United States Patent 9,724,353 (Ceftolozane + Tazobactam): Claim Scope, Patent Estate Map, and Freedom-to-Operate Pressure Points

United States Patent 9,724,353 is a US method-of-treatment patent focused on dosing ceftolozane plus tazobactam for hospital-acquired and ventilator-associated pneumonias, with core claim elements that fix (i) indication class, (ii) repeat IV dosing schedule (about every 8 hours), and (iii) dose amounts (2.0 g ceftolozane and 1.0 g tazobactam). Dependent claim fallbacks tighten administration form (60-minute infusion), salt/free-base status of ceftolozane, and combination as a single pharmaceutical composition, plus example pathogen sets.

What does US Patent 9,724,353 claim and what is its effective scope for ceftolozane/tazobactam pneumonia dosing?

Core claim 1 scope (method-of-treatment):

Infection/indication: “selected from the group consisting of: nosocomial pneumonia, ventilator acquired pneumonia and hospital acquired pneumonia.”
Treatment method: “repeatedly intravenously administering”
- Ceftolozane: 2.0 g
- Tazobactam: 1.0 g
Dosing cadence: “about once every 8 hours.”
Subject: “a subject in need thereof.”

Practical meaning: Claim 1 is an infringement hook for any clinician or protocol that administers this ceftolozane/tazobactam dosing regimen by IV on an ~q8h schedule for HAP/VAP/nosocomial pneumonia categories.

How broad is “nosocomial pneumonia” in claim 1?

The “nosocomial pneumonia” umbrella can be read to cover hospital-acquired pneumonia and related healthcare-associated pneumonia, but the claim text explicitly also covers “ventilator acquired pneumonia” and “hospital acquired pneumonia.” That redundancy suggests the patentee intended to cover multiple clinical labels that could be used in trials, practice, or FDA labeling.

Risk translation for FTO: If a competitor’s clinical protocol or label wording maps to these categories, the induction element for claim 1 stays intact.

How “about once every 8 hours” affects design-around?

“About” typically grants some tolerance. From a scope standpoint, infringement analysis will examine whether a proposed regimen is still reasonably close to q8h. Protocols using q6h or q12h reduce closeness to 8 hours, but still could be argued depending on “about” interpretation. Continuous infusion or nonstandard intervals are also potential design-arounds, but only if they break the “about once every 8 hours” limitation.

How do the dependent claims narrow or strengthen infringement risk (60-minute infusion, salt form, single composition, pathogens)?

Claim 2: What is protected about administration timing (60-minute infusion)?

Claim 2 narrows claim 1 by requiring:

60-minute infusion for ceftolozane.

Infringement consequence: A competitor using a different infusion duration (for example, faster push or shorter infusion) may attempt non-infringement on this element. However, if a regimen still meets “60-minute infusion” under claim construction (again “60-minute” is likely not perfectly rigid), the protection still attaches.

Claim 3: What salt form limitations exist (ceftolozane hydrogen sulfate)?

Claim 3 limits ceftolozane to:

hydrogen sulfate salt.

Infringement consequence: A formulation using a different ceftolozane salt form could avoid claim 3 specifically, but not necessarily claim 1, because claim 1 does not require a particular salt.

Claim 4-5: What is protected by dosing as a single pharmaceutical composition?

Claim 4: ceftolozane and tazobactam are administered as a single pharmaceutical composition.
Claim 5: that composition is administered as a 60-minute infusion.

Infringement consequence: Separation into two products (two vials mixed separately or co-administered but not in one pharmaceutical composition) can be a potential design-around for these dependent claims. But claim 1 does not require “single composition,” so co-administration still risks claim 1 if both drugs are administered together in the regimen.

Claims 6-8: How are pneumonia subtypes independently protected?

Claim 6-8 pick out:

nosocomial pneumonia
ventilator acquired pneumonia
hospital acquired pneumonia

Infringement consequence: These do not expand beyond claim 1 at the scope level; they create additional, separately asserted dependent routes that may matter if claim 1’s clinical label interpretation is contested.

Claims 9-13: What is protected by ceftolozane free base vs salt form?

Claim 9: ceftolozane administered as free base
Claim 10: ceftolozane administered in salt form
Claim 11-12: those same distinctions applied to nosocomial pneumonia

Infringement consequence: The claim set is drafted to cover multiple ceftolozane chemical forms. Claim 9 and claim 10 are alternative dependent limitations; together they reduce the utility of “salt selection” as a design-around strategy.

Claim 13: What pathogen coverage exists?

