Details for Patent: 12,303,497
Which drugs does patent 12,303,497 protect, and when does it expire?
Patent 12,303,497 protects ERLEADA and is included in one NDA.
This patent has seventeen patent family members in fourteen countries.
Summary for Patent: 12,303,497
| Title: | Anti-androgens for the treatment of metastatic castration-sensitive prostate cancer |
| Abstract: | Described herein are methods of treating metastatic castration-sensitive prostate cancer with anti-androgens, including but not limited to, 4-[7-(6-cyano-5-trifluoromethylpyridin-3-yl)-8-oxo-6-thioxo-5,7-diazaspiro[3.4]oct-5-yl]-2-fluoro-N-methylbenzamide. |
| Inventor(s): | Margaret K. Yu |
| Assignee: | Aragon Pharmaceuticals Inc |
| Application Number: | US18/498,542 |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for patent 12,303,497 |
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Patent Claim Types: see list of patent claims | Use; Delivery; Dosage form; |
Drugs Protected by US Patent 12,303,497
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Patented / Exclusive Use | Submissiondate |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Janssen Biotech | ERLEADA | apalutamide | TABLET;ORAL | 210951-001 | Feb 14, 2018 | AB | RX | Yes | No | ⤷ Start Trial | ⤷ Start Trial | IMPROVEMENT OF OVERALL SURVIVAL AND PROGRESSION FREE SURVIVAL IN METASTATIC, CASTRATION-SENSITIVE PROSTATE CANCER (MCSPC) PATIENTS BY TREATMENT WITH 240 MG ORAL APALUTAMIDE IN COMBINATION WITH ANDROGEN DEPRIVATION THERAPY | ⤷ Start Trial | |||
| Janssen Biotech | ERLEADA | apalutamide | TABLET;ORAL | 210951-001 | Feb 14, 2018 | AB | RX | Yes | No | ⤷ Start Trial | ⤷ Start Trial | DOSAGE MODIFICATION FOLLOWING GRADE 3 TOXICITY OR INTOLERABLE SIDE EFFECT BY DISCONTINUING APALUTAMIDE UNTIL IMPROVEMENT TO ORIGINAL GRADE OR GRADE I IN TREATMENT OF MCSPC PATIENTS THAT INCREASES OVERALL SURVIVAL AND PROGRESSION FREE SURVIVAL | ⤷ Start Trial | |||
| Janssen Biotech | ERLEADA | apalutamide | TABLET;ORAL | 210951-002 | Feb 17, 2023 | RX | Yes | Yes | ⤷ Start Trial | ⤷ Start Trial | IMPROVEMENT OF OVERALL SURVIVAL AND PROGRESSION FREE SURVIVAL IN METASTATIC, CASTRATION-SENSITIVE PROSTATE CANCER (MCSPC) PATIENTS BY TREATMENT WITH 240 MG ORAL APALUTAMIDE IN COMBINATION WITH ANDROGEN DEPRIVATION THERAPY | ⤷ Start Trial | ||||
| Janssen Biotech | ERLEADA | apalutamide | TABLET;ORAL | 210951-002 | Feb 17, 2023 | RX | Yes | Yes | ⤷ Start Trial | ⤷ Start Trial | DOSAGE MODIFICATION FOLLOWING GRADE 3 TOXICITY OR INTOLERABLE SIDE EFFECT BY DISCONTINUING APALUTAMIDE UNTIL IMPROVEMENT TO ORIGINAL GRADE OR GRADE I IN TREATMENT OF MCSPC PATIENTS THAT INCREASES OVERALL SURVIVAL AND PROGRESSION FREE SURVIVAL | ⤷ Start Trial | ||||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Patented / Exclusive Use | >Submissiondate |
International Family Members for US Patent 12,303,497
| Country | Patent Number | Estimated Expiration | Supplementary Protection Certificate | SPC Country | SPC Expiration |
|---|---|---|---|---|---|
| Australia | 2020215176 | ⤷ Start Trial | |||
| Brazil | 112021014969 | ⤷ Start Trial | |||
| Canada | 3128331 | ⤷ Start Trial | |||
| China | 113365623 | ⤷ Start Trial | |||
| >Country | >Patent Number | >Estimated Expiration | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration |
