MEFOXIN IN PLASTIC CONTAINER Drug Patent Profile

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When do Mefoxin In Plastic Container patents expire, and when can generic versions of Mefoxin In Plastic Container launch?

Mefoxin In Plastic Container is a drug marketed by Pharmobedient and is included in one NDA.

The generic ingredient in MEFOXIN IN PLASTIC CONTAINER is cefoxitin sodium. There is one drug master file entry for this compound. Six suppliers are listed for this compound. Additional details are available on the cefoxitin sodium profile page.

Summary for MEFOXIN IN PLASTIC CONTAINER

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	63
Clinical Trials:	1
Patent Applications:	5,409
DailyMed Link:	MEFOXIN IN PLASTIC CONTAINER at DailyMed

Recent Clinical Trials for MEFOXIN IN PLASTIC CONTAINER

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

Sponsor	Phase
Bristol-Myers Squibb	N/A
University of KwaZulu	N/A

See all MEFOXIN IN PLASTIC CONTAINER clinical trials

US Patents and Regulatory Information for MEFOXIN IN PLASTIC CONTAINER

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Pharmobedient	MEFOXIN IN PLASTIC CONTAINER	cefoxitin sodium	INJECTABLE;INJECTION	063182-001	Jan 25, 1993		DISCN	No	No
Pharmobedient	MEFOXIN IN PLASTIC CONTAINER	cefoxitin sodium	INJECTABLE;INJECTION	063182-002	Jan 25, 1993		DISCN	No	No

Mefoxin in Plastic Container: Market Dynamics, Patent Position, and Financial Trajectory

Last updated: October 12, 2026

Mefoxin in Plastic Container is a legacy injectable presentation of cefoxitin sodium, a second-generation cephamycin antibiotic. Its commercial position is mature and largely genericized. The product has no meaningful remaining patent moat, no biologic exclusivity, and limited standalone financial disclosure. Revenue is driven by hospital procurement, manufacturing reliability, contract pricing, and supply availability rather than clinical differentiation.

What is Mefoxin in Plastic Container?

Mefoxin is the branded injectable formulation of cefoxitin sodium, administered intravenously or intramuscularly. The plastic-container presentation is a packaging and delivery format, not a separate active pharmaceutical ingredient or new molecular entity.

Attribute	Product profile
Brand	Mefoxin
Active ingredient	Cefoxitin sodium
Drug class	Cephamycin antibacterial
FDA status	Legacy approved prescription injectable
Primary setting	Hospitals and other institutional care
Administration	Intravenous or intramuscular
Commercial category	Mature sterile generic market
Patent status	Original product and basic compound protection expired
Biosimilar exposure	Not applicable
Main commercial risks	Price erosion, supply interruptions, sterile manufacturing constraints

FDA labeling identifies cefoxitin for treatment of susceptible bacterial infections, including selected intra-abdominal, gynecologic, respiratory, urinary-tract, skin, and bone and joint infections.[1] Its use is constrained by antimicrobial stewardship, local resistance patterns, renal dosing requirements, and the availability of alternative beta-lactam antibiotics.

What is the FDA regulatory status of Mefoxin?

Mefoxin was approved decades ago and is regulated as a conventional small-molecule injectable, not as a biologic. The original regulatory approval does not provide current market exclusivity.

The regulatory distinction between the Mefoxin brand and cefoxitin generic products is commercially important:

• The active ingredient is cefoxitin sodium.
• Generic manufacturers can compete through abbreviated new drug applications, subject to FDA requirements for quality, sterility, strength, labeling, and bioequivalence.
• A plastic container may require separate manufacturing, container-closure, stability, and compatibility controls.
• The container presentation does not create a new chemical entity or independent period of statutory exclusivity.
• Product availability can vary by strength, package size, manufacturer, and National Drug Code.

FDA’s Orange Book identifies approved drug products and their therapeutic equivalence information. For an older injectable such as cefoxitin, the relevant competitive issue is generally the number and reliability of approved generic suppliers rather than brand exclusivity.[2]

When does Mefoxin lose exclusivity?

