FDA Orange Book · active-ingredient family
Apalutamide
Apalutamide is approved as 1 brand and 1 generic application in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:ERLEADA · NDA 210951
1
Brand (NDA)
1
Generics (ANDA)
14
Listed patents
0
Exclusivity periods
Brand (NDA) products · tablet
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| ERLEADARLD×2 | JANSSEN BIOTECH | NDA 210951 | AB | Feb 14, 2018 |
Generic (ANDA) products (1)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| APALUTAMIDE | ZYDUS LIFESCIENCES | ANDA 217113 | AB | Mar 17, 2025 |
Listed patents (14)
| Patent | Expires | In | Type |
|---|---|---|---|
| 8802689 | Mar 27, 2027 | in 9 mo | U-2237 |
| 9987261 | Mar 27, 2027 | in 9 mo | Product |
| 9388159 | Mar 27, 2027 | in 9 mo | SubstanceProduct |
| 8445507 | Feb 14, 2032 | in 5 yr 9 mo | SubstanceProductU-2624 |
| 9481663 | Jun 04, 2033 | in 7 yr 1 mo | SubstanceProductU-2624 |
| 9884054 | Sep 23, 2033 | in 7 yr 4 mo | U-2237 |
| RE50642 | Sep 23, 2033 | in 7 yr 4 mo | U-4450 |
| RE49353 | Sep 23, 2033 | in 7 yr 4 mo | U-2381 |
| 10849888 | Sep 23, 2033 | in 7 yr 4 mo | U-3013 |
| 12303493 | Dec 03, 2035 | in 9 yr 7 mo | Product |
| 10702508 | Apr 30, 2038 | in 12 yr | U-3012 |
| 12303497 | Jan 30, 2040 | in 13 yr 10 mo | U-4448 |
| 11963952 | Jan 30, 2040 | in 13 yr 10 mo | U-3901 |
| 11723898 | Jan 14, 2041 | in 14 yr 9 mo | U-4449 |
Apalutamide — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
