DrugPatentWatch Database Preview
ERLEADA Drug Profile
When do Erleada patents expire, and what generic alternatives are available?
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 forty-nine patent family members in thirty-seven countries.
The generic ingredient in ERLEADA is apalutamide. One supplier is listed for this compound. Additional details are available on the apalutamide profile page.
Summary for ERLEADA
| International Patents: | 149 |
| US Patents: | 7 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 1 |
| Bulk Api Vendors: | 61 |
| Patent Applications: | 74 |
| 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.
Synonyms for ERLEADA
| 1361232-32-7 |
| 4-(7-(6-Cyano-5-(trifluoromethyl)pyridin-3-yl)-8-oxo-6-thioxo-5,7-diazaspiro(3.4)octan-5-yl)-2-fluoro-N-methylbenzamide |
| 4-(7-(6-CYANO-5-(TRIFLUOROMETHYL)PYRIDIN-3-YL)-8-OXO-6-THIOXO-5,7-DIAZASPIRO[3.4]OCTAN-5-YL)-2-FLUORO-N-METHYLBENZAMIDE |
| 4-(7-(6-cyano-5-(trifluoroMethyl)pyridin-3-yl)-8-oxo-6-thioxo-5,7-diazaspirooctan-5-yl)-2-fluoro-N-MethylbenzaMide |
| 4-[7-[6-cyano-5-(trifluoromethyl)-3-pyridinyl]-8-oxo-6-thioxo-5,7-diazaspiro[3.4]oct-5-yl]-2-fluoro-N-methyl-benzamide |
| 4-[7-[6-cyano-5-(trifluoromethyl)pyridin-3-yl]-8-oxo-6-sulfanylidene-5,7-diazaspiro[3.4]octan-5-yl]-2-fluoro-N-methylbenzamide |
| 4-{7-[6-cyano-5-(trifluoromethyl)pyridin-3-yl]-8-oxo-6-sulfanylidene-5,7-diazaspiro[3.4]octan-5-yl}-2-fluoro-N-methylbenzamide |
| 4T36H88UA7 |
| 956104-40-8 |
| AB0008189 |
| ABP001022 |
| AC-27403 |
| ACN-031562 |
| AK174739 |
| AKOS025401932 |
| AMX10207 |
| apalutamide |
| Apalutamide (JAN/INN) |
| Apalutamide [INN] |
| Apalutamide pound ARN509 pound(c) |
| AR509 |
| AR509/AR-509 |
| ARN 509 |
| ARN-509 |
| ARN509 |
| AS-35181 |
| BC600521 |
| BCP05829 |
| BDBM50094975 |
| C21H15F4N5O2S |
| CHEMBL3183409 |
| CS-0885 |
| D11040 |
| DB11901 |
| DTXSID40241899 |
| Erleada (TN) |
| EX-A089 |
| GTPL9043 |
| HJBWBFZLDZWPHF-UHFFFAOYSA-N |
| HMS3656N12 |
| HY-16060 |
| J-519596 |
| JNJ 56021927 |
| JNJ-56021927 |
| KB-74733 |
| KS-00000SN8 |
| MLS006011109 |
| MolPort-027-720-961 |
| NCGC00346725-01 |
| NCGC00346725-06 |
| PB27306 |
| QCR-211 |
| RL06020 |
| s2840 |
| SCHEMBL909297 |
| SMR004702891 |
| SW220300-1 |
| Tube705 |
| UNII-4T36H88UA7 |
| W-5908 |
| Y0375 |
| ZINC43174901 |
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 | Start Trial | ||||
| Janssen Biotech | ERLEADA | apalutamide | TABLET;ORAL | 210951-001 | Feb 14, 2018 | RX | Yes | Yes | Start Trial | Start Trial | 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 | Y | Y | 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 |
|---|---|---|
| Philippines | 12016501470 | Start Trial |
| Slovenia | 3100727 | Start Trial |
| Singapore | 10201610248S | Start Trial |
| Denmark | 3100727 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for ERLEADA
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 2368550 | PA2019512 | Lithuania | Start Trial | PRODUCT NAME: APALUTAMIDAS ARBA JO FARMACINIU POZIURIU PRIIMTINA DRUSKA; REGISTRATION NO/DATE: EU/1/18/1342 20190114 |
| 2368550 | 300993 | Netherlands | Start Trial | PRODUCT NAME: APALUTAMIDE OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN; REGISTRATION NO/DATE: EU/1/18/1342 20190116 |
| 2368550 | 122019000060 | Germany | Start Trial | PRODUCT NAME: APALUTAMID ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON; REGISTRATION NO/DATE: EU/1/18/1342 20190114 |
| 2368550 | LUC00123 | Luxembourg | Start Trial | PRODUCT NAME: APALUTAMIDE OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI; AUTHORISATION NUMBER AND DATE: EU/1/18/1342 20190116 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
