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FDA Paragraph IV list

Drybench Patent.

FDA Paragraph IV list: K

The rows of FDA's Paragraph IV certifications list as captured on 17 October 2026 whose group's drug name, as listed, starts with K, grouped by the NDA number the list gives.

FDA capture · review pending. Each row is shown as captured from FDA's list. Spreadsheet day numbers are shown as dates; a cell that cannot be read as one date is shown as written. A row is placed under an NDA only by the number in its RLD/NDA cell; nothing is joined by name. How this page reads the list has not been independently reviewed by a regulatory-affairs reviewer.

Paragraph IV list captured
17 October 2026
Last checked
30 October 2026

Rows as FDA lists them, not a forecast of market entry and not legal, regulatory or investment advice.

FDA's list is not complete and names no ANDA applicant, patent number or litigation. A product not shown here may still have had a Paragraph IV certification submitted; a product shown under an NDA may have more rows among those kept apart.

The list gives the last qualifying patent's expiry without pediatric exclusivity; in the app's Patents view, the Orange Book lists any *PED period as a separate row with its own date. The two dates describe different things. A blank cell is one FDA left blank in its list. Dates are FDA's own; the last qualifying patent expiry is not recomputed from the Orange Book.

Paragraph IV certificationWhat changed, by week

Ketoconazole

NDA 021738 · 1 row · Listed patents and exclusivities · Open in the app

  • Foam · 0.02

    RLD/NDA as listed: Extina 21738
    First PIV submission
    30 Jul 2009
    ANDAs
    1
    180-day status
    Eligible
    Decision posted
    29 Jun 2020
    First applicant approval
    25 Aug 2011
    First marketing
    25 Aug 2011
    Last qualifying patent expiry (as listed by FDA)
    19 Oct 2018

Ketoprofen

NDA 018754 · 1 row · Listed patents and exclusivities · Open in the app

  • Capsules · 25 mg, 50 mg and 75 mg

    RLD/NDA as listed: Orudis 18754
    First PIV submission
    Pre-MMA
    ANDAs
    blank
    180-day status
    blank
    Decision posted
    blank
    First applicant approval
    blank
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    blank

Ketorolac Tromethamine

NDA 019645 · 1 row · Listed patents and exclusivities · Open in the app

  • Tablets · 10 mg

    RLD/NDA as listed: Toradol 19645
    First PIV submission
    Pre-MMA
    ANDAs
    blank
    180-day status
    blank
    Decision posted
    blank
    First applicant approval
    blank
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    blank

Ketorolac Tromethamine

NDA 019698 · 1 row · Listed patents and exclusivities · Open in the app

  • Injection · 15 mg/mL and 30 mg/mL

    RLD/NDA as listed: Toradol 19698
    First PIV submission
    Pre-MMA
    ANDAs
    blank
    180-day status
    blank
    Decision posted
    blank
    First applicant approval
    blank
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    blank

Ketorolac Tromethamine

NDA 021528 · 1 row · Listed patents and exclusivities · Open in the app

  • Ophthalmic Solution · 0.4%

    RLD/NDA as listed: Acular LS 21528
    First PIV submission
    28 Jan 2005
    ANDAs
    1
    180-day status
    Extinguished
    Decision posted
    29 Jun 2020
    First applicant approval
    5 Nov 2009
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    5 May 2011

Ketorolac Tromethamine

NDA 022382 · 1 row · Listed patents and exclusivities · Open in the app

  • Nasal Spray · 15.75 mg/spray

    RLD/NDA as listed: Sprix 22382
    First PIV submission
    12 Mar 2012
    ANDAs
    1
    180-day status
    Extinguished
    Decision posted
    10 Mar 2020
    First applicant approval
    blank
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    25 Dec 2018

Ketorolac Tromethamine

NDA 022427 · 1 row · Listed patents and exclusivities · Open in the app

  • Ophthalmic Solution · 4.4999999999999997E-3

    RLD/NDA as listed: Acuvail 22427
    First PIV submission
    24 Aug 2011
    ANDAs
    1
    180-day status
    Eligible
    Decision posted
    29 Jun 2020
    First applicant approval
    10 Feb 2014
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    15 Aug 2029

Ketotifen Fumarate

NDA 021066 · 1 row · Listed patents and exclusivities · Open in the app

  • Ophthalmic Solution · 0.025%

    RLD/NDA as listed: Zaditor 21066
    First PIV submission
    23 Dec 2004
    ANDAs
    1
    180-day status
    Eligible
    Decision posted
    27 Jul 2020
    First applicant approval
    9 May 2006
    First marketing
    3 Jul 2006
    Last qualifying patent expiry (as listed by FDA)
    13 Jan 2019