When will the MEPHYTON patents expire, and when will MEPHYTON go generic?

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Bausch	MEPHYTON	phytonadione	TABLET;ORAL	010104-003	Approved Prior to Jan 1, 1982		DISCN	Yes	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

Last updated: October 16, 2026

Mephyton is a mature oral phytonadione, or vitamin K1, product marketed in 5 mg tablets. Its commercial profile is shaped by limited clinical differentiation, low pricing power, generic and nonprescription vitamin K alternatives, and competition from injectable vitamin K products. Mephyton has no meaningful remaining composition-of-matter exclusivity, and Merck does not separately disclose product revenue. The brand’s value is therefore concentrated in physician familiarity, supply reliability, institutional purchasing relationships, and the limited availability of an approved oral prescription formulation.

What is Mephyton and what is it used for?

Mephyton is the brand name for phytonadione tablets, a synthetic form of vitamin K1. The product is supplied as 5 mg oral tablets and is used when vitamin K supplementation or replacement is clinically indicated, including selected cases of vitamin K deficiency and hypoprothrombinemia associated with certain conditions or therapies [1].

Mephyton active ingredient and dosage form

Attribute	Mephyton profile
Active ingredient	Phytonadione, vitamin K1
Dosage form	Oral tablet
Strength	5 mg
Prescription status	Prescription drug
Primary therapeutic use	Correction or prevention of vitamin K deficiency-related coagulation abnormalities
Reference product	Mephyton
FDA application	NDA 008866
Therapeutic category	Vitamin K replacement and coagulation support
Main alternatives	Injectable phytonadione, generic products, dietary vitamin K products

The oral tablet differs commercially from injectable phytonadione products used when rapid or reliable absorption is required. It is generally more relevant to outpatient treatment, maintenance therapy, and patients who can take medication orally.

What is the FDA regulatory status of Mephyton?

Mephyton is an FDA-approved prescription product. Its regulatory history dates to the early era of vitamin K therapy, placing it among mature pharmaceutical products with limited remaining regulatory exclusivity [1, 2].

The principal regulatory distinction is between an approved prescription product and dietary supplements containing vitamin K. Dietary supplements are not interchangeable with Mephyton under the FDA prescription-drug framework. Their strength, labeling, manufacturing controls, and clinical claims can differ.

Is Mephyton an FDA-approved drug?

Yes. Mephyton is an FDA-approved phytonadione tablet product. Its approved labeling identifies the product as an oral vitamin K1 formulation for conditions involving vitamin K deficiency or impaired coagulation [1].

What is the Orange Book status of Mephyton?

The FDA Orange Book is the relevant source for current approval, therapeutic-equivalence, patent, and exclusivity information. Mephyton’s commercial position is consistent with an old reference drug rather than a product protected by active new-drug exclusivity.

The product’s principal barriers are operational and commercial, not regulatory exclusivity. These include maintaining an approved supply, meeting quality requirements, securing distribution, and retaining prescriber awareness.

When does Mephyton lose exclusivity?

Mephyton’s original patent and regulatory exclusivity periods expired decades ago. The product is not positioned as a recently approved medicine with remaining Hatch-Waxman exclusivity.

Exclusivity category	Mephyton position
New chemical entity exclusivity	Expired
Original composition-of-matter patent	Expired
Orphan-drug exclusivity	Not applicable
Pediatric exclusivity	No current commercial significance
New formulation exclusivity	No publicly evident material exclusivity supporting the brand
Current commercial protection	Brand recognition, supply, approval status and distribution

An exact modern patent expiration date is not commercially meaningful for the product because the underlying active ingredient and historical approval are longstanding. Current FDA Orange Book data should control any product-specific patent or listing analysis [2].

What patents protect Mephyton?

No active patent estate appears to provide material protection for the core Mephyton product. Phytonadione is an established vitamin K1 compound, and the basic oral tablet technology is conventional.

Formulation patents

The commercial risk from formulation patents is low. A standard 5 mg oral tablet generally does not require a technically complex delivery system, controlled-release architecture, device, or specialized manufacturing process.

Potentially relevant patent categories could include:

Tablet composition and excipient combinations
Stability-enhancing formulations
Methods for improving oral absorption
Packaging designed to protect light-sensitive vitamin K
Manufacturing processes
Combination products involving anticoagulation management

These categories do not appear to create a substantial blocking estate around conventional Mephyton tablets. A competitor could still encounter regulatory and manufacturing requirements, but those are different from patent barriers.

Method-of-use patents

Mephyton’s approved uses are established medical uses for vitamin K replacement. Method-of-use patents associated with routine correction of vitamin K deficiency would face significant validity and enforcement challenges because of the age of the therapy and extensive prior art.

A new method involving a distinct patient population, dosing schedule, biomarker, or anticoagulation-management protocol could theoretically support patent protection. Such a patent would not automatically block conventional generic phytonadione tablets for the original indications.

How many patents cover Mephyton?

