ANCEF Drug Patent Profile

« Back to Dashboard

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

Ancef is a drug marketed by Glaxosmithkline and Baxter Hlthcare and is included in three NDAs.

The generic ingredient in ANCEF is cefazolin sodium. There is one drug master file entry for this compound. Sixteen suppliers are listed for this compound. Additional details are available on the cefazolin sodium profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Ancef

A generic version of ANCEF was approved as cefazolin sodium by SANDOZ on December 9^th, 1988.

Summary for ANCEF

US Patents:	0
Applicants:	2
NDAs:	3
Raw Ingredient (Bulk) Api Vendors:	70
Patent Applications:	4,045
DailyMed Link:	ANCEF at DailyMed

US Patents and Regulatory Information for ANCEF

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Glaxosmithkline	ANCEF	cefazolin sodium	INJECTABLE;INJECTION	050461-003	Approved Prior to Jan 1, 1982		DISCN	Yes	No
Baxter Hlthcare	ANCEF IN DEXTROSE 5% IN PLASTIC CONTAINER	cefazolin sodium	INJECTABLE;INJECTION	050566-004	Jun 8, 1983		DISCN	Yes	No
Glaxosmithkline	ANCEF	cefazolin sodium	INJECTABLE;INJECTION	050461-001	Approved Prior to Jan 1, 1982		DISCN	Yes	No

ANCEF Market Dynamics, Generic Competition, and Financial Trajectory

Last updated: October 26, 2026

ANCEF is the historical brand name for cefazolin sodium, a first-generation cephalosporin antibiotic administered by injection. Its commercial profile is now determined by generic cefazolin supply, hospital purchasing contracts, manufacturing capacity, and periodic shortage risk rather than brand pricing or patent exclusivity. No standalone ANCEF revenue is publicly reported, and cefazolin sales are generally embedded in broader generic injectable portfolios.

What is ANCEF and who markets cefazolin today?

ANCEF contains cefazolin sodium for injection. Cefazolin is used primarily for perioperative surgical prophylaxis and treatment of susceptible bacterial infections, including skin and soft-tissue, bone and joint, urinary-tract, biliary-tract, and respiratory infections. The drug is administered intravenously or intramuscularly.

The original ANCEF brand was commercialized decades ago. The U.S. market has since shifted to generic cefazolin products supplied by multiple manufacturers, including large injectable-drug companies and hospital-distribution suppliers. Product availability varies by vial size, concentration, presentation, and manufacturer.

Market attribute	ANCEF and cefazolin position
Active ingredient	Cefazolin sodium
Drug class	First-generation cephalosporin
Administration	Intravenous and intramuscular injection
Primary use	Surgical prophylaxis and treatment of susceptible infections
U.S. regulatory pathway	Legacy branded NDA and multiple generic ANDAs
Current exclusivity	No meaningful active brand exclusivity
Biosimilar exposure	None; cefazolin is a small-molecule drug
Main commercial channel	Hospitals, health systems, group purchasing organizations, and wholesalers
Pricing model	Generic injectable contract pricing
Principal risk	Supply interruption and manufacturing concentration
Standalone ANCEF revenue	Not publicly disclosed

The current commercial product is therefore better analyzed as the cefazolin injectable market than as a branded ANCEF franchise.

What is the FDA regulatory status of ANCEF?

FDA-approved cefazolin products remain available through generic manufacturers, while the branded ANCEF label has limited commercial relevance in the United States. FDA labeling identifies cefazolin sodium injection as an approved antibacterial product for susceptible infections and perioperative prophylaxis.[1]

The regulatory structure has three important consequences:

1. Generic manufacturers can rely on the abbreviated new drug application pathway.
2. Therapeutic substitution is relatively straightforward because cefazolin is an established injectable antibiotic.
3. Hospitals can change suppliers when price, allocation, or availability changes.

The relevant regulatory risk is product continuity, not loss of regulatory exclusivity. FDA drug-shortage monitoring has historically included injectable antibiotics, and cefazolin availability can be affected by manufacturing interruptions, raw-material constraints, quality actions, and demand spikes.[2]

Is ANCEF still an FDA-protected brand?