Claim 13 specifies pathogens:

Pseudomonas aeruginosa
E. coli
K. pneumoniae

Infringement consequence: Claim 13 provides a route where infringement is easier to establish if the case is tied to those pathogens. In a litigation posture, the accused regimen involving these organisms can be presented as directly within the claim narrative. It does not necessarily narrow claim 1 because claim 1 already broadly requires the pneumonia type, not pathogen identity.

How does the claim construction likely read for US method-of-treatment claims (administering a dosage schedule)?

Method-of-treatment claims in the US typically require:

a defined patient condition or indication,
administration of a drug,
and compliance with dosage and timing limitations.

For 9,724,353, the tightest proof points will be:

the clinical diagnosis category (HAP/VAP/nosocomial pneumonia),
the administered dose amounts (2.0 g ceftolozane + 1.0 g tazobactam),
the administration route (intravenous),
the dosing interval (about q8h), and
for dependent claims: infusion duration, salt form, and single composition formulation.

This creates an evidentiary dependence on treatment records, pharmacy dispensing records, infusion sheets, electronic medical records, and study protocols.

What patent estate surrounds US 9,724,353 for ceftolozane/tazobactam pneumonia therapy?

The most relevant landscape feature is that ceftolozane/tazobactam as a fixed combination for serious Gram-negative infections is already historically associated with major branded and generic exclusivity blocks and multiple patent layers:

drug substance and formulation patents (composition, salt selection, stability),
manufacturing method patents,
method-of-use patents for specific indications and dosing regimens,
and life-cycle patents (dose, infusion time, administration format, and patient population constraints).

What 9,724,353 adds materially: It pins down a repeat q8h dosing scheme with specific gram amounts, plus a 60-minute infusion and optional salt/free-base variants. That makes it a “protocol” style method-of-use patent, not a general “treat infection with ceftolozane/tazobactam” claim.

Where this claim fits in a typical FTO stack

Even if formulation patents expire, method-of-use patents tied to a labeled or used dosing regimen can still block generic at-risk clinical use.
Even if method-of-use is narrow to pneumonia subtypes, it can still be strategically important because HAP/VAP is a meaningful clinical segment and part of standard dosing protocols.

Patent estate mapping approach (how it is usually litigated)

In practice, enforcement for a method-of-use patent like 9,724,353 is aligned to:

the branded prescribing information dosing regimen,
and the clinical standard for HAP/VAP.

So the patent landscape analysis usually needs two layers:

whether there are earlier or later method-of-use patents covering the same dosing regimen,
whether any formulation/manufacturing patents overlap with what a generic would need to make and distribute.

However, this response is constrained to the claim scope you provided for 9,724,353 and does not include a separate prosecution-history claim chart or a verified list of other US family members, since those require bibliographic confirmation and full-document parsing beyond what’s supplied here.

When does US 9,724,353 lose exclusivity or become vulnerable for generic entry?

A complete “when” analysis depends on:

the patent filing date, nonprovisional priority, and prosecution events,
any adjustments,
and whether the Orange Book lists a corresponding patent for the relevant FDA-approved product.

No expiration timetable can be produced from the claim text alone. This is because loss of exclusivity in the US depends on the patent term mechanics and any regulatory exclusivity linkages that cannot be derived from the claims provided.

What Paragraph IV challenges or patent litigation risks exist for ceftolozane/tazobactam HAP/VAP dosing patents like 9,724,353?

Paragraph IV litigation risk is typically driven by:

whether 9,724,353 is listed in the FDA Orange Book for the relevant NDA(s),
whether a generic filer’s ANDA attempts at-risk marketing tied to that product before the relevant listed patent expires,
and whether the generic’s label contains the same dosing regimen and indication that map to method-of-use claims.

This response cannot produce a litigation docket or settlement timeline for 9,724,353 from claim text alone because it requires:

Orange Book listing confirmation,
ANDA/label mapping,
and verified court filings.

What formulations are protected (single pharmaceutical composition, infusion form, ceftolozane salt form)?

Even though 9,724,353 is a method-of-treatment patent, it includes “composition delivery” limitations in dependent claims:

Single pharmaceutical composition (claims 4-5): both actives administered as one composition.
60-minute infusion (claims 2 and 5): administration duration is a protected limitation.
Ceftolozane hydrogen sulfate (claim 3): specific salt form narrows that dependent claim.
Free base vs salt form (claims 9-12): broadens dependent coverage across chemical forms.

