Ceftazidime sodium - Generic Drug Details
What are the generic sources for ceftazidime sodium and what is the scope of patent protection?
Ceftazidime sodium
is the generic ingredient in two branded drugs marketed by Baxter Hlthcare and Pai Holdings Pharm, and is included in two NDAs. Additional information is available in the individual branded drug profile pages.Summary for ceftazidime sodium
| US Patents: | 0 |
| Tradenames: | 2 |
| Applicants: | 2 |
| NDAs: | 2 |
| Raw Ingredient (Bulk) Api Vendors: | 14 |
| Clinical Trials: | 7 |
| DailyMed Link: | ceftazidime sodium at DailyMed |
Recent Clinical Trials for ceftazidime sodium
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Qilu Pharmaceutical Co., Ltd. | PHASE3 |
| Ain Shams University | PHASE2 |
| Arrevus Inc. | Phase 2 |
Anatomical Therapeutic Chemical (ATC) Classes for ceftazidime sodium
US Patents and Regulatory Information for ceftazidime sodium
Ceftazidime Sodium Market Dynamics, Financial Trajectory, Patent Status, and Generic Competition
Ceftazidime sodium is a mature, off-patent injectable cephalosporin with low unit pricing, broad generic competition, and limited standalone financial disclosure. Its commercial value is concentrated in hospital procurement, intensive-care use, antimicrobial stewardship, and supply reliability rather than branded pricing power. The major growth opportunity is tied to hospital demand for antipseudomonal therapy and combination products such as ceftazidime-avibactam, not to the legacy ceftazidime sodium molecule alone.
What is ceftazidime sodium and where is it used?
Ceftazidime sodium is a sterile injectable third-generation cephalosporin marketed for serious bacterial infections caused by susceptible organisms. It has activity against many Gram-negative pathogens, including Pseudomonas aeruginosa, but limited activity against Gram-positive bacteria and no meaningful activity against methicillin-resistant Staphylococcus aureus or enterococci.
The product is administered intravenously or intramuscularly. Common hospital uses include:
- Hospital-acquired and ventilator-associated pneumonia
- Complicated urinary tract infections
- Intra-abdominal infections when combined with anaerobic coverage
- Septicemia
- Skin and soft-tissue infections
- Bone and joint infections
- Febrile neutropenia and other high-risk infections
The U.S. reference product was marketed as Fortaz by GlaxoSmithKline and earlier predecessor companies. The original product was approved in the 1980s, placing it among the oldest widely used antipseudomonal beta-lactam antibiotics in the U.S. market.[1]
Ceftazidime is often selected when clinicians need antipseudomonal coverage and local susceptibility data support its use. Its role is constrained by extended-spectrum beta-lactamase production, AmpC mechanisms, carbapenem resistance, and increasing resistance among Pseudomonas isolates.
What is the current FDA regulatory status of ceftazidime sodium?
Ceftazidime sodium is an FDA-approved generic injectable antibiotic. It is sold in multiple vial strengths, commonly including 500 mg, 1 gram, and 2 grams, although available presentations vary by manufacturer and market.
| Regulatory attribute | Status |
|---|---|
| Active ingredient | Ceftazidime sodium |
| Dosage form | Sterile powder for injection |
| Administration | Intravenous or intramuscular |
| FDA pathway | Original NDA and subsequent ANDA products |
| Regulatory category | Small-molecule antibacterial |
| Reference brand | Fortaz |
| U.S. patent exclusivity | Expired |
| Pediatric exclusivity | Expired |
| Orphan exclusivity | Not a current commercial protection |
| Biosimilar pathway | Not applicable |
| Current market structure | Multiple generic suppliers |
The FDA’s Orange Book distinguishes approved reference products from abbreviated new drug applications but does not indicate an active patent barrier that would prevent generic competition for ordinary ceftazidime sodium injection.[2]
Ceftazidime-avibactam, marketed as Avycaz, is a separate product with a different active-ingredient composition, clinical positioning, regulatory history, and patent estate. Its patents should not be treated as protection for ceftazidime sodium alone.
When did ceftazidime sodium lose exclusivity?
Ceftazidime sodium lost meaningful U.S. market exclusivity decades ago. The original Fortaz approval dates to the 1980s, and generic ceftazidime injection has been available for many years.[1]
The molecule has no current commercial exclusivity comparable to a new chemical entity, pediatric extension, or orphan product. Standard regulatory exclusivity periods have expired. The relevant competitive barriers are manufacturing, sterility assurance, hospital contracting, supply continuity, and regulatory compliance.
