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Drybench Patent.

SELINEXOR, NDA 212306

The patents and exclusivities FDA's Orange Book lists for NDA 212306 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.

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Listed protection

Listed dates run from 3 Jul 2026 to 14 Aug 2035, each by its own rule; no one date stands for this product.

Earliest listed date
3 Jul 2026ODE* exclusivityRule R3 · Products 002, 003, 004, 005, 006
Source lines

exclusivity.txt lines 1,050, 1,053, 1,056, 1,059, 1,062

Latest listed date
14 Aug 2035US 11,807,629, substance patentRule R1 · Products 005, 006
Source lines

patent.txt lines 13,920, 13,939

Latest substance patent
14 Aug 2035US 11,807,629, substance patentRule R1 · Products 005, 006
Source lines

patent.txt lines 13,920, 13,939

Latest listed patent
14 Aug 2035US 11,807,629, substance patentRule R1 · Products 005, 006
Source lines

patent.txt lines 13,920, 13,939

Latest exclusivity
18 Dec 2027ODE-346 exclusivityRule R3 · Product 001
Source lines

exclusivity.txt line 1,048

Listed dates of other NDAs in the same years:20262027203220332035

97 use-code patents, blocking the coded use only

Products

Each product number FDA lists under NDA 212306, as listed. The sections below name products by these numbers.

  • Product 001 · XPOVIO

    Dosage form; route
    TABLET;ORAL
    Strength
    20MG
    Approval date as listed
    3 Jul 2019
    Type as listed
    RX
    Applicant as listed
    KARYOPHARM THERAPEUTICS INC
  • Product 002 · XPOVIO

    Dosage form; route
    TABLET;ORAL
    Strength
    40MG
    Approval date as listed
    15 Apr 2021
    Type as listed
    RX
    Applicant as listed
    KARYOPHARM THERAPEUTICS INC
  • Product 003 · XPOVIO

    Dosage form; route
    TABLET;ORAL
    Strength
    50MG
    Approval date as listed
    15 Apr 2021
    Type as listed
    RX
    Applicant as listed
    KARYOPHARM THERAPEUTICS INC
  • Product 004 · XPOVIO

    Dosage form; route
    TABLET;ORAL
    Strength
    60MG
    Approval date as listed
    15 Apr 2021
    Type as listed
    RX
    Applicant as listed
    KARYOPHARM THERAPEUTICS INC
  • Product 005 · XPOVIO

    Dosage form; route
    TABLET;ORAL
    Strength
    10MG
    Approval date as listed
    10 Mar 2025
    Type as listed
    RX
    Applicant as listed
    KARYOPHARM THERAPEUTICS INC
  • Product 006 · XPOVIO

    Dosage form; route
    TABLET;ORAL
    Strength
    80MG
    Approval date as listed
    20 Oct 2025
    Type as listed
    RX
    Applicant as listed
    KARYOPHARM THERAPEUTICS 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.

21 entries from 115 rows as listed; rows merge only where every cell shown is the same, each with its product numbers.

  • US 10,544,108, use patent

    patent.txt lines 13,833, 13,853, 13,872, 13,891, 13,910, 13,929
    Expiry as listed
    26 Jul 2032
    Rule
    R1
    Flags
    use code U-2584
    Product numbers
    001, 002, 003, 004, 005, 006
  • US 10,544,108, use patent

    patent.txt lines 13,834, 13,854, 13,873, 13,892, 13,911, 13,930
    Expiry as listed
    26 Jul 2032
    Rule
    R1
    Flags
    use code U-3018
    Product numbers
    001, 002, 003, 004, 005, 006
  • US 11,034,660, use patent

    patent.txt lines 13,835, 13,855, 13,874, 13,893, 13,912, 13,931
    Expiry as listed
    26 Jul 2032
    Rule
    R1
    Flags
    use code U-2584
    Product numbers
    001, 002, 003, 004, 005, 006
  • US 11,034,660, use patent

