Assyro AI

Orange Book product · Brand (NDA)

FANAPT

ILOPERIDONE

Brand (NDA)NDA 022192RX VANDA PHARMS INC

At a glance

May 06, 2009

Approved

Brand (NDA)

Application

Not listed

TE code

10

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    May 06, 2009

    17 yr 4 mo ago

  2. Today

  3. Exclusivity ends · I-939

    New indication exclusivity (3 years)

    Apr 02, 2027

    in 10 mo

  4. Patent 8586610 expires

    Listed method-of-use patent (U-1625) expiration.

    Nov 02, 2027

    in 1 yr 5 mo

  5. Patent 9157121 expires

    Listed method-of-use patent (U-1674) expiration.

    Apr 05, 2030

    in 3 yr 10 mo

  6. Patent 8652776 expires

    Listed method-of-use patent (U-1685) expiration.

    Aug 31, 2030

    in 4 yr 3 mo

  7. Patent 12606869 expires

    Listed method-of-use patent (U-4504) expiration.

    Sep 22, 2030

    in 4 yr 4 mo

  8. Patent 12606869 expires

    Listed method-of-use patent (U-4505) expiration.

    Sep 22, 2030

    in 4 yr 4 mo

  9. Patent 8999638 expires

    Listed method-of-use patent (U-1674) expiration.

    Oct 28, 2030

    in 4 yr 5 mo

  10. Patent 9074255 expires

    Listed method-of-use patent (U-1674) expiration.

    Dec 17, 2030

    in 4 yr 7 mo

  11. Patent 9072742 expires

    Listed method-of-use patent (U-1674) expiration.

    Jan 16, 2031

    in 4 yr 8 mo

  12. Patent 9074256 expires

    Listed method-of-use patent (U-1674) expiration.

    Feb 10, 2031

    in 4 yr 9 mo

  13. Patent 9074254 expires

    Listed method-of-use patent (U-1674) expiration.

    Dec 28, 2031

    in 5 yr 7 mo

Pharmaceutical detail

Active ingredient

ILOPERIDONE

Strength

1MG

Dosage form

TABLET

Route

ORAL

TE code

Not listed

Application

NDA 022192

Product number

001

Marketing status

RX

Reference listed drug (RLD)

Yes

Reference standard (RS)

Yes

Active-ingredient family

View full family

This is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.

Marketing exclusivity (1)

  • I-939New indication exclusivity (3 years)

    Apr 02, 2027

    in 10 mo

Listed patents (10)

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
12606869Sep 22, 2030in 4 yr 4 mo
U-4505
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
Agent CTA Background

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