fentanyl · Btcp Pharma · NDA 202788
Subsys
Earliest generic entry, as listed · earliest of 7 marketed strengths
27 Apr 2030
No marketed reference-listed strength; date taken from all listed strengths.
Blocked by patent: US 8486972, US 8486973.
Listed patents · 10 unexpired
| Patent | Claims | Expires |
|---|---|---|
| US 8486972 | product | 27 Apr 2030 |
| US 8486973 | use U-55 | 27 Apr 2030 |
| US 10016403 | product | 25 Jan 2027 |
| US 10610523 | product | 25 Jan 2027 |
| US 8835459 | product | 25 Jan 2027 |
| US 8835460 | product, use U-55 | 25 Jan 2027 |
| US 9241935 | product | 25 Jan 2027 |
| US 9289387 | product, use U-55 | 25 Jan 2027 |
| US 9642797 | product, use U-55 | 25 Jan 2027 |
| US 9642844 | product | 25 Jan 2027 |
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 · 7
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 202788 · 001 · RLD · discontinued | spray, sublingual | 0.1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | 27 Apr 2030 |
| 202788 · 002 · RLD · discontinued | spray, sublingual | 0.2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | 27 Apr 2030 |
| 202788 · 003 · RLD · discontinued | spray, sublingual | 0.4MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | 27 Apr 2030 |
| 202788 · 004 · RLD · discontinued | spray, sublingual | 0.6MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | 27 Apr 2030 |
| 202788 · 005 · RLD · discontinued | spray, sublingual | 0.8MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | 27 Apr 2030 |
| 202788 · 006 · RLD · discontinued | spray, sublingual | 1.2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | 27 Apr 2030 |
| 202788 · 007 · RLD · discontinued | spray, sublingual | 1.6MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | 27 Apr 2030 |