Kyleena is a drug owned by Bayer Healthcare Pharmaceuticals Inc. It is protected by 7 US drug patents filed from 2016 to 2024. Out of these, 6 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 Kyleena'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 active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
| US7252839 | Delivery system and a manufacturing process of a delivery system |
Nov, 2023
(8 months ago) |
Expired
|
| US11628088 | Ultrasonically detectable intrauterine system and a method for enhancing ultrasound detection |
Feb, 2027
(2 years from now) | Active |
| US11850182 | Inserter |
Sep, 2029
(5 years from now) | Active |
| US9615965 | Inserter |
Sep, 2029
(5 years from now) | Active |
| US10561524 | Inserter |
Sep, 2029
(5 years from now) | Active |
| US10987244 | Inserter |
Apr, 2031
(6 years from now) | Active |
| US9668912 | Inserter |
Apr, 2031
(6 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 Kyleena's patents.
Latest Legal Activities on Kyleena's Patents
Given below is the list of recent legal activities going on the following patents of Kyleena.
| Event | Date | Patent/Publication |
|---|---|---|
 | ||
| Patent eGrant Notification | 26 Dec, 2023 | US11850182 |
| Patent Issue Date Used in PTA Calculation | 26 Dec, 2023 | US11850182 |
| Recordation of Patent eGrant | 26 Dec, 2023 | US11850182 |
| Email Notification | 26 Dec, 2023 | US11850182 |
| Mail Patent eGrant Notification | 26 Dec, 2023 | US11850182 |
| Recordation of Patent Grant Mailed | 26 Dec, 2023 | US11850182 |
| Email Notification | 07 Dec, 2023 | US11850182 |
| Issue Notification Mailed | 06 Dec, 2023 | US11850182 |
| Dispatch to FDC | 16 Nov, 2023 | US11850182 |
| Application Is Considered Ready for Issue | 16 Nov, 2023 | US11850182 |
FDA has granted several exclusivities to Kyleena. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Kyleena, 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 Kyleena.
Exclusivity Information
Kyleena holds 1 exclusivities. All of its exclusivities have expired in 2019. Details of Kyleena's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Product(NP) | Sep 16, 2019 |
Several oppositions have been filed on Kyleena'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 Kyleena's generic, the next section provides detailed information on ongoing and past EP oppositions related to Kyleena patents.
Kyleena's oppositions filed in EPO
Kyleena has faced multiple oppositions in the European Patent Office. The earliest opposition was filed on Dec 03, 2008, by N.V. Organon. This opposition was filed on patent number EP03797325A. 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 |
| EP03797325A | Dec, 2008 | N.V. Organon | Patent maintained as amended |
US patents provide insights into the exclusivity only within the United States, but Kyleena 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 Kyleena's family patents as well as insights into ongoing legal events on those patents.
Kyleena's family patents
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Generic Launch
Generic Release Date:
Kyleena'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)
Kyleena Generics:
Levonorgestrel is the generic name for the brand Kyleena. 16 different companies have already filed for the generic of Kyleena, with Xiromed having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Kyleena's generic
About Kyleena
Kyleena is a drug owned by Bayer Healthcare Pharmaceuticals Inc. It is used for preventing pregnancy with the intrauterine system (IUS). Kyleena uses Levonorgestrel as an active ingredient. Kyleena was launched by Bayer Hlthcare in 2016.
Market Authorisation Date:
Kyleena was approved by FDA for market use on 16 September, 2016.
Active Ingredient:
Kyleena uses Levonorgestrel as the active ingredient. Check out other Drugs and Companies using Levonorgestrel ingredient
Treatment:
Kyleena is used for preventing pregnancy with the intrauterine system (IUS).
Dosage:
Kyleena is available in system form for intrauterine use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 19.5MG | SYSTEM | Prescription | INTRAUTERINE |