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FDA Paragraph IV list

Drybench Patent.

FDA Paragraph IV list: Z

The rows of FDA's Paragraph IV certifications list as captured on 17 October 2026 whose group's drug name, as listed, starts with Z, 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

Zafirlukast

NDA 020547 · 1 row · Listed patents and exclusivities · Open in the app

  • Tablets · 10 mg and 20 mg

    RLD/NDA as listed: Accolate 20547
    First PIV submission
    29 Feb 2008
    ANDAs
    1
    180-day status
    Eligible
    Decision posted
    27 Jul 2020
    First applicant approval
    18 Nov 2010
    First marketing
    18 Nov 2010
    Last qualifying patent expiry (as listed by FDA)
    18 Mar 2014

Zaleplon

NDA 020859 · 1 row · Listed patents and exclusivities · Open in the app

  • Capsules · 5 mg and 10 mg

    RLD/NDA as listed: Sonata 20859
    First PIV submission
    21 Jun 2005
    ANDAs
    1
    180-day status
    Extinguished
    Decision posted
    27 Jul 2020
    First applicant approval
    6 Jun 2008
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    6 Jun 2008

Zanubrutinib

NDA 213217 · 1 row · Listed patents and exclusivities · Open in the app

  • Capsules · 80 mg

    RLD/NDA as listed: Brukinsa 213217
    First PIV submission
    14 Nov 2023
    ANDAs
    2
    180-day status
    blank
    Decision posted
    blank
    First applicant approval
    blank
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    19 Jan 2043

Zanubrutinib

NDA 218785 · 1 row · Listed patents and exclusivities · Open in the app

  • Tablets · 160 mg

    RLD/NDA as listed: Brukinsa 218785
    First PIV submission
    13 Nov 2025
    ANDAs
    1
    180-day status
    blank
    Decision posted
    blank
    First applicant approval
    blank
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    19 Jan 2043

Ziprasidone Hydrochloride

NDA 020825 · 1 row · Listed patents and exclusivities · Open in the app

  • Capsules · 20 mg, 40 mg, 60 mg and 80 mg

    RLD/NDA as listed: Geodon 20825
    First PIV submission
    7 Feb 2005
    ANDAs
    5
    180-day status
    Eligible
    Decision posted
    27 Jul 2020
    First applicant approval
    2 Mar 2012
    First marketing
    2 Mar 2012
    Last qualifying patent expiry (as listed by FDA)
    27 May 2019

Zoledronic Acid

NDA 021223 · 2 rows · Listed patents and exclusivities · Open in the app

  • Injection · 0.8 mg (base) /mL

    RLD/NDA as listed: Zometa 21223
    First PIV submission
    11 Jun 2008
    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)
    2 Sep 2012

  • Injection · 4 mg/100 mL, 100 mL vial

    RLD/NDA as listed: Zometa 21223
    First PIV submission
    31 Jan 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)
    5 Feb 2028

Zoledronic Acid

NDA 021817 · 1 row · Listed patents and exclusivities · Open in the app

  • Injection · 0.05 mg/mL, 100 mL vial

    RLD/NDA as listed: Reclast 21817
    First PIV submission
    29 Aug 2008
    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)
    2 Sep 2012

Zolmitriptan

NDA 021450 · 2 rows · Listed patents and exclusivities · Open in the app

  • Nasal Spray · 2.5 mg/spray

    RLD/NDA as listed: Zomig 21450
    First PIV submission
    9 Jun 2016
    ANDAs
    1
    180-day status
    Extinguished
    Decision posted
    27 Jul 2020
    First applicant approval
    blank
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    28 Nov 2020

  • Nasal Spray · 5 mg/spray

    RLD/NDA as listed: Zomig 21450
    First PIV submission
    14 Nov 2013
    ANDAs
    1
    180-day status
    Extinguished
    Decision posted
    12 Jan 2021
    First applicant approval
    blank
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    28 Nov 2020

Zolpidem Tartrate

NDA 021774 · 2 rows · Listed patents and exclusivities · Open in the app

  • Extended-release Tablets · 12.5 mg

    RLD/NDA as listed: Ambien CR 21774
    First PIV submission
    19 Jan 2006
    ANDAs
    1
    180-day status
    Non-Forfeiture
    Decision posted
    27 Jul 2020
    First applicant approval
    3 Dec 2010
    First marketing
    6 Dec 2010
    Last qualifying patent expiry (as listed by FDA)
    1 Jun 2020

  • Extended-release Tablets · 6.25 mg

    RLD/NDA as listed: Ambien CR 21774
    First PIV submission
    24 Feb 2006
    ANDAs
    1
    180-day status
    Non-Forfeiture
    Decision posted
    27 Jul 2020
    First applicant approval
    13 Oct 2010
    First marketing
    13 Oct 2010
    Last qualifying patent expiry (as listed by FDA)
    1 Jun 2020

Zolpidem Tartrate

NDA 021997 · 1 row · Listed patents and exclusivities · Open in the app

  • Sublingual Tablets · 5 mg and 10 mg

    RLD/NDA as listed: Edluar 21997
    First PIV submission
    29 Apr 2010
    ANDAs
    1
    180-day status
    Extinguished
    Decision posted
    27 Jul 2020
    First applicant approval
    1 Aug 2016
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    24 Sep 2018

Zolpidem Tartrate

NDA 022328 · 1 row · Listed patents and exclusivities · Open in the app

  • Sublingual Tablets · 1.75 mg and 3.5 mg

    RLD/NDA as listed: Intermezzo 22328
    First PIV submission
    10 Apr 2012
    ANDAs
    1
    180-day status
    Eligible
    Decision posted
    27 Jul 2020
    First applicant approval
    3 Jun 2015
    First marketing
    23 Mar 2016
    Last qualifying patent expiry (as listed by FDA)
    15 Apr 2027

Zonisamide

NDA 214273 · 1 row · Listed patents and exclusivities · Open in the app

  • Oral Suspension · 100 mg/5 mL

    RLD/NDA as listed: Zonisade 214273
    First PIV submission
    4 Feb 2025
    ANDAs
    1
    180-day status
    blank
    Decision posted
    blank
    First applicant approval
    blank
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    18 Aug 2038