Scope and Claims of US Patent 12,233,105: Sterile Corticotropin Handling, Needle-Gauge Administration, and Formulation Parameters

US Patent 12,233,105 is written as a tightly constrained set of US method claims covering (i) temperature conditioning, (ii) specific dose of corticotropin in USP units, (iii) administration logistics via defined needle gauges, and (iv) formulation quality attributes tied to vasopressin impurity limits and/or acidified WFI pH, with multiple dependent claims adding gel-to-liquid behavior, needle switching, route, indication lists, and particle-count specs. The patent estate is likely to be enforceable primarily against products that match its operational envelope and composition constraints, not against broader corticotropin use in general.

What is US Patent 12,233,105 and what do its claims cover?

Direct answer: The independent claim set defines a method of warming, then injecting a specified dose (80 USP units) of sterile corticotropin into a human, where the corticotropin is defined by sequence/identity (AA 1-39 of SEQ ID NO:1) and the sterile composition is constrained by either:

impurity control: ≤0.05 USP Vasopressin Units per USP Corticotropin Units, and/or
solution condition: acidified WFI pH 2.8 to 3.2.

It also includes administration claims requiring needle gauge selection (notably 20G for withdrawal and 23G for injection in dependent claims).

Claim architecture (high level)

Claim 1: Core “store at 2–8°C → warm to 18–26°C → inject 80 USP units after warming” plus corticotropin identity and formulation constraints.
Claims 2–5: Gel storage and gel-to-liquid conversion; needle gauge configuration (20G/23G); specific biological source (whole porcine pituitary including anterior and posterior).
Claims 6, 16: Indication list (SLE, acute MS exacerbations, acute gouty arthritis, severe psoriasis, atopic dermatitis, allergic conjunctivitis).
Claims 7–21: Second independent method theme: warming + withdrawing + needle replacement with different gauge + injecting, plus formulation variants (80 units/mL, route, phenol/gelatin ranges, particle limits, preservative-free), and an adrenal responsiveness verification step using urinary/plasma corticosteroid rises and dosing ranges (20 to 80 USP units/mL).
Claims 22–24: Broad “delivery method” via vial withdrawal + syringe injection with different needle gauge, again tied to the same corticotropin identity and impurity/pH constraints.
Claims 25–30: Dependent compositions linked to 80 units/mL, indication list, phenol and gelatin ranges, gelatin type and pyrogen-free constraint, and a specific compositional recipe.

What is the independent-method claim 1 actually requiring?

Direct answer: Claim 1 requires all of the following in sequence:

Store a sterile corticotropin composition at 2–8°C
Warm to 18–26°C
Inject into a human 80 USP units of sterile corticotropin after warming
The corticotropin must satisfy one of the following identity/composition constraints (the claim is drafted with alternative qualifying clauses):
- Corticotropin comprises amino acids 1–39 of SEQ ID NO: 1, or
- Composition has not more than 0.05 USP Vasopressin Units / USP Corticotropin Units, or
- Composition comprises acidified WFI pH 2.8 to 3.2

Practical scope implications

The operational steps (2–8°C storage, 18–26°C warming, then injection) create a procedural infringement hook against handling practices and prescribing/administration protocols that mirror the claim.
The claim is not framed as “any corticotropin use.” It is framed as sterile corticotropin composition and specific physical/chemical constraints.
The dose is constrained to 80 USP units in the independent claim 1. Any regimen that uses a materially different unit dose for the asserted method step likely avoids claim 1.

What do claims 2–5 add: gel formation, needle gauge, and porcine source?

Claim 2: solid gel storage, liquid gel after warming

Requires the sterile corticotropin composition to be stored as a solid gel and become a liquid gel after step b (after warming from 2–8°C to 18–26°C).

Enforcement impact: Infringement depends on whether the product and preparation protocol exhibit the specified gel state transitions at the claimed temperature steps.

Claim 3: withdrawal needle gauge fixed at 20G

Adds: withdrawal with a first needle having first gauge size 20G, and injection with a second needle (gauge size specified in claim 4).

