Orange Book product · Brand (NDA)
BALVERSA
ERDAFITINIB
At a glance
Apr 12, 2019
Approved
Brand (NDA)
Application
Not listed
TE code
17
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Apr 12, 2019
7 yr 4 mo ago
Today
Exclusivity ends · I-930
New indication exclusivity (3 years)
Jan 19, 2027
in 7 mo
Patent 9464071 expires
Listed method-of-use patent (U-3805) expiration.
Apr 28, 2031
in 4 yr 11 mo
Patent 8895601 expires
Listed drug substance patent expiration.
Apr 12, 2033
in 6 yr 11 mo
Patent 9902714 expires
Listed drug product patent expiration.
Mar 26, 2035
in 8 yr 11 mo
Patent 12037644 expires
Listed method-of-use patent (U-3972) expiration.
Oct 18, 2035
in 9 yr 6 mo
Patent 10898482 expires
Listed drug product patent expiration.
Feb 09, 2036
in 9 yr 9 mo
Patent 10898482 expires
Listed drug product patent expiration.
Feb 09, 2036
in 9 yr 9 mo
Patent 10898482 expires
Listed drug product patent expiration.
Feb 09, 2036
in 9 yr 9 mo
Patent 10898482 expires
Listed drug product patent expiration.
Feb 09, 2036
in 9 yr 9 mo
Patent 10898482 expires
Listed drug product patent expiration.
Feb 09, 2036
in 9 yr 9 mo
Patent 10898482 expires
Listed drug product patent expiration.
Feb 09, 2036
in 9 yr 9 mo
Patent 10898482 expires
Listed drug product patent expiration.
Feb 09, 2036
in 9 yr 9 mo
Patent 11684620 expires
Listed method-of-use patent (U-3805) expiration.
Feb 09, 2036
in 9 yr 9 mo
Patent 11684620 expires
Listed method-of-use patent (U-3807) expiration.
Feb 09, 2036
in 9 yr 9 mo
Patent 11684620 expires
Listed method-of-use patent (U-3806) expiration.
Feb 09, 2036
in 9 yr 9 mo
Patent 10478494 expires
Listed method-of-use patent (U-3902) expiration.
Aug 13, 2036
in 10 yr 4 mo
Patent 11077106 expires
Listed method-of-use patent (U-3196) expiration.
Feb 02, 2038
in 11 yr 10 mo
Patent 11077106 expires
Listed method-of-use patent (U-3808) expiration.
Feb 02, 2038
in 11 yr 10 mo
Pharmaceutical detail
Active ingredient
ERDAFITINIB
Strength
3MG
Dosage form
TABLET
Route
ORAL
TE code
Not listed
Application
NDA 212018
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.
Marketing exclusivity (1)
- I-930New indication exclusivity (3 years)
Jan 19, 2027
in 7 mo
Listed patents (17)
| Patent | Expires | In | Type |
|---|---|---|---|
| 9464071 | Apr 28, 2031 | in 4 yr 11 mo | U-3805 |
| 8895601 | Apr 12, 2033 | in 6 yr 11 mo | SubstanceProduct |
| 9902714 | Mar 26, 2035 | in 8 yr 11 mo | Product |
| 12037644 | Oct 18, 2035 | in 9 yr 6 mo | U-3972 |
| 10898482 | Feb 09, 2036 | in 9 yr 9 mo | ProductU-3066 |
| 10898482 | Feb 09, 2036 | in 9 yr 9 mo | ProductU-3065 |
| 10898482 | Feb 09, 2036 | in 9 yr 9 mo | ProductU-3067 |
| 10898482 | Feb 09, 2036 | in 9 yr 9 mo | ProductU-2518 |
| 10898482 | Feb 09, 2036 | in 9 yr 9 mo | ProductU-3805 |
| 10898482 | Feb 09, 2036 | in 9 yr 9 mo | ProductU-3807 |
| 10898482 | Feb 09, 2036 | in 9 yr 9 mo | ProductU-3806 |
| 11684620 | Feb 09, 2036 | in 9 yr 9 mo | U-3805 |
| 11684620 | Feb 09, 2036 | in 9 yr 9 mo | U-3807 |
| 11684620 | Feb 09, 2036 | in 9 yr 9 mo | U-3806 |
| 10478494 | Aug 13, 2036 | in 10 yr 4 mo | U-3902 |
| 11077106 | Feb 02, 2038 | in 11 yr 10 mo | U-3196 |
| 11077106 | Feb 02, 2038 | in 11 yr 10 mo | U-3808 |