No meaningful current U.S. exclusivity protects ANCEF as a commercial franchise. Cefazolin has been marketed for many years, and generic versions have entered the market. Any remaining brand-name regulatory listing should not be confused with market exclusivity.

The FDA Orange Book remains the principal source for current listed patents and regulatory exclusivity associated with approved drug products.[3] For a legacy injectable antibiotic such as cefazolin, the commercial value is not supported by a live composition-of-matter patent or a modern exclusivity period.

When does ANCEF lose patent and market exclusivity?

ANCEF lost practical market exclusivity long ago. The precise expiration dates of the earliest cefazolin patents are less relevant than the current market structure: multiple generic cefazolin products are approved and commercially available.

Exclusivity category	ANCEF status
Original compound protection	Expired
Original branded approval exclusivity	Expired
Pediatric exclusivity	No current material relevance
Orphan-drug exclusivity	Not applicable
New chemical entity exclusivity	Expired
Formulation exclusivity	No material current barrier identified
Method-of-use exclusivity	No material current barrier identified
Current patent-based generic block	None of commercial significance

Generic entry eliminates the pricing power associated with a protected branded antibiotic. Cefazolin is now an established generic injectable, and a prospective entrant generally competes through manufacturing approval, quality systems, supply reliability, and contract access.

What patents protect ANCEF and cefazolin?

No current patent estate appears to protect cefazolin as a commercially exclusive product in the United States. The original active-ingredient protection is expired. Any modern patents that might relate to a particular container, concentration, manufacturing process, or delivery presentation would not recreate broad ANCEF exclusivity unless they were enforceable, listed where required, and commercially difficult to design around.

Are there formulation patents for cefazolin?

Cefazolin is sold in conventional injectable formats, including powder for reconstitution and ready-to-use or premixed presentations depending on supplier and market. Product-specific formulation or container claims could affect a narrow presentation, but they do not generally prevent competition from standard cefazolin powder-for-injection products.

The principal competitive distinction is often operational:

• vial size and concentration;
• reconstitution requirements;
• storage conditions;
• premixed versus pharmacy-compounded presentation;
• packaging configuration;
• shelf life;
• availability during shortages.

These characteristics can influence hospital purchasing without creating broad patent protection.

Are there method-of-use patents for ANCEF?

Cefazolin’s major use in surgical prophylaxis and treatment of susceptible bacterial infections is longstanding. Method-of-use patents are not a meaningful source of present-day commercial protection for ANCEF. Hospitals can use generic cefazolin for the same approved indications, subject to product labeling, clinical policy, and applicable substitution rules.

How many patents cover ANCEF?

The economically relevant answer is zero current patents that create broad, enforceable exclusivity for cefazolin itself. Historical patents may appear in patent databases, but expired patents do not constrain generic entry.

Patent counting can produce misleading results for old antibiotics because it may include:

• expired compound patents;
• abandoned applications;
• process patents with narrow scope;
• patents covering noncommercial dosage forms;
• foreign patents with no U.S. relevance;
• patents assigned to entities that no longer market the product.

For investment and competitive purposes, the more useful question is whether a current patent can block an approved generic cefazolin product. The public market structure indicates that no such broad barrier exists.

How does the cefazolin market make money?

Cefazolin is a high-volume, low-unit-price hospital injectable. Revenue is generated through aggregate volume rather than brand-level price premiums.

The commercial chain generally includes:

1. Active pharmaceutical ingredient production.
2. Sterile formulation and filling.
3. Vial, container, and packaging operations.
4. Wholesaler and distributor sales.
5. Hospital, health-system, and group-purchasing contracts.

Generic injectable economics are more sensitive to manufacturing utilization and supply continuity than to consumer demand. Cefazolin is used in routine hospital procedures, which creates relatively stable baseline demand. Surgical volume, hospital admissions, infection-control practices, and changes in antibiotic protocols affect unit demand.

What determines cefazolin pricing?

Hospital cefazolin pricing is shaped by:

• number of approved suppliers;
• GPO contract terms;
• annual purchasing commitments;
• vial configuration;
• generic competition;
• shortage status;
• manufacturing reliability;
• distribution and allocation policies.

