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RISPERIDONE, NDA 213586

The patents and exclusivities FDA's Orange Book lists for NDA 213586 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 appRISPERIDONE in the molecule app

Listed protection

Listed dates run from 28 Apr 2026 to 17 Mar 2042, each by its own rule; no one date stands for this product.

Earliest listed date
28 Apr 2026NP exclusivityRule R3 · Products 001, 002, 003, 004, 005, 006, 007
Source lines

exclusivity.txt lines 1,232–1,238

Latest listed date
17 Mar 2042US 12,329,851, use patentRule R1 · Products 001, 002, 003, 004, 005, 006, 007
Source lines

patent.txt lines 15,089, 15,098, 15,107, 15,115, 15,121, 15,127, 15,133

Latest substance patent
None listed
Latest listed patent
17 Mar 2042US 12,329,851, use patentRule R1 · Products 001, 002, 003, 004, 005, 006, 007
Source lines

patent.txt lines 15,089, 15,098, 15,107, 15,115, 15,121, 15,127, 15,133

Latest exclusivity
28 Apr 2026NP exclusivityRule R3 · Products 001, 002, 003, 004, 005, 006, 007
Source lines

exclusivity.txt lines 1,232–1,238

Listed dates of other NDAs in the same years:20262027203320402042

44 use-code patents, blocking the coded use only

Products

Each product number FDA lists under NDA 213586, as listed. The sections below name products by these numbers.

  • Product 001 · UZEDY

    Dosage form; route
    SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS
    Strength
    50MG/0.14ML (50MG/0.14ML)
    Approval date as listed
    28 Apr 2023
    Type as listed
    RX
    Applicant as listed
    TEVA NEUROSCIENCE INC

  • Product 002 · UZEDY

    Dosage form; route
    SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS
    Strength
    75MG/0.21ML (75MG/0.21ML)
    Approval date as listed
    28 Apr 2023
    Type as listed
    RX
    Applicant as listed
    TEVA NEUROSCIENCE INC

  • Product 003 · UZEDY

    Dosage form; route
    SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS
    Strength
    100MG/0.28ML (100MG/0.28ML)
    Approval date as listed
    28 Apr 2023
    Type as listed
    RX
    Applicant as listed
    TEVA NEUROSCIENCE INC

  • Product 004 · UZEDY

    Dosage form; route
    SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS
    Strength
    125MG/0.35ML (125MG/0.35ML)
    Approval date as listed
    28 Apr 2023
    Type as listed
    RX
    Applicant as listed
    TEVA NEUROSCIENCE INC

  • Product 005 · UZEDY

    Dosage form; route
    SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS
    Strength
    150MG/0.42ML (150MG/0.42ML)
    Approval date as listed
    28 Apr 2023
    Type as listed
    RX
    Applicant as listed
    TEVA NEUROSCIENCE INC

  • Product 006 · UZEDY

    Dosage form; route
    SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS
    Strength
    200MG/0.56ML (200MG/0.56ML)
    Approval date as listed
    28 Apr 2023
    Type as listed
    RX
    Applicant as listed
    TEVA NEUROSCIENCE INC

  • Product 007 · UZEDY

    Dosage form; route
    SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS
    Strength
    250MG/0.7ML (250MG/0.7ML)
    Approval date as listed
    28 Apr 2023
    Type as listed
    RX
    Applicant as listed
    TEVA NEUROSCIENCE 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.

9 entries from 51 rows as listed; rows merge only where every cell shown is the same, each with its product numbers.

  • US 8,221,778, product and use patent

    patent.txt lines 15,093, 15,102, 15,111
    Expiry as listed
    12 Nov 2027
    Rule
    R1
    Flags
    product · use code U-601
    Product numbers
    001, 002, 003

  • US 8,221,778, product and use patent

    patent.txt lines 15,092, 15,101, 15,110, 15,117, 15,123, 15,129, 15,135
    Expiry as listed
    12 Nov 2027
    Rule
    R1
    Flags
    product · use code U-543
    Product numbers
    001, 002, 003, 004, 005, 006, 007

  • US 8,741,327, product and use patent

    patent.txt lines 15,094, 15,103, 15,112, 15,118, 15,124, 15,130, 15,136
    Expiry as listed
    12 Nov 2027
    Rule
    R1
    Flags
    product · use code U-543
    Product numbers
    001, 002, 003, 004, 005, 006, 007

  • US 9,023,897, product patent

    patent.txt lines 15,095, 15,104, 15,113, 15,119, 15,125, 15,131, 15,137
    Expiry as listed
    5 Apr 2033
    Rule
    R1
    Flags
    product
    Product numbers
    001, 002, 003, 004, 005, 006, 007

  • US 12,128,132, product and use patent

    patent.txt lines 15,088, 15,097, 15,106
    Expiry as listed
    11 Sep 2040
    Rule
    R1
    Flags
    product · use code U-601
    Product numbers
    001, 002, 003

  • US 12,128,132, product and use patent

    patent.txt lines 15,087, 15,096, 15,105, 15,114, 15,120, 15,126, 15,132
    Expiry as listed
    11 Sep 2040
    Rule
    R1
    Flags
    product · use code U-543
    Product numbers
    001, 002, 003, 004, 005, 006, 007

  • US 12,383,493, product and use patent

    patent.txt lines 15,091, 15,100, 15,109
    Expiry as listed
    11 Sep 2040
    Rule
    R1
    Flags
    product · use code U-601
    Product numbers
    001, 002, 003

  • US 12,383,493, product and use patent

    patent.txt lines 15,090, 15,099, 15,108, 15,116, 15,122, 15,128, 15,134
    Expiry as listed
    11 Sep 2040
    Rule
    R1
    Flags
    product · use code U-543
    Product numbers
    001, 002, 003, 004, 005, 006, 007

  • US 12,329,851, use patent

    patent.txt lines 15,089, 15,098, 15,107, 15,115, 15,121, 15,127, 15,133
    Expiry as listed
    17 Mar 2042
    Rule
    R1
    Flags
    use code U-4214
    Product numbers
    001, 002, 003, 004, 005, 006, 007

Listed exclusivities

Each exclusivity FDA lists for NDA 213586, with its code, FDA's definition of the code where the store's code list gives one, and its date as listed.

  • NP exclusivity

    exclusivity.txt lines 1,232–1,238
    Date
    28 Apr 2026
    Rule
    R3
    Definition
    New product (to be checked against FDA's list)
    Product numbers
    001, 002, 003, 004, 005, 006, 007

Paragraph IV list rows giving NDA 213586

The rows of FDA's Paragraph IV certifications list as captured on 17 October 2026 whose RLD/NDA cell gives NDA 213586, 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 213586 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