Claim 4: injection needle gauge fixed at 23G

Adds: second needle gauge size 23G.

Enforcement impact: Needle gauge switching is a classic design-around point. If a competitor withdraws using a different gauge or injects using a different gauge, it may avoid these dependent claims, even if claim 1 is otherwise met.

Claim 5: whole porcine pituitary including anterior and posterior portions

Requires the corticotropin be derived from whole porcine pituitary including both anterior and posterior portions.

Enforcement impact: This is a source constraint. Any recombinant or differently sourced corticotropin used in the claimed composition might not satisfy this dependent claim.

Which medical indications are explicitly claimed (and what does that do to enforcement)?

Direct answer: Claims 6 and 16 list the following human conditions:

Systemic lupus erythematosus
Acute exacerbations of multiple sclerosis (MS)
Acute gouty arthritis
Severe psoriasis
Atopic dermatitis
Allergic conjunctivitis

Enforcement impact: These are dependent claim limits. For infringement, a plaintiff must map not only the product/handling steps but also the patient condition under the accused use. A product used outside those indications could avoid these dependent claims while still potentially triggering broader independent claim coverage if the independent steps are satisfied.

How does independent claim 7 differ from claim 1?

Direct answer: Claim 7 is a broader administration workflow that includes a needle replacement step:

Warm the sterile corticotropin composition from 2–8°C to 18–26°C
Withdraw using a first needle (gauge unspecified in claim 7 itself)
Replace the needle with a second needle of a different gauge
Inject into the human after replacement

Claim 7 also includes the same corticotropin identity constraint alternatives:

AA 1–39 of SEQ ID NO: 1, or
vasopressin impurity ≤0.05 USP Vasopressin Units/USP Corticotropin Units, or
acidified WFI pH 2.8–3.2

Claim 8: composition concentration (80 USP units/mL)

Adds that the sterile corticotropin composition of “purified corticotropin” comprises 80 USP units/mL.

Claim 9: routes of administration

Specifies subcutaneous or intramuscular administration.

Claim 10: anti-infective co-therapy

Adds an “anti-infective therapy” step.

Design-around note: Needle replacement logic in claim 7 is less specific than claim 3/4. However, it still requires a change in gauge between withdrawal and injection needles.

What formulation parameters are claimed beyond temperature and dose?

The patent includes multiple dependent claims specifying formulation compositions and quality attributes.

Phenol and gelatin content

Claim 11: phenol ~0.1–1% w/w
Claim 12: gelatin ~10–20% w/w
Claim 13: specific formulation: 0.5% w/w phenol, 15.0% w/w gelatin, water, HCl, and NaOH

Particle size limits (quality attribute)

Claim 14: composition has:
- <6000 particles ≥10 μm, and/or
- <600 particles ≥25 μm

Preservative status

Claim 15: composition is preservative-free, antimicrobial-free, or both.

Enforcement impact: These dependent claims create multiple “landing zones” that can be mapped to manufacturing specs and release criteria. A product that matches the temperature/dose/needle method but differs on phenol/gelatin, particle counts, or preservative status may still avoid dependent claims while potentially meeting independent claims depending on how the independent claim is structured in the asserted theory.

What is the adrenal responsiveness verification step in claims 18–21?

Direct answer: Claims 18–21 claim a protocol element where, after the first corticotropin administration, the clinician verifies adrenal responsiveness by monitoring urinary and plasma corticosteroid values rising.

Claim 18: verify adrenal responsiveness after first time

“Verifying adrenal responsiveness” by a rise in urinary corticosteroid and plasma corticosteroid after administering the sterile corticotropin composition.

Claim 19: verification dosing range

Specifies injecting 20 to 80 USP units/ml.

Claim 20: divided dosing series

Specifies the 20–80 USP units/ml is administered over two or more injections.

Claim 21: response measurement after SC or IM

Specifies response after first-time SC or IM dosing.

Enforcement impact: This is a narrower procedural claim that targets clinical monitoring practices. It is unlikely to be met if the accused use does not include this verification step or uses a materially different monitoring protocol.