The meaningful patent and regulatory exclusivity periods for Mefoxin have already expired. Cefoxitin was approved in the late 1970s, placing the product firmly outside the commercial life of its original compound and formulation protections.[1]

Exclusivity category	Mefoxin position
New chemical entity exclusivity	Expired
Original compound patent protection	Expired
Original formulation protection	Expired or commercially irrelevant
Orphan-drug exclusivity	Not applicable
Pediatric exclusivity	No material current effect
Biosimilar exclusivity	Not applicable
Current brand-based barrier	None identified in FDA product materials

The plastic-container version does not reset patent life. A packaging change normally cannot extend exclusivity unless it is supported by a separately patentable invention with enforceable claims. For this mature product, the commercial market is therefore governed by generic competition and manufacturing economics.

What patents protect Mefoxin in Plastic Container?

No active patent barrier is central to the current commercial position of Mefoxin in Plastic Container. The relevant intellectual-property categories would have included:

1. The cefoxitin compound.
2. Cefoxitin sodium composition and preparation.
3. Injectable formulation.
4. Sterile manufacturing processes.
5. Container-closure and packaging systems.
6. Method-of-use claims for particular infections.

The compound and original product protections are historical. Any later packaging or manufacturing claims would have been narrower and would not ordinarily prevent generic cefoxitin injection from entering through a different container system.

The key commercial conclusion is that the plastic-container presentation is not protected by an exclusivity structure comparable to a patented delivery device, long-acting formulation, or combination product.

How many patents cover Mefoxin?

There is no commercially meaningful active patent estate associated with the legacy Mefoxin presentation based on the FDA regulatory profile and the product’s age. Patent counts can vary depending on whether expired, abandoned, foreign, process, packaging, and assignment records are included. A raw count would not accurately measure competitive protection.

For business purposes, the estate should be classified as:

Patent category	Competitive relevance
Active compound patents	None expected
Active formulation patents	No material barrier identified
Active method-of-use patents	No material barrier identified
Packaging patents	Potentially narrow and presentation-specific
Manufacturing know-how	Potentially important but not publicly equivalent to patent exclusivity
Regulatory exclusivity	None of material commercial significance

What is the market dynamics for cefoxitin injection?

Cefoxitin operates in a mature institutional injectable market. Demand is relatively stable but does not have the growth characteristics of specialty pharmaceuticals.

Hospital procurement drives sales

Hospitals and group purchasing organizations generally evaluate cefoxitin on:

• Contract price.
• Reliable fill rates.
• FDA-compliant sterile manufacturing.
• Shortage history.
• Package and concentration availability.
• Compatibility with hospital pharmacy workflow.
• Clinical familiarity.
• Supplier redundancy.

The branded Mefoxin name has limited pricing power where therapeutically substitutable cefoxitin products are available. Purchasing departments typically treat the molecule as a standardized injectable antibiotic rather than as a differentiated brand.

Clinical demand is stable but replaceable

Cefoxitin remains useful for selected infections and surgical or perioperative protocols. Its demand is supported by established clinical experience and inclusion in institutional treatment pathways. It is exposed to substitution by other cephalosporins, beta-lactam/beta-lactamase inhibitor combinations, carbapenems, and other agents selected according to microbiology and resistance patterns.

The product’s demand is therefore less sensitive to consumer marketing and more sensitive to:

• Hospital procedure volume.
• Local formulary status.
• Antimicrobial stewardship policies.
• Bacterial susceptibility trends.
• Availability of competing injectables.
• National drug shortages.

What is the financial trajectory of Mefoxin?

No standalone public revenue series is generally reported for Mefoxin in Plastic Container. Public company filings typically aggregate mature injectable antibiotics within broader hospital-product or generic-pharmaceutical categories. The product’s financial trajectory must therefore be assessed through market structure rather than a reported brand revenue line.

Historical trajectory

The likely commercial pattern is:

Period	Financial profile
Initial launch	Brand pricing and innovation-supported margins
Patent-protected period	Higher pricing and limited direct competition
Generic entry	Rapid price and share pressure
Mature generic period	Low unit economics and contract-driven sales
Current phase	Stable or declining base demand, with episodic pricing during shortages

Once generic cefoxitin became available, Mefoxin’s economic value shifted from exclusivity-driven pricing to supply-chain execution. The brand could retain limited institutional demand through recognition, purchasing contracts, or supplier continuity, but it would face a substantial price disadvantage against approved generic products.

