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CEFOXITIN IN PLASTIC CONTAINER Drug Patent Profile
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When do Cefoxitin In Plastic Container patents expire, and when can generic versions of Cefoxitin In Plastic Container launch?
Cefoxitin In Plastic Container is a drug marketed by Samson Medcl and is included in one NDA.
The generic ingredient in CEFOXITIN IN PLASTIC CONTAINER is cefoxitin sodium. There are eight drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the cefoxitin sodium profile page.
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Questions you can ask:
- What is the 5 year forecast for CEFOXITIN IN PLASTIC CONTAINER?
- What are the global sales for CEFOXITIN IN PLASTIC CONTAINER?
- What is Average Wholesale Price for CEFOXITIN IN PLASTIC CONTAINER?
Summary for CEFOXITIN IN PLASTIC CONTAINER
| US Patents: | 0 |
| Applicants: | 1 |
| NDAs: | 1 |
US Patents and Regulatory Information for CEFOXITIN 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Samson Medcl | CEFOXITIN IN PLASTIC CONTAINER | cefoxitin sodium | POWDER;INTRAVENOUS | 200938-001 | Nov 16, 2015 | RX | No | 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 |
Cefoxitin in Plastic Container (Injection): Investment Scenario and Fundamentals Analysis
Executive summary
Cefoxitin in a plastic container is an injectable cephalosporin formulation (cefoxitin sodium) whose investability is driven by (1) patent/market exclusivity end dates for the specific containerized presentation, (2) FDA supply stability and manufacturing/IP friction, (3) hospital and IDU channel purchasing contracts, and (4) competitive generic density at the strength and dosage-form level. For an investor or licensee, the key diligence target is not “cefoxitin” broadly, but the Orange Book status and patent estate tied to the plastic-container presentation, since container and/or manufacturing process claims can create a narrow but tradable exclusivity window even where the active ingredient is mature.
What patents protect cefoxitin in plastic container products?
Answer: Patent protection, if any, is most likely presentation-specific (packaging), formulation, or manufacturing-process related rather than core antibiotic composition-of-matter, given cefoxitin’s age as an API. For investment positioning, the enforceable risk typically comes from Orange Book-listed patents on the specific NDA/strength/package and from process patents affecting sterile manufacture or container compatibility.
How does “plastic container” change the patent risk profile?
Plastic containers can create distinct IP around:
- Container-closure system and extractables/leachables (materials compatibility).
- Sterile fill-finish process parameters (adsorption on container surfaces, filtration/holding time).
- Stability claims linked to plastic materials (potency retention, pH drift, degradation products).
Where to focus in the patent estate
For valuation, map:
- Drug substance composition patents (usually expired or near-expired for legacy antibacterials).
- Drug product patents that claim the finished sterile powder-to-solution format, concentrations, and stability behavior in the specific container.
- Method-of-manufacture patents tied to aseptic preparation steps that differ by packaging.
Which jurisdictions matter for enforcement
- US: enforceability via Hatch-Waxman Orange Book and injunctive relief in ANDA litigation.
- EU/UK: less likely to matter for container-only differentiation if CE marking and pharmacovigilance are straightforward, but still relevant for process patents.
- Other markets: if the presentation is sold internationally, local packaging and manufacturing-process patents can block imports even after API expiry.
What is the Orange Book status of cefoxitin injection in plastic containers?
Answer: Orange Book status determines whether any US exclusivity or enforceable patents still delay generic entry for the specific presentation (strength, dosage form, and container type).
What Orange Book fields should be extracted
For each cefoxitin-in-plastic-container listing, collect:
- Active ingredient and dosage form (Injection).
- NDA number for the specific package.
- Orange Book patent numbers (listed patents, not just “patents in general”).
- Patent expiration dates and exclusivity codes tied to:
- New chemical entity (NCE) / 3-year exclusivity (unlikely for cefoxitin, but still check presentation-specific changes).
- 505(b)(2) exclusivity (possible only if the presentation or reformulation drove a new application).
- Patent certification (Paragraph I, II, III, IV) for ANDAs.
What to model for investors
- A presentation with no Orange Book-listed patents is a lower-risk, higher-volume commodity entry.
- A presentation with one or more Orange Book patents increases litigation probability but can also create a clear “time-to-launch” window for a licensee with a clean technical package.
When does cefoxitin injection lose exclusivity for this specific container presentation?
Answer: Exclusivity and patent expiry must be assessed at the NDA and strength level tied to the plastic container label. For cefoxitin, the API-era exclusivity is usually long past, but the packaging-specific patents or formulation stability patents can still govern.
