CEFOXITIN Drug Patent Profile

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Which patents cover Cefoxitin, and when can generic versions of Cefoxitin launch?

Cefoxitin is a drug marketed by Acs Dobfar, Acs Dobfar Spa, Fresenius Kabi Usa, Hikma, Hikma Farmaceutica, Hospira Inc, B Braun, and Samson Medcl. and is included in fourteen NDAs.

The generic ingredient in CEFOXITIN 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 CEFOXITIN

US Patents:	0
Applicants:	8
NDAs:	14
Finished Product Suppliers / Packagers:	4
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	20
Patent Applications:	5,937
Drug Prices:	Drug price information for CEFOXITIN
DailyMed Link:	CEFOXITIN at DailyMed

See drug prices for CEFOXITIN

Recent Clinical Trials for CEFOXITIN

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

Sponsor	Phase
Asan Medical Center	NA
Agency for Healthcare Research and Quality (AHRQ)	PHASE1
University of Michigan	PHASE1

See all CEFOXITIN clinical trials

Pharmacology for CEFOXITIN

Drug Class

Cephalosporin Antibacterial

US Patents and Regulatory Information for CEFOXITIN

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Acs Dobfar	CEFOXITIN	cefoxitin sodium	INJECTABLE;INJECTION	065414-001	Jun 12, 2009	AP	RX	No	Yes
Hospira Inc	CEFOXITIN	cefoxitin sodium	INJECTABLE;INJECTION	065312-001	Feb 13, 2006		DISCN	No	No
Fresenius Kabi Usa	CEFOXITIN	cefoxitin sodium	INJECTABLE;INJECTION	065012-001	Jul 3, 2000		DISCN	No	No
Acs Dobfar Spa	CEFOXITIN	cefoxitin sodium	INJECTABLE;INJECTION	065467-001	Aug 31, 2011		DISCN	No	No
Hikma	CEFOXITIN	cefoxitin sodium	INJECTABLE;INJECTION	065050-001	Sep 11, 2000	AP	RX	No	No
B Braun	CEFOXITIN AND DEXTROSE IN DUPLEX CONTAINER	cefoxitin sodium	INJECTABLE;INJECTION	065214-002	Mar 10, 2006	AP	RX	Yes	Yes

Cefoxitin Market Dynamics and Financial Trajectory: Generic Injectable Antibiotic Analysis

Last updated: October 26, 2026

Cefoxitin is a mature, off-patent cephamycin antibiotic sold primarily as cefoxitin sodium for injection. Its commercial value comes from hospital and surgical demand rather than branded pricing or patent exclusivity. The product has no meaningful current composition-of-matter protection, limited differentiation among suppliers, and low revenue per treatment course. Financial performance is therefore driven by manufacturing reliability, hospital contracting, shortage conditions, and formulary position.

What is the current market position of cefoxitin?

Cefoxitin is a second-generation cephamycin related to the cephalosporins. It is administered intravenously or intramuscularly and is used against susceptible gram-positive and gram-negative bacteria, including selected anaerobes.

The FDA-approved label covers treatment of infections involving the:

• Lower respiratory tract
• Urinary tract
• Intra-abdominal organs
• Gynecologic organs
• Skin and skin structures
• Bones and joints

Cefoxitin is also used for perioperative prophylaxis in selected procedures and for treatment of uncomplicated gonorrhea under historical labeling. Current clinical use depends on local resistance patterns and institutional protocols. [1]

The product occupies a narrow but durable hospital niche. It is particularly relevant where clinicians need cephalosporin activity with anaerobic coverage but do not want to use broader-spectrum agents such as piperacillin-tazobactam or carbapenems.

