Liletta is a drug owned by Medicines360. It is protected by 4 US drug patents filed from 2018 to 2024 out of which none have expired yet. Based on its patents and exclusivities, its generic launch date is estimated to be Sep 07, 2040. Details of Liletta's patents and their expiration are given in the table below.
| Drug Patent Number | Drug Patent Title | Drug Patent Expiry | Status |
|---|---|---|---|
| These drug patents protect the active ingredient(API) of the drug. Only drug patent owner can launch products that use this active ingredient until these patents expire. | |||
| US12004992 | Kits for intrauterine systems and IUD insertion devices |
Oct, 2033
(8 years from now) | Active |
| These drug patents focus on the other aspects of the drug like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
| US11571328 | IUD insertion devices |
Sep, 2040
(15 years from now) | Active |
| US10028858 | Intrauterine systems, IUD insertion devices, and related methods and kits therefor |
Mar, 2034
(9 years from now) | Active |
| US11090186 | Methods for using intrauterine systems and IUD insertion devices |
Oct, 2033
(8 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 Liletta's patents.
Latest Legal Activities on Liletta's Patents
Given below is the list of recent legal activities going on the following patents of Liletta.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Recordation of Patent Grant Mailed Critical | 07 Feb, 2023 | US11571328 |
| Patent Issue Date Used in PTA Calculation Critical | 07 Feb, 2023 | US11571328 |
| Email Notification Critical | 19 Jan, 2023 | US11571328 |
| Issue Notification Mailed Critical | 18 Jan, 2023 | US11571328 |
| Email Notification Critical | 06 Jan, 2023 | US11571328 |
| Mailing Corrected Notice of Allowability | 06 Jan, 2023 | US11571328 |
| Corrected Notice of Allowability | 28 Dec, 2022 | US11571328 |
| Pubs Case Remand to TC Critical | 05 Dec, 2022 | US11571328 |
| Email Notification Critical | 02 Dec, 2022 | US11571328 |
| Mailing Corrected Notice of Allowability | 02 Dec, 2022 | US11571328 |
FDA has granted several exclusivities to Liletta. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Liletta, 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 Liletta.
Exclusivity Information
Liletta holds 2 exclusivities out of which 1 have expired. Its last outstanding exclusivity is set to expire in 2026. Details of Liletta's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Product(NP) | Feb 26, 2018 |
| New Indication(I-917) | Jun 29, 2026 |
Several oppositions have been filed on Liletta'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 Liletta's generic, the next section provides detailed information on ongoing and past EP oppositions related to Liletta patents.
Liletta's Oppositions Filed in EPO
Liletta has faced multiple oppositions in the European Patent Office. The earliest opposition was filed on Jun 11, 2019, by Bayer Intellectual Property Gmbh / Bayer Oy / Bayerag. This opposition was filed on patent number EP12811921A. Click below to reveal the latest opposition data.
| Application | Filing Date | Opposition Party | Legal Status |
|---|---|---|---|
 | |||
| EP12811921A | Jun, 2019 | Bayer Intellectual Property GmbH / Bayer Oy / BayerAG | Patent maintained as amended |
US patents provide insights into the exclusivity only within the United States, but Liletta 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 Liletta's family patents as well as insights into ongoing legal events on those patents.
Liletta's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Liletta's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Sep 07, 2040 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Liletta Generic API suppliers:
Levonorgestrel is the generic name for the brand Liletta. 16 different companies have already filed for the generic of Liletta, with Xiromed having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Liletta's generic
Alternative Brands for Liletta
Liletta which is used for birth control and prevention of pregnancy., has several other brand drugs 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.
| Drug Owner | Drug Name | |||||
|---|---|---|---|---|---|---|
| Agile |
| |||||
| Avion Pharms |
| |||||
| Bayer Hlthcare |
| |||||
| Teva Branded Pharm |
| |||||
| Wyeth Pharms Inc |
|
Apart from brand drugs containing the same ingredient, some generics have also been filed for Levonorgestrel, Liletta's active ingredient. Check the complete list of approved generic manufacturers for Liletta
About Liletta
Liletta is a drug owned by Medicines360. It is used for birth control and prevention of pregnancy. Liletta uses Levonorgestrel as an active ingredient. Liletta was launched by Medicines360 in 2015.
Approval Date:
Liletta was approved by FDA for market use on 26 February, 2015.
Active Ingredient:
Liletta uses Levonorgestrel as the active ingredient. Check out other Drugs and Companies using Levonorgestrel ingredient
Treatment:
Liletta is used for birth control and prevention of pregnancy.
Dosage:
Liletta 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 |