.

Formulary position

Hospitals often purchase vitamin K products through tenders. Price, supply reliability, approved presentation, stability and procurement history can outweigh brand recognition.

How does menadiol sodium diphosphate compare with phytonadione?

Phytonadione is the principal commercial comparator. It is a naturally occurring vitamin K1 analogue and has broader modern recognition, wider regulatory use and stronger presence in hospital formularies.

Factor	Menadiol sodium diphosphate	Phytonadione
Vitamin K type	Synthetic water-soluble analogue	Vitamin K1
Current commercial reach	Narrow and regional	Broad
U.S. market presence	Limited or absent as a major product	Established
Hospital familiarity	Legacy or specialist	High
Formulations	Regional tablets and injectables	Injectable, oral and other products depending on market
Generic competition	Limited market relevance	Established generic competition
Patent risk	Low	Generally low for legacy products
Substitution risk	High	Lower because of wider adoption

Menadiol sodium diphosphate competes mainly on availability, formulation and local clinical practice. It lacks a strong global differentiation story that would support premium pricing.

What generic entry risks exist for menadiol sodium diphosphate?

Generic-entry risk is high in principle because the active ingredient is old and patent protection is not a meaningful constraint. Commercial entry remains limited by market size and technical economics.

Oral products

Oral products face relatively low manufacturing complexity. If a jurisdiction has an active reference product and a viable regulatory pathway, competition can emerge through conventional generic development. The main barriers are market registration, bioequivalence requirements, demand volume and commercial return.

Injectable products

Injectables are more difficult to replicate because developers must address:

• Sterility assurance
• Container-closure integrity
• Stability
• Particulate control
• Preservative or excipient compatibility
• Supply of qualified active ingredient
• Manufacturing validation
• Regulatory inspection requirements

These barriers can reduce the number of suppliers even when patents have expired. They are manufacturing barriers, not exclusivity rights.

Launch scenarios

Scenario	Commercial result
Existing supplier remains reliable	Stable low-volume market
Supplier discontinues product	Rapid substitution or shortage
New generic enters	Price erosion and tender pressure
Substitute vitamin K product becomes scarce	Temporary demand transfer
Regulatory failure occurs	Regional withdrawal and procurement disruption

Which companies are challenging or commercializing menadiol sodium diphosphate?

No major current multinational patent challenger or high-profile generic entrant is publicly associated with menadiol sodium diphosphate. Commercialization has historically been linked to regional pharmaceutical companies and specialist suppliers rather than large innovative-drug manufacturers.

The competitive landscape should be monitored through:

• National marketing-authorisation databases
• Hospital tender awards
• Discontinued-product notices
• Shortage databases
• Supplier changes
• Pharmacopoeial and procurement records

A company may hold a national authorization without disclosing sales or actively promoting the product. Manufacturer identity can also change through licensing, divestiture or transfer of legacy portfolios.

Are there licensing deals or settlement agreements?

No material public licensing deal, Paragraph IV settlement, or patent settlement agreement has been identified for menadiol sodium diphosphate. The lack of litigation is consistent with an old, low-value product that has no significant remaining patent estate.

Commercial agreements, if any, are more likely to involve:

• Supply contracts
• Contract manufacturing
• National distribution
• Marketing-authorisation transfers
• Portfolio acquisitions

These arrangements are often private and do not produce the public disclosures associated with major patented drugs.

What is the litigation status for menadiol sodium diphosphate?

No significant current patent litigation involving menadiol sodium diphosphate has been identified in major public litigation sources. There is no visible litigation pattern involving:

• Paragraph IV certifications
• Hatch-Waxman enforcement
• Biosimilar challenges
• Formulation patent disputes
• Method-of-use litigation
• Antitrust settlements

Litigation risk is therefore low. Product liability, quality, shortage and regulatory-compliance risks are more relevant than patent enforcement.

How strong is the menadiol sodium diphosphate commercial position?

