US12233105 — Methods for storing and warming purified corticotropin compositions
Method of Use · Assigned to ANI Pharmaceuticals Inc · Expires 2043-10-27 · 17y remaining
What this patent protects
This patent protects a method of using a purified corticotropin composition, specifically Acthar Gel, by storing and warming it before injecting 80 USP units into a human subject.
USPTO 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.
Drugs covered by this patent
- Acthar Gel (CORTICOTROPIN) · Mallinckrodt Ireland
FDA Patent Use Codes
When a patent is method-of-use, FDA lists it once per applicable indication ("U-code"). Each U-code carves out a specific therapeutic use that generic filers must either license or design around.
| Code | Description | Drug |
|---|---|---|
U-3912 |
— | Acthar Gel |
Bibliographic data sourced from FDA Orange Book + USPTO public records. Plain-English summary generated by AI grounded in source text. Patent term extensions (PTR, SPC, pediatric) may shift the effective expiry. Not legal advice.
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