Implication: From a product strategy viewpoint, the safest non-infringing route is not simply switching ceftolozane salt form, because the claim set includes alternative dependent coverage for free base and salt.

How strong is the patent estate for dosing-based method-of-use claims like 9,724,353?

Claim strength indicators based on the provided claims:

The independent claim is highly specific on both dose amounts and dosing cadence, which can make infringement proof straightforward when clinicians follow the regimen.
Specific pneumonia categories reduce reliance on broad “infection” interpretation.
Dependent claims add multiple “extra” ways to satisfy the method, particularly via infusion duration and single composition.

Vulnerability indicators:

Narrowness can be an attack surface if an accused regimen deviates in dose, timing, infusion duration, or the clinical label used.
The presence of “about” and alternative dependent routes can complicate non-infringement arguments for defendants, but it also creates more factual disputes in claim construction.

Net: the claim is designed to track real-world administration protocols, which usually strengthens enforcement posture against at-risk prescribing aligned with the labeled regimen.

How does US 9,724,353 compare with adjacent ceftolozane/tazobactam patent claim strategies?

Method-of-use patents in this therapeutic area typically fall into three families:

Indication-only (e.g., treat HAP/VAP with ceftolozane/tazobactam) with broad language.
Dose + schedule (like this patent) that fixes grams and q8h interval.
Administration/infusion + formulation (e.g., 60-minute infusion, specific composition format).

9,724,353 combines (2) and parts of (3), which makes it more resilient than pure indication-only claims but potentially narrower than “any dosing” claims.

What generic entry risks exist for ceftolozane/tazobactam HAP/VAP once method-of-use patents expire?

Once a dosing-specific method-of-use patent like 9,724,353 expires, a generic product may still face:

other listed patents (formulation, manufacturing, other method-of-use claims),
labeling-driven risks (if label is written to avoid infringing dosing instructions),
and clinical practice mapping (off-label or label-congruent use can still create exposure if other patents remain).

A full “generic launch scenario” requires Orange Book and label mapping, which cannot be built from claim text alone.

Key Takeaways

US 9,724,353 is a dosing-and-schedule method-of-treatment patent for HAP/VAP/nosocomial pneumonia using IV ceftolozane 2.0 g + tazobactam 1.0 g about every 8 hours.
Dependent claims tighten administration mechanics: 60-minute infusion, single pharmaceutical composition, and ceftolozane salt/free-base variations (including hydrogen sulfate).
Pathogen-specific dependent coverage includes P. aeruginosa, E. coli, and K. pneumoniae, supporting straightforward infringement narratives in those clinical settings.
Design-around leverage is limited because the claim set covers both salt and free-base forms and includes single-composition dependent fallbacks while the independent claim does not.
Expiration, Orange Book status, Paragraph IV exposure, and litigation outcomes cannot be determined from claim text alone.

FAQs

Can a different infusion time avoid infringement of US 9,724,353?
Dependent claims require a “60-minute infusion” for certain embodiments, so a non-60-minute infusion regimen targets those dependent limitations, but claim 1 may still apply if the q8h and dose amounts are used.
Does switching ceftolozane from a salt to free base avoid the patent?
The dependent claims expressly cover both free base and salt forms, so this is not a complete design-around if the dosing regimen matches the independent claim limitations.
Does the patent require treating specific pathogens to infringe?
No. Claim 1 only requires the pneumonia indication category. Pathogen language is in a dependent claim.
Is co-administering ceftolozane and tazobactam from separate products a safe non-infringement route?
It may avoid dependent claims requiring a single pharmaceutical composition, but it does not necessarily avoid claim 1, which requires repeated IV administration of the dose amounts on the q8h schedule.
What is the most important evidentiary record in enforcement of this type of method claim?
Proof will hinge on treatment records showing the exact dose amounts, IV route, dosing interval (“about once every 8 hours”), infusion duration (for dependent claims), and the clinical pneumonia diagnosis category.

References

United States Patent 9,724,353 (claim text provided in prompt).

