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DEXMETHYLPHENIDATE HYDROCHLORIDE, NDA 021802

The patents and exclusivities FDA's Orange Book lists for NDA 021802 as captured on 14 October 2026, each date named by its rule and its rows, and the rows of FDA's Paragraph IV list that give this NDA's number, as captured on 17 October 2026. Listed protection is a range of dates, never one date.

FDA capture · review pending. Each row is shown as captured from FDA's Orange Book files and Paragraph IV list. Dates are FDA's own; spreadsheet day numbers are shown as dates, and a cell that cannot be read as one date is shown as written and left out of the range. Where FDA lists a *PED row without flags, its flags are read from the base row and marked so. A Paragraph IV row is placed here only by the number in its RLD/NDA cell; nothing is joined by name. How this page reads FDA's files has not been independently reviewed by a regulatory-affairs reviewer.

Orange Book captured
14 October 2026
Paragraph IV list captured
17 October 2026
Last checked
30 October 2026
Data-branch commit
dadcab56563716abea6c5e31a5e1970080c778ef

Listed protection is a range of the dates FDA lists, not a forecast of market entry, and not legal, regulatory or investment advice.

Dates as listed in FDA's Orange Book capture of 14 October 2026. This page does not say whether a date has passed; compare it with today's date and FDA's current Orange Book. This page shows only what the capture of 14 October 2026 lists. It does not show patents or exclusivities listed before and since removed.

Open in the appDEXMETHYLPHENIDATE HYDROCHLORIDE in the molecule app

Listed protection

The Orange Book capture of 14 October 2026 lists no patent and no exclusivity for NDA 021802.

Products

Each product number FDA lists under NDA 021802, as listed. The sections below name products by these numbers.

  • Product 001 · FOCALIN XR

    Dosage form; route
    CAPSULE, EXTENDED RELEASE;ORAL
    Strength
    5MG
    Approval date as listed
    26 May 2005
    Type as listed
    RX
    Applicant as listed
    SANDOZ INC

  • Product 002 · FOCALIN XR

    Dosage form; route
    CAPSULE, EXTENDED RELEASE;ORAL
    Strength
    10MG
    Approval date as listed
    26 May 2005
    Type as listed
    RX
    Applicant as listed
    SANDOZ INC

  • Product 003 · FOCALIN XR

    Dosage form; route
    CAPSULE, EXTENDED RELEASE;ORAL
    Strength
    20MG
    Approval date as listed
    26 May 2005
    Type as listed
    RX
    Applicant as listed
    SANDOZ INC

  • Product 004 · FOCALIN XR

    Dosage form; route
    CAPSULE, EXTENDED RELEASE;ORAL
    Strength
    15MG
    Approval date as listed
    1 Aug 2006
    Type as listed
    RX
    Applicant as listed
    SANDOZ INC

  • Product 005 · FOCALIN XR

    Dosage form; route
    CAPSULE, EXTENDED RELEASE;ORAL
    Strength
    30MG
    Approval date as listed
    23 Oct 2009
    Type as listed
    RX
    Applicant as listed
    SANDOZ INC

  • Product 006 · FOCALIN XR

    Dosage form; route
    CAPSULE, EXTENDED RELEASE;ORAL
    Strength
    40MG
    Approval date as listed
    11 Aug 2010
    Type as listed
    RX
    Applicant as listed
    SANDOZ INC

  • Product 007 · FOCALIN XR

    Dosage form; route
    CAPSULE, EXTENDED RELEASE;ORAL
    Strength
    35MG
    Approval date as listed
    21 Apr 2011
    Type as listed
    RX
    Applicant as listed
    SANDOZ INC

  • Product 008 · FOCALIN XR

    Dosage form; route
    CAPSULE, EXTENDED RELEASE;ORAL
    Strength
    25MG
    Approval date as listed
    21 Apr 2011
    Type as listed
    RX
    Applicant as listed
    SANDOZ INC

Listed patents

Every patent the FDA lists for this product, as the application holder submitted it, with its flags. The FDA does not verify listings.

The Orange Book capture of 14 October 2026 lists no patent for NDA 021802.

Listed exclusivities

Each exclusivity FDA lists for NDA 021802, with its code, FDA's definition of the code where the store's code list gives one, and its date as listed.

The Orange Book capture of 14 October 2026 lists no exclusivity for NDA 021802.

Paragraph IV list rows giving NDA 021802

The rows of FDA's Paragraph IV certifications list as captured on 17 October 2026 whose RLD/NDA cell gives NDA 021802, each cell as listed.

FDA's Paragraph IV list names no patent number, so it does not say which of the patents on this page an applicant certified against.

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.

Rows whose RLD/NDA cell we could not read as exactly one NDA number are kept apart on the list page; some may concern this product.

Rows on FDA's Paragraph IV list whose RLD/NDA cell gives NDA 021802

  • Dexmethylphenidate · Extended-release Capsules · 25 mg

    RLD/NDA as listed: Focalin XR 21802
    First PIV submission
    30 Sep 2011
    ANDAs
    1
    180-day status
    Eligible
    Decision posted
    27 Jan 2020
    First applicant approval
    30 Nov 2016
    First marketing
    5 Jan 2017
    Last qualifying patent expiry (as listed by FDA)
    1 Nov 2019

  • Dexmethylphenidate · Extended-release Capsules · 35 mg

    RLD/NDA as listed: Focalin XR 21802
    First PIV submission
    29 Sep 2011
    ANDAs
    1
    180-day status
    Eligible
    Decision posted
    27 Jan 2020
    First applicant approval
    30 Nov 2016
    First marketing
    5 Jan 2017
    Last qualifying patent expiry (as listed by FDA)
    1 Nov 2019

  • Dexmethylphenidate Hydrochloride · Extended-release Capsules · 15 mg

    RLD/NDA as listed: Focalin XR 21802
    First PIV submission
    14 May 2007
    ANDAs
    1
    180-day status
    Eligible
    Decision posted
    27 Jan 2020
    First applicant approval
    18 Nov 2013
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    1 Nov 2019

  • Dexmethylphenidate Hydrochloride · Extended-release Capsules · 5 mg, 10 mg and 20 mg

    RLD/NDA as listed: Focalin XR 21802
    First PIV submission
    30 Mar 2007
    ANDAs
    1
    180-day status
    Eligible
    Decision posted
    27 Jan 2020
    First applicant approval
    19 Nov 2013
    First marketing
    10 Nov 2014
    Last qualifying patent expiry (as listed by FDA)
    1 Nov 2019

  • Dexmethylphenidate Hydrochloride · Extended-release Capsules · 30 mg

    RLD/NDA as listed: Focalin XR 21802
    First PIV submission
    15 Dec 2010
    ANDAs
    1
    180-day status
    Eligible
    Decision posted
    27 Jan 2020
    First applicant approval
    28 Aug 2013
    First marketing
    18 Nov 2013
    Last qualifying patent expiry (as listed by FDA)
    1 Nov 2019

  • Dexmethylphenidate Hydrochloride · Extended-release Capsules · 40 mg

    RLD/NDA as listed: Focalin XR 21802
    First PIV submission
    20 Dec 2010
    ANDAs
    1
    180-day status
    Eligible
    Decision posted
    27 Jan 2020
    First applicant approval
    19 Nov 2013
    First marketing
    22 Nov 2013
    Last qualifying patent expiry (as listed by FDA)
    1 Nov 2019

Notes from the trace

  • R6 tentative approvals: not in the Orange Book data files as captured; the Drugs@FDA join is a later ruling.

Patents vs FDA exclusivityHow to read the Orange Book data filesParagraph IV certificationWhat changed, by week