Price compression is normally severe when multiple suppliers are active. Prices can rise when one or more manufacturers experience a quality event, plant outage, product discontinuation, or raw-material constraint.

The result is an asymmetric market: normal conditions favor low prices, while disruption conditions can create temporary price increases without producing durable brand value.

What is the financial trajectory for ANCEF?

ANCEF does not have a separately disclosed current financial trajectory. The brand’s economic contribution declined after generic entry, and cefazolin revenue is now distributed across generic suppliers rather than reported as a standalone ANCEF line item.

Period	Financial interpretation
Original branded period	Higher price and brand control
Generic-entry period	Rapid erosion of branded share and price
Mature generic period	Low unit prices, high volume, contract-driven sales
Shortage periods	Temporary pricing and allocation volatility
Current market	Stable demand with limited product-level margin visibility

The financial trajectory is therefore best described as a transition from branded pharmaceutical economics to mature generic injectable economics.

A supplier may generate meaningful revenue from cefazolin because of volume, but that does not imply high product-level profitability. Costs include sterile manufacturing, quality testing, regulatory compliance, inventory management, cold-chain or controlled-storage requirements where applicable, and the cost of maintaining redundant production capacity.

Public companies generally do not disclose cefazolin revenue separately. Their filings typically aggregate products into broader categories such as generic injectables, hospital products, or specialty pharmaceuticals.[4][5] Any estimate of ANCEF-specific sales would therefore be speculative without proprietary prescription, shipment, or contract data.

What generic entry risks exist for ANCEF?

Generic entry risk is no longer a future event. It is the defining market condition.

Which companies are challenging ANCEF?

The relevant competitors are manufacturers of generic cefazolin sodium injection rather than companies pursuing a new branded ANCEF product. Competition can include large generic manufacturers, injectable specialists, contract manufacturers, and hospital-supply companies.

Competitive intensity depends on the number of active suppliers rather than the number of historical approvals. An approved manufacturer that is not shipping product does not provide effective market competition. FDA shortage data and current wholesaler availability are better indicators of competitive supply than approval counts alone.[2]

Are there Paragraph IV challenges involving ANCEF?

Paragraph IV litigation is not a material current driver for a legacy cefazolin product. Paragraph IV certifications are most significant when a generic applicant seeks entry before expiration of a listed patent. Cefazolin’s mature generic status means that competition is generally based on ordinary ANDA approval and commercial supply rather than active patent challenges to ANCEF.

What is the biosimilar risk for ANCEF?

Biosimilar risk is not applicable. Cefazolin is a chemically synthesized small-molecule antibiotic, not a biologic. Generic cefazolin products use the ANDA framework under section 505(j) of the Federal Food, Drug, and Cosmetic Act rather than the biosimilar pathway under the Public Health Service Act.

This distinction matters because:

• there is no biologic reference-product exclusivity;
• no biosimilar interchangeability process is required;
• generic substitution is governed by small-molecule drug rules;
• market entry is primarily dependent on ANDA approval and manufacturing capacity.

What patent litigation and settlements affect ANCEF?

No material current patent litigation or settlement structure is central to the cefazolin market. The product is commercially mature, and competition is not constrained by a major branded patent settlement.

The relevant legal exposure is more likely to involve:

• manufacturing compliance;
• product-quality investigations;
• recalls;
• supply contracts;
• procurement disputes;
• antitrust issues in generic supply;
• false-claims or reimbursement matters.

These risks can affect supplier economics without changing the underlying patent position.

How does ANCEF compare with competing antibiotics?

Cefazolin competes clinically with other perioperative and injectable antibiotics, but its commercial position differs from newer branded therapies.

Product category	Market position versus cefazolin
Generic cefazolin	Direct commercial substitute; strongest price competition
Cefuroxime and other cephalosporins	Clinical alternatives in selected indications
Anti-staphylococcal penicillins	Alternative for certain susceptible infections
Vancomycin	Used where resistant gram-positive organisms or allergy concerns apply
Broad-spectrum beta-lactams	Used when broader coverage is clinically required
Branded novel antibiotics	Higher price, narrower or differentiated clinical positioning

Cefazolin benefits from established clinical familiarity, broad hospital use, and low acquisition cost. Its limitations include lack of activity against methicillin-resistant Staphylococcus aureus and certain resistant gram-negative organisms. These clinical boundaries preserve demand for alternative antibiotics but do not materially restore pricing power to ANCEF.