Title:	Methods for treating intrapulmonary infections
Abstract:	This disclosure relates to the treatment of intrapulmonary bacterial infections, including treatment of nosocomial pneumonia lung infections with pharmaceutical compositions containing the cephalosporin ceftolozane.
Inventor(s):	Gurudatt A. Chandorkar, Jennifer A. Huntington, Tara Parsons, Obiamiwe C. Umeh
Assignee:	Merck Sharp and Dohme LLC , Calixa Therapeutics Inc
Application Number:	US14/512,608
Patent Claim Types: see list of patent claims	Use; Composition;
Patent landscape, scope, and claims:	United States Patent 9,724,353 (Ceftolozane + Tazobactam): Claim Scope, Patent Estate Map, and Freedom-to-Operate Pressure Points United States Patent 9,724,353 is a US method-of-treatment patent focused on dosing ceftolozane plus tazobactam for hospital-acquired and ventilator-associated pneumonias, with core claim elements that fix (i) indication class, (ii) repeat IV dosing schedule (about every 8 hours), and (iii) dose amounts (2.0 g ceftolozane and 1.0 g tazobactam). Dependent claim fallbacks tighten administration form (60-minute infusion), salt/free-base status of ceftolozane, and combination as a single pharmaceutical composition, plus example pathogen sets. What does US Patent 9,724,353 claim and what is its effective scope for ceftolozane/tazobactam pneumonia dosing? Core claim 1 scope (method-of-treatment): Infection/indication: “selected from the group consisting of: nosocomial pneumonia, ventilator acquired pneumonia and hospital acquired pneumonia.” Treatment method: “repeatedly intravenously administering” Ceftolozane: 2.0 g Tazobactam: 1.0 g Dosing cadence: “about once every 8 hours.” Subject: “a subject in need thereof.” Practical meaning: Claim 1 is an infringement hook for any clinician or protocol that administers this ceftolozane/tazobactam dosing regimen by IV on an ~q8h schedule for HAP/VAP/nosocomial pneumonia categories. How broad is “nosocomial pneumonia” in claim 1? The “nosocomial pneumonia” umbrella can be read to cover hospital-acquired pneumonia and related healthcare-associated pneumonia, but the claim text explicitly also covers “ventilator acquired pneumonia” and “hospital acquired pneumonia.” That redundancy suggests the patentee intended to cover multiple clinical labels that could be used in trials, practice, or FDA labeling. Risk translation for FTO: If a competitor’s clinical protocol or label wording maps to these categories, the induction element for claim 1 stays intact. How “about once every 8 hours” affects design-around? “About” typically grants some tolerance. From a scope standpoint, infringement analysis will examine whether a proposed regimen is still reasonably close to q8h. Protocols using q6h or q12h reduce closeness to 8 hours, but still could be argued depending on “about” interpretation. Continuous infusion or nonstandard intervals are also potential design-arounds, but only if they break the “about once every 8 hours” limitation. How do the dependent claims narrow or strengthen infringement risk (60-minute infusion, salt form, single composition, pathogens)? Claim 2: What is protected about administration timing (60-minute infusion)? Claim 2 narrows claim 1 by requiring: 60-minute infusion for ceftolozane. Infringement consequence: A competitor using a different infusion duration (for example, faster push or shorter infusion) may attempt non-infringement on this element. However, if a regimen still meets “60-minute infusion” under claim construction (again “60-minute” is likely not perfectly rigid), the protection still attaches. Claim 3: What salt form limitations exist (ceftolozane hydrogen sulfate)? Claim 3 limits ceftolozane to: hydrogen sulfate salt. Infringement consequence: A formulation using a different ceftolozane salt form could avoid claim 3 specifically, but not necessarily claim 1, because claim 1 does not require a particular salt. Claim 4-5: What is protected by dosing as a single pharmaceutical composition? Claim 4: ceftolozane and tazobactam are administered as a single pharmaceutical composition. Claim 5: that composition is administered as a 60-minute infusion. Infringement consequence: Separation into two products (two vials mixed separately or co-administered but not in one pharmaceutical composition) can be a potential design-around for these dependent claims. But claim 1 does not require “single composition,” so co-administration still risks claim 1 if both drugs are administered together in the regimen. Claims 6-8: How are pneumonia subtypes independently protected? Claim 6-8 pick out: nosocomial pneumonia ventilator acquired pneumonia hospital acquired pneumonia Infringement consequence: These do not expand beyond claim 1 at the scope level; they create additional, separately asserted dependent routes that may matter if claim 1’s clinical label interpretation is contested. Claims 9-13: What is protected by ceftolozane free base vs salt form? Claim 9: ceftolozane administered as free base Claim 10: ceftolozane administered in salt form Claim 11-12: those same distinctions applied to nosocomial pneumonia Infringement consequence: The claim set is drafted to cover multiple ceftolozane chemical forms. Claim 9 and claim 10 are alternative dependent limitations; together they reduce the utility of “salt selection” as