Ella is a drug owned by Laboratoire Hra Pharma. It is protected by 8 US drug patents filed from 2013 to 2021 out of which none have expired yet. Ella's patents have been open to challenges since 13 August, 2014. Based on its patents and exclusivities, its generic launch date is estimated to be Jun 12, 2030. Details of Ella'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). | |||
| US8426392 | Method for providing emergency contraception |
Jun, 2030
(5 years from now) | Active |
| US8962603 | Method for post coital contraception in overweight or obese female subjects using ulipristal acetate |
Jun, 2030
(5 years from now) | Active |
| US8512745 | Ulipristal acetate tablets |
Jun, 2030
(5 years from now) | Active |
| US10159681 | Method for on-demand contraception |
Apr, 2030
(5 years from now) | Active |
| US10772897 | Method for on-demand contraception |
Apr, 2030
(5 years from now) | Active |
| US9283233 | Method for on-demand contraception |
Apr, 2030
(5 years from now) | Active |
| US8735380 | Ulipristal acetate tablets |
Feb, 2029
(4 years from now) | Active |
| US9844510 | Ulipristal acetate tablets |
Dec, 2028
(4 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 Ella's patents.
Latest Legal Activities on Ella's Patents
Given below is the list of recent legal activities going on the following patents of Ella.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 4th Year, Large Entity | 27 Feb, 2024 | US10772897 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 05 Sep, 2023 | US9283233 |
| Payment of Maintenance Fee, 4th Year, Large Entity | 07 Jun, 2022 | US10159681 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 09 Nov, 2021 | US8735380 (Litigated) |
| Payment of Maintenance Fee, 4th Year, Large Entity | 01 Jun, 2021 | US9844510 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 19 Feb, 2021 | US8512745 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 06 Oct, 2020 | US8426392 |
| Patent Issue Date Used in PTA Calculation Critical | 15 Sep, 2020 | US10772897 |
| Recordation of Patent Grant Mailed Critical | 15 Sep, 2020 | US10772897 |
| Email Notification Critical | 27 Aug, 2020 | US10772897 |
FDA has granted several exclusivities to Ella. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Ella, 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 Ella.
Exclusivity Information
Ella holds 2 exclusivities. All of its exclusivities have expired in 2024. Details of Ella's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Chemical Entity Exclusivity(NCE) | Aug 13, 2015 |
| M(M-271) | Jun 24, 2024 |
Several oppositions have been filed on Ella'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 Ella's generic, the next section provides detailed information on ongoing and past EP oppositions related to Ella patents.
Ella's Oppositions Filed in EPO
Ella has faced multiple oppositions in the European Patent Office. The earliest opposition was filed on Apr 19, 2017, by Hexal Ag. This opposition was filed on patent number EP09764855A. Click below to reveal the latest opposition data.
| Application | Filing Date | Opposition Party | Legal Status |
|---|---|---|---|
 | |||
| EP10717084A | May, 2017 | Mutlu, Aydin | Revoked |
| EP10717084A | May, 2017 | Generics (U.K.) Limited | Revoked |
| EP10717084A | May, 2017 | EGIS Gyógyszergyár Zártkörüen Müködö Részvénytársaság | Revoked |
| EP10717084A | May, 2017 | Stada-Arzneimittel Aktiengesellschaft | Revoked |
| EP10717084A | May, 2017 | HEXAL PHARMA AG | Revoked |
| EP10717084A | May, 2017 | Helm AG | Revoked |
| EP09764855A | Apr, 2017 | Cyndea Pharma. S.L. | Revoked |
| EP10717084A | Apr, 2017 | Teva Pharmaceutical Industries Ltd. | Revoked |
| EP09764855A | Apr, 2017 | Helm AG | Revoked |
| EP09764855A | Apr, 2017 | Hexal AG | Revoked |
US patents provide insights into the exclusivity only within the United States, but Ella 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 Ella's family patents as well as insights into ongoing legal events on those patents.
Ella's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Ella's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Jun 12, 2030 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Ella Generic API suppliers:
Ulipristal Acetate is the generic name for the brand Ella. 1 company has already filed for the generic of Ella. Check out the entire list of companies who have already received approval for Ella's generic
How can I launch a generic of Ella before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Ella's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Ella's sponsor is invalid, unenforceable, or will not be infringed by your generic product.
Given below are the details of the already filed Para IV certificates on Ella -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 30 mg | 13 Aug, 2014 | 1 | 13 Feb, 2017 | 12 Jun, 2030 | Eligible |
About Ella
Ella is a drug owned by Laboratoire Hra Pharma. It is used for emergency contraception within 120 hours after unprotected intercourse, particularly effective in overweight women. Ella uses Ulipristal Acetate as an active ingredient. Ella was launched by Lab Hra Pharma in 2010.
Approval Date:
Ella was approved by FDA for market use on 13 August, 2010.
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 Ella is 13 August, 2010, its NCE-1 date is estimated to be 13 August, 2014.
Active Ingredient:
Ella uses Ulipristal Acetate as the active ingredient. Check out other Drugs and Companies using Ulipristal Acetate ingredient
Treatment:
Ella is used for emergency contraception within 120 hours after unprotected intercourse, particularly effective in overweight women.
Dosage:
Ella is available in tablet form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 30MG | TABLET | Prescription | ORAL |