Revenue exposure

Mefoxin is unlikely to represent a material share of a diversified pharmaceutical manufacturer’s consolidated revenue. The financial exposure is more relevant in three situations:

1. The product is part of a sterile injectable portfolio with shared manufacturing capacity.
2. The manufacturer has a supply contract with a hospital network or group purchasing organization.
3. A competitor shortage temporarily increases demand or pricing.

The product can have operational importance that exceeds its reported revenue. A shortage of cefoxitin may force hospitals to procure higher-cost alternatives, but that does not necessarily translate into durable revenue growth for the Mefoxin brand.

What generic entry risks exist for Mefoxin?

Generic entry risk is high because the core product is old, clinically established, and not protected by meaningful current exclusivity.

Risk factor	Assessment
Patent challenge	Low relevance because original protections are expired
ANDA competition	High
Price erosion	High
Brand retention	Limited
Supply disruption	Material
Substitution by other antibiotics	Material
Formulation differentiation	Limited
Regulatory complexity	Moderate because the product is sterile injectable

The main barrier to entry is not patent law. It is the technical and commercial difficulty of manufacturing sterile injectable products at acceptable yield, stability, and quality levels. This can limit the number of reliable suppliers even when legal entry is open.

Are Paragraph IV challenges relevant to Mefoxin?

Paragraph IV litigation is generally not the principal entry mechanism for an old cefoxitin product whose original patents have expired. A generic applicant would not need to challenge an unexpired compound patent if no relevant patent blocks approval.

Paragraph IV risk would become relevant only if a manufacturer asserted a later patent covering a specific formulation, container system, manufacturing process, or method of use. Such a patent would need to be listed or otherwise asserted in a manner capable of delaying approval or launch. The economic importance of that scenario appears limited for the legacy plastic-container presentation.

The more relevant regulatory pathways are:

• ANDA approval for generic cefoxitin sodium injection.
• Supplemental manufacturing or packaging approvals.
• Site transfers and facility changes.
• FDA enforcement or inspection actions affecting supply.
• Drug-shortage management.

What formulation patents protect the plastic container?

The plastic-container format may require proprietary technical knowledge involving:

• Container-closure integrity.
• Extractables and leachables.
• Product-contact compatibility.
• Oxygen and moisture control.
• Terminal sterilization or aseptic processing.
• Shelf-life stability.
• Reconstitution or ready-to-use handling.
• Shipping and storage conditions.

These controls can create manufacturing friction but do not necessarily create durable patent exclusivity. A competitor can use a different container material, bag design, closure system, filling process, or presentation if it meets FDA requirements.

This distinction matters for valuation. Manufacturing know-how can protect a supplier’s cost position and reliability without preventing legal market entry.

What litigation and settlement agreements affect Mefoxin?

No major current patent-litigation or settlement framework is central to the commercial evaluation of Mefoxin in Plastic Container. The product’s market is primarily shaped by expired exclusivity, generic competition, hospital contracting, and supply reliability.

Any historical disputes would be more likely to involve:

• ANDA approval timing.
• Product quality.
• Sterile manufacturing.
• Facility compliance.
• Supply contracts.
• Labeling or promotion.
• Antitrust claims arising from generic competition.

A historical patent settlement would have limited present value unless it imposed continuing contractual restrictions, which is unlikely for a legacy cefoxitin product.

Is there biosimilar risk for Mefoxin?

Biosimilar risk is not applicable. Cefoxitin sodium is a conventional small-molecule antibiotic, not a biologic. Competition proceeds through generic-drug pathways rather than the biosimilar framework established under the Public Health Service Act.

The relevant competitive threats are generic cefoxitin products and therapeutic alternatives, not biosimilars.

How does Mefoxin compare with competing antibiotics?

Product category	Competitive relationship with cefoxitin
Generic cefoxitin injection	Direct substitution
Cefotetan	Closely related cephamycin alternative
Ceftriaxone and other cephalosporins	Indication- and susceptibility-dependent substitution
Ampicillin/sulbactam	Alternative for selected polymicrobial infections
Piperacillin/tazobactam	Broader-spectrum alternative
Carbapenems	Higher-spectrum alternative, often reserved for resistant infections
Oral antibiotics	Substitute in clinically appropriate step-down therapy

Cefoxitin’s value is strongest where clinicians want established cephamycin coverage and institutional protocols support its use. Its value is weaker when broader-spectrum therapy, resistance concerns, or simpler dosing favors another agent.

Which companies are competing in the cefoxitin market?

