Orange Book product · Brand (NDA)
NUBEQA
DAROLUTAMIDE
At a glance
Jul 30, 2019
Approved
Brand (NDA)
Application
Not listed
TE code
17
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Jul 30, 2019
7 yr ago
Today
Exclusivity ends · I-971
New indication exclusivity (3 years)
Jun 03, 2028
in 2 yr
Patent 10711013 expires
Listed drug substance patent expiration.
Oct 27, 2030
in 4 yr 5 mo
Patent 11046713 expires
Listed drug substance patent expiration.
Oct 27, 2030
in 4 yr 5 mo
Patent 9657003 expires
Listed drug substance patent expiration.
Oct 27, 2030
in 4 yr 5 mo
Patent 9657003 expires
Listed drug substance patent expiration.
Oct 27, 2030
in 4 yr 5 mo
Patent 9657003 expires
Listed drug substance patent expiration.
Oct 27, 2030
in 4 yr 5 mo
Patent 8975254 expires
Listed drug substance patent expiration.
Mar 25, 2033
in 6 yr 10 mo
Patent 8975254 expires
Listed drug substance patent expiration.
Mar 25, 2033
in 6 yr 10 mo
Patent 8975254 expires
Listed drug substance patent expiration.
Mar 25, 2033
in 6 yr 10 mo
Patent 10010530 expires
Listed drug substance patent expiration.
Jan 28, 2036
in 9 yr 9 mo
Patent 10383853 expires
Listed drug substance patent expiration.
Jan 28, 2036
in 9 yr 9 mo
Patent 10835515 expires
Listed drug product patent expiration.
Jan 28, 2036
in 9 yr 9 mo
Patent 10835515 expires
Listed drug product patent expiration.
Jan 28, 2036
in 9 yr 9 mo
Patent 10835515 expires
Listed drug product patent expiration.
Jan 28, 2036
in 9 yr 9 mo
Patent 10835515 expires
Listed drug product patent expiration.
Jan 28, 2036
in 9 yr 9 mo
Patent 11168058 expires
Listed drug substance patent expiration.
Feb 27, 2038
in 11 yr 10 mo
Patent 12611397 expires
Listed drug product patent expiration.
Jul 02, 2040
in 14 yr 3 mo
Patent 12329742 expires
Listed drug product patent expiration.
Jun 17, 2042
in 16 yr 3 mo
Pharmaceutical detail
Active ingredient
DAROLUTAMIDE
Strength
300MG
Dosage form
TABLET
Route
ORAL
TE code
Not listed
Application
NDA 212099
Product number
001
Marketing status
RX
Reference listed drug (RLD)
Yes
Reference standard (RS)
Yes
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.
Marketing exclusivity (1)
- I-971New indication exclusivity (3 years)
Jun 03, 2028
in 2 yr
Listed patents (17)
| Patent | Expires | In | Type |
|---|---|---|---|
| 10711013 | Oct 27, 2030 | in 4 yr 5 mo | SubstanceProduct |
| 11046713 | Oct 27, 2030 | in 4 yr 5 mo | Substance |
| 9657003 | Oct 27, 2030 | in 4 yr 5 mo | SubstanceProductU-4209 |
| 9657003 | Oct 27, 2030 | in 4 yr 5 mo | SubstanceProductU-4208 |
| 9657003 | Oct 27, 2030 | in 4 yr 5 mo | SubstanceProductU-4210 |
| 8975254 | Mar 25, 2033 | in 6 yr 10 mo | SubstanceProductU-4208 |
| 8975254 | Mar 25, 2033 | in 6 yr 10 mo | SubstanceProductU-4210 |
| 8975254 | Mar 25, 2033 | in 6 yr 10 mo | SubstanceProductU-4209 |
| 10010530 | Jan 28, 2036 | in 9 yr 9 mo | Substance |
| 10383853 | Jan 28, 2036 | in 9 yr 9 mo | Substance |
| 10835515 | Jan 28, 2036 | in 9 yr 9 mo | ProductU-4210 |
| 10835515 | Jan 28, 2036 | in 9 yr 9 mo | ProductU-4208 |
| 10835515 | Jan 28, 2036 | in 9 yr 9 mo | ProductU-4209 |
| 10835515 | Jan 28, 2036 | in 9 yr 9 mo | ProductU-2605 |
| 11168058 | Feb 27, 2038 | in 11 yr 10 mo | SubstanceProduct |
| 12611397 | Jul 02, 2040 | in 14 yr 3 mo | Product |
| 12329742 | Jun 17, 2042 | in 16 yr 3 mo | Product |