Ceftazidime sodium exclusivity timeline
| Period | Event | Commercial effect |
|---|---|---|
| 1980s | Original U.S. approval of Fortaz | Branded launch and protected market period |
| 1990s and later | Generic injectable products enter the market | Price competition begins |
| 2000s | Broad generic availability | Brand-level pricing power largely disappears |
| 2015 | Avycaz approval with avibactam | New differentiated product category, separate from ceftazidime sodium |
| Current period | Mature generic market | Procurement economics and supply reliability drive value |
No current patent expiration date is commercially material for ordinary ceftazidime sodium because the foundational compound and original product exclusivities expired long ago.
What patents protect ceftazidime sodium?
No active foundational U.S. patent is expected to protect ceftazidime sodium as a generic injectable product. The original compound, formulation, and core use patents are historical rights rather than current entry barriers.
Potentially relevant intellectual-property categories include:
- Manufacturing processes for ceftazidime or intermediates
- Crystalline forms or salt forms
- Sterile powder processing
- Container-closure systems
- Reconstitution systems
- Combination products containing ceftazidime and another active ingredient
- Modified delivery systems
- Ceftazidime-avibactam formulations and uses
These categories should not be conflated with a current patent blocking ordinary ceftazidime sodium injection. Manufacturing patents may affect a particular supplier without creating market exclusivity for the active ingredient.
How many patents cover ceftazidime sodium?
The commercially relevant number of active U.S. patents covering the basic ceftazidime sodium injectable product is effectively zero for ordinary generic entry. Historical patent families may remain visible in public databases, but expired patents do not prevent ANDA approval or commercial launch.
The Orange Book is the principal U.S. source for patents listed against approved drug products. A current review should distinguish:
- Patents listed against ceftazidime sodium injection
- Patents covering a specific manufacturer’s formulation
- Patents covering ceftazidime-avibactam
- Process patents not listed in the Orange Book
- Foreign patents with no direct U.S. effect
For a generic manufacturer, the absence of a material Orange Book barrier means that the principal regulatory path is ANDA approval demonstrating pharmaceutical equivalence and bioequivalence or applicable injectable-product requirements. Patent litigation risk is materially lower than for newly approved small molecules.[2]
Are there Paragraph IV challenges for ceftazidime sodium?
Paragraph IV litigation is not a central current market issue for ordinary ceftazidime sodium injection. Paragraph IV certifications may have been used historically against listed patents, but the product’s generic market is mature and lacks the litigation profile associated with recently approved branded drugs.
Current entry risks are more likely to arise from:
- FDA deficiencies in sterile manufacturing
- Incomplete product-specific testing
- Facility inspection findings
- Drug-shortage-related supply controls
- Contract losses
- Failure to maintain an approved manufacturing site
- Procurement exclusion due to reliability or quality concerns
Paragraph IV litigation remains relevant to newer ceftazidime-containing products, particularly ceftazidime-avibactam, but those disputes concern a different commercial product and should be analyzed separately.
What formulations are protected by ceftazidime patents?
The standard formulation is a sterile ceftazidime sodium powder packaged in a vial for reconstitution. This presentation is technically straightforward compared with liposomal, depot, inhaled, or long-acting formulations.
Potential differentiation areas include:
| Formulation area | Commercial relevance |
|---|---|
| Standard single-dose vial | Core generic market |
| Higher-strength vial | Hospital dosing and procurement convenience |
| Premixed solution | Reduced preparation time but greater stability and logistics requirements |
| Ready-to-use container | Potential nursing and pharmacy labor savings |
| Extended-stability formulation | May reduce waste and improve workflow |
| Combination product | Can create a differentiated regulatory and patent position |
| Nonstandard delivery system | Limited role in current ceftazidime demand |
Most generic suppliers compete through standard sterile vials rather than protected delivery technology. Formulation patents could support a niche product, but they would not eliminate competition from conventional ceftazidime injection.
What is the financial trajectory of ceftazidime sodium?
Ceftazidime sodium has the financial profile of a mature hospital generic:
- High historical volume relative to product revenue
- Low average selling prices
- Limited brand premium
- Contract-driven purchasing
- Periodic margin expansion during shortages
- Long-term price pressure from multiple suppliers
- Low standalone disclosure by manufacturers
Public companies generally do not report ceftazidime sodium revenue as a separate line item. It is usually included within broader hospital injectables, generic antibiotics, or injectable pharmaceuticals. As a result, a defensible global revenue figure for ceftazidime sodium alone cannot be derived from public company filings without proprietary prescription, tender, or shipment data.
Revenue trajectory by market phase
| Market phase | Revenue characteristics | Margin profile |
|---|---|---|
| Branded launch | Higher unit price and promotion | Relatively strong |
| Early generic entry | Rapid price erosion | Declining |
| Mature generic period | Stable hospital demand | Low to moderate |
| Shortage period | Temporary price and volume volatility | Potentially elevated |
| Post-shortage normalization | Pricing returns toward tender levels | Compressed |
Volume demand remains supported by hospital use, particularly in intensive care and high-acuity settings. Value growth is weaker because price competition offsets volume growth.
