Orange Book product · Brand (NDA)
ORLADEYO
BEROTRALSTAT DIHYDROCHLORIDE
At a glance
Dec 03, 2020
Approved
Brand (NDA)
Application
Not listed
TE code
32
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Dec 03, 2020
5 yr 7 mo ago
Today
Exclusivity ends · ODE-333
Orphan-drug exclusivity (7 years)
Dec 03, 2027
in 1 yr 6 mo
Exclusivity ends · PED
Pediatric exclusivity (adds 6 months)
Jun 03, 2028
in 2 yr
Patent 10329260 expires
Listed drug substance patent expiration.
Mar 09, 2035
in 8 yr 10 mo
Patent 10689346 expires
Listed method-of-use patent (U-3010) expiration.
Mar 09, 2035
in 8 yr 10 mo
Patent 11230530 expires
Listed method-of-use patent (U-3300) expiration.
Mar 09, 2035
in 8 yr 10 mo
Patent 11708333 expires
Listed method-of-use patent (U-3300) expiration.
Mar 09, 2035
in 8 yr 10 mo
Patent 12116346 expires
Listed drug substance patent expiration.
Mar 09, 2035
in 8 yr 10 mo
Patent 10125102 expires
Listed drug substance patent expiration.
Apr 07, 2035
in 8 yr 11 mo
Patent 10329260*PED expires
Listed listed patent expiration.
Sep 09, 2035
in 9 yr 4 mo
Patent 10689346*PED expires
Listed listed patent expiration.
Sep 09, 2035
in 9 yr 4 mo
Patent 11230530*PED expires
Listed listed patent expiration.
Sep 09, 2035
in 9 yr 4 mo
Patent 11708333*PED expires
Listed listed patent expiration.
Sep 09, 2035
in 9 yr 4 mo
Patent 12116346*PED expires
Listed listed patent expiration.
Sep 09, 2035
in 9 yr 4 mo
Patent 10125102*PED expires
Listed listed patent expiration.
Oct 07, 2035
in 9 yr 5 mo
Patent 10662160 expires
Listed drug substance patent expiration.
Nov 01, 2039
in 13 yr 7 mo
Patent 11117867 expires
Listed drug product patent expiration.
Nov 01, 2039
in 13 yr 7 mo
Patent 11618733 expires
Listed method-of-use patent (U-3300) expiration.
Nov 01, 2039
in 13 yr 7 mo
Patent 12344585 expires
Listed method-of-use patent (U-3010) expiration.
Nov 01, 2039
in 13 yr 7 mo
Patent 12545645 expires
Listed drug substance patent expiration.
Nov 01, 2039
in 13 yr 7 mo
Patent 12545646 expires
Listed drug substance patent expiration.
Nov 01, 2039
in 13 yr 7 mo
Patent 12545647 expires
Listed drug substance patent expiration.
Nov 01, 2039
in 13 yr 7 mo
Patent 12552750 expires
Listed drug substance patent expiration.
Nov 01, 2039
in 13 yr 7 mo
Patent 12590068 expires
Listed drug substance patent expiration.
Nov 01, 2039
in 13 yr 7 mo
Patent 12590069 expires
Listed drug substance patent expiration.
Nov 01, 2039
in 13 yr 7 mo
Patent 10662160*PED expires
Listed listed patent expiration.
May 01, 2040
in 14 yr 1 mo
Patent 11117867*PED expires
Listed listed patent expiration.
May 01, 2040
in 14 yr 1 mo
Patent 11618733*PED expires
Listed listed patent expiration.
May 01, 2040
in 14 yr 1 mo
Patent 12344585*PED expires
Listed listed patent expiration.
May 01, 2040
in 14 yr 1 mo
Patent 12545645*PED expires
Listed listed patent expiration.
May 01, 2040
in 14 yr 1 mo
Patent 12545646*PED expires
Listed listed patent expiration.
