apremilast · Amgen Inc · NDA 210745
Otezla Xr
Earliest generic entry, as listed
27 May 2042
Blocked by patent: US 11752129, US 11969409, US 12427136.
Listed patents · 5 unexpired
9 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 11752129 | drug product, use U-4264, U-4265, U-4266 | 27 May 2042 |
| US 11752129 listing row | drug product, use U-4264 · sets the listed date | 27 May 2042 |
| US 11752129 listing row | drug product, use U-4265 · sets the listed date | 27 May 2042 |
| US 11752129 listing row | drug product, use U-4266 · sets the listed date | 27 May 2042 |
| US 11969409 | drug product · sets the listed date | 27 May 2042 |
| US 12427136 | use U-1858, U-4290, U-4291 | 27 May 2042 |
| US 12427136 listing row | use U-1858 · sets the listed date | 27 May 2042 |
| US 12427136 listing row | use U-4290 · sets the listed date | 27 May 2042 |
| US 12427136 listing row | use U-4291 · sets the listed date | 27 May 2042 |
| US 10092541 | use U-2659 | 29 May 2034 |
| US 7427638 | drug substance, drug product | 16 Feb 2028 |
Exclusivities · 1 unexpired
| PED | pediatric (6 months added) | 20 Jan 2027 |
| PED | pediatric (6 months added) | 19 Jan 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
- Exclusivity expires within 90 days PED · 210745-001Exclusivity expires 20 Jan 2027Detected 24 Oct 2026
- Exclusivity expires within 90 days PED · 210745-001Exclusivity expires 19 Jan 2027Detected 24 Oct 2026
Products covered · 1
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 210745 · 001 · RLD | tablet, extended release, oral | 75MG | 27 May 2042 |
Expired or delisted (2)
- M-299 · 20 Jul 2026
- ODE* · 19 Jul 2026