Mimrylo is a drug owned by Takeda Pharmaceuticals America Inc. It is protected by 6 US drug patents filed in 2026 out of which none have expired yet. Mimrylo's patents will be open to challenges from 28 August, 2030. Based on its patents and exclusivities, its generic launch date is estimated to be Mar 17, 2034. Details of Mimrylo's patents and their expiration are given in the table below.
| Drug Patent Number | Drug Patent Title | Drug Patent Expiry | Status |
|---|---|---|---|
| These drug patents protect the active ingredient(API) of the drug. Only drug patent owner can launch products that use this active ingredient until these patents expire. | |||
| US10030061 | Hepcidin Analogues And Uses Thereof |
Mar, 2034
(7 years from now) | Active |
| US9822157 | Hepcidin Analogues And Uses Thereof |
Mar, 2034
(7 years from now) | Active |
| US10442846 | Hepcidin Analogues And Uses Thereof |
Mar, 2034
(7 years from now) | Active |
| US10501515 | Hepcidin Analogues And Uses Thereof |
Mar, 2034
(7 years from now) | Active |
| These drug patents focus on the other aspects of the drug like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
| US11807674 | Hepcidin Analogues And Uses Thereof |
Mar, 2034
(7 years from now) | Active |
| US12269856 | Hepcidin Analogues And Uses Thereof |
Mar, 2034
(7 years from now) | Active |
FDA has granted several exclusivities to Mimrylo. Till the time
these exclusivities
are active, no other company can market a generic or bioequivalent version of Mimrylo, regardless of the status of it's patents. These exclusivities hence play a crucial role in
delaying the generic
launch. Given below are details of the exclusivities granted to
Mimrylo.
Exclusivity Information
Mimrylo holds 1 exclusivities out of which none have expired. Its last outstanding exclusivity is set to expire in 2031. Details of Mimrylo's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Chemical Entity Exclusivity(NCE) | Aug 28, 2031 |
US patents provide insights into the exclusivity only within the United States, but
Mimrylo is protected by patents in multiple countries.
Understanding
the full scope
of patent protection is crucial in strategizing market entry. By looking at the broader patent
landscape, you can
identify markets with weaker patent protection which could be ideal generic entry points. The
following section offers
details on Mimrylo's family patents as well as insights into
ongoing legal events
on those patents.
Mimrylo's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Mimrylo's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Mar 17, 2034 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Mimrylo Generics:
There are no approved generic versions for Mimrylo as of now.
About Mimrylo
Mimrylo is a drug owned by Takeda Pharmaceuticals America Inc. Mimrylo uses Rusfertide Acetate as an active ingredient. Mimrylo was launched by Takeda Am in 2026.
Approval Date:
Mimrylo was approved by FDA for market use on 28 August, 2026.
NCE-1 date:
NCE-1 date also known as the four year date occurs four years after the original drug approval and marks the first opportunity for a generic manufacturer to file an ANDA with a Paragraph IV certification. This is the earliest point when generic competition might begin, provided the challenge is successful. Since the approval date for Mimrylo is 28 August, 2026, its NCE-1 date is estimated to be 28 August, 2030.
Active Ingredient:
Mimrylo uses Rusfertide Acetate as the active ingredient. Check out other Drugs and Companies using Rusfertide Acetate ingredient
Dosage:
Mimrylo is available in powder form for subcutaneous use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| EQ 41MG BASE/VIAL | POWDER | Prescription | SUBCUTANEOUS |
| EQ 19MG BASE/VIAL | POWDER | Prescription | SUBCUTANEOUS |
| EQ 28MG BASE/VIAL | POWDER | Prescription | SUBCUTANEOUS |
| EQ 9.5MG BASE/VIAL | POWDER | Prescription | SUBCUTANEOUS |
| EQ 54MG BASE/VIAL | POWDER | Prescription | SUBCUTANEOUS |