brexpiprazole · Otsuka · NDA 205422
Rexulti
Earliest generic entry, as listed · earliest of 6 marketed strengths
23 Jun 2029
Other strengths are listed to 12 Apr 2033.
Blocked by patent: US RE48059 (pediatric extension).
Listed patents · 2 unexpired
4 Orange Book listing rows for 2 patents, including 2 pediatric extensions. FDA lists a patent once for each use code, and lists its pediatric extension as a separate row.
| Patent | Claims | Expires |
|---|---|---|
| US 10307419 | drug product | 12 Apr 2033 |
| US 10307419 listing row | drug product | 12 Oct 2032 |
| US 10307419 listing row | pediatric extension | 12 Apr 2033 |
| US RE48059 | drug substance | 23 Jun 2029 |
| US RE48059 listing row | drug substance | 23 Dec 2028 |
| US RE48059 listing row | pediatric extension · sets the listed date | 23 Jun 2029 |
Exclusivities · 3 unexpired
| M-315 | miscellaneous (3 years) | 9 May 2028 |
| PED | pediatric (6 months added) | 8 Nov 2027 |
| M-14 | miscellaneous (3 years) | 8 May 2027 |
| PED | pediatric (6 months added) | 10 Nov 2026 |
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 · 205422-006Exclusivity expires 10 Nov 2026Detected 24 Oct 2026
- Exclusivity expires within 90 days PED · 205422-005Exclusivity expires 10 Nov 2026Detected 24 Oct 2026
- Exclusivity expires within 90 days PED · 205422-004Exclusivity expires 10 Nov 2026Detected 24 Oct 2026
- Exclusivity expires within 90 days PED · 205422-003Exclusivity expires 10 Nov 2026Detected 24 Oct 2026
- Exclusivity expires within 90 days PED · 205422-002Exclusivity expires 10 Nov 2026Detected 24 Oct 2026
- Exclusivity expires within 90 days PED · 205422-001Exclusivity expires 10 Nov 2026Detected 24 Oct 2026
Products covered · 6
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 205422 · 001 · RLD | tablet, oral | 0.25MG | 12 Apr 2033 |
| 205422 · 002 · RLD | tablet, oral | 0.5MG | 12 Apr 2033 |
| 205422 · 003 · RLD | tablet, oral | 1MG | 12 Apr 2033 |
| 205422 · 004 · RLD | tablet, oral | 2MG | 12 Apr 2033 |
| 205422 · 005 · RLD | tablet, oral | 3MG | 12 Apr 2033 |
| 205422 · 006 · RLD | tablet, oral | 4MG | 23 Jun 2029 |
Expired or delisted (10)
- US 8349840 · — · 12 Oct 2026
- US 8618109 · — · 12 Oct 2026
- US 9839637 · — · 12 Oct 2026
- US 8349840 · product, use U-1529 · 12 Apr 2026
- US 8618109 · use U-3281 · 12 Apr 2026
- US 8618109 · use U-543 · 12 Apr 2026
- US 9839637 · product, use U-1529 · 12 Apr 2026
- US 9839637 · product, use U-3281 · 12 Apr 2026
- US 9839637 · product, use U-543 · 12 Apr 2026
- I-913 · 10 May 2026