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ERLEADA Drug Profile
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» See Plans and PricingWhen do Erleada patents expire, and when can generic versions of Erleada launch?
Erleada is a drug marketed by Janssen Biotech and is included in one NDA. There are seven patents protecting this drug.
This drug has one hundred and seventy-one patent family members in thirty-nine countries.
The generic ingredient in ERLEADA is apalutamide. One supplier is listed for this compound. Additional details are available on the apalutamide profile page.
US ANDA Litigation and Generic Entry Outlook for Erleada
Erleada will be eligible for patent challenges on February 14, 2022. This date may extended up to six months if a pediatric exclusivity extension is applied to the drug's patents.
By analyzing the patents and regulatory protections it appears that the earliest date
for generic entry will be June 4, 2033. This may change due to patent challenges or generic licensing.
There have been two patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.
Indicators of Generic Entry
Summary for ERLEADA
| International Patents: | 171 |
| US Patents: | 7 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 1 |
| Bulk Api Vendors: | 64 |
| Clinical Trials: | 3 |
| Patent Applications: | 84 |
| Drug Prices: | Drug price information for ERLEADA |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for ERLEADA |
| DailyMed Link: | ERLEADA at DailyMed |
Generic Entry Opportunity Date for ERLEADA
Generic Entry Date for ERLEADA*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
TABLET;ORAL |
*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.
Recent Clinical Trials for ERLEADA
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| ECOG-ACRIN Cancer Research Group | Phase 3 |
| OHSU Knight Cancer Institute | Phase 2 |
| National Cancer Institute (NCI) | Phase 2 |
US Patents and Regulatory Information for ERLEADA
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Janssen Biotech | ERLEADA | apalutamide | TABLET;ORAL | 210951-001 | Feb 14, 2018 | RX | Yes | Yes | Start Trial | Start Trial | Y | Y | Start Trial | ||
| Janssen Biotech | ERLEADA | apalutamide | TABLET;ORAL | 210951-001 | Feb 14, 2018 | RX | Yes | Yes | Start Trial | Start Trial | Y | Y | Start Trial | ||
| Janssen Biotech | ERLEADA | apalutamide | TABLET;ORAL | 210951-001 | Feb 14, 2018 | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | ||||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
International Patents for ERLEADA
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| New Zealand | 702203 | Start Trial |
| Japan | 2018150365 | Start Trial |
| Colombia | 7240407 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for ERLEADA
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 2368550 | 1990032-3 | Sweden | Start Trial | PRODUCT NAME: APALUTAMIDE; REG. NO/DATE: EU/1/1342 20190116 |
| 2368550 | 2019C/529 | Belgium | Start Trial | PRODUCT NAME: APALUTAMIDE OU UN SEL PHARMACOLOGIQUEMENT ADMISSIBLE DE CELLES-CI; AUTHORISATION NUMBER AND DATE: EU/1/18/1342 20190116 |
| 2368550 | CA 2019 00029 | Denmark | Start Trial | PRODUCT NAME: APALUTAMID ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; REG. NO/DATE: EU/1/18/1342 20190116 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
