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FDA Orange Book · active-ingredient family

Iopamidol

Iopamidol is approved as 2 brand and 12 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.

Reference-listed drug:ISOVUE-250 · NDA 020327

2

Brand (NDA)

12

Generics (ANDA)

0

Listed patents

4

Exclusivity periods

Brand (NDA) products · injectable

ProductApplicantApplicationTEApproved
ISOVUE-250RLD×4BRACCONDA 020327—Oct 12, 1994
ISOVUE-200RLD×7BRACCONDA 018735AP2Jul 07, 1987

Generic (ANDA) products (12)

ProductApplicantApplicationTEApproved
IOPAMIDOL×4HAINAN POLYANDA 217134AP2Sep 27, 2023
IOPAMIDOL×2HAINAN POLYANDA 215382AP1Feb 27, 2023
SCANLUX-300×2SANOCHEMIA CORP USAANDA 090394—Jun 18, 2010
IOPAMIDOL-200×4COOK IMAGINGANDA 074881—Jul 28, 2000
IOPAMIDOL-250×3HOSPIRAANDA 075005—Feb 24, 1998
IOPAMIDOL-200×4HOSPIRAANDA 074898—Dec 30, 1997
IOPAMIDOL-200 IN PLASTIC CONTAINER×4HOSPIRAANDA 074636—Dec 30, 1997
IOPAMIDOL-300ABBVIEANDA 074638—Apr 30, 1997
IOPAMIDOL-300 IN PLASTIC CONTAINERHOSPIRAANDA 074637—Apr 03, 1997
IOPAMIDOL-250×3FRESENIUS KABI USAANDA 074679—Apr 02, 1997
IOPAMIDOL×2HOSPIRAANDA 074734—Dec 10, 1996
IOPAMIDOL×4BAXTER HLTHCAREANDA 074629—Nov 06, 1996

Marketing exclusivity (4)

  • I-975New indication exclusivity (3 years)

    Oct 10, 2028

    in 2 yr 4 mo

  • I-975New indication exclusivity (3 years)

    Oct 10, 2028

    in 2 yr 4 mo

  • I-975New indication exclusivity (3 years)

    Oct 10, 2028

    in 2 yr 4 mo

  • I-975New indication exclusivity (3 years)

    Oct 10, 2028

    in 2 yr 4 mo

Listed patents

No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.

Iopamidol — frequently asked questions

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

Agent CTA Background

Your Next Submission Could Take 6+ Fewer Weeks and Cost $250K Less.

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