apalutamide · Janssen Biotech · NDA 210951
Erleada
Earliest generic entry, as listed · earliest of 2 marketed strengths
14 Jan 2041
Blocked by patent: US 11723898. Only method-of-use patents remain, so a generic may carve out the protected indication and enter earlier.
Listed patents · 14 unexpired
18 Orange Book listing rows for 14 patents. FDA lists a patent once for each use code, and lists its pediatric extension as a separate row.
| Patent | Claims | Expires |
|---|---|---|
| US 11723898 | use U-4449 · sets the listed date | 14 Jan 2041 |
| US 11963952 | use U-3901 | 30 Jan 2040 |
| US 12303497 | use U-4448, U-4494 | 30 Jan 2040 |
| US 12303497 listing row | use U-4448 | 30 Jan 2040 |
| US 12303497 listing row | use U-4494 | 30 Jan 2040 |
| US 10702508 | use U-3012 | 30 Apr 2038 |
| US 12303493 | drug product | 3 Dec 2035 |
| US 10849888 | use U-3013 | 23 Sep 2033 |
| US 9884054 | use U-2237 | 23 Sep 2033 |
| US RE49353 | use U-2381 | 23 Sep 2033 |
| US RE50642 | use U-4450 | 23 Sep 2033 |
| US 9481663 | drug substance, drug product, use U-2237, U-2624 | 4 Jun 2033 |
| US 9481663 listing row | drug substance, drug product, use U-2237 | 4 Jun 2033 |
| US 9481663 listing row | drug substance, drug product, use U-2624 | 4 Jun 2033 |
| US 8445507 | drug substance, drug product, use U-2237, U-2624 | 14 Feb 2032 |
| US 8445507 listing row | drug substance, drug product, use U-2237 | 14 Feb 2032 |
| US 8445507 listing row | drug substance, drug product, use U-2624 | 14 Feb 2032 |
| US 8802689 | use U-2237, U-2624 | 27 Mar 2027 |
| US 8802689 listing row | use U-2237 | 27 Mar 2027 |
| US 8802689 listing row | use U-2624 | 27 Mar 2027 |
| US 9388159 | drug substance, drug product | 27 Mar 2027 |
| US 9987261 | drug product | 27 Mar 2027 |
Exclusivities · 0 unexpired
No unexpired exclusivities listed.
Paragraph IV certifications · 0
No Paragraph IV certification listed by FDA for this drug.
The list shows that a generic applicant certified to FDA that a listed patent is invalid or not infringed. It does not show litigation, settlements or launch timing.
Event history
No events yet. The first ingestion only records products entering their 12-month window; changes appear from the next Orange Book update.
Products covered · 2
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 210951 · 001 · RLD | tablet, oral | 60MG | 14 Jan 2041 |
| 210951 · 002 · RLD | tablet, oral | 240MG | 14 Jan 2041 |