Orange Book product · Brand (NDA)
ORLADEYO
BEROTRALSTAT DIHYDROCHLORIDE
At a glance
Dec 11, 2025
Approved
Brand (NDA)
Application
Not listed
TE code
22
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Dec 11, 2025
6 mo ago
Today
Exclusivity ends · NP
New product exclusivity (3 years)
Dec 11, 2028
in 2 yr 6 mo
Exclusivity ends · PED
Pediatric exclusivity (adds 6 months)
Jun 11, 2029
in 3 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-4535) expiration.
Mar 09, 2035
in 8 yr 10 mo
Patent 11230530 expires
Listed method-of-use patent (U-4535) expiration.
Mar 09, 2035
in 8 yr 10 mo
Patent 11708333 expires
Listed method-of-use patent (U-4535) 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 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-4535) expiration.
Nov 01, 2039
in 13 yr 7 mo
Patent 12344585 expires
Listed method-of-use patent (U-4535) 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 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 96MG BASE/PACKET
Dosage form
PELLETS
Route
ORAL
TE code
Not listed
Application
NDA 219776
Product number
002
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 (2)
- NPNew product exclusivity (3 years)
Dec 11, 2028
in 2 yr 6 mo
- PEDPediatric exclusivity (adds 6 months)
Jun 11, 2029
in 3 yr
Listed patents (22)
| Patent | Expires | In | Type |
|---|---|---|---|
| 10329260 | Mar 09, 2035 | in 8 yr 10 mo | Substance |
| 10689346 | Mar 09, 2035 | in 8 yr 10 mo | U-4535 |
| 11230530 | Mar 09, 2035 | in 8 yr 10 mo | U-4535 |
| 11708333 | Mar 09, 2035 | in 8 yr 10 mo | U-4535 |
| 12116346 | Mar 09, 2035 | in 8 yr 10 mo | Substance |
| 10125102 | Apr 07, 2035 | in 8 yr 11 mo | SubstanceU-4535 |
| 10662160 | Nov 01, 2039 | in 13 yr 7 mo | SubstanceU-4535 |
| 11117867 | Nov 01, 2039 | in 13 yr 7 mo | ProductU-4535 |
| 11618733 | Nov 01, 2039 | in 13 yr 7 mo | U-4535 |
| 12344585 | Nov 01, 2039 | in 13 yr 7 mo | U-4535 |
| 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 |
| 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 |
