Orange Book product · Brand (NDA)
FABHALTA
IPTACOPAN HYDROCHLORIDE
At a glance
Dec 05, 2023
Approved
Brand (NDA)
Application
Not listed
TE code
10
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Dec 05, 2023
2 yr 7 mo ago
Today
Exclusivity ends · I-949
New indication exclusivity (3 years)
Aug 07, 2027
in 1 yr 2 mo
Exclusivity ends · I-963
New indication exclusivity (3 years)
Mar 20, 2028
in 1 yr 9 mo
Exclusivity ends · NCE
New chemical entity exclusivity (5 years)
Dec 05, 2028
in 2 yr 6 mo
Exclusivity ends · ODE-456
Orphan-drug exclusivity (7 years)
Dec 05, 2030
in 4 yr 6 mo
Exclusivity ends · ODE-524
Orphan-drug exclusivity (7 years)
Mar 20, 2032
in 5 yr 10 mo
Patent 10093663 expires
Listed method-of-use patent (U-4161) expiration.
Jul 14, 2034
in 8 yr 2 mo
Patent 10093663 expires
Listed method-of-use patent (U-3980) expiration.
Jul 14, 2034
in 8 yr 2 mo
Patent 9682968 expires
Listed drug substance patent expiration.
Jul 14, 2034
in 8 yr 2 mo
Patent 11723901 expires
Listed method-of-use patent (U-3980) expiration.
Aug 30, 2038
in 12 yr 5 mo
Patent 12285422 expires
Listed method-of-use patent (U-4181) expiration.
Aug 30, 2038
in 12 yr 5 mo
Patent 12384758 expires
Listed method-of-use patent (U-3980) expiration.
May 17, 2041
in 15 yr 2 mo
Patent 12384758 expires
Listed method-of-use patent (U-4161) expiration.
May 17, 2041
in 15 yr 2 mo
Patent 11603363 expires
Listed drug substance patent expiration.
May 25, 2041
in 15 yr 2 mo
Patent 11951101 expires
Listed method-of-use patent (U-3895) expiration.
Jul 15, 2041
in 15 yr 4 mo
Patent 12453726 expires
Listed method-of-use patent (U-4300) expiration.
Jul 15, 2041
in 15 yr 4 mo
Pharmaceutical detail
Active ingredient
IPTACOPAN HYDROCHLORIDE
Strength
EQ 200MG BASE
Dosage form
CAPSULE
Route
ORAL
TE code
Not listed
Application
NDA 218276
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 (5)
- I-949New indication exclusivity (3 years)
Aug 07, 2027
in 1 yr 2 mo
- I-963New indication exclusivity (3 years)
Mar 20, 2028
in 1 yr 9 mo
- NCENew chemical entity exclusivity (5 years)
Dec 05, 2028
in 2 yr 6 mo
- ODE-456Orphan-drug exclusivity (7 years)
Dec 05, 2030
in 4 yr 6 mo
- ODE-524Orphan-drug exclusivity (7 years)
Mar 20, 2032
in 5 yr 10 mo
Listed patents (10)
| Patent | Expires | In | Type |
|---|---|---|---|
| 10093663 | Jul 14, 2034 | in 8 yr 2 mo | U-4161 |
| 10093663 | Jul 14, 2034 | in 8 yr 2 mo | U-3980 |
| 9682968 | Jul 14, 2034 | in 8 yr 2 mo | SubstanceProduct |
| 11723901 | Aug 30, 2038 | in 12 yr 5 mo | U-3980 |
| 12285422 | Aug 30, 2038 | in 12 yr 5 mo | U-4181 |
| 12384758 | May 17, 2041 | in 15 yr 2 mo | U-3980 |
| 12384758 | May 17, 2041 | in 15 yr 2 mo | U-4161 |
| 11603363 | May 25, 2041 | in 15 yr 2 mo | SubstanceProduct |
| 11951101 | Jul 15, 2041 | in 15 yr 4 mo | U-3895 |
| 12453726 | Jul 15, 2041 | in 15 yr 4 mo | U-4300 |