May 01, 2040
in 14 yr 1 mo
Patent 12545647*PED expires
Listed listed patent expiration.
May 01, 2040
in 14 yr 1 mo
Patent 12552750*PED expires
Listed listed patent expiration.
May 01, 2040
in 14 yr 1 mo
Patent 12590068*PED expires
Listed listed patent expiration.
May 01, 2040
in 14 yr 1 mo
Patent 12590069*PED expires
Listed listed patent expiration.
May 01, 2040
in 14 yr 1 mo
Pharmaceutical detail
Active ingredient
BEROTRALSTAT DIHYDROCHLORIDE
Strength
EQ 150MG BASE
Dosage form
CAPSULE
Route
ORAL
TE code
Not listed
Application
NDA 214094
Product number
002
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 (2)
- ODE-333Orphan-drug exclusivity (7 years)
Dec 03, 2027
in 1 yr 6 mo
- PEDPediatric exclusivity (adds 6 months)
Jun 03, 2028
in 2 yr
Listed patents (32)
| Patent | Expires | In | Type |
|---|---|---|---|
| 10329260 | Mar 09, 2035 | in 8 yr 10 mo | Substance |
| 10689346 | Mar 09, 2035 | in 8 yr 10 mo | U-3010 |
| 11230530 | Mar 09, 2035 | in 8 yr 10 mo | U-3300 |
| 11708333 | Mar 09, 2035 | in 8 yr 10 mo | U-3300 |
| 12116346 | Mar 09, 2035 | in 8 yr 10 mo | Substance |
| 10125102 | Apr 07, 2035 | in 8 yr 11 mo | SubstanceU-3010 |
| 10329260*PED | Sep 09, 2035 | in 9 yr 4 mo | |
| 10689346*PED | Sep 09, 2035 | in 9 yr 4 mo | |
| 11230530*PED | Sep 09, 2035 | in 9 yr 4 mo | |
| 11708333*PED | Sep 09, 2035 | in 9 yr 4 mo | |
| 12116346*PED | Sep 09, 2035 | in 9 yr 4 mo | |
| 10125102*PED | Oct 07, 2035 | in 9 yr 5 mo | |
| 10662160 | Nov 01, 2039 | in 13 yr 7 mo | SubstanceU-3010 |
| 11117867 | Nov 01, 2039 | in 13 yr 7 mo | ProductU-3010 |
| 11618733 | Nov 01, 2039 | in 13 yr 7 mo | U-3300 |
| 12344585 | Nov 01, 2039 | in 13 yr 7 mo | U-3010 |
| 12545645 | Nov 01, 2039 | in 13 yr 7 mo | SubstanceProduct |
| 12545646 | Nov 01, 2039 | in 13 yr 7 mo | SubstanceProduct |
| 12545647 | Nov 01, 2039 | in 13 yr 7 mo | SubstanceProduct |
| 12552750 | Nov 01, 2039 | in 13 yr 7 mo | SubstanceProduct |
| 12590068 | Nov 01, 2039 | in 13 yr 7 mo | SubstanceProduct |
| 12590069 | Nov 01, 2039 | in 13 yr 7 mo | SubstanceProduct |
| 10662160*PED | May 01, 2040 | in 14 yr 1 mo | |
| 11117867*PED | May 01, 2040 | in 14 yr 1 mo | |
| 11618733*PED | May 01, 2040 | in 14 yr 1 mo | |
| 12344585*PED | May 01, 2040 | in 14 yr 1 mo | |
| 12545645*PED | May 01, 2040 | in 14 yr 1 mo | |
| 12545646*PED | May 01, 2040 | in 14 yr 1 mo | |
| 12545647*PED | May 01, 2040 | in 14 yr 1 mo | |
| 12552750*PED | May 01, 2040 | in 14 yr 1 mo | |
| 12590068*PED | May 01, 2040 | in 14 yr 1 mo | |
| 12590069*PED | May 01, 2040 | in 14 yr 1 mo |
