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FDA Paragraph IV list

Drybench Patent.

FDA Paragraph IV list: Q

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

Quetiapine Fumarate

NDA 020639 · 3 rows · Listed patents and exclusivities · Open in the app

  • Tablets · 100 mg, 200 mg and 300 mg

    RLD/NDA as listed: Seroquel 20639
    First PIV submission
    21 Feb 2006
    ANDAs
    1
    180-day status
    Extinguished
    Decision posted
    24 Aug 2020
    First applicant approval
    27 Mar 2012
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    26 Sep 2011

  • Tablets · 25 mg

    RLD/NDA as listed: Seroquel 20639
    First PIV submission
    12 Aug 2005
    ANDAs
    1
    180-day status
    Extinguished
    Decision posted
    24 Aug 2020
    First applicant approval
    27 Mar 2012
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    26 Sep 2011

  • Tablets · 50 mg, 150 mg and 400 mg

    RLD/NDA as listed: Seroquel 20639
    First PIV submission
    12 Feb 2007
    ANDAs
    1
    180-day status
    Extinguished
    Decision posted
    24 Aug 2020
    First applicant approval
    27 Mar 2012
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    26 Sep 2011

Quetiapine Fumarate

NDA 022047 · 4 rows · Listed patents and exclusivities · Open in the app

  • Extended-release Tablets · 150 mg

    RLD/NDA as listed: Seroquel XR 22047
    First PIV submission
    17 Nov 2008
    ANDAs
    1
    180-day status
    Eligible
    Decision posted
    24 Aug 2020
    First applicant approval
    9 May 2017
    First marketing
    1 Nov 2016
    Last qualifying patent expiry (as listed by FDA)
    28 May 2017

  • Extended-release Tablets · 200 mg and 300 mg

    RLD/NDA as listed: Seroquel XR 22047
    First PIV submission
    12 Jun 2008
    ANDAs
    1
    180-day status
    Eligible
    Decision posted
    24 Aug 2020
    First applicant approval
    9 May 2017
    First marketing
    1 Nov 2016
    Last qualifying patent expiry (as listed by FDA)
    28 May 2017

  • Extended-release Tablets · 400 mg

    RLD/NDA as listed: Seroquel XR 22047
    First PIV submission
    18 Jun 2008
    ANDAs
    1
    180-day status
    Eligible
    Decision posted
    24 Aug 2020
    First applicant approval
    1 Nov 2016
    First marketing
    1 Nov 2016
    Last qualifying patent expiry (as listed by FDA)
    28 May 2017

  • Extended-release Tablets · 50 mg

    RLD/NDA as listed: Seroquel XR 22047
    First PIV submission
    17 Oct 2008
    ANDAs
    1
    180-day status
    Eligible
    Decision posted
    24 Aug 2020
    First applicant approval
    9 May 2017
    First marketing
    1 Nov 2016
    Last qualifying patent expiry (as listed by FDA)
    28 May 2017

Quinapril Hydrochloride

NDA 019885 · 1 row · Listed patents and exclusivities · Open in the app

  • Tablets · 5 mg, 10 mg, 20 mg and 40 mg

    RLD/NDA as listed: Accupril 19885
    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

Quinapril Hydrochloride/ Hydrochlorothiazide

NDA 020125 · 1 row · Listed patents and exclusivities · Open in the app

  • Tablets · 10 mg/12.5 mg 20 mg/12.5 mg 20mg/25 mg

    RLD/NDA as listed: Accuretic 20125
    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