Annovera is a drug owned by Mayne Pharma Llc. It is protected by 8 US drug patents filed from 2020 to 2024 out of which none have expired yet. Annovera's patents have been open to challenges since 10 August, 2022. Based on its patents and exclusivities, its generic launch date is estimated to be Jun 21, 2039. Details of Annovera'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). | |||
| US10940157 | System for providing birth control |
Jun, 2039
(14 years from now) | Active |
| US11529308 | System for providing birth control |
Jun, 2039
(14 years from now) | Active |
| US10918649 | System for providing birth control |
Jun, 2039
(14 years from now) | Active |
| US10925882 | System for providing birth control |
Jun, 2039
(14 years from now) | Active |
| US11850251 | System for providing birth control |
Jun, 2039
(14 years from now) | Active |
| US10632066 | Method of providing birth control |
Feb, 2039
(14 years from now) | Active |
| US10765628 | Method of providing birth control |
Feb, 2039
(14 years from now) | Active |
| US10780047 | Method of providing birth control |
Feb, 2039
(14 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 Annovera's patents.
Latest Legal Activities on Annovera's Patents
Given below is the list of recent legal activities going on the following patents of Annovera.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Entity Status Set To Undiscounted (Initial Default Setting or Status Change) | 05 May, 2024 | US10918649 |
| Entity Status Set To Undiscounted (Initial Default Setting or Status Change) | 05 May, 2024 | US10940157 |
| Entity Status Set To Undiscounted (Initial Default Setting or Status Change) | 05 May, 2024 | US10925882 |
| Payment of Maintenance Fee, 4th Year, Large Entity | 08 Mar, 2024 | US10765628 |
| Entity Status Set To Undiscounted (Initial Default Setting or Status Change) | 29 Jan, 2024 | US10780047 |
| Entity Status Set To Undiscounted (Initial Default Setting or Status Change) | 29 Jan, 2024 | US10765628 |
| Email Notification Critical | 26 Dec, 2023 | US11850251 |
| Mail Patent eGrant Notification | 26 Dec, 2023 | US11850251 |
| Patent eGrant Notification | 26 Dec, 2023 | US11850251 |
| Patent Issue Date Used in PTA Calculation Critical | 26 Dec, 2023 | US11850251 |
FDA has granted several exclusivities to Annovera. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Annovera, 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 Annovera.
Exclusivity Information
Annovera holds 1 exclusivities. All of its exclusivities have expired in 2023. Details of Annovera's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Chemical Entity Exclusivity(NCE) | Aug 10, 2023 |
US patents provide insights into the exclusivity only within the United States, but Annovera 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 Annovera's family patents as well as insights into ongoing legal events on those patents.
Annovera's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Annovera's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Jun 21, 2039 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Annovera Generics:
There are no approved generic versions for Annovera as of now.
About Annovera
Annovera is a drug owned by Mayne Pharma Llc. It is used for hormonal contraception. Annovera uses Ethinyl Estradiol; Segesterone Acetate as an active ingredient. Annovera was launched by Mayne Pharma in 2018.
Approval Date:
Annovera was approved by FDA for market use on 10 August, 2018.
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 Annovera is 10 August, 2018, its NCE-1 date is estimated to be 10 August, 2022.
Active Ingredient:
Annovera uses Ethinyl Estradiol; Segesterone Acetate as the active ingredient. Check out other Drugs and Companies using Ethinyl Estradiol; Segesterone Acetate ingredient
Treatment:
Annovera is used for hormonal contraception.
Dosage:
Annovera is available in ring form for vaginal use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 0.013MG/24HR;0.15MG/24HR | RING | Prescription | VAGINAL |