What do claims 22–24 add: a “delivery method” with needle gauge separation?

Direct answer: Claim 22 requires:

Withdraw from a vial using a first needle of a first gauge/diameter
Inject using a syringe with a second needle of a second gauge/diameter
Corticotropin is defined by AA 1–39 of SEQ ID NO:1 and the sterile composition satisfies either:
- vasopressin impurity ≤0.05 USP Vasopressin Units/USP Corticotropin Units, or
- acidified WFI pH 2.8–3.2
Corticotropin source is whole porcine pituitary including anterior and posterior

Claim 23 narrows to explicitly the vasopressin impurity limitation.
Claim 24 narrows to explicitly the acidified WFI pH 2.8–3.2 limitation.

Enforcement impact: Compared with claim 1, claim 22 is a more direct “handling and delivery” framing. It may be easier to assert against administration technique records if the required identity and formulation constraints are matched.

Which values and ranges are hard-edged in the composition constraints?

A plaintiff or challenger typically maps infringement by checking release and manufacturing specs. The hard-edged parameters here are:

Parameter	Claim hook	Values
Storage temperature	Claim 1 / Claim 7	2–8°C
Warming temperature	Claim 1 / Claim 7	18–26°C
Dose (units)	Claim 1	80 USP units
Concentration	Claim 8 / Claim 19	80 USP units/mL; and 20–80 USP units/mL for adrenal verification
Needle gauges	Claim 3 / Claim 4	20G (withdrawal); 23G (injection)
Vasopressin impurity	Claim 1 / Claim 22	≤0.05 USP Vasopressin Units per USP Corticotropin Units
Acidified WFI pH	Claim 1 / Claim 22	pH 2.8 to 3.2
Phenol content	Claims 11 and 13	0.1–1% w/w; or 0.5% w/w (with gelatin 15%)
Gelatin content	Claims 12 and 13	10–20% w/w; or 15% w/w
Particle limits	Claim 14	<6000 particles ≥10 μm; and/or <600 particles ≥25 μm
Preservative status	Claim 15	preservative-free and/or antimicrobial-free
Gel state	Claim 2	solid gel pre-warming; liquid gel post-warming
Corticotropin identity	multiple	AA 1–39 of SEQ ID NO:1
Source	Claims 5 / 22	whole porcine pituitary including anterior and posterior

What generic-entry risks exist for US corticotropin methods like these?

Because the claims are tied to administration and formulation parameters rather than broad therapeutic use alone, generic-entry risk is best assessed as a function of three elements:

Does the generic match the claimed sterile corticotropin formulation attributes?
- vasopressin impurity limit or acidified WFI pH
- phenol/gelatin content, preservative status
- particle count limits
Does the generic administration protocol mirror the claimed handling workflow?
- storage at 2–8°C; warming to 18–26°C
- injection of 80 USP units after warming
Do clinical workflows use the claimed needles?
- withdrawal 20G and injection 23G for the dependent path
- needle replacement with different gauge for the broader administration path

If a challenger uses a different needle gauge strategy, omits warming steps, varies unit dosing, or reformulates outside the pH/impurity specs, it may avoid core dependent claim coverage while still taking the risk that independent claims could be asserted depending on the exact claim construction and litigation theory.

How strong is the patent estate for this type of corticotropin claim?

Direct answer: Based on claim text alone, the strength is high for products that match both (i) handling parameters and (ii) composition constraints, and materially lower for products that only share the drug indication or generic substitution at a high level.

The strongest claim components from an assertion standpoint typically are:

the temperature and timing workflow (2–8°C storage; 18–26°C warming; then injection)
the vasopressin impurity limit or acidified WFI pH range
the dose (80 USP units) in claim 1 and concentration (80 USP units/mL) in claim 8
needle gauge switching (20G/23G) or “different gauge” replacement steps

Weakness vectors include:

changing needle gauges in withdrawal and injection
altering dose units or administration schedule
changing formulation away from the impurity or pH ranges
using preservative-free or non-gel formulations if dependent claims are targeted

What must a licensing or litigation strategy focus on for US Patent 12,233,105?

