US11975047 — 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 for storing and warming a specific type of corticotropin composition, such as Acthar Gel, in a multiple-dose vial.
USPTO Abstract
A method of storing and warming a sterile corticotropin composition by storing the sterile corticotropin composition in a multiple-dose vial comprising 80 USP units/mL of the sterile corticotropin composition, wherein the vial comprises a rubber stopper coated with cross-linked silicones, at a temperature of 2° to 8° C.; and warming the vial to a temperature of 18° to 26° C., 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.
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-3904 |
— | 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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