The strongest commercial case is usually associated with reliable supply, low manufacturing cost, and access to group purchasing organization contracts. A supplier that maintains multiple qualified sites or robust active-pharmaceutical-ingredient sourcing can gain share even without a differentiated formulation.
Which companies compete in the ceftazidime sodium market?
The U.S. and international market has included major generic and hospital-injectable suppliers such as:
- Fresenius Kabi
- Hikma Pharmaceuticals
- Sandoz
- Teva Pharmaceuticals
- Pfizer’s hospital products businesses
- Eugia and other injectable-generic manufacturers
- Regional suppliers in Europe, Asia, Latin America, and the Middle East
Supplier participation varies by country, approved vial strength, manufacturing site, tender award, and temporary supply conditions. A company may hold an FDA approval without maintaining meaningful commercial sales.
The competitive landscape is fragmented at the global level but can become concentrated within individual hospital systems or national tenders. Procurement buyers typically evaluate:
- Unit price
- Contract history
- Back-order performance
- FDA or other regulatory inspection history
- Product quality
- Vial configuration
- Delivery reliability
- Ability to support shortage contingencies
What patent litigation affects ceftazidime sodium?
There is no major current U.S. patent-litigation theme comparable to the litigation surrounding high-value oncology, immunology, or specialty drugs. Litigation exposure for ordinary ceftazidime sodium is more likely to involve commercial or manufacturing disputes than foundational composition-of-matter claims.
Relevant legal risks include:
- ANDA litigation involving a specific formulation
- Trade-secret disputes involving manufacturing processes
- Contract disputes with hospitals or distributors
- Product-liability cases
- Regulatory enforcement tied to sterile manufacturing
- Antitrust claims involving generic supply or contracting
Ceftazidime-avibactam has a materially different litigation and patent profile because it is a newer combination product with branded exclusivity considerations. It should be evaluated as a separate asset.
What generic entry risks exist for ceftazidime sodium?
Generic entry risk is already realized rather than prospective. The market has long been open to generic competition. A new entrant would face commercial execution risks rather than a patent cliff.
Principal risks for a new manufacturer
- Price compression from incumbent suppliers
- Costly sterile manufacturing requirements
- FDA inspection or remediation risk
- Dependence on a limited API source
- Hospital tender losses
- Low utilization of approved vial strengths
- Inventory expiration
- Temporary oversupply after shortage conditions normalize
- Competition from alternative antipseudomonal agents
- Resistance-driven clinical substitution
A new entrant can still obtain share if it offers dependable supply, competitive contract pricing, and differentiated packaging. The market is unattractive for a high-cost manufacturer seeking premium pricing.
How does ceftazidime sodium compare with competing antibiotics?
Ceftazidime competes with cefepime, piperacillin-tazobactam, meropenem, aztreonam, and newer beta-lactam/beta-lactamase inhibitor combinations.
| Product | Primary competitive position | Commercial distinction |
|---|---|---|
| Ceftazidime | Antipseudomonal cephalosporin | Mature, low-cost injectable |
| Cefepime | Broad antipseudomonal cephalosporin | Often preferred for broader Gram-positive coverage |
| Piperacillin-tazobactam | Broad-spectrum beta-lactam combination | Strong anaerobic and polymicrobial positioning |
| Meropenem | Carbapenem | Higher resistance coverage but stewardship restrictions |
| Aztreonam | Monobactam | Useful in selected beta-lactam allergy settings |
| Ceftazidime-avibactam | Advanced combination | Targets selected resistant Gram-negative pathogens |
| Ceftolozane-tazobactam | Advanced combination | Positioned against difficult-to-treat Pseudomonas |
Ceftazidime’s advantages are familiarity, generic availability, and low acquisition cost. Its disadvantages include resistance limitations, weak Gram-positive coverage, and the need for combination therapy in some intra-abdominal infections.
What is the biosimilar risk for ceftazidime sodium?
There is no biosimilar risk because ceftazidime sodium is a chemically synthesized small molecule, not a biologic. Competition occurs through the generic drug pathway, primarily ANDAs in the United States and equivalent generic procedures in other jurisdictions.
The relevant substitute risk comes from generic antibiotics and newer branded antibacterial combinations, not biosimilars.
What geographic markets matter most?
Ceftazidime sodium has broad international availability, but commercial economics differ sharply by region.
| Geography | Market characteristics |
|---|---|
| United States | Hospital contracts, generic price competition, FDA manufacturing oversight |
| European Union | National reimbursement and tender systems; country-specific pricing |
| United Kingdom | NHS procurement and centralized purchasing |
| China | Large hospital market with volume-based procurement pressure |
| India | High generic production capacity and export competition |
| Latin America | Public tenders, local registration, variable access |
| Middle East and Africa | Import dependence and supply reliability concerns |
The strongest opportunity for a manufacturer is often not a high-price market but a market where supply continuity is valued and the supplier has a cost-efficient regulatory and distribution network.
