FDA Orange Book · active-ingredient family
Lurasidone hydrochloride
Lurasidone hydrochloride: 1 brand, 19 generics; first approved Oct 28, 2010; generic available.
Generic availableHas discontinued products
Generic status & protection
Generic available: 19 ANDA applications approved.
Earliest patent expiry
Brands (NDA)
1
Generics (ANDA)
19
Listed patents
10
Next patent expiry
May 26, 2026
5 mo ago
Brand (NDA) products
Originator applications
- LATUDARLDSUNOVION PHARMS INCNDA 20060320115 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 40MG TABLET ORAL Rx AB 80MG TABLET ORAL Rx AB 20MG TABLET ORAL Rx AB 120MG TABLET ORAL Rx AB 60MG TABLET ORAL Rx AB
Generic (ANDA) products (19)
Abbreviated applications
- LURASIDONE HYDROCHLORIDEJUBILANT GENERICSANDA 21038820245 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 20MG TABLET ORAL Rx AB 40MG TABLET ORAL Rx AB 60MG TABLET ORAL Rx AB 80MG TABLET ORAL Rx AB 120MG TABLET ORAL Rx AB - LURASIDONE HYDROCHLORIDEANNORA PHARMAANDA 21817420245 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 20MG TABLET ORAL Rx AB 40MG TABLET ORAL Rx AB 60MG TABLET ORAL Rx AB 80MG TABLET ORAL Rx AB 120MG TABLET ORAL Rx AB - LURASIDONE HYDROCHLORIDEMACLEODS PHARMSANDA 21212420235 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 20MG TABLET ORAL Rx AB 40MG TABLET ORAL Rx AB 60MG TABLET ORAL Rx AB 80MG TABLET ORAL Rx AB 120MG TABLET ORAL Rx AB - LURASIDONE HYDROCHLORIDEAUROBINDO PHARMA LTDANDA 20804520235 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 20MG TABLET ORAL Rx AB 40MG TABLET ORAL Rx AB 60MG TABLET ORAL Rx AB 80MG TABLET ORAL Rx AB 120MG TABLET ORAL Rx AB - LURASIDONE HYDROCHLORIDEALKEM LABS LTDANDA 21224420225 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 20MG TABLET ORAL Rx AB 40MG TABLET ORAL Rx AB 60MG TABLET ORAL Rx AB 80MG TABLET ORAL Rx AB 120MG TABLET ORAL Rx AB - LURASIDONE HYDROCHLORIDEMSNANDA 20803720225 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 20MG TABLET ORAL Rx AB 40MG TABLET ORAL Rx AB 60MG TABLET ORAL Rx AB 80MG TABLET ORAL Rx AB 120MG TABLET ORAL Rx AB - LURASIDONE HYDROCHLORIDEDR REDDYSANDA 20804720214 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 20MG TABLET ORAL Rx AB 40MG TABLET ORAL Rx AB 60MG TABLET ORAL Rx AB 80MG TABLET ORAL Rx AB - LURASIDONE HYDROCHLORIDEALEMBICANDA 21324820215 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 20MG TABLET ORAL Rx AB 40MG TABLET ORAL Rx AB 60MG TABLET ORAL Rx AB 80MG TABLET ORAL Rx AB 120MG TABLET ORAL Rx AB - LURASIDONE HYDROCHLORIDEWATSON LABS TEVAANDA 20801620215 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 20MG TABLET ORAL Discontinued — 40MG TABLET ORAL Discontinued — 60MG TABLET ORAL Discontinued — 80MG TABLET ORAL Discontinued — 120MG TABLET ORAL Discontinued — - LURASIDONE HYDROCHLORIDECHARTWELL RXANDA 21209120205 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 20MG TABLET ORAL Rx AB 40MG TABLET ORAL Rx AB 60MG TABLET ORAL Rx AB 80MG TABLET ORAL Rx AB 120MG TABLET ORAL Rx AB - LURASIDONE HYDROCHLORIDEHERITAGE PHARMA AVETANDA 20805820195 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 20MG TABLET ORAL Rx AB 40MG TABLET ORAL Rx AB 60MG TABLET ORAL Rx AB 80MG TABLET ORAL Rx AB 120MG TABLET ORAL Rx AB - LURASIDONE HYDROCHLORIDETEVA PHARMS USAANDA 20806020195 