BEROTRALSTAT DIHYDROCHLORIDE | N219776 | BIOCRYST PHARMACEUTICALS INC
| Patent # | Expiration | PED | Drug Substance | Drug Product | Use Code | Delist |
|---|---|---|---|---|---|---|
| 10125102 | Apr 7, 2035PED: Oct 7, 2035 | PED | Yes | — | — | |
| 10329260 | Mar 9, 2035PED: Sep 9, 2035 | PED | Yes | — | — | — |
| 10662160 | Nov 1, 2039PED: May 1, 2040 | PED | Yes | — | — | |
| 10689346 | Mar 9, 2035PED: Sep 9, 2035 | PED | — | — | — | |
| 11117867 | Nov 1, 2039PED: May 1, 2040 | PED | — | Yes | — | |
| 11230530 | Mar 9, 2035PED: Sep 9, 2035 | PED | — | — | — | |
| 11618733 | Nov 1, 2039PED: May 1, 2040 | PED | — | — | — | |
| 11708333 | Mar 9, 2035PED: Sep 9, 2035 | PED | — | — | — | |
| 12116346 | Mar 9, 2035PED: Sep 9, 2035 | PED | Yes | — | — | — |
| 12344585 | Nov 1, 2039PED: May 1, 2040 | PED | — | — | — | |
| 12545645 | Nov 1, 2039PED: May 1, 2040 | PED | Yes | Yes | — | — |
| 12545646 | Nov 1, 2039PED: May 1, 2040 | PED | Yes | Yes | — | — |
| 12545647 | Nov 1, 2039PED: May 1, 2040 | PED | Yes | Yes | — | — |
| 12552750 | Nov 1, 2039PED: May 1, 2040 | PED | Yes | Yes | — | — |
| 12590068 | Nov 1, 2039PED: May 1, 2040 | PED | Yes | Yes | — | — |
| 12590069 | Nov 1, 2039PED: May 1, 2040 | PED | Yes | Yes | — | — |
| Code | Date | Status |
|---|---|---|
| NP | Dec 11, 2028 | Active |
| PED | Jun 11, 2029 | Active |
| NP*PEDNewly listed — daily FDA feed, not yet in monthly Orange Book edition | Jun 11, 2029 | Active |
Berotralstat dihydrochloride (Orladeyo) received pediatric exclusivity, extending its regulatory exclusivity period to Jun 2029.
New: ORLADEYO (BEROTRALSTAT DIHYDROCHLORIDE) — exclusivity NP*PED exp 06/11/2029
ORLADEYO (berotralstat dihydrochloride) gained pediatric exclusivity with expiration in Jun 2029.
New: ORLADEYO (BEROTRALSTAT DIHYDROCHLORIDE) — exclusivity NP*PED exp 06/11/2029
ORLADEYO (berotralstat dihydrochloride) gained non-patent pediatric exclusivity expiring Jun 2029.
New: ORLADEYO (BEROTRALSTAT DIHYDROCHLORIDE) — exclusivity NP*PED exp 06/11/2029
ORLADEYO (berotralstat dihydrochloride) gained pediatric exclusivity extending to Jun 2029.
New: ORLADEYO (BEROTRALSTAT DIHYDROCHLORIDE) — exclusivity NP*PED exp 06/11/2029