berotralstat dihydrochloride · Biocryst · NDA 214094, 219776
Orladeyo
Blocked by patent: US 10662160 (pediatric extension), US 11117867 (pediatric extension), US 11618733 (pediatric extension), US 12344585 (pediatric extension), US 12545645 (pediatric extension), US 12545646 (pediatric extension), US 12545647 (pediatric extension), US 12552750 (pediatric extension), US 12590068 (pediatric extension), US 12590069 (pediatric extension).
Listed patents · 16 unexpired
40 Orange Book listing rows for 16 patents, including 16 pediatric extensions. FDA lists a patent once for each use code, and lists its pediatric extension as a separate row.
| Patent | Claims | Expires |
|---|---|---|
| US 10662160 | drug substance, use U-3010, U-4535 | 1 May 2040 |
| US 10662160 listing row | drug substance, use U-3010 | 1 Nov 2039 |
| US 10662160 listing row | drug substance, use U-4535 | 1 Nov 2039 |
| US 10662160 listing row | pediatric extension · sets the listed date | 1 May 2040 |
| US 11117867 | drug product, use U-3010, U-4535 | 1 May 2040 |
| US 11117867 listing row | drug product, use U-3010 | 1 Nov 2039 |
| US 11117867 listing row | drug product, use U-4535 | 1 Nov 2039 |
| US 11117867 listing row | pediatric extension · sets the listed date | 1 May 2040 |
| US 11618733 | use U-3300, U-4535 | 1 May 2040 |
| US 11618733 listing row | use U-3300 | 1 Nov 2039 |
| US 11618733 listing row | use U-4535 | 1 Nov 2039 |
| US 11618733 listing row | pediatric extension · sets the listed date | 1 May 2040 |
| US 12344585 | use U-3010, U-4535 | 1 May 2040 |
| US 12344585 listing row | use U-3010 | 1 Nov 2039 |
| US 12344585 listing row | use U-4535 | 1 Nov 2039 |
| US 12344585 listing row | pediatric extension · sets the listed date | 1 May 2040 |
| US 12545645 | drug substance, drug product | 1 May 2040 |
| US 12545645 listing row | drug substance, drug product | 1 Nov 2039 |
| US 12545645 listing row | pediatric extension · sets the listed date | 1 May 2040 |
| US 12545646 | drug substance, drug product | 1 May 2040 |
| US 12545646 listing row | drug substance, drug product | 1 Nov 2039 |
| US 12545646 listing row | pediatric extension · sets the listed date | 1 May 2040 |
| US 12545647 | drug substance, drug product | 1 May 2040 |
| US 12545647 listing row | drug substance, drug product | 1 Nov 2039 |
| US 12545647 listing row | pediatric extension · sets the listed date | 1 May 2040 |
| US 12552750 | drug substance, drug product | 1 May 2040 |
| US 12552750 listing row | drug substance, drug product | 1 Nov 2039 |
| US 12552750 listing row | pediatric extension · sets the listed date | 1 May 2040 |
| US 12590068 | drug substance, drug product | 1 May 2040 |
| US 12590068 listing row | drug substance, drug product | 1 Nov 2039 |
| US 12590068 listing row | pediatric extension · sets the listed date | 1 May 2040 |
| US 12590069 | drug substance, drug product | 1 May 2040 |
| US 12590069 listing row | drug substance, drug product | 1 Nov 2039 |
| US 12590069 listing row | pediatric extension · sets the listed date | 1 May 2040 |
| US 10125102 | drug substance, use U-3010, U-4535 | 7 Oct 2035 |
| US 10125102 listing row | drug substance, use U-3010 | 7 Apr 2035 |
| US 10125102 listing row | drug substance, use U-4535 | 7 Apr 2035 |
| US 10125102 listing row | pediatric extension | 7 Oct 2035 |
| US 10329260 | drug substance | 9 Sep 2035 |
| US 10329260 listing row | drug substance | 9 Mar 2035 |
| US 10329260 listing row | pediatric extension | 9 Sep 2035 |
| US 10689346 | use U-3010, U-4535 | 9 Sep 2035 |
| US 10689346 listing row | use U-3010 | 9 Mar 2035 |
| US 10689346 listing row | use U-4535 | 9 Mar 2035 |
| US 10689346 listing row | pediatric extension | 9 Sep 2035 |
| US 11230530 | use U-3300, U-4535 | 9 Sep 2035 |
| US 11230530 listing row | use U-3300 | 9 Mar 2035 |
| US 11230530 listing row | use U-4535 | 9 Mar 2035 |
| US 11230530 listing row | pediatric extension | 9 Sep 2035 |
| US 11708333 | use U-3300, U-4535 | 9 Sep 2035 |
| US 11708333 listing row | use U-3300 | 9 Mar 2035 |
| US 11708333 listing row | use U-4535 | 9 Mar 2035 |
| US 11708333 listing row | pediatric extension | 9 Sep 2035 |
| US 12116346 | drug substance | 9 Sep 2035 |
| US 12116346 listing row | drug substance | 9 Mar 2035 |
| US 12116346 listing row | pediatric extension | 9 Sep 2035 |
Exclusivities · 3 unexpired
| PED | pediatric (6 months added) | 11 Jun 2029 |
| NP | new product | 11 Dec 2028 |
| PED | pediatric (6 months added) | 3 Jun 2028 |
| ODE-333 | orphan drug (7 years) | 3 Dec 2027 |
Paragraph IV certifications · 0
No Paragraph IV certification listed by FDA for this drug.
The list shows that a generic applicant certified to FDA that a listed patent is invalid or not infringed. It does not show litigation, settlements or launch timing.
Event history
No events yet. The first ingestion only records products entering their 12-month window; changes appear from the next Orange Book update.
Products covered · 6
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 214094 · 001 · RLD | capsule, oral | EQ 110MG BASE | 1 May 2040 |
| 214094 · 002 · RLD | capsule, oral | EQ 150MG BASE | 1 May 2040 |
| 219776 · 001 · RLD | pellets, oral | EQ 72MG BASE/PACKET | 1 May 2040 |
| 219776 · 002 · RLD | pellets, oral | EQ 96MG BASE/PACKET | 1 May 2040 |
| 219776 · 003 · RLD | pellets, oral | EQ 108MG BASE/PACKET | 1 May 2040 |
| 219776 · 004 · RLD | pellets, oral | EQ 132MG BASE/PACKET | 1 May 2040 |