Direct answer: The litigation map is dominated by proving that the accused product and use satisfy the claim’s narrow operational and formulation parameters. High-value diligence targets are:

Release specs and assay methods for vasopressin impurity expressed in “USP Vasopressin Units per USP Corticotropin Units”
WFI acidification and pH control at the time of administration
Phenol/gelatin recipe and whether the product is preservative-free/antimicrobial-free
Particle size distributions (≥10 μm and ≥25 μm counts)
Needle gauge actually used in the administration protocol
Temperature conditioning instructions and real-world preparation steps consistent with the claim
Dose units (USP units) actually administered and whether the workflow includes the adrenal verification step (if that dependent path is asserted)

Key Takeaways

US Patent 12,233,105 is a narrow, operationally specific corticotropin patent that ties together temperature handling, USP unit dosing, and sterile composition constraints (vasopressin impurity ≤0.05 USP units/USP corticotropin units and/or acidified WFI pH 2.8–3.2).
It contains needle-gauge-limited dependent claims (notably 20G withdrawal and 23G injection) and a broader “needle replacement with different gauge” workflow.
It adds formulation-dependent limitations: phenol and gelatin ranges, particle count thresholds, preservative/antimicrobial status, and a defined phenol/gelatin recipe.
Indication coverage is present but only via dependent claims with a defined list of conditions, making enforcement more fact- and workflow-dependent.
Generic or biosimilar design-around risk hinges on changing formulation specs and/or administration workflow rather than on changing indication.

FAQs

1) Does US Patent 12,233,105 cover any corticotropin injection regardless of warming or dose?
No. The claim language requires specific temperature conditioning and, in claim 1, injection of 80 USP units after warming.

2) What is the role of the vasopressin impurity limit in the patent?
It is a qualifying formulation constraint: ≤0.05 USP Vasopressin Units/USP Corticotropin Units can satisfy the claim’s corticotropin/sterile composition requirement as drafted.

3) Are needle gauges an essential element of infringement?
In the dependent claims that specify 20G/23G, yes for those claim paths. In claim 7’s administration method, the essential element is a needle replacement with a different gauge.

4) Can a product avoid the patent by being preservative-free?
Preservative-free is a dependent claim feature (claim 15). Depending on which claims are asserted, that could avoid claim 15 but does not automatically avoid independent claim coverage.

5) Is the adrenal responsiveness verification step mandatory for all claimed uses?
No. It appears only in dependent claims 18–21, so it applies only if those dependent claims are asserted.

References

US Patent 12,233,105 (claims as provided in prompt).

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Ani Pharms	PURIFIED CORTROPHIN GEL	corticotropin	INJECTABLE;INJECTION	008975-002	Approved Prior to Jan 1, 1982		RX	Yes	Yes	12,233,105	⤷ Start Trial				ATOPIC DERMATITIS	⤷ Start Trial
Ani Pharms	PURIFIED CORTROPHIN GEL	corticotropin	INJECTABLE;INJECTION	008975-002	Approved Prior to Jan 1, 1982		RX	Yes	Yes	12,233,105	⤷ Start Trial				CHORIORETINITIS	⤷ Start Trial
Ani Pharms	PURIFIED CORTROPHIN GEL	corticotropin	INJECTABLE;INJECTION	008975-002	Approved Prior to Jan 1, 1982		RX	Yes	Yes	12,233,105	⤷ Start Trial				DIFFUSE POSTERIOR UVEITIS AND CHOROIDITIS	⤷ Start Trial
Ani Pharms	PURIFIED CORTROPHIN GEL	corticotropin	INJECTABLE;INJECTION	008975-002	Approved Prior to Jan 1, 1982		RX	Yes	Yes	12,233,105	⤷ Start Trial				DURING AN EXACERBATION OR AS MAINTENANCE THERAPY IN SELECTED CASES OF: SYSTEMIC DERMATOMYOSITIS (POLYMYOSITIS)	⤷ 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

Details for Patent: 12,233,105

Which drugs does patent 12,233,105 protect, and when does it expire?

Summary for Patent: 12,233,105