Mirena is a drug owned by Bayer Healthcare Pharmaceuticals Inc. It is protected by 6 US drug patents filed from 2013 to 2024. Out of these, 5 drug patents are active and 1 has expired. Based on its patents and exclusivities, its generic launch date is estimated to be Apr 01, 2031. Details of Mirena'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). | |||
| US10987244 | Inserter |
Apr, 2031
(5 years from now) | Active |
| US9668912 | Inserter |
Apr, 2031
(5 years from now) | Active |
| US9615965 | Inserter |
Sep, 2029
(3 years from now) | Active |
| US10561524 | Inserter |
Sep, 2029
(3 years from now) | Active |
| US11850182 | Inserter |
Sep, 2029
(3 years from now) | Active |
| US5785053 | Inserter for the positioning of an intrauterine device |
Dec, 2015
(9 years ago) |
Expired
|
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 Mirena's patents.
Latest Legal Activities on Mirena's Patents
Given below is the list of recent legal activities going on the following patents of Mirena.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Patent eGrant Notification | 26 Dec, 2023 | US11850182 |
| Patent Issue Date Used in PTA Calculation
Critical | 26 Dec, 2023 | US11850182 |
| Recordation of Patent Grant Mailed
Critical | 26 Dec, 2023 | US11850182 |
| Recordation of Patent eGrant | 26 Dec, 2023 | US11850182 |
| Mail Patent eGrant Notification | 26 Dec, 2023 | US11850182 |
| Email Notification
Critical | 26 Dec, 2023 | US11850182 |
| Email Notification
Critical | 07 Dec, 2023 | US11850182 |
| Issue Notification Mailed
Critical | 06 Dec, 2023 | US11850182 |
| Dispatch to FDC | 16 Nov, 2023 | US11850182 |
| Application Is Considered Ready for Issue
Critical | 16 Nov, 2023 | US11850182 |
FDA has granted several exclusivities to Mirena. Till the time
these exclusivities
are active, no other company can market a generic or bioequivalent version of Mirena, 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
Mirena.
Exclusivity Information
Mirena holds 2 exclusivities. All of its exclusivities have expired in 2023. Details of Mirena's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Indication(I-610) | Oct 01, 2012 |
| New Dosing Schedule(D-181) | Aug 20, 2023 |
Several oppositions have been filed on Mirena's European patents.
EP oppositions
can significantly impact the timeline for the generic launch of drugs. If an opposition results in the
revocation or
amendment of a patent, it can shorten the exclusivity period of the original drug. This can lead to an
earlier entry
of generic versions into the market. To help you estimate the potential early arrival of Mirena's generic, the next section provides detailed information on
ongoing and past
EP oppositions related to Mirena patents.
Mirena's Oppositions Filed in EPO
Mirena has faced multiple oppositions in the European Patent Office. The earliest opposition was filed on Sep 18, 2013, by Actavis Group Ptc Ehf. This opposition was filed on patent number EP09736244A. Click below to reveal the latest opposition data.
| Application | Filing Date | Opposition Party | Legal Status |
|---|---|---|---|
 | |||
| EP09736608A | Feb, 2014 | Actavis Group PTC ehf | Patent maintained as amended |
| EP09736244A | Sep, 2013 | Actavis Group PTC EHF | Patent maintained as amended |
US patents provide insights into the exclusivity only within the United States, but
Mirena 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 Mirena's family patents as well as insights into
ongoing legal events
on those patents.
Mirena's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Mirena's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Apr 01, 2031 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Mirena Generic API suppliers:
Levonorgestrel is the generic name for the brand Mirena. 17 different companies have already filed for the generic of Mirena, with Xiromed having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Mirena's generic
Alternative Brands for Mirena
Mirena which is used for contraception by insertion of an intrauterine system., has several other brand drugs in the same treatment category and using the same active ingredient (Levonorgestrel). 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.
Apart from drugs working in same treatment category, there are also some brand drugs where treatment area is different, but the active ingredient used is same i.e. Levonorgestrel. Given below is the list of those drugs and companies owning them.
| Drug Owner | Drug Name | |||||
|---|---|---|---|---|---|---|
| Agile |
| |||||
| Avion Pharms |
| |||||
| Bayer Hlthcare |
| |||||
| Medicines360 |
| |||||
| Teva Branded Pharm |
| |||||
| Wyeth Pharms Inc |
|
Apart from brand drugs containing the same ingredient, some generics have also been filed for Levonorgestrel, Mirena's active ingredient. Check the complete list of approved generic manufacturers for Mirena
About Mirena
Mirena is a drug owned by Bayer Healthcare Pharmaceuticals Inc. It is used for contraception by insertion of an intrauterine system. Mirena uses Levonorgestrel as an active ingredient. Mirena was launched by Bayer Hlthcare in 2000.
Approval Date:
Mirena was approved by FDA for market use on 06 December, 2000.
Active Ingredient:
Mirena uses Levonorgestrel as the active ingredient. Check out other Drugs and Companies using Levonorgestrel ingredient
Treatment:
Mirena is used for contraception by insertion of an intrauterine system.
Dosage:
Mirena is available in system form for intrauterine use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 52MG | SYSTEM | Prescription | INTRAUTERINE |