Patent 10,583,110 (US) Cabazitaxel Premedication Regimen for Castration-Resistant Metastatic Prostate Cancer: Claim Scope, Scope-Limiting Elements, and US Patent Landscape

US Patent 10,583,110 claims a specific cabazitaxel dosing schedule (new cycle every 3 weeks) combined with defined premedication doses (dexchlorpheniramine 5 mg, dexamethasone 8 mg, plus an H2 antagonist) for patients with castration-resistant metastatic prostate cancer (CRmPC) that progressed during or after docetaxel. The practical enforcement surface is narrow because the claim requires both the clinical indication and the exact premedication composition and dosing timing, with dose-range cabazitaxel limitations.

What does US Patent 10,583,110 claim and what is its core novelty?

The asserted claim set is method-of-treatment oriented. The inventive core is not cabazitaxel itself, nor the general concept of steroid/antihistamine/H2-blocker premedication, which is widely used in oncology infusion regimens. The actionable novelty is the particular regimen structure:

Disease/clinical qualifier: castration-resistant metastatic prostate cancer
Prior therapy qualifier: progressed during or after treatment with docetaxel
Cabazitaxel schedule: “as a new cycle every three weeks”
Premedication components and doses:
- dexchlorpheniramine at 5 mg
- dexamethasone at 8 mg
- an H2 antagonist
Timing relationship: premedication is administered prior to cabazitaxel, and in dependent claims, specifically 30 minutes prior

Claim 1 is the broadest independent scope

Claim 1 covers:

Administering cabazitaxel (or a hydrate/solvate)
In CRmPC patients who progressed during or after docetaxel
As a new cycle every 3 weeks
With premedication given prior to each cabazitaxel administration:
- dexchlorpheniramine 5 mg
- dexamethasone 8 mg
- an H2 antagonist

It also recites the method purpose as increasing survival.

What claim elements can be used to “design around”?

The enforceable hook is the combination, not any single component. A “non-infringing” alternative generally needs to break at least one mandatory limitation:

change premedication doses (especially dexchlorpheniramine 5 mg and dexamethasone 8 mg)
omit or replace the H2 antagonist with an alternative that is not an H2 antagonist
change timing (e.g., administer premedications at a different time than “30 minutes prior” for dependent claims)
change cabazitaxel cycle timing away from “every three weeks”
use cabazitaxel outside the recited CRmPC post-docetaxel progression setting (e.g., earlier-line disease or different progression criterion)

How strong is the claim scope given the exact dosing and timing requirements?

The claim language creates multiple constraining “filters,” each of which can narrow the set of infringement-eligible uses in the real world.

The “must include” triad: dexchlorpheniramine 5 mg + dexamethasone 8 mg + H2 antagonist

Because claim 1 requires all three premedication categories and two exact doses, many otherwise similar infusion premed protocols fall outside. In practical formulation terms, the H2 antagonist requirement can be satisfied by common H2 blockers (class-level), but claim 1 does not specify which one, only that it is an H2 antagonist.

What claim 1 does not do:

It does not limit the H2 antagonist identity, salt form, or route in your excerpt.
It does not specify the exact premedication administration route or schedule beyond being “prior to” cabazitaxel (except dependent claim 2).

Dependent claim 2 tightens timing to a specific interval

Claim 2 requires:

dexchlorpheniramine, dexamethasone, and H2 antagonist administered 30 minutes prior to cabazitaxel.

This timing constraint provides a common infringement fence for sites that use different timing windows.

Dependent claims 3–6 lock cabazitaxel dose ranges for additional embodiments

Claim 3: cabazitaxel dose is 15–25 mg/m²
Claim 4: cabazitaxel dose is 25 mg/m²
Claim 5: cabazitaxel dose is 20 mg/m²
Claim 6: cabazitaxel dose is 15 mg/m²

These are dose-specific limitations that can materially affect infringement depending on how cabazitaxel is actually prescribed in practice and how dose modifications occur for toxicity.

Functional implication for enforcement

Even if a clinician uses cabazitaxel for the correct indication and uses steroid/antihistamine/H2 blocker premedication, infringement turns on whether the regimen matches the claimed combination of:

exact dexchlorpheniramine and dexamethasone doses,
inclusion of an H2 antagonist,
and (for claim 2) 30-minute timing,
and (for claims 3–6) cabazitaxel dose (15, 20, or 25 mg/m²).

What is the “survival” limitation and does it narrow the claim?

The claim recites: “A method of increasing survival comprising…” followed by the regimen steps.

In many method claims, “increasing survival” is treated as a treatment result intended to confer a clinical benefit. It can narrow scope in two ways:

the method is tied to a survival benefit context for the claimed patient population
it may be used in prosecution and litigation to distinguish from prior art methods that did not claim that objective

In practice, enforcement typically relies less on proving the survival endpoint for each patient and more on showing that a healthcare provider performed the claimed steps for the defined patient population. Still, the survival purpose does add a prosecutorial framing that can resist art that teaches similar administration for different endpoints.

How does the claim cover cabazitaxel hydrates/solvates and what does “hydrate of solvate thereof” do?

