Nextstellis is a drug owned by Mayne Pharma Llc. It is protected by 5 US drug patents filed from 2021 to 2025 out of which none have expired yet. Nextstellis's patents have been open to challenges since 15 April, 2025. Based on its patents and exclusivities, its generic launch date is estimated to be Feb 09, 2043. Details of Nextstellis'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). | |||
| US12233074 | Contraceptive methods with improved pearl index |
Feb, 2043
(17 years from now) | Active |
| US11957694 | Orodispersible dosage unit containing an estetrol component |
Jun, 2036
(10 years from now) | Active |
| US11793760 | Orodispersible dosage unit containing an estetrol component |
Jun, 2036
(10 years from now) | Active |
| US11964055 | Orodispersible dosage unit containing an estetrol component |
Jun, 2036
(10 years from now) | Active |
| US7732430 | Drug delivery system comprising a tetrahydroxilated estrogen for use in hormonal contraception |
Jan, 2028
(2 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 Nextstellis's patents.
Latest Legal Activities on Nextstellis's Patents
Given below is the list of recent legal activities going on the following patents of Nextstellis.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Email Notification Critical | 21 May, 2024 | US11793760 |
| Mail Patent eCofC Notification | 21 May, 2024 | US11793760 |
| Patent eCofC Notification | 21 May, 2024 | US11793760 |
| Recordation of Patent eCertificate of Correction | 21 May, 2024 | US11793760 |
| Mail Patent eGrant Notification | 23 Apr, 2024 | US11964055 |
| Patent eGrant Notification | 23 Apr, 2024 | US11964055 |
| Patent Issue Date Used in PTA Calculation Critical | 23 Apr, 2024 | US11964055 |
| Email Notification Critical | 23 Apr, 2024 | US11964055 |
| Recordation of Patent eGrant | 23 Apr, 2024 | US11964055 |
| Recordation of Patent Grant Mailed Critical | 23 Apr, 2024 | US11964055 |
FDA has granted several exclusivities to Nextstellis. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Nextstellis, 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 Nextstellis.
Exclusivity Information
Nextstellis holds 1 exclusivities out of which none have expired. Its last outstanding exclusivity is set to expire in 2026. Details of Nextstellis's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Chemical Entity Exclusivity(NCE) | Apr 15, 2026 |
US patents provide insights into the exclusivity only within the United States, but Nextstellis 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 Nextstellis's family patents as well as insights into ongoing legal events on those patents.
Nextstellis's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Nextstellis's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Feb 09, 2043 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Nextstellis Generics:
There are no approved generic versions for Nextstellis as of now.
About Nextstellis
Nextstellis is a drug owned by Mayne Pharma Llc. It is used for contraception in females of reproductive potential. Nextstellis uses Drospirenone; Estetrol as an active ingredient. Nextstellis was launched by Mayne Pharma in 2021.
Approval Date:
Nextstellis was approved by FDA for market use on 15 April, 2021.
NCE-1 date:
NCE-1 date also known as the four year date occurs four years after the original drug approval and marks the first opportunity for a generic manufacturer to file an ANDA with a Paragraph IV certification. This is the earliest point when generic competition might begin, provided the challenge is successful. Since the approval date for Nextstellis is 15 April, 2021, its NCE-1 date is estimated to be 15 April, 2025.
Active Ingredient:
Nextstellis uses Drospirenone; Estetrol as the active ingredient. Check out other Drugs and Companies using Drospirenone; Estetrol ingredient
Treatment:
Nextstellis is used for contraception in females of reproductive potential.
Dosage:
Nextstellis is available in tablet form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 3MG;14.2MG | TABLET | Prescription | ORAL |