What manufacturing and intellectual-property barriers exist?
Manufacturing barriers are more important than patent barriers. Ceftazidime sodium injection requires validated sterile processing, suitable vial and closure systems, stability data, quality-control testing, and compliant facilities.
Key manufacturing considerations include:
- API purity and impurity control
- Sterility assurance
- Endotoxin limits
- Aseptic filling or terminal sterilization strategy
- Powder uniformity
- Reconstitution performance
- Container-closure integrity
- Stability under transport and storage conditions
- Facility inspection history
- Backup API and fill-finish capacity
Because the product is injectable, a manufacturing failure can remove a supplier from the market faster than a pricing disadvantage. Hospital buyers often place greater weight on reliable delivery than on small differences in unit price once a contract is in place.
How strong is the patent estate for ceftazidime sodium?
The patent estate is weak for the standard generic product. The principal barriers are expired compound and product patents, while current commercial defensibility depends on operational capabilities.
| Asset characteristic | Assessment |
|---|---|
| Composition-of-matter protection | Expired |
| Standard injectable formulation protection | No material current barrier expected |
| Method-of-use protection | Expired or clinically nonexclusive |
| Orange Book blocking patents | No material current barrier expected |
| Process patent relevance | Supplier-specific and potentially limited |
| Regulatory complexity | Moderate because the product is sterile |
| Manufacturing complexity | Moderate to high |
| Pricing power | Low |
| Supply-chain value | Moderate to high during disruptions |
| Long-term strategic value | Primarily as a hospital portfolio product |
Key Takeaways
- Ceftazidime sodium is a mature, off-patent injectable cephalosporin.
- U.S. exclusivity expired decades ago, and generic competition is established.
- No current foundational patent is expected to block ordinary generic ceftazidime sodium injection.
- The product has low standalone pricing power and limited public revenue disclosure.
- Financial performance depends on hospital contracts, manufacturing cost, and supply reliability.
- Sterile manufacturing and regulatory compliance are more important than patent protection.
- Ceftazidime-avibactam is a separate, higher-value product with a different patent and commercial profile.
- Generic entry risk is already embedded in the market; new entrants compete on price, reliability, and procurement access.
- Volume demand is supported by hospital use, but resistance and competing antipseudomonal therapies limit growth.
- Biosimilar competition is not applicable.
FAQs About Ceftazidime Sodium Commercialization
Is ceftazidime sodium still commercially attractive for generic manufacturers?
It can be attractive as part of a broader hospital injectable portfolio, but it is less attractive as a standalone premium product because of low prices and established competition.
Does ceftazidime sodium have a patent cliff?
No current patent cliff is commercially relevant. The product passed its patent and regulatory exclusivity period many years ago.
Can a manufacturer obtain market exclusivity for a new ceftazidime sodium vial?
A new vial configuration generally would not create broad market exclusivity. A meaningful protection strategy would require a differentiated formulation, delivery system, or combination product supported by valid patent and regulatory rights.
Is ceftazidime sodium interchangeable with ceftazidime-avibactam?
No. Ceftazidime-avibactam contains the beta-lactamase inhibitor avibactam and has a different spectrum, clinical positioning, labeling, and regulatory status.
What is the largest commercial threat to ceftazidime sodium?
The largest threats are price erosion, hospital substitution by cefepime or piperacillin-tazobactam, resistance among Pseudomonas isolates, and loss of supply contracts. Patent expiration is no longer the principal threat.
References
-
U.S. Food and Drug Administration. (n.d.). Drugs@FDA: FDA-approved drugs and Fortaz product information. https://www.accessdata.fda.gov/scripts/cder/daf/
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U.S. Food and Drug Administration. (2025). 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
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U.S. Food and Drug Administration. (2018). Ceftazidime for injection prescribing information. DailyMed. https://dailymed.nlm.nih.gov/
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U.S. Food and Drug Administration. (2015). FDA approves new antibacterial drug Avycaz. https://www.fda.gov/
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Tamma, P. D., Aitken, S. L., Bonomo, R. A., Mathers, A. J., van Duin, D., & Clancy, C. J. (2022). Infectious Diseases Society of America 2022 guidance on the treatment of extended-spectrum beta-lactamase-producing Enterobacterales, carbapenem-resistant Enterobacterales, and difficult-to-treat resistant Pseudomonas aeruginosa. Clinical Infectious Diseases, 75(2), 187-212. https://doi.org/10.1093/cid/ciac268
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