Cefoxitin product profile

Attribute	Cefoxitin
Active ingredient	Cefoxitin sodium
Drug class	Cephamycin beta-lactam
Route	Intravenous and intramuscular
Primary setting	Hospitals and ambulatory surgical centers
Dosage form	Sterile powder for injection
U.S. reference product	Mefoxin
Commercial status	Generic injectable
Patent position	Legacy, off-patent product
Main buyers	Hospitals, group purchasing organizations, wholesalers
Main competitors	Cefotetan, ceftriaxone plus metronidazole, piperacillin-tazobactam, ertapenem

When did cefoxitin lose exclusivity?

Cefoxitin lost meaningful market exclusivity decades ago. Merck originally marketed the product as Mefoxin, and FDA approval dates to the late 1970s. The product is now supplied principally through generic manufacturers and contract distributors.

The commercial implications are significant:

1. No current branded premium supports the product.
2. Generic manufacturers compete primarily on price, reliability, and contract terms.
3. Hospital customers can switch suppliers when supply or pricing deteriorates.
4. Product-level revenue is generally too small to receive separate disclosure in public company filings.

Cefoxitin is not a current exclusivity-driven asset. It does not have the profile of a branded antibiotic with remaining patent life, pediatric exclusivity, orphan exclusivity, or a substantial regulatory exclusivity period.

What patents protect cefoxitin?

No commercially material active patent estate is generally associated with the original cefoxitin molecule or the conventional cefoxitin sodium injectable formulation.

The original compound and core use patents, if any, expired long ago. The FDA Orange Book remains the relevant source for listed patents associated with approved drug products, but generic cefoxitin’s commercial position is not dependent on an active patent thicket. [2]

Cefoxitin patent position

Patent category	Current commercial relevance
Composition-of-matter patent	Expired
Original formulation patent	Expired or commercially irrelevant
Method-of-use patents	No material blocking estate identified
Manufacturing patents	May exist at process level but are not product-blocking
Device patents	Generally not applicable to standard vial products
Orange Book-listed patents	No meaningful barrier to generic supply expected

The absence of patent protection does not eliminate supply barriers. Sterile manufacturing, validated aseptic processing, active pharmaceutical ingredient sourcing, and FDA compliance remain practical entry requirements.

What is the FDA regulatory status of cefoxitin?

Cefoxitin is an FDA-approved prescription antibacterial drug. Generic versions are approved through abbreviated new drug applications under section 505(j) of the Federal Food, Drug, and Cosmetic Act.

The product is typically distributed as sterile cefoxitin sodium powder in single-dose or multi-dose vials. Labels specify reconstitution instructions, stability periods after dilution, compatible infusion solutions, dosing by infection type, and renal dose adjustments. [1]

FDA regulatory characteristics

Cefoxitin has several regulatory features that limit commercial differentiation:

• It is a conventional small-molecule injectable.
• Generic manufacturers generally rely on pharmaceutical equivalence and bioequivalence pathways.
• The product does not require a biosimilar pathway.
• There is no biologic manufacturing barrier.
• Labeling is largely standardized across approved generic products.
• Changes in vial size, strength, packaging, or manufacturing site require FDA review.

The main regulatory risk is manufacturing compliance rather than clinical development. FDA warning letters, Form 483 observations, recalls, or site-transfer problems can remove a supplier from the market quickly because sterile injectable production has limited tolerance for contamination or process failures.

How many patents cover cefoxitin?

No meaningful number of active patents is expected to block generic cefoxitin entry in the United States. The commercial market is best characterized as patent-free or effectively patent-free.

The relevant barriers are operational:

• Sterile injectable manufacturing capacity
• Cefoxitin sodium API availability
• Validated aseptic filling
• Container-closure integrity
• Stability data
• FDA inspection history
• Hospital contract access
• Wholesaler and group purchasing organization relationships

This distinction matters for investors and licensing teams. A company cannot create durable cefoxitin pricing power through ordinary patent filing. Any defensible position would more likely come from supply reliability, a differentiated presentation, a manufacturing cost advantage, or a portfolio contract covering multiple hospital antibiotics.

What formulations are protected by cefoxitin patents?