Competition has historically included branded and generic injectable manufacturers serving hospitals, wholesalers, and group purchasing organizations. Supplier identity can change as companies discontinue products, transfer approvals, divest portfolios, or exit sterile manufacturing.

The competitive field should be assessed at the NDC and facility level rather than by brand name alone. Important indicators include:

• Active FDA listing.
• Current marketing status.
• Manufacturer and packager.
• Approved strengths.
• National drug shortage status.
• Wholesaler availability.
• Contract participation.
• Recent product recalls.
• Manufacturing-site concentration.

A company with a small cefoxitin product line can gain temporary commercial leverage during a competitor shortage, but such gains are usually episodic and vulnerable to new supply entering the market.

What generic launch scenarios are most likely?

Base case

Multiple generic suppliers remain available. Prices stay low, hospital contracts determine volume, and the Mefoxin brand has limited share.

Shortage-driven upside

One or more suppliers experience manufacturing, inspection, or logistics problems. Remaining suppliers gain volume and may achieve temporary price improvement.

Downside case

Demand declines because of formulary substitution, antimicrobial stewardship, or reduced use of the relevant clinical indications. Suppliers rationalize low-volume presentations, increasing discontinuation risk.

Manufacturing-disruption case

A sterile facility interruption removes a major source of supply. Hospitals substitute other antibiotics, potentially creating secondary shortages and raising procurement costs across the category.

What is the geographic coverage of Mefoxin?

Mefoxin’s commercial relevance is primarily tied to jurisdictions where cefoxitin injection is approved, reimbursed, and purchased through institutional channels. The United States market is governed by FDA approval, Orange Book status, NDC listing, hospital contracting, and Medicare or commercial reimbursement practices.[2][3]

International markets may use different brand names, formulations, container systems, and regulatory approvals. U.S. approval does not establish authorization in Europe, Canada, Japan, or emerging markets. Geographic expansion would require local registration, manufacturing compliance, pharmacopoeial conformity, and commercial distribution.

Key Takeaways

• Mefoxin in Plastic Container is a legacy cefoxitin sodium injectable presentation.
• Its original patent and regulatory exclusivity have expired.
• The plastic container is a delivery and packaging format, not a separate protected active ingredient.
• Generic entry risk is high, while Paragraph IV risk is limited because the principal exclusivity period is historical.
• No biosimilar pathway applies.
• Financial performance is likely low-margin, contract-driven, and not separately disclosed in most public filings.
• The main value drivers are sterile manufacturing capacity, supply reliability, hospital contracts, and shortage conditions.
• The principal commercial threats are generic price erosion, therapeutic substitution, and discontinuation of low-volume presentations.
• The main upside scenario is temporary pricing and volume improvement during competitor shortages.
• Patent strength is weak; manufacturing execution is more important than intellectual-property protection.

FAQs

Is Mefoxin in Plastic Container still a branded product?

Yes. Mefoxin is the brand associated with cefoxitin sodium injection, although commercial availability and marketing status can vary by presentation and manufacturer.

Is cefoxitin injection protected by an active patent?

The original compound and product protections are expired. No material active patent barrier is central to the legacy Mefoxin presentation.

Can a generic manufacturer use a plastic container for cefoxitin?

Yes, provided the manufacturer satisfies FDA requirements for the formulation, container-closure system, sterility, stability, labeling, and manufacturing controls.

Does Mefoxin have a biosimilar competitor?

No. Cefoxitin is a small-molecule antibiotic. Its competitors are generic cefoxitin products and alternative antibacterial drugs.

Why can an old antibiotic remain commercially relevant after patent expiry?

Hospital demand, established treatment protocols, limited sterile manufacturing capacity, and periodic shortages can sustain commercial relevance even when patent protection has ended.

References

1. U.S. Food and Drug Administration. (1978). Mefoxin (cefoxitin sodium) injection prescribing information. FDA Drugs@FDA.

2. U.S. Food and Drug Administration. (n.d.). Approved drug products with therapeutic equivalence evaluations. FDA Orange Book.

3. U.S. Food and Drug Administration. (n.d.). National Drug Code directory. FDA.

4. U.S. Food and Drug Administration. (n.d.). Drug shortages database. FDA.

5. DailyMed. (n.d.). Cefoxitin sodium injection product labeling. National Library of Medicine.