The product’s commercial position is weak but potentially durable in narrow markets. Its value depends on continued availability rather than exclusivity.

Strengths

• Established pharmacological history
• Low patent burden
• Potential usefulness where water-soluble vitamin K is required
• Possible niche demand in hospital and pediatric settings
• Limited competition in individual national markets

Weaknesses

• Small and fragmented market
• No transparent product-level revenue
• High substitution by vitamin K1
• Low pricing power under hospital tenders
• Potential discontinuation risk
• Limited prescriber differentiation
• Injectable manufacturing complexity
• No visible innovation pipeline

What is the financial trajectory for menadiol sodium diphosphate?

The most supportable financial outlook is a mature-product trajectory:

1. Stable or declining baseline demand.
2. Low visibility into standalone revenue.
3. Occasional price or volume volatility caused by shortages.
4. Continued substitution by phytonadione and other vitamin K products.
5. Limited incentive for major new clinical or formulation investment.
6. Value concentrated in reliable supply and regulatory continuity.

Menadiol sodium diphosphate is unlikely to become a material growth asset without a change in clinical guidelines, a shortage of competing vitamin K products, or a new delivery technology. Its investment value is more consistent with a small portfolio-maintenance product than with a growth pharmaceutical asset.

Key Takeaways

• Menadiol sodium diphosphate is an old synthetic vitamin K analogue with regional use.
• Its original patent protection is no longer commercially relevant.
• No significant current U.S. Orange Book franchise or Paragraph IV litigation position is evident.
• Public sources do not disclose reliable standalone market size or revenue.
• Phytonadione is the principal commercial substitute and has broader market adoption.
• Generic entry is legally feasible, but low demand and injectable manufacturing requirements limit enthusiasm.
• Supply continuity, regulatory maintenance and hospital procurement are more important than patent exclusivity.
• The financial trajectory is mature, low-growth and vulnerable to discontinuation or substitution.

FAQs About Menadiol Sodium Diphosphate

Is menadiol sodium diphosphate the same as vitamin K1?

No. Menadiol sodium diphosphate is a synthetic vitamin K analogue. Vitamin K1 is phytonadione, a different active ingredient with broader contemporary use.

Is menadiol sodium diphosphate available in the United States?

It does not have a material current U.S. commercial presence based on public FDA product and Orange Book records. Availability may differ by jurisdiction and institutional procurement channel.

Does menadiol sodium diphosphate have biosimilar competition?

No. Biosimilar regulation applies to biological products. Menadiol sodium diphosphate is a chemically synthesized small molecule.

Can a company launch a generic menadiol sodium diphosphate product?

Potentially, subject to national regulatory requirements, product availability, reference-product status, formulation development and manufacturing validation. Patent expiration is unlikely to be the main barrier.

Why might an old vitamin K product remain on the market?

A legacy product can remain commercially useful where clinicians recognize it, hospitals require a specific formulation, alternatives are unavailable, or a supplier can operate profitably at low volume.

References

1. U.S. Food and Drug Administration. (n.d.). Approved drug products with therapeutic equivalence evaluations: Orange Book. https://www.fda.gov/drugs/drug-approvals-and-databases/approved-drug-products-therapeutic-equivalence-evaluations-orange-book

2. U.S. Food and Drug Administration. (n.d.). Drugs@FDA: FDA-approved drugs. https://www.accessdata.fda.gov/scripts/cder/daf/

3. National Library of Medicine. (n.d.). PubChem compound summary: Menadiol sodium diphosphate. PubChem. https://pubchem.ncbi.nlm.nih.gov/

4. Electronic Medicines Compendium. (n.d.). Synkavit product information. https://www.medicines.org.uk/emc/

5. World Health Organization Collaborating Centre for Drug Statistics Methodology. (n.d.). ATC/DDD index. https://atcddd.fhi.no/atc_ddd_index/