Standard cefoxitin products are sterile powder vials that require reconstitution before administration. There is no widely recognized active formulation patent that materially limits competitors from selling the conventional presentation.

Potential product-development opportunities could involve:

• Ready-to-use premixed solutions
• Extended-stability presentations
• Smaller vial sizes for ambulatory surgery
• Pharmacy bulk packages
• Simplified reconstitution systems
• Reduced-waste packaging
• Temperature-stable distribution formats

Those products would face commercial rather than purely patent-driven hurdles. Hospitals would need a clear economic or workflow benefit to switch from low-cost powder vials. Premixed products may reduce pharmacy labor and preparation risk, but they also create higher manufacturing, packaging, and storage costs.

Which companies supply cefoxitin?

The U.S. cefoxitin market has historically included large generic manufacturers and injectable specialists. Public product listings have included companies such as Fresenius Kabi, Hikma Pharmaceuticals, Pfizer through its generic injectable operations, Sagent Pharmaceuticals, and other FDA-approved generic suppliers, depending on product availability and time period. Manufacturer participation can change as products are discontinued, transferred, or placed on allocation.

Because cefoxitin is usually sold through institutional contracts, the relevant competitive set includes:

• Generic injectable manufacturers
• Contract manufacturers
• Hospital wholesalers
• Group purchasing organizations
• Integrated pharmacy distributors

Supplier count is less important than the number of qualified manufacturers with active production and reliable inventory. A market with several approved suppliers can still experience shortages if only one or two facilities are actively producing the product.

What drives cefoxitin demand?

Cefoxitin demand is tied to hospital procedure volumes, infection-management protocols, and antibiotic stewardship.

Surgical and inpatient demand

Cefoxitin has continuing relevance in:

• Colorectal and abdominal surgery
• Gynecologic surgery
• Intra-abdominal infections
• Polymicrobial infections involving anaerobes
• Selected skin, bone, joint, and urinary infections

Surgical procedure volumes create a relatively stable demand base. However, hospitals often substitute among multiple antibiotics based on local antibiograms, formulary policy, and availability.

Antimicrobial stewardship

Stewardship programs can support or reduce cefoxitin use. Cefoxitin may be selected when it provides adequate coverage with less broad-spectrum exposure than carbapenems. Conversely, increasing resistance among Enterobacterales and concerns about inducible AmpC beta-lactamases can lead institutions to avoid cefoxitin for certain organisms.

Treatment decisions are therefore highly local. National utilization can remain stable while individual hospitals remove or restrict the product.

How strong is the cefoxitin commercial position?

Cefoxitin has a durable but weakly differentiated commercial position.

Commercial factor	Assessment
Clinical demand	Stable, concentrated in hospitals
Pricing power	Low
Patent protection	None of practical significance
Switching risk	Moderate to high
Supply-chain sensitivity	High
Brand loyalty	Limited
Manufacturing complexity	Moderate to high because it is sterile injectable
Revenue predictability	Moderate at the category level, low for individual suppliers
Margin potential	Low to moderate, depending on supply conditions

The product can generate recurring revenue for a generic manufacturer with efficient production and hospital access. It is unlikely to become a major standalone growth driver without a shortage, acquisition, or differentiated delivery format.

What is the financial trajectory for cefoxitin?

Public companies generally do not report cefoxitin revenue separately. It is usually included within broader generic injectable, hospital products, or anti-infective segments. As a result, no reliable public standalone revenue series exists for the molecule.

The financial trajectory is best described in phases:

1. Branded growth phase

The original Mefoxin franchise generated branded revenue after launch and during the period when Merck controlled the market. Revenue was supported by product novelty, physician adoption, and branded pricing.

2. Generic erosion phase

After patent and exclusivity expiration, multiple suppliers entered the market. Average selling prices declined, and the product became a hospital procurement item rather than a branded pharmaceutical franchise.

