FDA Orange Book · active-ingredient family
Berotralstat dihydrochloride
Berotralstat dihydrochloride is approved in 2 FDA applications, with therapeutic-equivalence codes, listed patents, and marketing exclusivity from the FDA Orange Book.
Reference-listed drug:ORLADEYO · NDA 219776
2
Brand (NDA)
0
Generics (ANDA)
32
Listed patents
12
Exclusivity periods
Brand (NDA) products · capsule, pellets
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| ORLADEYORLD×4 | BIOCRYST | NDA 219776 | — | Dec 11, 2025 | |
| ORLADEYORLD×2 | BIOCRYST | NDA 214094 | — | Dec 03, 2020 |
Marketing exclusivity (12)
- 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
- 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
- NPNew product exclusivity (3 years)
Dec 11, 2028
in 2 yr 6 mo
- PEDPediatric exclusivity (adds 6 months)
Jun 11, 2029
in 3 yr
- NPNew product exclusivity (3 years)
Dec 11, 2028
in 2 yr 6 mo
- PEDPediatric exclusivity (adds 6 months)
Jun 11, 2029
in 3 yr
- NPNew product exclusivity (3 years)
Dec 11, 2028
in 2 yr 6 mo
- PEDPediatric exclusivity (adds 6 months)
Jun 11, 2029
in 3 yr
- 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 (32)
| Patent | Expires | In | Type |
|---|---|---|---|
| 11230530 | Mar 09, 2035 | in 8 yr 10 mo | U-3300 |
| 11708333 | Mar 09, 2035 | in 8 yr 10 mo | U-3300 |
| 10689346 | Mar 09, 2035 | in 8 yr 10 mo | U-3010 |
| 10329260 | Mar 09, 2035 | in 8 yr 10 mo | Substance |
| 12116346 | Mar 09, 2035 | in 8 yr 10 mo | Substance |
| 10125102 | Apr 07, 2035 | in 8 yr 11 mo | SubstanceU-3010 |
| 12116346*PED | Sep 09, 2035 | in 9 yr 4 mo | |
| 11708333*PED | Sep 09, 2035 | in 9 yr 4 mo | |
| 11230530*PED | Sep 09, 2035 | in 9 yr 4 mo | |
| 10689346*PED | Sep 09, 2035 | in 9 yr 4 mo | |
| 10329260*PED | Sep 09, 2035 | in 9 yr 4 mo | |
| 10125102*PED | Oct 07, 2035 | in 9 yr 5 mo | |
| 11117867 | Nov 01, 2039 | in 13 yr 7 mo | ProductU-3010 |
| 12344585 | Nov 01, 2039 | in 13 yr 7 mo | U-3010 |
| 10662160 | Nov 01, 2039 | in 13 yr 7 mo | SubstanceU-3010 |
| 11618733 | Nov 01, 2039 | in 13 yr 7 mo | U-3300 |
| 12552750 | Nov 01, 2039 | in 13 yr 7 mo | SubstanceProduct |
| 12590068 | Nov 01, 2039 | in 13 yr 7 mo | SubstanceProduct |
| 12545647 | Nov 01, 2039 | in 13 yr 7 mo | SubstanceProduct |
| 12545645 | Nov 01, 2039 | in 13 yr 7 mo | SubstanceProduct |
| 12590069 | Nov 01, 2039 | in 13 yr 7 mo | SubstanceProduct |
| 12545646 | Nov 01, 2039 | in 13 yr 7 mo | SubstanceProduct |
| 12344585*PED | May 01, 2040 | in 14 yr 1 mo | |
| 11618733*PED | May 01, 2040 | in 14 yr 1 mo | |
| 12590069*PED | May 01, 2040 | in 14 yr 1 mo | |
| 12590068*PED | May 01, 2040 | in 14 yr 1 mo | |
| 11117867*PED | May 01, 2040 | in 14 yr 1 mo | |
| 12552750*PED | May 01, 2040 | in 14 yr 1 mo | |
| 12545647*PED | May 01, 2040 | in 14 yr 1 mo | |
| 12545646*PED | May 01, 2040 | in 14 yr 1 mo | |
| 12545645*PED | May 01, 2040 | in 14 yr 1 mo | |
| 10662160*PED | May 01, 2040 | in 14 yr 1 mo |
Berotralstat dihydrochloride — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