What geographic markets matter for cefazolin?

The United States is a mature generic market. International markets may have different brand names, suppliers, regulatory classifications, tender structures, and price levels. Cefazolin is commonly purchased through institutional channels, including public tenders and hospital systems.

Geographic commercial factors include:

• local registration requirements;
• government procurement;
• national price controls;
• sterile-manufacturing capacity;
• import dependence;
• hospital formulary standards;
• regional shortage conditions.

A manufacturer with reliable regional production can have greater commercial value than a nominally approved competitor that depends on a constrained foreign plant.

How strong is the ANCEF patent estate?

The ANCEF patent estate is commercially weak because broad exclusivity has expired and generic cefazolin is established. The stronger assets in this market are operational rather than legal:

• validated sterile production;
• FDA-compliant manufacturing;
• reliable API sourcing;
• short lead times;
• diversified plant capacity;
• favorable hospital contracts;
• shortage-response capability.

For an acquirer or licensee, the key diligence question is not whether ANCEF has patent strength. It is whether a cefazolin supplier can maintain quality and supply at acceptable margins.

What is the outlook for ANCEF and cefazolin?

The outlook is stable in demand but limited in brand economics. Cefazolin should continue to have a durable role in hospitals because of its use in surgical prophylaxis and treatment of susceptible infections. Revenue growth is likely to track unit demand, hospital procedure volume, supply availability, and contract wins rather than price expansion.

The main upside for a supplier is share capture during competitor shortages or through lower-cost, higher-reliability production. The main downside is sustained price erosion, manufacturing disruption, or loss of a major hospital or GPO contract.

Key Takeaways

• ANCEF is the legacy brand associated with cefazolin sodium injection.
• The U.S. market is now a mature generic injectable market.
• No meaningful current patent or regulatory exclusivity protects the ANCEF franchise.
• Cefazolin is not exposed to biosimilar competition because it is a small-molecule drug.
• Current value is concentrated in manufacturing reliability, sterile capacity, contracts, and shortage resilience.
• Standalone ANCEF revenue is not publicly disclosed.
• Generic cefazolin demand is relatively stable, but product-level margins are vulnerable to price competition.
• Supply disruptions can create temporary pricing volatility without restoring durable branded economics.
• The principal investment risks are manufacturing, quality, supply, procurement, and contract risks rather than patent litigation.

FAQs

Is ANCEF the same as cefazolin?

Yes. ANCEF is the historical brand name associated with cefazolin sodium injection. Current hospital use is largely supplied through generic cefazolin products.

Can hospitals substitute generic cefazolin for ANCEF?

In the United States, approved generic cefazolin products are generally used as substitutes for the branded product, subject to institutional purchasing rules, product availability, and applicable state substitution requirements.

Does cefazolin have a 180-day generic exclusivity period today?

No current 180-day exclusivity period is a meaningful commercial barrier for the mature cefazolin market. Any exclusivity would depend on a specific ANDA and FDA regulatory record.

Is cefazolin vulnerable to antibiotic-resistance-driven revenue growth?

Resistance can shift prescribing toward alternative antibiotics, but it can also preserve demand for cefazolin in susceptible infections and surgical prophylaxis. Resistance trends are therefore indication-specific rather than a straightforward revenue-growth driver.

What is the main commercial risk for cefazolin manufacturers?

The main risk is supply disruption combined with low generic pricing. A manufacturer can lose share quickly if it cannot meet hospital demand, while another supplier may face margin pressure when all major plants operate normally.

References

1. U.S. Food and Drug Administration. (n.d.). Cefazolin sodium injection prescribing information. FDA.
2. U.S. Food and Drug Administration. (n.d.). Drug shortages: Cefazolin injection. FDA Drug Shortages Database.
3. U.S. Food and Drug Administration. (2024). Approved drug products with therapeutic equivalence evaluations. Center for Drug Evaluation and Research.
4. Fresenius Kabi AG. (2024). Annual report 2023.
5. Hikma Pharmaceuticals PLC. (2024). Annual report and accounts 2023.