odevixibat · Ipsen · NDA 215498
Bylvay
Earliest generic entry, as listed · earliest of 4 marketed strengths
12 Nov 2041
Blocked by patent: US 11583539, US 12447156. Only method-of-use patents remain, so a generic may carve out the protected indication and enter earlier.
Listed patents · 16 unexpired
28 Orange Book listing rows for 16 patents. FDA lists a patent once for each use code, and lists its pediatric extension as a separate row.
| Patent | Claims | Expires |
|---|---|---|
| US 11583539 | use U-3186 · sets the listed date | 12 Nov 2041 |
| US 12447156 | use U-3186 · sets the listed date | 12 Nov 2041 |
| US 10975046 | drug substance | 20 Jun 2039 |
| US 11365182 | use U-3186, U-3648 | 20 Jun 2039 |
| US 11365182 listing row | use U-3186 | 20 Jun 2039 |
| US 11365182 listing row | use U-3648 | 20 Jun 2039 |
| US 11801226 | drug product | 20 Jun 2039 |
| US 11802115 | drug product | 20 Jun 2039 |
| US 12091394 | drug substance | 20 Jun 2039 |
| US 12508234 | use U-3186, U-3648 | 20 Jun 2039 |
| US 12508234 listing row | use U-3186 | 20 Jun 2039 |
| US 12508234 listing row | use U-3648 | 20 Jun 2039 |
| US 9694018 | use U-3186, U-3648 | 18 Mar 2034 |
| US 9694018 listing row | use U-3186 | 18 Mar 2034 |
| US 9694018 listing row | use U-3648 | 18 Mar 2034 |
| US 10011633 | use U-3186, U-3648 | 8 Nov 2031 |
| US 10011633 listing row | use U-3186 | 8 Nov 2031 |
| US 10011633 listing row | use U-3648 | 8 Nov 2031 |
| US 10093697 | use U-3186, U-3648 | 8 Nov 2031 |
| US 10093697 listing row | use U-3186 | 8 Nov 2031 |
| US 10093697 listing row | use U-3648 | 8 Nov 2031 |
| US 10487111 | use U-3186, U-3648 | 8 Nov 2031 |
| US 10487111 listing row | use U-3186 | 8 Nov 2031 |
| US 10487111 listing row | use U-3648 | 8 Nov 2031 |
| US 10981952 | use U-3186, U-3187, U-3648, U-3649 | 8 Nov 2031 |
| US 10981952 listing row | use U-3186 | 8 Nov 2031 |
| US 10981952 listing row | use U-3187 | 8 Nov 2031 |
| US 10981952 listing row | use U-3648 | 8 Nov 2031 |
| US 10981952 listing row | use U-3649 | 8 Nov 2031 |
| US 11732006 | use U-3186, U-3648 | 8 Nov 2031 |
| US 11732006 listing row | use U-3186 | 8 Nov 2031 |
| US 11732006 listing row | use U-3648 | 8 Nov 2031 |
| US 12187812 | use U-3186, U-3648 | 8 Nov 2031 |
| US 12187812 listing row | use U-3186 | 8 Nov 2031 |
| US 12187812 listing row | use U-3648 | 8 Nov 2031 |
| US 12545705 | use U-3186, U-3648 | 8 Nov 2031 |
| US 12545705 listing row | use U-3186 | 8 Nov 2031 |
| US 12545705 listing row | use U-3648 | 8 Nov 2031 |
Exclusivities · 2 unexpired
| ODE-436 | orphan drug (7 years) | 13 Jun 2030 |
| ODE-363 | orphan drug (7 years) | 20 Jul 2028 |
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 · 4
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 215498 · 001 · RLD | capsule, pellets, oral | 0.2MG | 12 Nov 2041 |
| 215498 · 002 · RLD | capsule, oral | 0.4MG | 12 Nov 2041 |
| 215498 · 003 · RLD | capsule, pellets, oral | 0.6MG | 12 Nov 2041 |
| 215498 · 004 · RLD | capsule, oral | 1.2MG | 12 Nov 2041 |
Expired or delisted (2)
- NCE · 20 Jul 2026
- I-918 · 13 Jun 2026