Claim 1 covers:

cabazitaxel, or
a hydrate of solvate thereof

This matters because it expands coverage beyond free base/cabalitaxel in one solid state form. If competitors develop or sell a different solid form labeled as a hydrate or solvate of cabazitaxel, that form can still land within “cabazitaxel, or a hydrate of solvate thereof.”

Practical effect:

Solid-form diversification is less likely to provide a clean design-around if the product is a hydrate/solvate of cabazitaxel itself.
However, an alternative drug substance that is not a hydrate/solvate of cabazitaxel is outside claim coverage.

What are the major infringement scenarios under US Patent 10,583,110?

Scenario A: Routine label-like premedication matching the claimed doses

If a treatment protocol uses:

cabazitaxel every 3 weeks for CRmPC post-docetaxel progression, plus
dexchlorpheniramine 5 mg
dexamethasone 8 mg
an H2 antagonist administered prior to infusion, then performing the regimen can fall within claim 1.

Scenario B: Same regimen but different timing

If premedications are administered at a different interval than 30 minutes prior, dependent claim 2 is the likely barrier; claim 1 could still be asserted depending on whether the “prior to” requirement is met.

Scenario C: Dose reductions or alternate dose selection

If the patient receives a cabazitaxel dose outside 15–25 mg/m², dependent claims 3–6 can be avoided. Claim 1 still requires cabazitaxel, but the excerpted dependent dose limitations suggest the independent claim may not require a numeric cabazitaxel dose beyond being administered as a 3-week cycle regimen.

Scenario D: Indication shift away from docetaxel progression

If cabazitaxel is used earlier than the post-docetaxel progression setting, or for a different cancer status not meeting “progressed during or after treatment with docetaxel,” the patient-qualifier may avoid infringement.

What US patent estate issues typically arise around cabazitaxel method-of-use and premedication regimens?

Even without reproducing the full patent list, the landscape logic for cabazitaxel typically partitions into three layers that affect litigation leverage:

Drug substance and composition patents (cabazitaxel itself and formulation variants)
Process/manufacturing patents (how cabazitaxel and its drug product are made)
Method-of-use patents (indications, dosing schedules, and adjunct regimens like premedication)

US Patent 10,583,110 is in layer (3), and its strength depends on how unique the claimed combination is relative to earlier clinical and regulatory disclosure.

How similar are “premedication triads” across oncology infusion?

Many taxane regimens and other infusion-associated hypersensitivity prevention regimens use:

a corticosteroid
an antihistamine (often H1-blocker)
and sometimes an H2-blocker
This makes claim novelty hinge on the exact combination of doses, timing, and the defined patient population (CRmPC post-docetaxel progression) and cycle interval (every 3 weeks).

Which claim elements are most likely to be attacked in validity challenges (obviousness/anticipation)?

From a litigation posture, the most attackable pieces are those that are easy to find in prior practice for taxanes and hypersensitivity mitigation.

Most likely prior-art pressure points

Use of dexamethasone as premedication for taxanes
Use of H1 antihistamines and H2 blockers as infusion premedication
Standard dosing schedules for cabazitaxel that may already align with q3-week cycles in clinical trials
Prior publications describing the same or similar patient population and dosing regimen

The strongest novelty anchor in this claim set

The specific premedication doses: dexchlorpheniramine 5 mg and dexamethasone 8 mg
The explicit timing relationship of 30 minutes prior (claim 2)
The combination of those with docetaxel-pretreated CRmPC and q3-week “new cycle”

If an earlier disclosure combines the same triad and the same doses/timing in that same indication, anticipation becomes a direct threat. If earlier disclosures cover the triad but not the same exact doses or timing, obviousness becomes the likely strategy.

When does exclusivity end for this type of method-of-use claim?

US method-of-use patents like this typically do not create Hatch-Waxman exclusivity on their own. The practical exclusivity question usually maps to:

when the patent(s) expire (filing date + statutory term)
whether any pediatric extension applies
whether there is a 30-month stay from Paragraph IV ANDA litigation (if it triggers)
whether settlement terms prevent generic launch

Because the prompt does not provide the filing date, expiration date, or Orange Book listing specifics for the patent, a precise exclusivity calendar cannot be derived from the excerpt alone.

What generic entry risks exist for cabazitaxel method-of-use patents like this?

Cabazitaxel is a cytotoxic chemotherapy. ANDA vs generic entry depends on the underlying product’s approval class (small molecule) and whether generics are approved.

Key risk logic for a method-of-use claim:

Generics that submit an application do not have to “carve out” method-of-use indications unless the labeling triggers infringement liability.
If the generic label instructs the same premedication regimen and is used in the patented population, doctors can still practice the patented steps, leading to potential infringement.
If the generic label is modified to avoid the patented regimen (e.g., different premed doses or timing), litigation risk can shift to the adequacy of label “design-around” and whether off-label prescribing infringes.

For this patent, the tight premed dose requirements and the q3-week cycle can make labeling carve-outs more feasible than if the claim were broader (e.g., “premedicate with an antihistamine and steroid”).