3. Mature commodity phase

The current market is mature. Unit demand is relatively stable, but revenue per vial is constrained by tenders, group purchasing agreements, and generic competition.

4. Shortage-driven volatility

Sterile injectable shortages can temporarily improve pricing and revenue for suppliers with available inventory. That benefit is usually unstable. Competitors may restart production, hospitals may substitute products, or regulators may resolve the shortage through imports and manufacturing changes. FDA shortage data and the American Society of Health-System Pharmacists track availability conditions, although shortage status can differ by strength and supplier. [3,4]

What revenue exposure do pharmaceutical companies have to cefoxitin?

Cefoxitin revenue exposure is typically immaterial at diversified pharmaceutical companies. It can be more meaningful for smaller generic injectable manufacturers with concentrated hospital portfolios.

Revenue sensitivity depends on:

• Number of approved suppliers
• Contract renewal timing
• Vial volume
• API cost
• Manufacturing yield
• Fill-finish utilization
• Hospital shortage conditions
• Wholesale inventory
• Competitor withdrawals

For a large pharmaceutical company, cefoxitin is unlikely to affect consolidated earnings materially. For a small injectable manufacturer, losing a cefoxitin contract or production site can affect quarterly results if the product represents a meaningful share of a narrow portfolio.

Are there Paragraph IV challenges involving cefoxitin?

Paragraph IV litigation is not a meaningful current market issue for standard generic cefoxitin. The original product is long past the period in which a patent challenge would determine market entry.

Any current ANDA activity would more likely involve:

• New generic suppliers
• Strength or package configurations
• Manufacturing-site changes
• Product reactivation
• Labeling or supply changes

The absence of active blocking patents means that litigation risk is much lower than for newer branded antibiotics. Commercial disputes are more likely to concern supply contracts, product quality, recalls, or distribution than patent infringement.

What generic entry risks exist for cefoxitin?

Generic entry risk is already reflected in the product’s mature pricing structure. The principal threat to an incumbent supplier is not a single new entrant but cumulative price and volume pressure from multiple qualified manufacturers.

Key risks include:

• A new manufacturer undercutting contract prices
• Hospital substitution with cefotetan or alternative regimens
• A competitor resolving a supply shortage
• FDA action against a manufacturing facility
• Declining use because of resistance concerns
• Reduced surgical volume
• Wholesaler inventory destocking

A new entrant can still face practical delays. Sterile injectable approval does not guarantee commercial success. Manufacturing validation, inspection readiness, API sourcing, and customer qualification can take substantial time.

How does cefoxitin compare with competing antibiotics?

Product	Main advantage versus cefoxitin	Main disadvantage versus cefoxitin
Cefotetan	Similar anaerobic and surgical use	Different resistance and availability profile
Ceftriaxone plus metronidazole	Flexible dosing and broad hospital familiarity	Requires combination therapy
Piperacillin-tazobactam	Broad coverage, including more difficult gram-negative pathogens	Broader-spectrum exposure and higher stewardship concerns
Ertapenem	Once-daily dosing and strong intra-abdominal utility	Carbapenem stewardship and higher cost
Cefazolin	Strong surgical prophylaxis position	Limited anaerobic coverage
Ampicillin-sulbactam	Anaerobic coverage and broad use	Resistance and availability vary

Cefoxitin’s value is highest when its spectrum fits the protocol and the product is available at a competitive price. It is less attractive when clinicians require broader gram-negative coverage or when local resistance undermines efficacy.

What patent litigation affects cefoxitin?

No major ongoing patent litigation is expected to affect conventional cefoxitin availability. The product is a mature generic antibiotic without a commercially important patent estate.

Potential litigation exposure is more likely to arise from:

• Manufacturing process disputes
• Contract-manufacturing agreements
• Product liability claims
• False advertising or substitution disputes
• Regulatory enforcement
• Antitrust issues involving generic supply

These risks are separate from exclusivity-based patent litigation and should be evaluated through company filings and court records rather than Orange Book patent listings.

