Orange Book product · Brand (NDA)
FINTEPLA
FENFLURAMINE HYDROCHLORIDE
At a glance
Jun 25, 2020
Approved
Brand (NDA)
Application
Not listed
TE code
31
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Jun 25, 2020
6 yr 1 mo ago
Today
Exclusivity ends · ODE-312
Orphan-drug exclusivity (7 years)
Jun 25, 2027
in 1 yr
Exclusivity ends · PED
Pediatric exclusivity (adds 6 months)
Dec 25, 2027
in 1 yr 6 mo
Exclusivity ends · ODE-393
Orphan-drug exclusivity (7 years)
Mar 25, 2029
in 2 yr 10 mo
Exclusivity ends · PED
Pediatric exclusivity (adds 6 months)
Sep 25, 2029
in 3 yr 4 mo
Patent 10478441 expires
Listed method-of-use patent (U-2860) expiration.
May 03, 2033
in 7 yr
Patent 10478442 expires
Listed method-of-use patent (U-2860) expiration.
May 03, 2033
in 7 yr
Patent 12097206 expires
Listed method-of-use patent (U-4013) expiration.
May 03, 2033
in 7 yr
Patent 9549909 expires
Listed method-of-use patent (U-2858) expiration.
May 03, 2033
in 7 yr
Patent 9603814 expires
Listed method-of-use patent (U-2858) expiration.
May 03, 2033
in 7 yr
Patent 9603815 expires
Listed method-of-use patent (U-2858) expiration.
May 03, 2033
in 7 yr
Patent 9610260 expires
Listed method-of-use patent (U-2858) expiration.
May 03, 2033
in 7 yr
Patent 10478441*PED expires
Listed listed patent expiration.
Nov 03, 2033
in 7 yr 6 mo
Patent 10478442*PED expires
Listed listed patent expiration.
Nov 03, 2033
in 7 yr 6 mo
Patent 12097206*PED expires
Listed listed patent expiration.
Nov 03, 2033
in 7 yr 6 mo
Patent 9549909*PED expires
Listed listed patent expiration.
Nov 03, 2033
in 7 yr 6 mo
Patent 9603814*PED expires
Listed listed patent expiration.
Nov 03, 2033
in 7 yr 6 mo
Patent 9603815*PED expires
Listed listed patent expiration.
Nov 03, 2033
in 7 yr 6 mo
Patent 9610260*PED expires
Listed listed patent expiration.
Nov 03, 2033
in 7 yr 6 mo
Patent 10947183 expires
Listed drug substance patent expiration.
Dec 20, 2036
in 10 yr 8 mo
Patent 10947183*PED expires
Listed listed patent expiration.
Jun 20, 2037
in 11 yr 2 mo
Patent 10603290 expires
Listed method-of-use patent (U-2861) expiration.
Aug 02, 2037
in 11 yr 3 mo
Patent 10603290 expires
Listed method-of-use patent (U-3347) expiration.
Aug 02, 2037
in 11 yr 3 mo
Patent 11040018 expires
Listed method-of-use patent (U-2861) expiration.
Aug 02, 2037
in 11 yr 3 mo
Patent 11040018 expires
Listed method-of-use patent (U-3347) expiration.
Aug 02, 2037
in 11 yr 3 mo
Patent 11406606 expires
Listed method-of-use patent (U-3406) expiration.
Aug 02, 2037
in 11 yr 3 mo
Patent 11406606 expires
Listed method-of-use patent (U-3407) expiration.
Aug 02, 2037
in 11 yr 3 mo
Patent 11759440 expires
Listed method-of-use patent (U-3694) expiration.
Aug 02, 2037
in 11 yr 3 mo
Patent 11786487 expires
Listed method-of-use patent (U-3733) expiration.
Aug 02, 2037
in 11 yr 3 mo
Patent 10603290*PED expires
Listed listed patent expiration.
Feb 02, 2038
in 11 yr 10 mo
Patent 11040018*PED expires
Listed listed patent expiration.
Feb 02, 2038
in 11 yr 10 mo
Patent 11406606*PED expires
Listed listed patent expiration.