How does this claim compare with typical cabazitaxel labeling and standard premed protocols?

Based on claim structure, the regimen appears aligned with a standardized hypersensitivity prophylaxis approach:

H1 antihistamine
steroid
H2 blocker
administered shortly before infusion
repeated on a q3-week cycle
used in post-docetaxel CRmPC

The claim differentiator is that it recites exact doses for dexchlorpheniramine and dexamethasone. If the marketed label’s premedication matches these doses and timing, that increases infringement alignment and reduces freedom for generics to alter instructions.

Key claim-by-claim scope map (what must be practiced)

Claim	Required patient population	Cabazitaxel schedule	Premedication requirements	Timing requirements	Cabazitaxel dose limits
1	CRmPC progressed during/after docetaxel	“new cycle every three weeks”	dexchlorpheniramine 5 mg + dexamethasone 8 mg + H2 antagonist, all prior to cabazitaxel	“prior to” (no fixed minutes)	None stated in claim 1 excerpt
2	Same as claim 1	Same	Same components/doses	exactly 30 minutes prior	None stated in claim 2 excerpt
3	Same as claim 1	Same	Same components/doses	From claim 2 dependency (30 minutes prior)	15–25 mg/m²
4	Same as claim 1	Same	Same components/doses	30 minutes prior	25 mg/m²
5	Same as claim 1	Same	Same components/doses	30 minutes prior	20 mg/m²
6	Same as claim 1	Same	Same components/doses	30 minutes prior	15 mg/m²

US Patent 10,583,110 landscape: what other patent types are most relevant for freedom-to-operate?

A robust FTO analysis typically layers:

Other US cabazitaxel method-of-use patents (different indications, different dose schedules, different adjuncts)
Formulation and solid-state patents (if the generic or competitor uses a different cabazitaxel form)
Process patents (if manufacturing uses a patented route)
Regulatory exclusivity protections (data exclusivity, orphan exclusivity if applicable, and patent term adjustments)

For enforcement risk tied to this specific patent, the most relevant are:

other method-of-use claims overlapping the same premedication triad and q3-week cycle
any cabazitaxel product patents that constrain making/supplying the underlying drug product

Key Takeaways

US Patent 10,583,110 targets a narrow method of increasing survival in CRmPC post-docetaxel progression by requiring a q3-week cabazitaxel “new cycle” regimen plus exact premedication dosing: dexchlorpheniramine 5 mg and dexamethasone 8 mg, plus an H2 antagonist given prior to cabazitaxel.
Dependent claim 2 adds a strict timing limitation: 30 minutes prior.
Dependent claims 3–6 further constrain cabazitaxel dose to 15–25 mg/m² and specific values (15, 20, 25 mg/m²).
The enforcement surface is greatest when real-world clinical use and labeling follow this exact premed dose-and-timing structure in the specified post-docetaxel CRmPC population.
The main design-around levers are changing the premedication doses, removing/changing the H2 antagonist, altering the timing window, changing the q3-week cycle, or avoiding the defined patient population/progression qualifier.

FAQs

1) Does US 10,583,110 cover premedication with an H1 antihistamine other than dexchlorpheniramine 5 mg?
Not if the regimen omits dexchlorpheniramine at 5 mg, because claim 1 recites that dose as a required element.

2) If premedication is given 45 minutes before cabazitaxel, which claims are implicated?
Claim 2 (30 minutes prior) is avoided, but claim 1 can still apply if “prior to” is satisfied and other elements match.

3) Can a cabazitaxel dose outside 15–25 mg/m² avoid dependent claims 3–6?
Yes, dependent claims 3–6 require doses within or equal to those values; claim 1 still requires the other regimen elements.

4) Does the patent cover cabazitaxel hydrates/solvates?
Yes. Claim 1 explicitly includes cabazitaxel and “a hydrate of solvate thereof.”

5) If cabazitaxel is used for CRmPC without docetaxel progression, is infringement possible?
Claim 1 requires CRmPC progressed during or after docetaxel treatment, so an unmet patient qualifier is a scope-limiting factor.

References

United States Patent 10,583,110. Claims as provided in prompt (method of increasing survival using cabazitaxel with dexchlorpheniramine 5 mg, dexamethasone 8 mg, and an H2 antagonist for castration-resistant metastatic prostate cancer post-docetaxel progression; q3-week cycles; dependent timing and dose limitations).

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Sanofi Aventis Us	JEVTANA KIT	cabazitaxel	SOLUTION;INTRAVENOUS	201023-001	Jun 17, 2010	AP	RX	Yes	Yes	10,583,110*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
Argentina	078824	⤷ Start Trial
Australia	2010310986	⤷ Start Trial
Australia	2015200149	⤷ Start Trial
Australia	2016200598	⤷ Start Trial
Australia	2017232227	⤷ Start Trial
Australia	2019203514	⤷ Start Trial
Brazil	112012011457	⤷ Start Trial
>Country	>Patent Number	>Estimated Expiration	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration

Details for Patent: 10,583,110

Which drugs does patent 10,583,110 protect, and when does it expire?

Summary for Patent: 10,583,110