FDA Orange Book · active-ingredient family
Iloperidone
Iloperidone: 1 brand, 3 generics; first approved May 06, 2009; generic available.
Generic available7 exclusivity periodsHas discontinued products
Generic status & protection
Generic available: 3 ANDA applications approved.
Earliest patent expiry Latest exclusivity ends
Brands (NDA)
1
Generics (ANDA)
3
Listed patents
11
Next patent expiry
Nov 02, 2027
in 1 yr 1 mo
Brand (NDA) products
Originator applications
- VANDA PHARMS INCNDA 02219220097 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1MG TABLET ORAL Rx — 2MG TABLET ORAL Rx — 4MG TABLET ORAL Rx — 6MG TABLET ORAL Rx — 8MG TABLET ORAL Rx — 10MG TABLET ORAL Rx — 12MG TABLET ORAL Rx —
Generic (ANDA) products (3)
Abbreviated applications
- ILOPERIDONELUPINANDA 20689020227 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1MG TABLET ORAL Discontinued — 2MG TABLET ORAL Discontinued — 4MG TABLET ORAL Discontinued — 6MG TABLET ORAL Discontinued — 8MG TABLET ORAL Discontinued — 10MG TABLET ORAL Discontinued — 12MG TABLET ORAL Discontinued — - ILOPERIDONETAROANDA 20709820197 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1MG TABLET ORAL Discontinued — 2MG TABLET ORAL Discontinued — 4MG TABLET ORAL Discontinued — 6MG TABLET ORAL Discontinued — 8MG TABLET ORAL Discontinued — 10MG TABLET ORAL Discontinued — 12MG TABLET ORAL Discontinued — - ILOPERIDONEINVENTIAANDA 20723120167 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1MG TABLET ORAL Discontinued — 2MG TABLET ORAL Discontinued — 4MG TABLET ORAL Discontinued — 6MG TABLET ORAL Discontinued — 8MG TABLET ORAL Discontinued — 10MG TABLET ORAL Discontinued — 12MG TABLET ORAL Discontinued —
Patent & exclusivity timeline
Protection horizon
Patent expiryExclusivity endToday
Marketing exclusivity
Hatch-Waxman
- I-939New indication exclusivity (3 years)
in 6 mo
- I-939New indication exclusivity (3 years)
in 6 mo
- I-939New indication exclusivity (3 years)
in 6 mo
- I-939New indication exclusivity (3 years)
in 6 mo
- I-939New indication exclusivity (3 years)
in 6 mo
- I-939New indication exclusivity (3 years)
in 6 mo
- I-939New indication exclusivity (3 years)
in 6 mo
Listed patents
Orange Book patent file
| Patent | Expires | In | Type |
|---|---|---|---|
| 8586610 | in 1 yr 1 mo | U-1625 | |
| 10570453 | in 1 yr 6 mo | U-4562 | |
| 9157121 | in 3 yr 6 mo | U-1674 | |
| 10563259 | in 3 yr 10 mo | U-4562 | |
| 8652776 | in 3 yr 11 mo | U-1685 | |
| 12606869 | in 4 yr | U-4504 | |
| 8999638 | in 4 yr 1 mo | U-1674 | |
| 9074255 | in 4 yr 3 mo | U-1674 | |
| 9072742 | in 4 yr 4 mo | U-1674 | |
| 9074256 | in 4 yr 5 mo | U-1674 | |
| 9074254 | in 5 yr 4 mo | U-1674 |
Approval history
FDA approval span
First approval
17 yr 8 mo ago
Most recent approval
4 yr 6 mo ago
Approvals span 2009–2022 across 4 FDA applications.
Brand (NDA) 125%
Generic (ANDA) 375%
Iloperidone: 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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