Key timeline mechanics
Investors should model three clocks in parallel:
- Patent expiry: last day any listed patent is enforceable.
- Exclusivity end date: if applicable from Orange Book exclusivity codes.
- Regulatory readiness: ANDA approval timelines and commercial launch scheduling.
How to translate into an investment case
- If the plastic-container presentation has future-dated patent expiry, the investment case hinges on financing to bridge development, bioequivalence/CMC, and market-access contracting until launch.
- If patent barriers are minimal, the case shifts to execution risk and cost position rather than litigation timing.
How many patents cover cefoxitin injection, and what types dominate?
Answer: For legacy antibacterials, the practical count of enforceable patents is often low and dominated by product/formulation or process claims rather than core composition claims.
Common dominant patent types investors should expect
- Stability/compatibility in specific container materials
- Manufacturing method steps (sterile compounding, hold times)
- Impurity control or degradation profile specifications linked to the packaging environment
Investment implication of patent mix
- Fewer, narrower patents often produce a more binary litigation or carve-out risk.
- A thicker estate can support longer delay but increases the probability that some claims are invalid or non-infringed, which can support settlement-driven entry strategies.
What generic entry risks exist for cefoxitin injection in plastic containers?
Answer: The principal risks are ANDA paragraph-triggered litigation (often Paragraph IV), packaging-related CMC non-equivalence, and supply-chain disruption that creates leverage for incumbents.
Paragraph IV and litigation-trigger risk
A generic applicant filing a Paragraph IV certification on Orange Book patents can face:
- Injunction risks if the applicant loses at a claim level.
- Settlement-driven entry dates (often aligned to a risk-acceptable launch window).
CMC risk specific to plastic containers
Key technical choke points:
- Adsorption or potency loss on container surfaces.
- Leachables/extractables profile compliance and stability data.
- Sterile fill-finish process reproducibility and container compatibility testing.
What patent litigation affects cefoxitin injection in plastic containers?
Answer: Litigation affects only the specific NDA and patent list for the plastic-container presentation. Any “cefoxitin litigation” that is not mapped to the exact Orange Book listing is not directly investable intelligence.
What to track in filings
- Case caption and court (typically US District Court).
- Paragraph IV patent numbers asserted.
- Claim construction outcomes and any summary judgment rulings.
- Settlement date and terms:
- Launch date
- Design-around requirements (container type or process changes)
- Royalty payments (if structured)
How litigation changes valuation
- A settlement with an early effective entry date can sharply reprice a licensee’s launch feasibility.
- An adverse injunction increases cash burn and can force a redesign.
Which companies market cefoxitin injection in plastic containers, and who is challenging whom?
Answer: Competitive dynamics depend on the manufacturer of the plastic-container presentation and which generics target the same NDA/strength/package.
Commercial channel realities
- Hospital group purchasing organizations (GPOs) drive volume.
- Distributor contracts can determine whether the product wins formulary access.
- Packaging and stability performance affect substitution decisions.
What to evaluate for investor diligence
- Number of competitors with approved ANDAs for that exact presentation.
- Recent discontinuations or supply disruptions (proxy for manufacturing intensity and margins).
- Price trajectory vs. other older beta-lactams with similar demand profiles.
How does cefoxitin injection compare with cefazolin, ceftizoxime, and other cephalosporins for investment leverage?
Answer: In investment terms, cefoxitin’s leverage is usually lower than newer-generation cephalosporins with higher clinical adoption. Its value tends to be tied to procurement cycles, resistance patterns, and formulary inertia in settings where cefoxitin is used.
Where cefoxitin can still win
- Use-case specificity in institutional protocols.
- Formulary preference where outcomes or antibiotic stewardship guidelines support the drug.
- Stable supply economics that reward manufacturers with low defect rates and consistent potency.
What comparative positioning means for forecasting
- If cefoxitin faces substitute pressures from broader-spectrum agents, volumes are more sensitive to payer and guideline shifts.
- If a local hospital network is locked into cefoxitin protocols, the base case volume is more stable and predictable.
What formulations are protected by cefoxitin injection plastic-container patents?
Answer: Formulation protection is usually linked to the finished injection characteristics: concentration, reconstitution behavior, stability profile, and container compatibility.
Typical protected elements to map
- Concentration range (strength-specific claims).
- Stability at storage conditions (shelf-life in the container).
- Impurity thresholds and degradation product control.
- Reconstitution volume and time if the label differs by packaging.
What method-of-use or indication patents matter for cefoxitin injections?
Answer: Method-of-use patents are less likely for legacy cefoxitin unless a distinct off-label use was newly claimed and tied to a specific NDA update. For most investors, enforceable value is usually in product/process claims.
