Details for New Drug Application (NDA): 220605
NDA 220605 describes MIMRYLO, which is a drug marketed by Takeda Pharms Am and is included in one NDA. It is available from one supplier. There are six patents protecting this drug. Additional details are available on the MIMRYLO profile page.
The generic ingredient in MIMRYLO is rusfertide acetate. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the rusfertide acetate profile page.
The generic ingredient in MIMRYLO is rusfertide acetate. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the rusfertide acetate profile page.
Summary for 220605
| Tradename: | MIMRYLO |
| Applicant: | Takeda Pharms Am |
| Ingredient: | rusfertide acetate |
| Patents: | 6 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 220605
Generic Entry Date for 220605*:
Constraining patent/regulatory exclusivity:
Dosage:
POWDER;SUBCUTANEOUS |
*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.
Suppliers and Packaging for NDA: 220605
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| MIMRYLO | rusfertide acetate | POWDER;SUBCUTANEOUS | 220605 | NDA | Takeda Pharmaceuticals America, Inc. | 63020-715 | 63020-715-10 | 1 KIT in 1 CARTON (63020-715-10) * 9.5 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-DOSE (63020-710-10) * .6 mL in 1 SYRINGE (63020-600-05) |
| MIMRYLO | rusfertide acetate | POWDER;SUBCUTANEOUS | 220605 | NDA | Takeda Pharmaceuticals America, Inc. | 63020-725 | 63020-725-20 | 1 KIT in 1 CARTON (63020-725-20) * 19 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL (63020-720-20) * .6 mL in 1 SYRINGE (63020-600-05) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | POWDER;SUBCUTANEOUS | Strength | EQ 9.5MG BASE/VIAL | ||||
| Approval Date: | Aug 28, 2026 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | Aug 28, 2031 | ||||||||
| Regulatory Exclusivity Use: | NEW CHEMICAL ENTITY | ||||||||
| Patent: | ⤷ Start Trial | Patent Expiration: | Mar 17, 2034 | Product Flag? | Y | Substance Flag? | Y | Delist Request? | |
| Patent: | ⤷ Start Trial | Patent Expiration: | Mar 17, 2034 | Product Flag? | Y | Substance Flag? | Y | Delist Request? | |
| Patented Use: | TREATMENT OF ERYTHROCYTOSIS IN ADULTS WITH POLYCYTHEMIA VERA (PV) | ||||||||
Complete Access Available with Subscription
