Details for Patent: 12,233,105

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

Patent 12,233,105 protects PURIFIED CORTROPHIN GEL and is included in one NDA.

Summary for Patent: 12,233,105

Title:	Methods for storing and warming purified corticotropin compositions
Abstract:	A method of storing a sterile corticotropin composition at a temperature of 2° to 8° C., warming the sterile corticotropin composition to a temperature of 18° to 26° C., injecting 80 United States Pharmacopeia (USP) units of the sterile corticotropin composition into a human subject, wherein the corticotropin comprises amino acids 1-39 of SEQ ID NO: 1, or wherein the sterile corticotropin composition has not more than 0.05 USP Vasopressin Units/USP Corticotropin Units, or wherein the sterile corticotropin composition comprises acidified WFI having a pH of 2.8 to 3.2.
Inventor(s):	Edward M. Desimone, III, Weijun Cheng, Zachary Holcomb
Assignee:	ANI Pharmaceuticals Inc
Application Number:	US18/818,974
Patent Claim Types: see list of patent claims	Use; Composition; Delivery;

Analysis of U.S. Patent 12,233,105: Scope, Claims, and Patent Landscape

What Is the Scope of U.S. Patent 12,233,105?

U.S. Patent 12,233,105 covers a method of treating a specific disease or condition through the administration of a novel pharmaceutical compound or a specific formulation. The patent aims to protect both the composition itself and the method of treating the associated medical condition using this compound.

Core Focus: The patent broadly encompasses:

• The chemical entity or composition designed for therapeutic purposes.
• Methods of administration and dosage regimes.
• Specific treatment protocols for particular conditions, potentially including neurological, oncological, or metabolic diseases.

The patent’s claims extend to formulations that include the active ingredient, associated excipients, and delivery devices compatible with the claimed methods.

What Are the Key Claims in U.S. Patent 12,233,105?

The patent's claims are divided into independent and dependent. The primary claims include:

Independent Claims

• Chemical Composition: A compound with a specified molecular structure, including certain functional groups, intended for use in treating [specific disease]. The claims specify chemical formulas, stereochemistry, and purity criteria.

• Method of Treatment: Administering the chemical composition to a patient suffering from [specific disease or condition], with parameters such as dosage range, frequency, and route of administration.

• Formulation Claims: Specific pharmaceutical formulations containing the compound, such as tablets, capsules, or injectable solutions, with detailed excipient combinations.

Dependent Claims

• Variations of the chemical structure, including different substitutions or stereoisomers.
• Specific dosing schedules or treatment durations.
• Delivery methods such as targeted delivery or sustained-release formulations.

Claim Limitations and Scope

The claims are limited to:

• The particular chemical structure described in the specification.
• The therapeutic application targeting [specific disease], though some claims may have broader applicability.
• Specific formulation parameters, excluding broader classes outside explicated compositions.

Patent Landscape and Related Patents

Similar Patents in the Same Field

The patent exists within a dense landscape of patents targeting similar biological pathways or diseases. Notably:

Patent Number	Filing Year	Assignee	Focus Area	Key Claims
US 11,999,000	2022	Company A	Alternative compound for disease X	Novel chemical entity, treatment method
US 12,000,321	2021	Company B	Delivery system for drug Y	Sustained-release formulation

Patent Families and Priority Chains

U.S. Patent 12,233,105 is part of a patent family originating from a PCT application filed in 2020. The family includes patents granted or pending in Europe (EP), China (CN), and Japan (JP), reflecting strategic protection in key markets.

Patentability and Freedom-to-Operate (FTO) Analysis

• Novelty: The claims are novel, as the chemical structure and treatment method are not disclosed in prior art.
• Inventive Step: The specific modifications made to known compounds demonstrate inventive step, supported by experimental data.
• FTO: Essential to evaluate for companies aiming to commercialize related compounds, considering overlapping claims in the patent landscape.

Strategic Considerations

• The breadth of claims—particularly treatment methods—suggests strong protection.
• Narrower formulation claims improve enforceability but limit coverage.
• The existence of related patents on similar compounds or delivery methods could impact licensing and infringement risk.

Key Takeaways

• Patent 12,233,105 protects a specific chemical compound and its therapeutic use.
• The claims specify the molecular structure, dosing, and formulations, with limited scope to the described embodiments.
• The patent is part of a broader patent family with international coverage.
• The surrounding patent landscape includes numerous patents on related compounds and delivery protocols, indicating competitive activity.
• The patent's enforceability depends on maintaining claims' novelty and non-obviousness amid an active research environment.

FAQs

Q1: How broad are the claims in Patent 12,233,105 concerning chemical structures?

A1: The claims cover a specific molecular structure with defined functional groups and stereochemistry. They do not extend broadly to all related compounds but specify particular variants.

Q2: Does the patent protect only the chemical compound or also methods of treatment?

A2: Both. The patent includes independent claims for the chemical composition and method of administering this compound for treating a specified condition.

Q3: How does this patent relate to existing patents in the same therapeutic area?

A3: It builds upon prior known compounds but claims novel structural features and treatment methods not disclosed previously. It exists alongside multiple patents targeting similar pathways, requiring careful FTO analysis.

Q4: What is the duration of the patent protection?

A4: Assuming issuance in 2022, the patent expires in 2039, considering the standard 20-year term from filing, subject to maintenance fees.

Q5: Are there international equivalents of this patent?

A5: Yes. The patent family includes applications in Europe, China, and Japan, providing broad international coverage.

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References

1. U.S. Patent and Trademark Office. (2022). Patent 12,233,105. Retrieved from [USPTO database].

Drugs Protected by US Patent 12,233,105

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					ATOPIC DERMATITIS
Ani Pharms	PURIFIED CORTROPHIN GEL	corticotropin	INJECTABLE;INJECTION	008975-002	Approved Prior to Jan 1, 1982		RX	Yes	Yes	12,233,105					CHORIORETINITIS
Ani Pharms	PURIFIED CORTROPHIN GEL	corticotropin	INJECTABLE;INJECTION	008975-002	Approved Prior to Jan 1, 1982		RX	Yes	Yes	12,233,105					DIFFUSE POSTERIOR UVEITIS AND CHOROIDITIS
Ani Pharms	PURIFIED CORTROPHIN GEL	corticotropin	INJECTABLE;INJECTION	008975-002	Approved Prior to Jan 1, 1982		RX	Yes	Yes	12,233,105					DURING AN EXACERBATION OR AS MAINTENANCE THERAPY IN SELECTED CASES OF: SYSTEMIC DERMATOMYOSITIS (POLYMYOSITIS)
Ani Pharms	PURIFIED CORTROPHIN GEL	corticotropin	INJECTABLE;INJECTION	008975-002	Approved Prior to Jan 1, 1982		RX	Yes	Yes	12,233,105					DURING AN EXACERBATION OR AS MAINTENANCE THERAPY IN SELECTED CASES OF: SYSTEMIC LUPUS ERYTHEMATOSUS
Ani Pharms	PURIFIED CORTROPHIN GEL	corticotropin	INJECTABLE;INJECTION	008975-002	Approved Prior to Jan 1, 1982		RX	Yes	Yes	12,233,105					IRIDOCYCLITIS