FDA Orange Book · active-ingredient family
Lurasidone hydrochloride
Lurasidone hydrochloride is approved as 1 brand and 19 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:LATUDA · NDA 200603
1
Brand (NDA)
19
Generics (ANDA)
10
Listed patents
0
Exclusivity periods
Brand (NDA) products · tablet
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| LATUDARLD×5 | SUNOVION PHARMS INC | NDA 200603 | AB | Dec 07, 2011 |
Generic (ANDA) products (19)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| LURASIDONE HYDROCHLORIDE×5 | JUBILANT GENERICS | ANDA 210388 | AB | Dec 06, 2024 | |
| LURASIDONE HYDROCHLORIDE×5 | ANNORA PHARMA | ANDA 218174 | AB | Aug 21, 2024 | |
| LURASIDONE HYDROCHLORIDE×5 | MACLEODS PHARMS LTD | ANDA 212124 | AB | Jun 09, 2023 | |
| LURASIDONE HYDROCHLORIDE×5 | AUROBINDO PHARMA LTD | ANDA 208045 | AB | Mar 10, 2023 | |
| LURASIDONE HYDROCHLORIDE×5 | ALKEM LABS LTD | ANDA 212244 | AB | Dec 13, 2022 | |
| LURASIDONE HYDROCHLORIDE×5 | MSN | ANDA 208037 | AB | Sep 09, 2022 | |
| LURASIDONE HYDROCHLORIDE×4 | DR REDDYS | ANDA 208047 | AB | Aug 24, 2021 | |
| LURASIDONE HYDROCHLORIDE×5 | ALEMBIC | ANDA 213248 | AB | May 13, 2021 | |
| LURASIDONE HYDROCHLORIDE×5 | WATSON LABS TEVA | ANDA 208016 | — | Feb 02, 2021 | |
| LURASIDONE HYDROCHLORIDE×5 | CHARTWELL RX | ANDA 212091 | AB | Dec 28, 2020 | |
| LURASIDONE HYDROCHLORIDE×5 | HERITAGE PHARMA AVET | ANDA 208058 | AB | Sep 04, 2019 | |
| LURASIDONE HYDROCHLORIDE×5 | TEVA PHARMS USA | ANDA 208060 | — | May 17, 2019 | |
| LURASIDONE HYDROCHLORIDE×5 | ZYDUS PHARMS | ANDA 208052 | AB | Mar 19, 2019 | |
| LURASIDONE HYDROCHLORIDE×5 | SUN PHARM | ANDA 208066 | AB | Jan 04, 2019 | |
| LURASIDONE HYDROCHLORIDE×5 | ACCORD HLTHCARE | ANDA 208049 | AB | Jan 03, 2019 | |
| LURASIDONE HYDROCHLORIDE×5 | AMNEAL PHARMS CO | ANDA 208002 | — | Jan 03, 2019 | |
| LURASIDONE HYDROCHLORIDE×5 | INVAGEN PHARMS | ANDA 208028 | AB | Jan 03, 2019 | |
| LURASIDONE HYDROCHLORIDE×5 | LUPIN | ANDA 208031 | AB | Jan 03, 2019 | |
| LURASIDONE HYDROCHLORIDE×5 | TORRENT | ANDA 208055 | AB | Jan 03, 2019 |
Listed patents (10)
| Patent | Expires | In | Type |
|---|---|---|---|
| 9555027 | May 26, 2026 | 24 d ago | ProductU-543 |
| 8883794 | May 26, 2026 | 24 d ago | Product |
| 8729085 | May 26, 2026 | 24 d ago | Product |
| 9907794 | May 26, 2026 | 24 d ago | Product |
| 8883794*PED | Nov 26, 2026 | in 5 mo | |
| 8729085*PED | Nov 26, 2026 | in 5 mo | |
| 9907794*PED | Nov 26, 2026 | in 5 mo | |
| 9259423 | May 23, 2031 | in 5 yr | U-1822 |
| 9827242 | May 23, 2031 | in 5 yr | U-2199 |
| 9259423*PED | Nov 23, 2031 | in 5 yr 6 mo |
Lurasidone hydrochloride — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