The commercially relevant number of unexpired, blocking patents is effectively zero based on the mature status of the product and the absence of a modern protected formulation or delivery platform. Historical patent records may exist, but expired patents do not prevent generic or alternative-product competition.

The key distinction is between:

Historical patents associated with phytonadione or early formulations.
Current Orange Book-listed patents.
Unexpired patents that could support litigation or delay approval.
Nonpatent barriers such as manufacturing validation and supply continuity.

For Mephyton, the fourth category is more important than the first three.

Which companies are challenging Mephyton?

There is no prominent current Paragraph IV litigation profile associated with Mephyton comparable to high-value branded products. The competitive pressure comes primarily from established generic and alternative vitamin K suppliers rather than from a high-profile patent challenge.

Paragraph IV challenges

A Paragraph IV certification is relevant when an abbreviated new drug application applicant asserts that a listed patent is invalid, unenforceable, or not infringed. Mephyton’s aged product profile provides little indication of a commercially significant patent-based delay strategy.

The likely competitive pathway is approval of an ANDA without a meaningful patent settlement dispute, subject to the availability of an applicable reference product and FDA requirements.

Litigation status and settlement agreements

No material, widely reported settlement agreement appears to define Mephyton’s market. The absence of high-value patent litigation is consistent with:

Low expected revenue per entrant
Limited patent protection
A mature therapeutic category
Low clinical switching costs
Greater focus on manufacturing economics than legal exclusivity

Any product-specific litigation review should use PACER, FDA Orange Book data, and FDA approval records because private commercial disputes or supply litigation may not be reflected in industry summaries.

What is the competitive landscape for Mephyton?

Mephyton competes across three overlapping markets: prescription phytonadione tablets, injectable vitamin K, and nonprescription vitamin K products.

Competitive segment	Competitive impact on Mephyton
Generic oral phytonadione	Direct price and formulary pressure
Injectable phytonadione	Preferred when rapid or dependable correction is needed
Vitamin K1 supplements	Lower-cost substitution for some non-acute uses, although not therapeutically interchangeable
Vitamin K2 supplements	Adjacent consumer category, with different clinical positioning
Hospital protocols	Can shift demand toward injectable or institutionally selected products
Warfarin-management alternatives	Reduce some demand for vitamin K intervention over time

Mephyton versus injectable phytonadione

Injectable products have a stronger position in acute care because they can be administered when oral intake is not possible and may provide more predictable clinical use in urgent settings. Mephyton retains relevance when oral administration is appropriate and immediate parenteral treatment is unnecessary.

Mephyton versus vitamin K supplements

Consumer supplements can compete for low-acuity demand but are not automatically substitutes for an FDA-approved prescription product. Differences include dose standardization, labeling, quality controls, clinical evidence, and intended use.

Mephyton versus generic phytonadione tablets

If therapeutically equivalent generic tablets are available, they are the most direct threat. Their effect depends on:

FDA approval and therapeutic-equivalence rating
Pharmacy substitution rules
Wholesale acquisition cost
Contracting and formulary placement
Availability during shortages
Prescriber familiarity with the brand

What is the financial trajectory of Mephyton?

Mephyton’s standalone revenue is not separately reported in Merck’s public financial statements. As a result, there is no reliable public basis for assigning annual sales, operating margin, or product-level growth to the brand.

The expected financial trajectory is mature to declining, with possible periods of stabilization when supply shortages, generic discontinuations, or institutional purchasing changes favor the brand.

Financial driver	Expected effect
Product age	Limits price expansion and market growth
Generic competition	Compresses price and volume
Limited innovation	Reduces ability to expand the addressable market
Prescription status	Preserves some reimbursement and institutional demand
Supply reliability	Can support temporary share gains
Injectable competition	Caps use in acute hospital settings
Lack of reported revenue	Prevents precise standalone valuation
Manufacturing scale	Determines margin more than clinical differentiation

Revenue exposure

Mephyton is unlikely to represent a material share of Merck’s consolidated pharmaceutical revenue. Merck reports performance by major business segments and selected products, not every mature legacy medicine. The product’s financial importance is more likely to be measured by portfolio contribution, channel economics, and strategic value than by its effect on consolidated earnings [3].

Pricing power

Pricing power is constrained by the availability of alternative phytonadione products and the absence of a defensible patent position. Any price increase risks substitution by generic tablets, injectable products, or other vitamin K products where clinically appropriate.

The brand may retain a premium when hospitals or pharmacies value:

Consistent supply
Familiar labeling
Established procurement history
Predictable quality
Reduced operational risk from changing suppliers

What generic entry risks exist for Mephyton?

Generic entry risk is structurally high. The product has a simple active ingredient, an established dosage form, and no apparent blocking patent estate. The most important limitation on generic entry is likely market size rather than legal protection.

