Orange Book product · Brand (NDA)
ERLEADA
APALUTAMIDE
At a glance
Feb 14, 2018
Approved
Brand (NDA)
Application
AB
TE code
18
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Feb 14, 2018
8 yr 6 mo ago
Today
Patent 8802689 expires
Listed method-of-use patent (U-2237) expiration.
Mar 27, 2027
in 9 mo
Patent 8802689 expires
Listed method-of-use patent (U-2624) expiration.
Mar 27, 2027
in 9 mo
Patent 9388159 expires
Listed drug substance patent expiration.
Mar 27, 2027
in 9 mo
Patent 9987261 expires
Listed drug product patent expiration.
Mar 27, 2027
in 9 mo
Patent 8445507 expires
Listed drug substance patent expiration.
Feb 14, 2032
in 5 yr 9 mo
Patent 8445507 expires
Listed drug substance patent expiration.
Feb 14, 2032
in 5 yr 9 mo
Patent 9481663 expires
Listed drug substance patent expiration.
Jun 04, 2033
in 7 yr 1 mo
Patent 9481663 expires
Listed drug substance patent expiration.
Jun 04, 2033
in 7 yr 1 mo
Patent 10849888 expires
Listed method-of-use patent (U-3013) expiration.
Sep 23, 2033
in 7 yr 4 mo
Patent 9884054 expires
Listed method-of-use patent (U-2237) expiration.
Sep 23, 2033
in 7 yr 4 mo
Patent RE49353 expires
Listed method-of-use patent (U-2381) expiration.
Sep 23, 2033
in 7 yr 4 mo
Patent RE50642 expires
Listed method-of-use patent (U-4450) expiration.
Sep 23, 2033
in 7 yr 4 mo
Patent 12303493 expires
Listed drug product patent expiration.
Dec 03, 2035
in 9 yr 7 mo
Patent 10702508 expires
Listed method-of-use patent (U-3012) expiration.
Apr 30, 2038
in 12 yr
Patent 11963952 expires
Listed method-of-use patent (U-3901) expiration.
Jan 30, 2040
in 13 yr 10 mo
Patent 12303497 expires
Listed method-of-use patent (U-4448) expiration.
Jan 30, 2040
in 13 yr 10 mo
Patent 12303497 expires
Listed method-of-use patent (U-4494) expiration.
Jan 30, 2040
in 13 yr 10 mo
Patent 11723898 expires
Listed method-of-use patent (U-4449) expiration.
Jan 14, 2041
in 14 yr 9 mo
Pharmaceutical detail
Active ingredient
APALUTAMIDE
Strength
60MG
Dosage form
TABLET
Route
ORAL
TE code
AB
Application
NDA 210951
Product number
001
Marketing status
RX
Reference listed drug (RLD)
Yes
Reference standard (RS)
No
Active-ingredient family
View full familyThis is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.
Listed patents (18)
| Patent | Expires | In | Type |
|---|---|---|---|
| 8802689 | Mar 27, 2027 | in 9 mo | U-2237 |
| 8802689 | Mar 27, 2027 | in 9 mo | U-2624 |
| 9388159 | Mar 27, 2027 | in 9 mo | SubstanceProduct |
| 9987261 | Mar 27, 2027 | in 9 mo | Product |
| 8445507 | Feb 14, 2032 | in 5 yr 9 mo | SubstanceProductU-2624 |
| 8445507 | Feb 14, 2032 | in 5 yr 9 mo | SubstanceProductU-2237 |
| 9481663 | Jun 04, 2033 | in 7 yr 1 mo | SubstanceProductU-2624 |
| 9481663 | Jun 04, 2033 | in 7 yr 1 mo | SubstanceProductU-2237 |
| 10849888 | Sep 23, 2033 | in 7 yr 4 mo | U-3013 |
| 9884054 | Sep 23, 2033 | in 7 yr 4 mo | U-2237 |
| RE49353 | Sep 23, 2033 | in 7 yr 4 mo | U-2381 |
| RE50642 | Sep 23, 2033 | in 7 yr 4 mo | U-4450 |
| 12303493 | Dec 03, 2035 | in 9 yr 7 mo | Product |
| 10702508 | Apr 30, 2038 | in 12 yr | U-3012 |
| 11963952 | Jan 30, 2040 | in 13 yr 10 mo | U-3901 |
| 12303497 | Jan 30, 2040 | in 13 yr 10 mo | U-4448 |
| 12303497 | Jan 30, 2040 | in 13 yr 10 mo | U-4494 |
| 11723898 | Jan 14, 2041 | in 14 yr 9 mo | U-4449 |
