Erleada is a drug owned by Janssen Biotech Inc. It is protected by 11 US drug patents filed from 2018 to 2024 out of which none have expired yet. Erleada's patents have been open to challenges since 14 February, 2022. Based on its patents and exclusivities, its generic launch date is estimated to be Jan 30, 2040. Details of Erleada's patents and their expiration are given in the table below.
| Drug Patent Number | Drug Patent Title | Drug Patent Expiry | Status |
|---|---|---|---|
| These drug patents protect the active ingredient(API) of the drug. Only drug patent owner can launch products that use this active ingredient until these patents expire. | |||
| US9481663 | Crystalline forms of an androgen receptor modulator |
Jun, 2033
(8 years from now) | Active |
| US8445507 | Androgen receptor modulator for the treatment of prostate cancer and androgen receptor-associated diseases |
Sep, 2030
(5 years from now) | Active |
| US9388159 | Substituted diazaspiroalkanes as androgen receptor modulators |
Mar, 2027
(1 year, 9 months from now) | Active |
| These drug patents focus on the other aspects of the drug like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
| US11963952 | Anti-androgens for the treatment of metastatic castration-sensitive prostate cancer |
Jan, 2040
(14 years from now) | Active |
| US10702508 | Anti-androgens for the treatment of non-metastatic castration-resistant prostate cancer |
Apr, 2038
(12 years from now) | Active |
| US10052314 | Anti-androgens for the treatment of non-metastatic castrate-resistant prostate cancer |
Sep, 2033
(8 years from now) | Active |
| USRE49353 | Anti-androgens for the treatment of non-metastatic castrate-resistant prostate cancer |
Sep, 2033
(8 years from now) | Active |
| US9884054 | Anti-androgens for the treatment of non-metastatic castrate-resistant prostate cancer |
Sep, 2033
(8 years from now) | Active |
| US10849888 | Anti-androgens for the treatment of non-metastatic castrate-resistant prostate cancer |
Sep, 2033
(8 years from now) | Active |
| US8802689 | Androgen receptor modulator for the treatment of prostate cancer and androgen receptor-associated diseases |
Mar, 2027
(1 year, 9 months from now) | Active |
| US9987261 | Substituted diazaspiroalkanes as androgen receptor modulators |
Mar, 2027
(1 year, 9 months 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 Erleada's patents.
Latest Legal Activities on Erleada's Patents
Given below is the list of recent legal activities going on the following patents of Erleada.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 4th Year, Large Entity | 15 May, 2024 | US10849888 |
| Recordation of Patent eCertificate of Correction | 30 Apr, 2024 | US10702508 |
| Email Notification Critical | 30 Apr, 2024 | US10702508 |
| Mail Patent eCofC Notification | 30 Apr, 2024 | US10702508 |
| Patent eCofC Notification | 30 Apr, 2024 | US10702508 |
| Patent eGrant Notification | 23 Apr, 2024 | US11963952 |
| Mail Patent eGrant Notification | 23 Apr, 2024 | US11963952 |
| Patent Issue Date Used in PTA Calculation Critical | 23 Apr, 2024 | US11963952 |
| Email Notification Critical | 23 Apr, 2024 | US11963952 |
| Recordation of Patent eGrant | 23 Apr, 2024 | US11963952 |
FDA has granted several exclusivities to Erleada. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Erleada, 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 Erleada.
Exclusivity Information
Erleada holds 2 exclusivities. All of its exclusivities have expired in 2023. Details of Erleada's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Indication(I-808) | Sep 17, 2022 |
| New Chemical Entity Exclusivity(NCE) | Feb 14, 2023 |
Several oppositions have been filed on Erleada'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 Erleada's generic, the next section provides detailed information on ongoing and past EP oppositions related to Erleada patents.
Erleada's Oppositions Filed in EPO
Erleada has faced multiple oppositions in the European Patent Office. The earliest opposition was filed on Jan 18, 2019, by Generics (U.K.) Limited. This opposition was filed on patent number EP13800681A. Click below to reveal the latest opposition data.
| Application | Filing Date | Opposition Party | Legal Status |
|---|---|---|---|
 | |||
| EP19169275A | Feb, 2022 | Generics [UK] Limited | Granted and Under Opposition |
| EP17187458A | Jun, 2021 | Teva Pharmaceutical Industries Ltd | Granted and Under Opposition |
| EP17187458A | Jun, 2021 | Sandoz AG | Granted and Under Opposition |
| EP17187458A | Jun, 2021 | Synthon BV | Granted and Under Opposition |
| EP18157435A | Apr, 2021 | SANDOZ AG | Granted and Under Opposition |
| EP18157435A | Apr, 2021 | Sagittarius Intellectual Property Consultants Ltd | Granted and Under Opposition |
| EP13800681A | Jan, 2019 | Luigi, Rumi | Granted and Under Opposition |
| EP13800681A | Jan, 2019 | Sagittarius Intellectual Property LLP | Granted and Under Opposition |
| EP13800681A | Jan, 2019 | Generics (U.K.) Limited | Granted and Under Opposition |
US patents provide insights into the exclusivity only within the United States, but Erleada 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 Erleada's family patents as well as insights into ongoing legal events on those patents.
Erleada's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Erleada's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Jan 30, 2040 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Erleada Generic API suppliers:
Apalutamide is the generic name for the brand Erleada. 1 company has already filed for the generic of Erleada. Check out the entire list of companies who have already received approval for Erleada's generic
How can I launch a generic of Erleada before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Erleada's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Erleada'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 Erleada -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 60 mg | 14 Feb, 2022 | 5 | 30 Apr, 2038 |
About Erleada
Erleada is a drug owned by Janssen Biotech Inc. It is used for treating various forms of prostate cancer, including non-metastatic and metastatic types, in combination with different therapies. Erleada uses Apalutamide as an active ingredient. Erleada was launched by Janssen Biotech in 2018.
Approval Date:
Erleada was approved by FDA for market use on 14 February, 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 Erleada is 14 February, 2018, its NCE-1 date is estimated to be 14 February, 2022.
Active Ingredient:
Erleada uses Apalutamide as the active ingredient. Check out other Drugs and Companies using Apalutamide ingredient
Treatment:
Erleada is used for treating various forms of prostate cancer, including non-metastatic and metastatic types, in combination with different therapies.
Dosage:
Erleada is available in tablet form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 240MG | TABLET | Prescription | ORAL |
| 60MG | TABLET | Prescription | ORAL |