Generic launch scenarios

Scenario	Market outcome
One approved generic entrant	Moderate price pressure and selective pharmacy substitution
Multiple generic entrants	Rapid commoditization and lower brand share
Generic supply disruption	Temporary recovery in brand demand
Brand price reduction	Partial defense but lower revenue per unit
Hospital preference for injectable therapy	Continued erosion of oral tablet volume
No reliable generic supply	Mephyton retains niche value despite patent expiry

A generic entrant may not aggressively pursue the market if expected annual volume is low or if manufacturing and distribution costs exceed the available margin. That commercial barrier can protect a mature brand without creating formal exclusivity.

What manufacturing and IP barriers affect Mephyton?

The principal manufacturing concerns are product quality, stability, packaging, and supply continuity. Vitamin K products require controlled manufacturing and appropriate protection from degradation, but the formulation is not generally viewed as a high-complexity biologic or advanced drug-delivery product.

Manufacturing barriers

Relevant operational issues include:

Active pharmaceutical ingredient sourcing
Tablet-content uniformity
Stability and shelf-life testing
Packaging and light protection
Good manufacturing practice compliance
Batch release and quality-control testing
Distribution continuity
Management of low-volume production economics

These requirements can discourage small entrants, but they do not create a strong proprietary moat.

Biosimilar risk

Biosimilar risk is not applicable. Mephyton is a small-molecule vitamin K1 tablet, not a biologic. Competition proceeds through conventional generic-drug pathways rather than the FDA biosimilar pathway.

What licensing deals involve Mephyton?

No major recent licensing transaction is publicly associated with Mephyton as a strategic growth asset. The product’s commercial value is more consistent with an established portfolio medicine than with an in-licensed development program.

A potential transaction involving Mephyton would likely be evaluated on:

Net sales after rebates and discounts
Manufacturing cost and minimum batch economics
Supply reliability
Regulatory maintenance obligations
Product-liability exposure
Remaining market exclusivity, which is limited
Cross-selling opportunities in hospital or anticoagulation portfolios

The product could have value in a mature-brand acquisition, but its standalone valuation would likely depend on cash generation and supply position rather than pipeline optionality.

How does Mephyton compare with other mature prescription drugs?

Factor	Mephyton	Typical protected specialty drug
Patent position	Minimal or expired	Often central to valuation
Regulatory exclusivity	Expired or immaterial	May extend for years
Generic risk	High	Delayed by patents and exclusivity
Clinical differentiation	Limited	Often supported by trials or mechanism
Pricing power	Low	Potentially high
Revenue disclosure	Usually not separate	Often reported if material
Manufacturing complexity	Low to moderate	May be high, especially for biologics
Commercial value	Niche cash flow and supply	Growth, exclusivity and pipeline value

Key Takeaways

Mephyton is an FDA-approved 5 mg oral phytonadione tablet.
Its original patent and regulatory exclusivity periods expired long ago.
The product has no apparent modern patent estate that materially blocks generic competition.
Generic oral phytonadione, injectable vitamin K, and vitamin K supplements create competitive pressure.
Mephyton’s standalone revenue is not separately disclosed by Merck.
Its expected financial trajectory is mature and vulnerable to volume and price erosion.
Supply reliability, procurement relationships, and brand familiarity are more important than patent protection.
Biosimilar competition is irrelevant because Mephyton is a small-molecule tablet.
The most credible commercial upside would come from supply disruptions affecting competitors, not from market expansion or new exclusivity.
The product’s value is likely that of a niche legacy medicine with limited strategic growth potential.

FAQs about Mephyton market dynamics

Is Mephyton still commercially relevant?

Yes, but its relevance is narrow. It remains useful where an approved oral phytonadione product is preferred and injectable treatment is unnecessary or impractical.

Can pharmacies substitute generic phytonadione for Mephyton?

Substitution depends on the availability of an FDA-rated therapeutically equivalent product and applicable state pharmacy rules. Product availability and payer policy also affect substitution.

Does Mephyton have orphan-drug protection?

No material orphan-drug exclusivity is associated with the established Mephyton product.

Is Mephyton exposed to vitamin K2 competition?

Only indirectly. Vitamin K2 supplements occupy an adjacent consumer market and are not automatically substitutes for prescription phytonadione used for vitamin K deficiency or coagulation management.

What would most improve Mephyton’s commercial outlook?

The strongest short-term support would come from reliable supply, favorable institutional contracting, and competitor shortages. New patent-based growth is unlikely given the product’s age and conventional formulation.

References

U.S. Food and Drug Administration. (n.d.). Mephyton (phytonadione) tablets prescribing information.
U.S. Food and Drug Administration. (n.d.). Approved drug products with therapeutic equivalence evaluations: Orange Book.
Merck & Co., Inc. (2024). Annual report pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934.

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	125
Clinical Trials:	1
Patent Applications:	3,542
Drug Prices:	Drug price information for MEPHYTON
What excipients (inactive ingredients) are in MEPHYTON?	MEPHYTON excipients list
DailyMed Link:	MEPHYTON at DailyMed

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