Miudella is a drug owned by Sebela Womens Health Inc. It is protected by 14 US drug patents filed from 2025 to 2026 out of which none have expired yet. Based on its patents and exclusivities, its generic launch date is estimated to be Jan 23, 2037. Details of Miudella's patents and their expiration are given in the table below.
| Drug Patent Number | Drug Patent Title | Drug Patent Expiry | Status |
|---|---|---|---|
| These drug patents focus on the other aspects of the drug like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
| US10918516 | Intrauterine device with controlled copper ion elution |
Jan, 2037
(10 years from now) | Active |
| US11207209 | Intrauterine device with retrieval thread |
Aug, 2034
(7 years from now) | Active |
| US10166141 | Intrauterine contraceptive device |
Jun, 2034
(7 years from now) | Active |
| US9265652 | Intrauterine contraceptive device |
Apr, 2034
(7 years from now) | Active |
| US9180040 | Intrauterine Device With Retrieval Thread |
Mar, 2034
(7 years from now) | Active |
| US10022264 | Intrauterine device with retrieval thread |
Mar, 2034
(7 years from now) | Active |
| US10398588 | Intrauterine device with retrieval thread |
Feb, 2034
(7 years from now) | Active |
| US9610191 | Intrauterine device with retrieval thread |
Feb, 2034
(7 years from now) | Active |
| US12138199 | Intrauterine device with retrieval thread |
Oct, 2033
(7 years from now) | Active |
| US9089418 | Intrauterine contraceptive device |
Apr, 2033
(6 years from now) | Active |
| US11850181 | Intrauterine contraceptive device |
Aug, 2032
(5 years from now) | Active |
| US9427351 | Intrauterine contraceptive device |
Aug, 2032
(5 years from now) | Active |
| US10159596 | Intrauterine contraceptive device |
Aug, 2032
(5 years from now) | Active |
| US10188546 | Intrauterine device with controlled copper ion elution |
Aug, 2032
(5 years from now) | Active |
A patent's expiry date may change depending upon legal activities going on that patent. Critical
activities like
abandoning of a patent, term extension of a patent or amendment of its claims can increase or decrease
the life of a
patent hence affecting its expiry date and in turn affecting the generic launch date of that drug.
Tracking these
ongoing activities on a patent application helps to keep an eye on the latest developments in the
patent process of
the drug which can give an idea of how early a drug's generic could be available. The next section
provides a list of
recent legal activities on Miudella's patents.
Latest Legal Activities on Miudella's Patents
Given below is the list of recent legal activities going on the following patents of Miudella.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 8th Yr, Small Entity | 31 Dec, 2025 | US10022264 |
| Payment of Maintenance Fee, 4th Yr, Small Entity | 11 Jun, 2025 | US11207209 |
| Recordation of Patent eGrant | 12 Nov, 2024 | US12138199 |
| Patent Issue Date Used in PTA Calculation | 12 Nov, 2024 | US12138199 |
| Patent eGrant Notification | 12 Nov, 2024 | US12138199 |
| Recordation of Patent Grant Mailed | 12 Nov, 2024 | US12138199 |
| Mail Patent eGrant Notification | 12 Nov, 2024 | US12138199 |
| Email Notification | 12 Nov, 2024 | US12138199 |
| Email Notification | 24 Oct, 2024 | US12138199 |
| Issue Notification Mailed | 23 Oct, 2024 | US12138199 |
FDA has granted several exclusivities to Miudella. Till the time
these exclusivities
are active, no other company can market a generic or bioequivalent version of Miudella, 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
Miudella.
Exclusivity Information
Miudella holds 1 exclusivities out of which none have expired. Its last outstanding exclusivity is set to expire in 2028. Details of Miudella's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Product(NP) | Feb 24, 2028 |
US patents provide insights into the exclusivity only within the United States, but
Miudella 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 Miudella's family patents as well as insights into
ongoing legal events
on those patents.
Miudella's Family Patents
Explore Our Curated Drug Screens
Clinical Trials
Recent Clinical Trials on Miudella:
Sometimes companies keep conducting clinical trials even after the drug's approval to discover new formulations, methods of use, or new treatment indications, so they could file for additional patents or receive regulatory exclusivity extensions, such as pediatric exclusivity, potentially delaying generic competition. Based on these recent clinical trials, generic companies need to consider the potential for new intellectual property or regulatory hurdles. These strategic moves by the drug owner might delay generic substitution or lead to additional sales of the brand drug, even after patent expiry.
Generic Launch
Generic Release Date:
Miudella's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Jan 23, 2037 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Miudella Generics:
There are no approved generic versions for Miudella as of now.
Alternative Brands for Miudella
There are several other brand drugs using the same active ingredient (Copper) as Miudella. Given below is the list of those companies and their brand drugs, to help you identify new opportunities, assess competitors, and plan your market strategies more effectively.
| Drug Owner | Drug Name | |
|---|---|---|
| Curium |
|
About Miudella
Miudella is a drug owned by Sebela Womens Health Inc. Miudella uses Copper as an active ingredient. Miudella was launched by Sebela in 2025.
Approval Date:
Miudella was approved by FDA for market use on 24 February, 2025.
Active Ingredient:
Miudella uses Copper as the active ingredient. Check out other Drugs and Companies using Copper ingredient
Dosage:
Miudella is available in system form for intrauterine use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| N/A | SYSTEM | Prescription | INTRAUTERINE |