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 20MG TABLET ORAL Discontinued — 40MG TABLET ORAL Discontinued — 60MG TABLET ORAL Discontinued — 80MG TABLET ORAL Discontinued — 120MG TABLET ORAL Discontinued — - LURASIDONE HYDROCHLORIDEZYDUS PHARMSANDA 20805220195 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 20MG TABLET ORAL Rx AB 40MG TABLET ORAL Rx AB 60MG TABLET ORAL Rx AB 80MG TABLET ORAL Rx AB 120MG TABLET ORAL Rx AB - LURASIDONE HYDROCHLORIDESUN PHARMANDA 20806620195 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 20MG TABLET ORAL Rx AB 40MG TABLET ORAL Rx AB 60MG TABLET ORAL Rx AB 80MG TABLET ORAL Rx AB 120MG TABLET ORAL Discontinued — - LURASIDONE HYDROCHLORIDEACCORD HLTHCAREANDA 20804920195 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 20MG TABLET ORAL Rx AB 40MG TABLET ORAL Rx AB 60MG TABLET ORAL Rx AB 80MG TABLET ORAL Rx AB 120MG TABLET ORAL Rx AB - LURASIDONE HYDROCHLORIDEAMNEAL PHARMS COANDA 20800220195 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 20MG TABLET ORAL Discontinued — 40MG TABLET ORAL Discontinued — 60MG TABLET ORAL Discontinued — 80MG TABLET ORAL Discontinued — 120MG TABLET ORAL Discontinued — - LURASIDONE HYDROCHLORIDEINVAGEN PHARMSANDA 20802820195 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 20MG TABLET ORAL Rx AB 40MG TABLET ORAL Rx AB 60MG TABLET ORAL Rx AB 80MG TABLET ORAL Rx AB 120MG TABLET ORAL Rx AB - LURASIDONE HYDROCHLORIDELUPINANDA 20803120195 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 20MG TABLET ORAL Rx AB 40MG TABLET ORAL Rx AB 60MG TABLET ORAL Rx AB 80MG TABLET ORAL Rx AB 120MG TABLET ORAL Rx AB - LURASIDONE HYDROCHLORIDETORRENTANDA 20805520195 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 20MG TABLET ORAL Rx AB 40MG TABLET ORAL Rx AB 80MG TABLET ORAL Rx AB 120MG TABLET ORAL Rx AB 60MG TABLET ORAL Rx AB
Patent & exclusivity timeline
Protection horizon
Patent expiryExclusivity endToday
Listed patents
Orange Book patent file
| Patent | Expires | In | Type |
|---|---|---|---|
| 9555027 | 5 mo ago | ProductU-543 | |
| 8883794 | 5 mo ago | Product | |
| 8729085 | 5 mo ago | Product | |
| 9907794 | 5 mo ago | Product | |
| 8883794*PED | in 2 mo | ||
| 8729085*PED | in 2 mo | ||
| 9907794*PED | in 2 mo | ||
| 9259423 | in 4 yr 8 mo | U-1822 | |
| 9827242 | in 4 yr 8 mo | U-2199 | |
| 9259423*PED | in 5 yr 2 mo |
Approval history
FDA approval span
First approval
16 yr 2 mo ago
Most recent approval
1 yr 9 mo ago
Approvals span 2010–2025 across 20 FDA applications.
Brand (NDA) 15%
Generic (ANDA) 1995%
Lurasidone hydrochloride: frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
Built directly from the FDA Orange Book data file (products, patents, and exclusivity). TE codes, RLD/RS flags, patent expirations, and exclusivity dates match the official FDA record. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
Related FDA reference tools
- FDA Purple BookLicensed biologics, biosimilars, interchangeables, BLA records, and exclusivity dates.
- FDA BiosimilarsFDA-approved biosimilars and interchangeable biosimilars, by reference product.
- 510(k) Predicate DatabaseSearch FDA 510(k) clearances and map predicate-device lineage.
- FDA 483 DatabaseFDA Form 483 observations and inspection records by firm, date, and citation.
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