Nexplanon is a drug owned by Organon Usa Llc. It is protected by 4 US drug patents filed from 2014 to 2021 out of which none have expired yet. Based on its patents and exclusivities, its generic launch date is estimated to be Jul 28, 2030. Details of Nexplanon'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). | |||
| US8888745 | Applicator for inserting an implant |
Aug, 2026
(2 years from now) | Active |
| US10821277 | Kit for and method of assembling an applicator for inserting an implant |
May, 2027
(2 years from now) | Active |
| US8722037 | X-ray visible drug delivery device |
Sep, 2027
(3 years from now) | Active |
| US9757552 | Applicator for inserting an implant |
Jul, 2030
(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 Nexplanon's patents.
Latest Legal Activities on Nexplanon's Patents
Given below is the list of recent legal activities going on the following patents of Nexplanon.
| Event | Date | Patent/Publication |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 4th Year, Large Entity | 11 Apr, 2024 | US10821277 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 12 Apr, 2022 | US8888745 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 14 Oct, 2021 | US8722037 |
| Post Issue Communication - Certificate of Correction | 19 Jan, 2021 | US10821277 |
| Email Notification | 21 Dec, 2020 | US10821277 |
| Mail Pub Notice re 312 amendment | 21 Dec, 2020 | US10821277 |
| POST ISSUE OTHER COMMUNICATION TO APPLICANT- CERTIFICATE OF CORRECTION | 17 Dec, 2020 | US10821277 |
| Post Issue Communication - Certificate of Correction Denied | 17 Dec, 2020 | US10821277 |
| Patent Issue Date Used in PTA Calculation | 03 Nov, 2020 | US10821277 |
| Recordation of Patent Grant Mailed | 03 Nov, 2020 | US10821277 |
FDA has granted several exclusivities to Nexplanon. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Nexplanon, 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 Nexplanon.
Exclusivity Information
Nexplanon holds 1 exclusivities. All of its exclusivities have expired in 2014. Details of Nexplanon's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Product(NP) | May 31, 2014 |
Several oppositions have been filed on Nexplanon'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 Nexplanon's generic, the next section provides detailed information on ongoing and past EP oppositions related to Nexplanon patents.
Nexplanon's oppositions filed in EPO
Nexplanon has faced multiple oppositions in the European Patent Office. The earliest opposition was filed on May 10, 2017, by Elkington And Fife Llp. This opposition was filed on patent number EP06707776A. Click below to reveal the latest opposition data.
| Application | Filing Date | Opposition Party | Legal Status |
|---|---|---|---|
 | |||
| EP18182632A | Jun, 2021 | Consilient Health Limited | Granted and Under Opposition |
| EP06707783A | Apr, 2019 | Holme Patent A/S | Granted and Under Opposition |
| EP06707776A | May, 2017 | ELKINGTON AND FIFE LLP | Opposition rejected |
US patents provide insights into the exclusivity only within the United States, but Nexplanon 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 Nexplanon's family patents as well as insights into ongoing legal events on those patents.
Nexplanon's family patents
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Generic Launch
Generic Release Date:
Nexplanon's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Jul 28, 2030 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Nexplanon Generics:
There are no approved generic versions for Nexplanon as of now.
About Nexplanon
Nexplanon is a drug owned by Organon Usa Llc. It is used for contraception. Nexplanon uses Etonogestrel as an active ingredient. Nexplanon was launched by Organon in 2006.
Market Authorisation Date:
Nexplanon was approved by FDA for market use on 17 July, 2006.
Active Ingredient:
Nexplanon uses Etonogestrel as the active ingredient. Check out other Drugs and Companies using Etonogestrel ingredient
Treatment:
Nexplanon is used for contraception.
Dosage:
Nexplanon is available in implant form for implantation use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 68MG/IMPLANT | IMPLANT | Prescription | IMPLANTATION |