Skyla is a drug owned by Bayer Healthcare Pharmaceuticals Inc. It is protected by 8 US drug patents filed from 2013 to 2024. Out of these, 6 drug patents are active and 2 have expired. Based on its patents and exclusivities, its generic launch date is estimated to be Apr 01, 2031. Details of Skyla'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
(6 years from now) | Active |
| US9668912 | Inserter |
Apr, 2031
(6 years from now) | Active |
| US9615965 | Inserter |
Sep, 2029
(4 years from now) | Active |
| US10561524 | Inserter |
Sep, 2029
(4 years from now) | Active |
| US11850182 | Inserter |
Sep, 2029
(4 years from now) | Active |
| US11628088 | Ultrasonically detectable intrauterine system and a method for enhancing ultrasound detection |
Feb, 2027
(2 years from now) | Active |
| US7252839 | Delivery system and a manufacturing process of a delivery system |
Nov, 2023
(1 year, 1 month ago) |
Expired
|
| US5785053 | Inserter for the positioning of an intrauterine device |
Dec, 2015
(9 years ago) |
Expired
|
FDA has granted several exclusivities to Skyla. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Skyla, 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 Skyla.
Exclusivity Information
Skyla holds 1 exclusivities. All of its exclusivities have expired in 2016. Details of Skyla's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Product(NP) | Jan 09, 2016 |
Several oppositions have been filed on Skyla'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 Skyla's generic, the next section provides detailed information on ongoing and past EP oppositions related to Skyla patents.
Skyla's Oppositions Filed in EPO
Skyla 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 Skyla 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 Skyla's family patents as well as insights into ongoing legal events on those patents.
Skyla's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Skyla'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)
Skyla Generic API suppliers:
Levonorgestrel is the generic name for the brand Skyla. 16 different companies have already filed for the generic of Skyla, with Xiromed having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Skyla's generic
Alternative Brands for Skyla
Skyla which is used for long-acting birth control & preventing pregnancy., 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, Skyla's active ingredient. Check the complete list of approved generic manufacturers for Skyla
About Skyla
Skyla is a drug owned by Bayer Healthcare Pharmaceuticals Inc. It is used for long-acting birth control & preventing pregnancy. Skyla uses Levonorgestrel as an active ingredient. Skyla was launched by Bayer Hlthcare in 2013.
Approval Date:
Skyla was approved by FDA for market use on 09 January, 2013.
Active Ingredient:
Skyla uses Levonorgestrel as the active ingredient. Check out other Drugs and Companies using Levonorgestrel ingredient
Treatment:
Skyla is used for long-acting birth control & preventing pregnancy.
Dosage:
Skyla is available in system form for intrauterine use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 13.5MG | SYSTEM | Prescription | INTRAUTERINE |