MIMRYLO Drug Patent Profile
Which patents cover Mimrylo, and what generic alternatives are available?
Mimrylo is a drug marketed by Takeda Pharms Am and is included in one NDA. There are six patents protecting this drug.
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.
DrugPatentWatch® Generic Entry Outlook for Mimrylo
Mimrylo will be eligible for patent challenges on August 28, 2030. This date may extended up to six months if a pediatric exclusivity extension is applied to the drug's patents.
By analyzing the patents and regulatory protections it appears that the earliest date
for generic entry will be March 17, 2034. This may change due to patent challenges or generic licensing.
There have been two patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.
Indicators of Generic Entry
AI Deep Research
Questions you can ask:
- What is the 5 year forecast for MIMRYLO?
- What are the global sales for MIMRYLO?
- What is Average Wholesale Price for MIMRYLO?
Summary for MIMRYLO
| US Patents: | 6 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for MIMRYLO |
| What excipients (inactive ingredients) are in MIMRYLO? | MIMRYLO excipients list |
| DailyMed Link: | MIMRYLO at DailyMed |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for MIMRYLO
Generic Entry Date for MIMRYLO*:
Constraining patent/regulatory exclusivity:
NDA:
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.
US Patents and Regulatory Information for MIMRYLO
MIMRYLO is protected by six US patents and one FDA Regulatory Exclusivity.
Based on analysis by DrugPatentWatch, the earliest date for a generic version of MIMRYLO is ⤷ Start Trial.
This potential generic entry date is based on patent 10,030,061.
Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Takeda Pharms Am | MIMRYLO | rusfertide acetate | POWDER;SUBCUTANEOUS | 220605-005 | Aug 28, 2026 | RX | Yes | Yes | 10,442,846 | ⤷ Start Trial | Y | Y | ⤷ Start Trial | ||
| Takeda Pharms Am | MIMRYLO | rusfertide acetate | POWDER;SUBCUTANEOUS | 220605-004 | Aug 28, 2026 | RX | Yes | Yes | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | ||||
| Takeda Pharms Am | MIMRYLO | rusfertide acetate | POWDER;SUBCUTANEOUS | 220605-005 | Aug 28, 2026 | RX | Yes | Yes | 9,822,157 | ⤷ Start Trial | Y | Y | ⤷ Start Trial | ||
| Takeda Pharms Am | MIMRYLO | rusfertide acetate | POWDER;SUBCUTANEOUS | 220605-005 | Aug 28, 2026 | RX | Yes | Yes | 12,269,856 | ⤷ Start Trial | ⤷ Start Trial | ||||
| Takeda Pharms Am | MIMRYLO | rusfertide acetate | POWDER;SUBCUTANEOUS | 220605-001 | Aug 28, 2026 | RX | Yes | Yes | 12,269,856 | ⤷ Start Trial | ⤷ Start Trial | ||||
| Takeda Pharms Am | MIMRYLO | rusfertide acetate | POWDER;SUBCUTANEOUS | 220605-003 | Aug 28, 2026 | RX | Yes | Yes | 10,442,846 | ⤷ Start Trial | Y | Y | ⤷ Start Trial | ||
| Takeda Pharms Am | MIMRYLO | rusfertide acetate | POWDER;SUBCUTANEOUS | 220605-004 | Aug 28, 2026 | RX | Yes | Yes | 10,501,515 | ⤷ Start Trial | Y | ⤷ Start Trial | |||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
International Patents for MIMRYLO
When does loss-of-exclusivity occur for MIMRYLO?
Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:
Australia
Patent: 14232954
Estimated Expiration: ⤷ Start Trial
Patent: 18260800
Estimated Expiration: ⤷ Start Trial
Canada
Patent: 06830
Estimated Expiration: ⤷ Start Trial
China
Patent: 5451755
Estimated Expiration: ⤷ Start Trial
Croatia
Patent: 0211911
Estimated Expiration: ⤷ Start Trial
Denmark
Patent: 68443
Estimated Expiration: ⤷ Start Trial
European Patent Office
Patent: 68443
Estimated Expiration: ⤷ Start Trial
Patent: 91624
Estimated Expiration: ⤷ Start Trial
Hong Kong
Patent: 20112
Estimated Expiration: ⤷ Start Trial
Hungary
Patent: 57168
Estimated Expiration: ⤷ Start Trial
Israel
Patent: 1043
Estimated Expiration: ⤷ Start Trial
Japan
Patent: 25471
Estimated Expiration: ⤷ Start Trial
Patent: 22227
Estimated Expiration: ⤷ Start Trial
Patent: 16521257
Estimated Expiration: ⤷ Start Trial
Patent: 18123169
Estimated Expiration: ⤷ Start Trial
Lithuania
Patent: 68443
Estimated Expiration: ⤷ Start Trial
New Zealand
Patent: 2029
Estimated Expiration: ⤷ Start Trial
Patent: 1741
Estimated Expiration: ⤷ Start Trial
Poland
Patent: 68443
Estimated Expiration: ⤷ Start Trial
Portugal
Patent: 68443
Estimated Expiration: ⤷ Start Trial
Serbia
Patent: 633
Estimated Expiration: ⤷ Start Trial
Singapore
Patent: 201707622X
Estimated Expiration: ⤷ Start Trial
Patent: 201507226Y
Estimated Expiration: ⤷ Start Trial
Slovenia
Patent: 68443
Estimated Expiration: ⤷ Start Trial
South Korea
Patent: 2236829
Estimated Expiration: ⤷ Start Trial
Patent: 160005332
Estimated Expiration: ⤷ Start Trial
Spain
Patent: 01704
Estimated Expiration: ⤷ Start Trial
Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.
See the table below for additional patents covering MIMRYLO around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Australia | 2014232954 | ⤷ Start Trial | |
| Australia | 2018260800 | ⤷ Start Trial | |
| Canada | 2906830 | ⤷ Start Trial | |
| China | 105451755 | ⤷ Start Trial | |
| Denmark | 2968443 | ⤷ Start Trial | |
| European Patent Office | 2968443 | ⤷ Start Trial | |
| European Patent Office | 4091624 | ⤷ Start Trial | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Make Better Decisions: Try a trial or see plans & pricing
Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. We do not provide individual investment advice. This service is not registered with any financial regulatory agency. The information we publish is educational only and based on our opinions plus our models. By using DrugPatentWatch you acknowledge that we do not provide personalized recommendations or advice. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.
ISSN: 2162-2639
Privacy and Cookies
Terms & Conditions
Site Map
DrugPatentWatch Alternatives
LOE / Major Patent Expirations 2026 - 2027
NCE-1 Patent Challenge Dates 2026 - 2027
Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2026, www.DrugPatentWatch.com.
See Primary Research Papers Citing DrugPatentWatch