octreotide acetate · Sun Pharm · NDA 213224
Bynfezia Pen
Earliest generic entry, as listed
29 Dec 2041
Blocked by patent: US 12350475. Only method-of-use patents remain, so a generic may carve out the protected indication and enter earlier.
Listed patents · 5 unexpired
13 Orange Book listing rows for 5 patents. FDA lists a patent once for each use code, and lists its pediatric extension as a separate row.
| Patent | Claims | Expires |
|---|---|---|
| US 12350475 | use U-4007, U-4008, U-4009 | 29 Dec 2041 |
| US 12350475 listing row | use U-4007 · sets the listed date | 29 Dec 2041 |
| US 12350475 listing row | use U-4008 · sets the listed date | 29 Dec 2041 |
| US 12350475 listing row | use U-4009 · sets the listed date | 29 Dec 2041 |
| US 11052196 | use U-4007, U-4008, U-4009 | 3 Nov 2040 |
| US 11052196 listing row | use U-4007 | 3 Nov 2040 |
| US 11052196 listing row | use U-4008 | 3 Nov 2040 |
| US 11052196 listing row | use U-4009 | 3 Nov 2040 |
| US 11246991 | use U-4007, U-4008, U-4009 | 3 Nov 2040 |
| US 11246991 listing row | use U-4007 | 3 Nov 2040 |
| US 11246991 listing row | use U-4008 | 3 Nov 2040 |
| US 11246991 listing row | use U-4009 | 3 Nov 2040 |
| US 11534553 | use U-4007, U-4008, U-4009 | 3 Nov 2040 |
| US 11534553 listing row | use U-4007 | 3 Nov 2040 |
| US 11534553 listing row | use U-4008 | 3 Nov 2040 |
| US 11534553 listing row | use U-4009 | 3 Nov 2040 |
| US 10342850 | drug product | 15 May 2038 |
Exclusivities · 0 unexpired
No unexpired exclusivities listed.
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 · 1
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 213224 · 001 · RLD | solution, subcutaneous | EQ 7MG BASE/2.8ML (EQ 2.5MG BASE/ML) | 29 Dec 2041 |