apremilast · Amgen Inc · NDA 205437
Otezla
Earliest generic entry, as listed · earliest of 3 marketed strengths
29 Nov 2034
Blocked by patent: US 10092541 (pediatric extension), US 9872854 (pediatric extension).
Listed patents · 4 unexpired
12 Orange Book listing rows for 4 patents, including 4 pediatric extensions. FDA lists a patent once for each use code, and lists its pediatric extension as a separate row.
| Patent | Claims | Expires |
|---|---|---|
| US 10092541 | use U-2403, U-2659 | 29 Nov 2034 |
| US 10092541 listing row | use U-2403 | 29 May 2034 |
| US 10092541 listing row | use U-2659 | 29 May 2034 |
| US 10092541 listing row | pediatric extension · sets the listed date | 29 Nov 2034 |
| US 9872854 | use U-2232, U-2233 | 29 Nov 2034 |
| US 9872854 listing row | use U-2232 | 29 May 2034 |
| US 9872854 listing row | use U-2233 | 29 May 2034 |
| US 9872854 listing row | pediatric extension · sets the listed date | 29 Nov 2034 |
| US 12576034 | drug product, use U-1858, U-4290, U-4291 | 30 May 2034 |
| US 12576034 listing row | drug product, use U-1858 | 30 Nov 2033 |
| US 12576034 listing row | drug product, use U-4290 | 30 Nov 2033 |
| US 12576034 listing row | drug product, use U-4291 | 30 Nov 2033 |
| US 12576034 listing row | pediatric extension | 30 May 2034 |
| US 7427638 | drug substance, drug product | 16 Aug 2028 |
| US 7427638 listing row | drug substance, drug product | 16 Feb 2028 |
| US 7427638 listing row | pediatric extension | 16 Aug 2028 |
Exclusivities · 2 unexpired
| PED | pediatric (6 months added) | 25 Oct 2027 |
| NPP | new patient population | 25 Apr 2027 |
| 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 · 205437-003Exclusivity expires 20 Jan 2027Detected 24 Oct 2026
- Exclusivity expires within 90 days PED · 205437-003Exclusivity expires 19 Jan 2027Detected 24 Oct 2026
- Exclusivity expires within 90 days PED · 205437-002Exclusivity expires 20 Jan 2027Detected 24 Oct 2026
- Exclusivity expires within 90 days PED · 205437-002Exclusivity expires 19 Jan 2027Detected 24 Oct 2026
- Exclusivity expires within 90 days PED · 205437-001Exclusivity expires 20 Jan 2027Detected 24 Oct 2026
- Exclusivity expires within 90 days PED · 205437-001Exclusivity expires 19 Jan 2027Detected 24 Oct 2026
Products covered · 3
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 205437 · 001 · RLD | tablet, oral | 10MG | 29 Nov 2034 |
| 205437 · 002 · RLD | tablet, oral | 20MG | 29 Nov 2034 |
| 205437 · 003 · RLD | tablet, oral | 30MG | 29 Nov 2034 |
Expired or delisted (2)
- M-299 · 20 Jul 2026
- ODE-248 · 19 Jul 2026