What to search in the patent list
- Any listed patents categorized as:
- Method of treatment
- Use claims
- Dosing regimen
- If the Orange Book listing for the cefoxitin plastic-container product includes such patents, it increases litigation complexity and may affect generic design-around.
What FDA regulatory pathway applies to cefoxitin in plastic containers?
Answer: For a generic version, the pathway is typically an ANDA referencing the listed NDA if the product is substitutable by bioequivalence standards and has compatible CMC.
Regulatory diligence checkpoints
- ANDA submission status and approval date for the exact presentation.
- Label and labeling changes that may indicate formulation differences.
- Chemistry, Manufacturing, and Controls (CMC) alignment:
- sterile manufacture
- container-closure system validation
- stability protocol
How strong is the patent estate for cefoxitin in plastic containers?
Answer: Strength should be measured by the count of Orange Book-listed patents, their remaining life, and the likely claim scope around container compatibility and sterile manufacturing. In mature legacy products, strength is often narrow but can still be commercially material if it blocks timely approval of a high-volume presentation.
A practical scoring framework
Score each listed patent for:
- Remaining term (months/years)
- Claim breadth (container/material/process scope)
- Infringement plausibility (based on likely manufacturing approach)
- Litigation history (if any exists for the same patent family)
What settlement agreements or licensing deals affect cefoxitin injection market entry?
Answer: Settlements in Hatch-Waxman cases define entry dates even when patents are contested. For an investor underwriting launch timing, the most material artifact is a settlement that sets an effective launch date for the generic plastic-container presentation.
What settlement terms typically govern
- Authorized launch date
- Scope limits (strength, container type)
- Design-around constraints
- Royalty structures, if any
What revenue exposure exists for a company tied to cefoxitin injection in plastic containers?
Answer: Revenue exposure depends on whether the company sells:
- only the plastic-container presentation, or
- multiple pack sizes tied to the same manufacturing line.
Sensitivity drivers
- Market share in hospital distribution for that strength
- Net price trend vs. alternate cephalosporins
- Manufacturing uptime and sterile fill-finish throughput
- Contract renewals with GPO and wholesalers
What investment scenarios fit cefoxitin in plastic containers: entry, license, or supply contract?
Answer: Three investable scenarios dominate.
Scenario 1: ANDA/generic entry
- Requires robust CMC for plastic-container compatibility.
- Valuation hinges on Orange Book patent life and litigation outcome likelihood.
Best fit: presentation where patent barriers are narrow and approval is on a fast CMC track.
Scenario 2: License from an NDA holder or brand owner
- Often the lowest regulatory risk if the license includes relevant know-how.
- Still requires careful assessment of packaging-related claims that may restrict a sublicensee’s manufacturing.
Best fit: projects where a design-around is hard but licensing rights can neutralize patent friction.
Scenario 3: Supply partnership or contract manufacturing
- Focus is execution: sterile quality, batch reliability, and cost position.
- Less exposure to patent validity if the supply is licensed or non-infringing.
Best fit: manufacturers with excess capacity and demonstrated sterile fill-finish performance.
Key Takeaways
- Cefoxitin’s investability is presentation-specific: plastic-container claims can create a tradable exclusivity window even for a legacy antibiotic.
- Orange Book mapping for the exact NDA/strength/container is the core diligence step that determines litigation and launch timing.
- The dominant risks tend to be narrow but material: container-closure compatibility, stability in plastic, and sterile manufacturing process alignment for CMC approval.
- Valuation should model three clocks: patent expiry, exclusivity end (if any), and regulatory readiness.
- Best investment paths depend on whether barriers are patent/litigation-driven (and can be licensed) or CMC/execution-driven (and can be won via cost and supply reliability).
FAQs
- How do container-closure system patents affect ANDA approval for cefoxitin injection?
- Do cefoxitin patents typically cover container materials or only the drug product?
- What CMC data is most critical to show stability of cefoxitin sodium in plastic containers?
- How do Paragraph IV challenges change launch timing for older antibiotic injectables?
- What is the typical role of GPO contracting in sustaining cefoxitin injection volumes?
References (APA)
- FDA. (n.d.). Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. U.S. Food and Drug Administration. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm
- FDA. (n.d.). ANDA Submissions and Information. U.S. Food and Drug Administration. https://www.fda.gov/drugs/abbreviated-new-drug-application-anda
- FDA. (n.d.). Patents and Exclusivity. U.S. Food and Drug Administration. https://www.fda.gov/drugs/patents-and-exclusivity
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