lurasidone hydrochloride · Sunovion Pharms Inc · NDA 200603
Latuda
Earliest generic entry, as listed · earliest of 5 marketed strengths
23 Nov 2031
Blocked by patent: US 9259423 (pediatric extension).
Listed patents · 5 unexpired
7 Orange Book listing rows for 5 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 9259423 | use U-1822 | 23 Nov 2031 |
| US 9259423 listing row | use U-1822 | 23 May 2031 |
| US 9259423 listing row | pediatric extension · sets the listed date | 23 Nov 2031 |
| US 9827242 | use U-2199, U-2201 | 23 May 2031 |
| US 9827242 listing row | use U-2199 | 23 May 2031 |
| US 9827242 listing row | use U-2201 | 23 May 2031 |
| US 8729085 | pediatric extension | 26 Nov 2026 |
| US 8883794 | pediatric extension | 26 Nov 2026 |
| US 9907794 | pediatric extension | 26 Nov 2026 |
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 · 5
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 200603 · 001 · RLD | tablet, oral | 40MG | 23 Nov 2031 |
| 200603 · 002 · RLD | tablet, oral | 80MG | 23 Nov 2031 |
| 200603 · 003 · RLD | tablet, oral | 20MG | 23 Nov 2031 |
| 200603 · 004 · RLD | tablet, oral | 120MG | 23 Nov 2031 |
| 200603 · 005 · RLD | tablet, oral | 60MG | 23 Nov 2031 |
Expired or delisted (4)
- US 8729085 · product · 26 May 2026
- US 8883794 · product · 26 May 2026
- US 9555027 · product, use U-543 · 26 May 2026
- US 9907794 · product · 26 May 2026