What licensing deals involve cefoxitin?

Cefoxitin is not generally associated with major recent licensing transactions. A licensing arrangement would likely involve:

• Transfer of an approved injectable product
• Acquisition of an ANDA
• Contract manufacturing
• Regional distribution rights
• Portfolio transactions involving hospital anti-infectives

The commercial logic for licensing cefoxitin is usually portfolio expansion, manufacturing utilization, or hospital-contract access. A stand-alone royalty stream is unlikely to be attractive because the product has low differentiation and limited pricing power.

What is the geographic coverage of cefoxitin?

Cefoxitin is marketed in the United States and has had availability in other regulated and emerging markets under national registrations or local generic brands. Geographic performance varies according to:

• National essential-medicine policies
• Hospital procurement systems
• Local generic competition
• API import dependence
• Regulatory approval requirements
• Resistance patterns
• Government tender pricing

The strongest commercial relevance remains institutional markets where injectable antibiotics are routinely purchased through centralized tenders or hospital systems.

What manufacturing and intellectual-property barriers remain?

Cefoxitin has low intellectual-property barriers but meaningful manufacturing barriers. Sterile beta-lactam production requires segregation, validated cleaning, environmental controls, and contamination prevention. Cefoxitin sodium also requires appropriate API quality, moisture control, stability testing, and validated reconstitution performance.

A manufacturer with an FDA-compliant sterile facility can gain a practical advantage over a nominal competitor that lacks reliable capacity. That advantage is operational and temporary rather than patent-based.

Key Takeaways

• Cefoxitin is a mature, off-patent injectable antibiotic.
• Its U.S. market is driven by hospital procurement, surgical demand, and supply reliability.
• No meaningful current patent estate is expected to block generic competition.
• Standalone cefoxitin revenue is generally not disclosed by pharmaceutical companies.
• Pricing power is low, but shortage conditions can create temporary revenue and margin increases.
• Sterile manufacturing and FDA compliance are more important than intellectual property.
• The main competitors are cefotetan, ceftriaxone plus metronidazole, piperacillin-tazobactam, and ertapenem.
• Patent litigation and Paragraph IV risk are limited.
• The product is commercially durable but unlikely to become a major growth asset without differentiated formulation, supply scarcity, or portfolio leverage.

FAQs

Is cefoxitin still commercially available?

Yes. Cefoxitin remains available as a generic injectable product, although availability can vary by manufacturer, strength, vial size, and local shortage conditions.

Is cefoxitin a branded drug or generic drug?

Cefoxitin is primarily a generic drug. Mefoxin was the original branded product, but current hospital supply is mainly generic cefoxitin sodium for injection.

Does cefoxitin have biosimilar competition?

No. Cefoxitin is a conventional small-molecule antibiotic, not a biologic. Its competitors are generic injectable antibiotics and alternative antibacterial regimens.

Can a new company obtain a patent on a cefoxitin formulation?

A new formulation could potentially receive patent protection if it meets novelty, non-obviousness, and other legal requirements. The patent would protect the specific formulation or delivery system, not the original cefoxitin molecule.

Is cefoxitin an attractive pharmaceutical licensing target?

Cefoxitin is generally more attractive as part of a broader hospital injectable portfolio than as a stand-alone licensing asset. Its value depends on manufacturing efficiency, supply reliability, regulatory status, and access to institutional contracts.

References

1. U.S. Food and Drug Administration. (n.d.). Cefoxitin sodium for injection prescribing information. FDA.
2. U.S. Food and Drug Administration. (2024). Approved drug products with therapeutic equivalence evaluations: Orange Book. FDA.
3. U.S. Food and Drug Administration. (n.d.). Drug shortages: Cefoxitin sodium injection. FDA Drug Shortages Database.
4. American Society of Health-System Pharmacists. (n.d.). Drug shortages database: Cefoxitin. ASHP.

DrugChatter Q&A for CEFOXITIN

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