a design-around strategy. Claim 13: What pathogen coverage exists? Claim 13 specifies pathogens: Pseudomonas aeruginosa E. coli K. pneumoniae Infringement consequence: Claim 13 provides a route where infringement is easier to establish if the case is tied to those pathogens. In a litigation posture, the accused regimen involving these organisms can be presented as directly within the claim narrative. It does not necessarily narrow claim 1 because claim 1 already broadly requires the pneumonia type, not pathogen identity. How does the claim construction likely read for US method-of-treatment claims (administering a dosage schedule)? Method-of-treatment claims in the US typically require: a defined patient condition or indication, administration of a drug, and compliance with dosage and timing limitations. For 9,724,353, the tightest proof points will be: the clinical diagnosis category (HAP/VAP/nosocomial pneumonia), the administered dose amounts (2.0 g ceftolozane + 1.0 g tazobactam), the administration route (intravenous), the dosing interval (about q8h), and for dependent claims: infusion duration, salt form, and single composition formulation. This creates an evidentiary dependence on treatment records, pharmacy dispensing records, infusion sheets, electronic medical records, and study protocols. What patent estate surrounds US 9,724,353 for ceftolozane/tazobactam pneumonia therapy? The most relevant landscape feature is that ceftolozane/tazobactam as a fixed combination for serious Gram-negative infections is already historically associated with major branded and generic exclusivity blocks and multiple patent layers: drug substance and formulation patents (composition, salt selection, stability), manufacturing method patents, method-of-use patents for specific indications and dosing regimens, and life-cycle patents (dose, infusion time, administration format, and patient population constraints). What 9,724,353 adds materially: It pins down a repeat q8h dosing scheme with specific gram amounts, plus a 60-minute infusion and optional salt/free-base variants. That makes it a “protocol” style method-of-use patent, not a general “treat infection with ceftolozane/tazobactam” claim. Where this claim fits in a typical FTO stack Even if formulation patents expire, method-of-use patents tied to a labeled or used dosing regimen can still block generic at-risk clinical use. Even if method-of-use is narrow to pneumonia subtypes, it can still be strategically important because HAP/VAP is a meaningful clinical segment and part of standard dosing protocols. Patent estate mapping approach (how it is usually litigated) In practice, enforcement for a method-of-use patent like 9,724,353 is aligned to: the branded prescribing information dosing regimen, and the clinical standard for HAP/VAP. So the patent landscape analysis usually needs two layers: whether there are earlier or later method-of-use patents covering the same dosing regimen, whether any formulation/manufacturing patents overlap with what a generic would need to make and distribute. However, this response is constrained to the claim scope you provided for 9,724,353 and does not include a separate prosecution-history claim chart or a verified list of other US family members, since those require bibliographic confirmation and full-document parsing beyond what’s supplied here. When does US 9,724,353 lose exclusivity or become vulnerable for generic entry? A complete “when” analysis depends on: the patent filing date, nonprovisional priority, and prosecution events, any adjustments, and whether the Orange Book lists a corresponding patent for the relevant FDA-approved product. No expiration timetable can be produced from the claim text alone. This is because loss of exclusivity in the US depends on the patent term mechanics and any regulatory exclusivity linkages that cannot be derived from the claims provided. What Paragraph IV challenges or patent litigation risks exist for ceftolozane/tazobactam HAP/VAP dosing patents like 9,724,353? Paragraph IV litigation risk is typically driven by: whether 9,724,353 is listed in the FDA Orange Book for the relevant NDA(s), whether a generic filer’s ANDA attempts at-risk marketing tied to that product before the relevant listed patent expires, and whether the generic’s label contains the same dosing regimen and indication that map to method-of-use claims. This response cannot produce a litigation docket or settlement timeline for 9,724,353 from claim text alone because it requires: Orange Book listing confirmation, ANDA/label mapping, and verified court filings. What formulations are protected (single pharmaceutical composition, infusion form, ceftolozane salt form)? Even though 9,724,353 is a method-of-treatment patent, it includes “composition delivery” limitations in dependent claims: Single pharmaceutical composition (claims 4-5): both actives administered as one composition. 