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MIMRYLO (RUSFERTIDE ACETATE) | LOERadar

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MIMRYLO

NDA

RUSFERTIDE ACETATE | N220605 | TAKEDA PHARMACEUTICALS AMERICA INC

5 strengths0 unique patents0 unique exclusivities

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

No ANDA patent litigation cases (NOS 835) matched from PACER

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Sep 1, 2026	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (5)

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#001 — EQ 9.5MG BASE/VIAL

RLD

0 patents0 exclusivities▴

POWDER;SUBCUTANEOUS | Approved: Aug 28, 2026

No patent or exclusivity listings for this strength.

#002 — EQ 19MG BASE/VIAL

RLD

0 patents0 exclusivities▾

POWDER;SUBCUTANEOUS | Approved: Aug 28, 2026

#003 — EQ 28MG BASE/VIAL

RLD

0 patents0 exclusivities▾

POWDER;SUBCUTANEOUS | Approved: Aug 28, 2026

#004 — EQ 41MG BASE/VIAL

RLD

0 patents0 exclusivities▾

POWDER;SUBCUTANEOUS | Approved: Aug 28, 2026

#005 — EQ 54MG BASE/VIAL

RLD

0 patents0 exclusivities▾

POWDER;SUBCUTANEOUS | Approved: Aug 28, 2026

Change History (5)

Recent changes detected for this application.

ADDED10/19/2026

Takeda Pharmaceuticals added new chemical entity exclusivity to MIMRYLO (rusfertide acetate), expiring Aug 2031.

New: MIMRYLO (RUSFERTIDE ACETATE) — exclusivity NCE exp 08/28/2031

ADDED10/19/2026

Takeda added new chemical entity (NCE) exclusivity to Mimrylo (rusfertide acetate), expiring Aug 2031, providing five years of regulatory exclusivity from its NDA approval date.

New: MIMRYLO (RUSFERTIDE ACETATE) — exclusivity NCE exp 08/28/2031

ADDED10/19/2026

Takeda Pharmaceuticals added new chemical entity (NCE) exclusivity to Mimrylo (rusfertide acetate), expiring Aug 2031.

New: MIMRYLO (RUSFERTIDE ACETATE) — exclusivity NCE exp 08/28/2031

ADDED10/19/2026

Takeda Pharmaceuticals added new chemical entity (NCE) exclusivity to MIMRYLO (rusfertide acetate), expiring Aug 2031.

New: MIMRYLO (RUSFERTIDE ACETATE) — exclusivity NCE exp 08/28/2031

ADDED10/19/2026

Takeda Pharmaceuticals added new chemical entity (NCE) exclusivity to MIMRYLO (rusfertide acetate), expiring Aug 2031.

New: MIMRYLO (RUSFERTIDE ACETATE) — exclusivity NCE exp 08/28/2031