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FDA Orange Book · active-ingredient family

Iloperidone

Iloperidone is approved as 1 brand and 3 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.

Reference-listed drug:FANAPT · NDA 022192

1

Brand (NDA)

3

Generics (ANDA)

9

Listed patents

7

Exclusivity periods

Brand (NDA) products · tablet

ProductApplicantApplicationTEApproved
FANAPTRLD×7VANDA PHARMS INCNDA 022192—May 06, 2009

Generic (ANDA) products (3)

ProductApplicantApplicationTEApproved
ILOPERIDONE×7LUPINANDA 206890—May 05, 2022
ILOPERIDONE×7TAROANDA 207098—Jul 22, 2019
ILOPERIDONE×7INVENTIAANDA 207231—Nov 28, 2016

Marketing exclusivity (7)

  • I-939New indication exclusivity (3 years)

    Apr 02, 2027

    in 10 mo

  • I-939New indication exclusivity (3 years)

    Apr 02, 2027

    in 10 mo

  • I-939New indication exclusivity (3 years)

    Apr 02, 2027

    in 10 mo

  • I-939New indication exclusivity (3 years)

    Apr 02, 2027

    in 10 mo

  • I-939New indication exclusivity (3 years)

    Apr 02, 2027

    in 10 mo

  • I-939New indication exclusivity (3 years)

    Apr 02, 2027

    in 10 mo

  • I-939New indication exclusivity (3 years)

    Apr 02, 2027

    in 10 mo

Listed patents (9)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
PatentExpiresInType
8586610Nov 02, 2027in 1 yr 5 mo
U-1625
9157121Apr 05, 2030in 3 yr 10 mo
U-1674
8652776Aug 31, 2030in 4 yr 3 mo
U-1685
12606869Sep 22, 2030in 4 yr 4 mo
U-4504
8999638Oct 28, 2030in 4 yr 5 mo
U-1674
9074255Dec 17, 2030in 4 yr 7 mo
U-1674
9072742Jan 16, 2031in 4 yr 8 mo
U-1674
9074256Feb 10, 2031in 4 yr 9 mo
U-1674
9074254Dec 28, 2031in 5 yr 7 mo
U-1674

Iloperidone — frequently asked questions

Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.

Agent CTA Background

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