Orange Book product · Brand (NDA)
LATUDA
LURASIDONE HYDROCHLORIDE
At a glance
Dec 07, 2011
Approved
Brand (NDA)
Application
AB
TE code
11
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Dec 07, 2011
14 yr 9 mo ago
Patent 8729085 expires
Listed drug product patent expiration.
May 26, 2026
24 d ago
Patent 8883794 expires
Listed drug product patent expiration.
May 26, 2026
24 d ago
Patent 9555027 expires
Listed drug product patent expiration.
May 26, 2026
24 d ago
Patent 9907794 expires
Listed drug product patent expiration.
May 26, 2026
24 d ago
Today
Patent 8729085*PED expires
Listed listed patent expiration.
Nov 26, 2026
in 5 mo
Patent 8883794*PED expires
Listed listed patent expiration.
Nov 26, 2026
in 5 mo
Patent 9907794*PED expires
Listed listed patent expiration.
Nov 26, 2026
in 5 mo
Patent 9259423 expires
Listed method-of-use patent (U-1822) expiration.
May 23, 2031
in 5 yr
Patent 9827242 expires
Listed method-of-use patent (U-2199) expiration.
May 23, 2031
in 5 yr
Patent 9827242 expires
Listed method-of-use patent (U-2201) expiration.
May 23, 2031
in 5 yr
Patent 9259423*PED expires
Listed listed patent expiration.
Nov 23, 2031
in 5 yr 6 mo
Pharmaceutical detail
Active ingredient
LURASIDONE HYDROCHLORIDE
Strength
20MG
Dosage form
TABLET
Route
ORAL
TE code
AB
Application
NDA 200603
Product number
003
Marketing status
RX
Reference listed drug (RLD)
Yes
Reference standard (RS)
No
Active-ingredient family
View full familyThis is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.
- 2024LURASIDONE HYDROCHLORIDEGeneric (ANDA)
ANDA 210388 · JUBILANT GENERICS
- 2024LURASIDONE HYDROCHLORIDEGeneric (ANDA)
ANDA 218174 · ANNORA PHARMA
- 2023LURASIDONE HYDROCHLORIDEGeneric (ANDA)
ANDA 212124 · MACLEODS PHARMS LTD
- 2023LURASIDONE HYDROCHLORIDEGeneric (ANDA)
ANDA 208045 · AUROBINDO PHARMA LTD
- 2022LURASIDONE HYDROCHLORIDEGeneric (ANDA)
ANDA 212244 · ALKEM LABS LTD
- 2022LURASIDONE HYDROCHLORIDEGeneric (ANDA)
ANDA 208037 · MSN
- 2021LURASIDONE HYDROCHLORIDEGeneric (ANDA)
ANDA 208047 · DR REDDYS
- 2021LURASIDONE HYDROCHLORIDEGeneric (ANDA)
ANDA 213248 · ALEMBIC
- 2021LURASIDONE HYDROCHLORIDEGeneric (ANDA)
ANDA 208016 · WATSON LABS TEVA
- 2020LURASIDONE HYDROCHLORIDEGeneric (ANDA)
ANDA 212091 · CHARTWELL RX
- 2019LURASIDONE HYDROCHLORIDEGeneric (ANDA)
ANDA 208058 · HERITAGE PHARMA AVET
- 2019LURASIDONE HYDROCHLORIDEGeneric (ANDA)
ANDA 208060 · TEVA PHARMS USA
Listed patents (11)
| Patent | Expires | In | Type |
|---|---|---|---|
| 8729085 | May 26, 2026 | 24 d ago | Product |
| 8883794 | May 26, 2026 | 24 d ago | Product |
| 9555027 | May 26, 2026 | 24 d ago | ProductU-543 |
| 9907794 | May 26, 2026 | 24 d ago | Product |
| 8729085*PED | Nov 26, 2026 | in 5 mo | |
| 8883794*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 |
| 9827242 | May 23, 2031 | in 5 yr | U-2201 |
| 9259423*PED | Nov 23, 2031 | in 5 yr 6 mo |
