APALUTAMIDE | N210951 | JANSSEN BIOTECH INC
| Case | Court | Filed | Status | Judge |
|---|---|---|---|---|
ARAGON PHARMACEUTICALS, INC. et al v. HETERO LABS LIMITED UNIT V et al 2 patentsANDA 220525apalutamide | D.N.J. | 2026-01-09 | Active | — |
ARAGON PHARMACEUTICALS, INC. et al v. HETERO LABS LIMITED UNIT V et al 9 patentsANDA 220525apalutamide | D.N.J. | 2025-06-18 | Active | — |
ARAGON PHARMACEUTICALS, INC. et al v. LUPIN LIMITED et al 1 patentANDA 217084apalutamide | D.N.J. | 2025-04-18 | Terminated 2025-08-06 | — |
Aragon Pharmaceuticals, Inc. et al v. Eugia Pharma Specialities Limited et al 5 patentsANDA 217104apalutamide | D. Del. | 2022-05-26 | Terminated 2022-09-07 | — |
Aragon Pharmaceuticals, Inc. et al v. Lupin Limited et al 1 patentANDA 217084apalutamide | D. Del. | 2022-05-13 | Terminated 2022-08-09 | — |
ARAGON PHARMACEUTICALS, INC. et al v. LUPIN LIMITED et al 5 patentsANDA 217084apalutamide | D.N.J. | 2022-05-13 | Terminated 2023-12-11 | — |
Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).
| Patent # | Expiration | PED | Drug Substance | Drug Product | Use Code | Delist |
|---|---|---|---|---|---|---|
| RE49353 | Sep 23, 2033 | — | — | — | — | |
| RE50642 | Sep 23, 2033 | — | — | — | U-4450 | — |
| 8445507 | Feb 14, 2032 | — | Yes | Yes | — | |
| 8802689 | Mar 27, 2027 | — | — | — | — | |
| 9388159 | Mar 27, 2027 | — | Yes | Yes | — | — |
| 9481663 | Jun 4, 2033 | — | Yes | Yes | — | |
| 9884054 | Sep 23, 2033 | — | — | — | — | |
| 9987261 | Mar 27, 2027 | — | — | Yes | — | — |
| 10702508 | Apr 30, 2038 | — | — | — | — | |
| 10849888 | Sep 23, 2033 | — | — | — | — | |
| 11723898 | Jan 14, 2041 | — | — | — | U-4449 | — |
| 11963952 | Jan 30, 2040 | — | — | — | — | |
| 12303493 | Dec 3, 2035 | — | — | Yes | — | — |
| 12303497 | Jan 30, 2040 | — | — | — | U-4448 | — |
Janssen Biotech updated the Orange Book patent expiration date for ERLEADA (apalutamide) U.S. Patent No. 8,445,507 from Sep 2030 to Feb 2032.
Old: Sep 15, 2030
New: Feb 14, 2032
Erleada (apalutamide) patent 8,445,507 expiration date extended from Sep 2030 to Feb 2032.
Old: Sep 15, 2030
New: Feb 14, 2032