Feb 02, 2038
in 11 yr 10 mo
Patent 11759440*PED expires
Listed listed patent expiration.
Feb 02, 2038
in 11 yr 10 mo
Patent 11786487*PED expires
Listed listed patent expiration.
Feb 02, 2038
in 11 yr 10 mo
Patent 10452815 expires
Listed method-of-use patent (U-2859) expiration.
Jun 29, 2038
in 12 yr 2 mo
Patent 10452815*PED expires
Listed listed patent expiration.
Dec 29, 2038
in 12 yr 9 mo
Pharmaceutical detail
Active ingredient
FENFLURAMINE HYDROCHLORIDE
Strength
EQ 2.2MG BASE/ML
Dosage form
SOLUTION
Route
ORAL
TE code
Not listed
Application
NDA 212102
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 (4)
- ODE-312Orphan-drug exclusivity (7 years)
Jun 25, 2027
in 1 yr
- PEDPediatric exclusivity (adds 6 months)
Dec 25, 2027
in 1 yr 6 mo
- ODE-393Orphan-drug exclusivity (7 years)
Mar 25, 2029
in 2 yr 10 mo
- PEDPediatric exclusivity (adds 6 months)
Sep 25, 2029
in 3 yr 4 mo
Listed patents (31)
| Patent | Expires | In | Type |
|---|---|---|---|
| 10478441 | May 03, 2033 | in 7 yr | U-2860 |
| 10478442 | May 03, 2033 | in 7 yr | U-2860 |
| 12097206 | May 03, 2033 | in 7 yr | U-4013 |
| 9549909 | May 03, 2033 | in 7 yr | U-2858 |
| 9603814 | May 03, 2033 | in 7 yr | U-2858 |
| 9603815 | May 03, 2033 | in 7 yr | U-2858 |
| 9610260 | May 03, 2033 | in 7 yr | U-2858 |
| 10478441*PED | Nov 03, 2033 | in 7 yr 6 mo | |
| 10478442*PED | Nov 03, 2033 | in 7 yr 6 mo | |
| 12097206*PED | Nov 03, 2033 | in 7 yr 6 mo | |
| 9549909*PED | Nov 03, 2033 | in 7 yr 6 mo | |
| 9603814*PED | Nov 03, 2033 | in 7 yr 6 mo | |
| 9603815*PED | Nov 03, 2033 | in 7 yr 6 mo | |
| 9610260*PED | Nov 03, 2033 | in 7 yr 6 mo | |
| 10947183 | Dec 20, 2036 | in 10 yr 8 mo | SubstanceProduct |
| 10947183*PED | Jun 20, 2037 | in 11 yr 2 mo | |
| 10603290 | Aug 02, 2037 | in 11 yr 3 mo | U-2861 |
| 10603290 | Aug 02, 2037 | in 11 yr 3 mo | U-3347 |
| 11040018 | Aug 02, 2037 | in 11 yr 3 mo | U-2861 |
| 11040018 | Aug 02, 2037 | in 11 yr 3 mo | U-3347 |
| 11406606 | Aug 02, 2037 | in 11 yr 3 mo | U-3406 |
| 11406606 | Aug 02, 2037 | in 11 yr 3 mo | U-3407 |
| 11759440 | Aug 02, 2037 | in 11 yr 3 mo | U-3694 |
| 11786487 | Aug 02, 2037 | in 11 yr 3 mo | U-3733 |
| 10603290*PED | Feb 02, 2038 | in 11 yr 10 mo | |
| 11040018*PED | Feb 02, 2038 | in 11 yr 10 mo | |
| 11406606*PED | Feb 02, 2038 | in 11 yr 10 mo | |
| 11759440*PED | Feb 02, 2038 | in 11 yr 10 mo | |
| 11786487*PED | Feb 02, 2038 | in 11 yr 10 mo | |
| 10452815 | Jun 29, 2038 | in 12 yr 2 mo | U-2859Delisted |
| 10452815*PED | Dec 29, 2038 | in 12 yr 9 mo |
