berotralstat dihydrochloride · Biocryst · NDA 214094, 219776
Orladeyo
Earliest generic entry, as listed · earliest of 6 marketed strengths
1 May 2040
Blocked by patent: US 10662160, US 11117867, US 11618733, US 12344585, US 12545645, US 12545646, US 12545647, US 12552750, US 12590068, US 12590069.
Listed patents · 40 unexpired
| Patent | Claims | Expires |
|---|---|---|
| US 10662160 | — | 1 May 2040 |
| US 11117867 | — | 1 May 2040 |
| US 11618733 | — | 1 May 2040 |
| US 12344585 | — | 1 May 2040 |
| US 12545645 | — | 1 May 2040 |
| US 12545646 | — | 1 May 2040 |
| US 12545647 | — | 1 May 2040 |
| US 12552750 | — | 1 May 2040 |
| US 12590068 | — | 1 May 2040 |
| US 12590069 | — | 1 May 2040 |
| US 10662160 | substance, use U-3010 | 1 Nov 2039 |
| US 10662160 | substance, use U-4535 | 1 Nov 2039 |
| US 11117867 | product, use U-3010 | 1 Nov 2039 |
| US 11117867 | product, use U-4535 | 1 Nov 2039 |
| US 11618733 | use U-4535 | 1 Nov 2039 |
| US 11618733 | use U-3300 | 1 Nov 2039 |
| US 12344585 | use U-4535 | 1 Nov 2039 |
| US 12344585 | use U-3010 | 1 Nov 2039 |
| US 12545645 | substance, product | 1 Nov 2039 |
| US 12545646 | substance, product | 1 Nov 2039 |
| US 12545647 | substance, product | 1 Nov 2039 |
| US 12552750 | substance, product | 1 Nov 2039 |
| US 12590068 | substance, product | 1 Nov 2039 |
| US 12590069 | substance, product | 1 Nov 2039 |
| US 10125102 | — | 7 Oct 2035 |
| US 10329260 | — | 9 Sep 2035 |
| US 10689346 | — | 9 Sep 2035 |
| US 11230530 | — | 9 Sep 2035 |
| US 11708333 | — | 9 Sep 2035 |
| US 12116346 | — | 9 Sep 2035 |
| US 10125102 | substance, use U-3010 | 7 Apr 2035 |
| US 10125102 | substance, use U-4535 | 7 Apr 2035 |
| US 10329260 | substance | 9 Mar 2035 |
| US 10689346 | use U-3010 | 9 Mar 2035 |
| US 10689346 | use U-4535 | 9 Mar 2035 |
| US 11230530 | use U-4535 | 9 Mar 2035 |
| US 11230530 | use U-3300 | 9 Mar 2035 |
| US 11708333 | use U-4535 | 9 Mar 2035 |
| US 11708333 | use U-3300 | 9 Mar 2035 |
| US 12116346 | substance | 9 Mar 2035 |
Exclusivities · 4 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 |