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METHYLPHENIDATE HYDROCHLORIDE, NDA 212038

The patents and exclusivities FDA's Orange Book lists for NDA 212038 as captured on 14 October 2026, each date named by its rule and its rows, and any rows of FDA's Paragraph IV list captured on 17 October 2026 that give this NDA's number. 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 appMETHYLPHENIDATE HYDROCHLORIDE in the molecule app

Listed protection

Listed dates run from 30 Oct 2035 to 19 Nov 2038, each by its own rule; no one date stands for this product.

Earliest listed date
30 Oct 2035US 10,111,839, use patentRule R1 · Products 001, 002, 003, 004, 005, 006
Source lines

patent.txt lines 13,444, 13,456, 13,468, 13,480, 13,492, 13,504

Latest listed date
19 Nov 2038US 10,722,473, use patentRule R1 · Products 001, 002, 003, 004, 005, 006
Source lines

patent.txt lines 13,454, 13,466, 13,478, 13,490, 13,502, 13,514

Latest substance patent
None listed
Latest listed patent
19 Nov 2038US 10,722,473, use patentRule R1 · Products 001, 002, 003, 004, 005, 006
Source lines

patent.txt lines 13,454, 13,466, 13,478, 13,490, 13,502, 13,514

Latest exclusivity
None listed

Listed dates of other NDAs in the same years:20352038

42 use-code patents, blocking the coded use only

Products

Each product number FDA lists under NDA 212038, as listed. The sections below name products by these numbers.

  • Product 001 · ADHANSIA XR

    Dosage form; route
    CAPSULE, EXTENDED RELEASE;ORAL
    Strength
    25MG
    Approval date as listed
    27 Feb 2019
    Type as listed
    DISCN
    Applicant as listed
    KNOA PHARMA LLC

  • Product 002 · ADHANSIA XR

    Dosage form; route
    CAPSULE, EXTENDED RELEASE;ORAL
    Strength
    35MG
    Approval date as listed
    27 Feb 2019
    Type as listed
    DISCN
    Applicant as listed
    KNOA PHARMA LLC

  • Product 003 · ADHANSIA XR

    Dosage form; route
    CAPSULE, EXTENDED RELEASE;ORAL
    Strength
    45MG
    Approval date as listed
    27 Feb 2019
    Type as listed
    DISCN
    Applicant as listed
    KNOA PHARMA LLC

  • Product 004 · ADHANSIA XR

    Dosage form; route
    CAPSULE, EXTENDED RELEASE;ORAL
    Strength
    55MG
    Approval date as listed
    27 Feb 2019
    Type as listed
    DISCN
    Applicant as listed
    KNOA PHARMA LLC

  • Product 005 · ADHANSIA XR

    Dosage form; route
    CAPSULE, EXTENDED RELEASE;ORAL
    Strength
    70MG
    Approval date as listed
    27 Feb 2019
    Type as listed
    DISCN
    Applicant as listed
    KNOA PHARMA LLC

  • Product 006 · ADHANSIA XR

    Dosage form; route
    CAPSULE, EXTENDED RELEASE;ORAL
    Strength
    85MG
    Approval date as listed
    27 Feb 2019
    Type as listed
    DISCN
    Applicant as listed
    KNOA PHARMA LLC

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.

12 entries from 72 rows as listed; rows merge only where every cell shown is the same, each with its product numbers.

  • US 10,111,839, use patent

    patent.txt lines 13,444, 13,456, 13,468, 13,480, 13,492, 13,504
    Expiry as listed
    30 Oct 2035
    Rule
    R1
    Flags
    use code U-2357
    Product numbers
    001, 002, 003, 004, 005, 006

  • US 10,292,938, product patent

    patent.txt lines 13,445, 13,457, 13,469, 13,481, 13,493, 13,505
    Expiry as listed
    30 Oct 2035
    Rule
    R1
    Flags
    product
    Product numbers
    001, 002, 003, 004, 005, 006

  • US 10,292,939, product and use patent

    patent.txt lines 13,446, 13,458, 13,470, 13,482, 13,494, 13,506
    Expiry as listed
    30 Oct 2035
    Rule
    R1
    Flags
    product · use code U-2357
    Product numbers
    001, 002, 003, 004, 005, 006

  • US 10,449,159, use patent

    patent.txt lines 13,447, 13,459, 13,471, 13,483, 13,495, 13,507
    Expiry as listed
    30 Oct 2035
    Rule
    R1
    Flags
    use code U-2357
    Product numbers
    001, 002, 003, 004, 005, 006

  • US 10,500,162, use patent

    patent.txt lines 13,448, 13,460, 13,472, 13,484, 13,496, 13,508
    Expiry as listed
    30 Oct 2035
    Rule
    R1
    Flags
    use code U-2357
    Product numbers
    001, 002, 003, 004, 005, 006

  • US 10,507,186, product patent

    patent.txt lines 13,449, 13,461, 13,473, 13,485, 13,497, 13,509
    Expiry as listed
    30 Oct 2035
    Rule
    R1
    Flags
    product
    Product numbers
    001, 002, 003, 004, 005, 006

  • US 10,512,612, product patent

    patent.txt lines 13,450, 13,462, 13,474, 13,486, 13,498, 13,510
    Expiry as listed
    30 Oct 2035
    Rule
    R1
    Flags
    product
    Product numbers
    001, 002, 003, 004, 005, 006

  • US 10,512,613, use patent

    patent.txt lines 13,451, 13,463, 13,475, 13,487, 13,499, 13,511
    Expiry as listed
    30 Oct 2035
    Rule
    R1
    Flags
    use code U-2357
    Product numbers
    001, 002, 003, 004, 005, 006

  • US 10,568,841, product and use patent

    patent.txt lines 13,452, 13,464, 13,476, 13,488, 13,500, 13,512
    Expiry as listed
    30 Oct 2035
    Rule
    R1
    Flags
    product · use code U-2357
    Product numbers
    001, 002, 003, 004, 005, 006

  • US 10,688,060, product patent

    patent.txt lines 13,453, 13,465, 13,477, 13,489, 13,501, 13,513
    Expiry as listed
    30 Oct 2035
    Rule
    R1
    Flags
    product
    Product numbers
    001, 002, 003, 004, 005, 006

  • US 9,974,752, product patent

    patent.txt lines 13,455, 13,467, 13,479, 13,491, 13,503, 13,515
    Expiry as listed
    30 Oct 2035
    Rule
    R1
    Flags
    product
    Product numbers
    001, 002, 003, 004, 005, 006

  • US 10,722,473, use patent

    patent.txt lines 13,454, 13,466, 13,478, 13,490, 13,502, 13,514
    Expiry as listed
    19 Nov 2038
    Rule
    R1
    Flags
    use code U-2357
    Product numbers
    001, 002, 003, 004, 005, 006

Listed exclusivities

Each exclusivity FDA lists for NDA 212038, 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 212038.

Paragraph IV list rows giving NDA 212038

The rows of FDA's Paragraph IV certifications list as captured on 17 October 2026 whose RLD/NDA cell gives NDA 212038, each cell as listed.

Rows with no NDA number this page can match are kept apart on the list page; some may concern this product.

No row of the Paragraph IV list captured on 17 October 2026 gives NDA 212038 in its RLD/NDA cell. This does not mean no certification was submitted or that no application challenges a patent listed here.

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