60-minute infusion (claims 2 and 5): administration duration is a protected limitation. Ceftolozane hydrogen sulfate (claim 3): specific salt form narrows that dependent claim. Free base vs salt form (claims 9-12): broadens dependent coverage across chemical forms. Implication: From a product strategy viewpoint, the safest non-infringing route is not simply switching ceftolozane salt form, because the claim set includes alternative dependent coverage for free base and salt. How strong is the patent estate for dosing-based method-of-use claims like 9,724,353? Claim strength indicators based on the provided claims: The independent claim is highly specific on both dose amounts and dosing cadence, which can make infringement proof straightforward when clinicians follow the regimen. Specific pneumonia categories reduce reliance on broad “infection” interpretation. Dependent claims add multiple “extra” ways to satisfy the method, particularly via infusion duration and single composition. Vulnerability indicators: Narrowness can be an attack surface if an accused regimen deviates in dose, timing, infusion duration, or the clinical label used. The presence of “about” and alternative dependent routes can complicate non-infringement arguments for defendants, but it also creates more factual disputes in claim construction. Net: the claim is designed to track real-world administration protocols, which usually strengthens enforcement posture against at-risk prescribing aligned with the labeled regimen. How does US 9,724,353 compare with adjacent ceftolozane/tazobactam patent claim strategies? Method-of-use patents in this therapeutic area typically fall into three families: Indication-only (e.g., treat HAP/VAP with ceftolozane/tazobactam) with broad language. Dose + schedule (like this patent) that fixes grams and q8h interval. Administration/infusion + formulation (e.g., 60-minute infusion, specific composition format). 9,724,353 combines (2) and parts of (3), which makes it more resilient than pure indication-only claims but potentially narrower than “any dosing” claims. What generic entry risks exist for ceftolozane/tazobactam HAP/VAP once method-of-use patents expire? Once a dosing-specific method-of-use patent like 9,724,353 expires, a generic product may still face: other listed patents (formulation, manufacturing, other method-of-use claims), labeling-driven risks (if label is written to avoid infringing dosing instructions), and clinical practice mapping (off-label or label-congruent use can still create exposure if other patents remain). A full “generic launch scenario” requires Orange Book and label mapping, which cannot be built from claim text alone. Key Takeaways US 9,724,353 is a dosing-and-schedule method-of-treatment patent for HAP/VAP/nosocomial pneumonia using IV ceftolozane 2.0 g + tazobactam 1.0 g about every 8 hours. Dependent claims tighten administration mechanics: 60-minute infusion, single pharmaceutical composition, and ceftolozane salt/free-base variations (including hydrogen sulfate). Pathogen-specific dependent coverage includes P. aeruginosa, E. coli, and K. pneumoniae, supporting straightforward infringement narratives in those clinical settings. Design-around leverage is limited because the claim set covers both salt and free-base forms and includes single-composition dependent fallbacks while the independent claim does not. Expiration, Orange Book status, Paragraph IV exposure, and litigation outcomes cannot be determined from claim text alone. FAQs Can a different infusion time avoid infringement of US 9,724,353? Dependent claims require a “60-minute infusion” for certain embodiments, so a non-60-minute infusion regimen targets those dependent limitations, but claim 1 may still apply if the q8h and dose amounts are used. Does switching ceftolozane from a salt to free base avoid the patent? The dependent claims expressly cover both free base and salt forms, so this is not a complete design-around if the dosing regimen matches the independent claim limitations. Does the patent require treating specific pathogens to infringe? No. Claim 1 only requires the pneumonia indication category. Pathogen language is in a dependent claim. Is co-administering ceftolozane and tazobactam from separate products a safe non-infringement route? It may avoid dependent claims requiring a single pharmaceutical composition, but it does not necessarily avoid claim 1, which requires repeated IV administration of the dose amounts on the q8h schedule. What is the most important evidentiary record in enforcement of this type of method claim? Proof will hinge on treatment records showing the exact dose amounts, IV route, dosing interval (“about once every 8 hours”), infusion duration (for dependent claims), and the clinical pneumonia diagnosis category. References United States Patent 9,724,353 (claim text provided in prompt). More… ↓ ⤷ Start Trial

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Cubist Pharms Llc	ZERBAXA	ceftolozane sulfate; tazobactam sodium	POWDER;INTRAVENOUS	206829-001	Dec 19, 2014		RX	Yes	Yes	9,724,353*PED	⤷ Start Trial			Y		⤷ Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Patented / Exclusive Use	>Submissiondate

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Canada	2848012	⤷ Start Trial
China	103945842	⤷ Start Trial
Eurasian Patent Organization	028342	⤷ Start Trial
Eurasian Patent Organization	201490590	⤷ Start Trial
European Patent Office	2753326	⤷ Start Trial
>Country	>Patent Number	>Estimated Expiration	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration

Details for Patent: 9,724,353

Which drugs does patent 9,724,353 protect, and when does it expire?

Summary for Patent: 9,724,353