    patent.txt lines 13,836, 13,856, 13,875, 13,894, 13,913, 13,932
    Expiry as listed
    26 Jul 2032
    Rule
    R1
    Flags
    use code U-3018
    Product numbers
    001, 002, 003, 004, 005, 006
  • US 11,787,771, use patent

    patent.txt line 13,842
    Expiry as listed
    26 Jul 2032
    Rule
    R1
    Flags
    use code U-2855
    Product numbers
    001
  • US 11,787,771, use patent

    patent.txt lines 13,841, 13,861, 13,880, 13,899, 13,918, 13,937
    Expiry as listed
    26 Jul 2032
    Rule
    R1
    Flags
    use code U-2584
    Product numbers
    001, 002, 003, 004, 005, 006
  • US 11,787,771, use patent

    patent.txt lines 13,843, 13,862, 13,881, 13,900, 13,919, 13,938
    Expiry as listed
    26 Jul 2032
    Rule
    R1
    Flags
    use code U-3018
    Product numbers
    001, 002, 003, 004, 005, 006
  • US 12,291,508, use patent

    patent.txt lines 13,845, 13,864, 13,883, 13,902, 13,921, 13,940
    Expiry as listed
    26 Jul 2032
    Rule
    R1
    Flags
    use code U-2584
    Product numbers
    001, 002, 003, 004, 005, 006
  • US 12,291,508, use patent

    patent.txt lines 13,846, 13,865, 13,884, 13,903, 13,922, 13,941
    Expiry as listed
    26 Jul 2032
    Rule
    R1
    Flags
    use code U-3018
    Product numbers
    001, 002, 003, 004, 005, 006
  • US 9,079,865, use patent

    patent.txt lines 13,848, 13,867, 13,886, 13,905, 13,924, 13,943
    Expiry as listed
    26 Jul 2032
    Rule
    R1
    Flags
    use code U-2584
    Product numbers
    001, 002, 003, 004, 005, 006
  • US 9,079,865, use patent

    patent.txt lines 13,849, 13,868, 13,887, 13,906, 13,925, 13,944
    Expiry as listed
    26 Jul 2032
    Rule
    R1
    Flags
    use code U-3018
    Product numbers
    001, 002, 003, 004, 005, 006
  • US 9,714,226, substance and product patent

    patent.txt lines 13,850, 13,869, 13,888, 13,907, 13,926, 13,945
    Expiry as listed
    26 Jul 2032
    Rule
    R1
    Flags
    substance · product
    Product numbers
    001, 002, 003, 004, 005, 006
  • US 8,999,996, substance and product patent

    patent.txt lines 13,847, 13,866, 13,885, 13,904, 13,923, 13,942
    Expiry as listed
    3 Jul 2033
    Rule
    R1
    Flags
    substance · product
    Product numbers
    001, 002, 003, 004, 005, 006
  • US 10,519,139, substance and product and use patent

    patent.txt lines 13,831, 13,851, 13,870, 13,889, 13,908, 13,927
    Expiry as listed
    14 Aug 2035
    Rule
    R1
    Flags
    substance · product · use code U-2584
    Product numbers
    001, 002, 003, 004, 005, 006
  • US 10,519,139, substance and product and use patent

    patent.txt lines 13,832, 13,852, 13,871, 13,890, 13,909, 13,928
    Expiry as listed
    14 Aug 2035
    Rule
    R1
    Flags
    substance · product · use code U-3018
    Product numbers
    001, 002, 003, 004, 005, 006
  • US 11,746,102, use patent

    patent.txt lines 13,837, 13,857, 13,876, 13,895, 13,914, 13,933
    Expiry as listed
    14 Aug 2035
    Rule
    R1
    Flags
    use code U-2584
    Product numbers
    001, 002, 003, 004, 005, 006
  • US 11,746,102, use patent

    patent.txt lines 13,838, 13,858, 13,877, 13,896, 13,915, 13,934
    Expiry as listed
    14 Aug 2035
    Rule
    R1
    Flags
    use code U-3018
    Product numbers
    001, 002, 003, 004, 005, 006
  • US 11,753,401, product and use patent

    patent.txt lines 13,839, 13,859, 13,878, 13,897, 13,916, 13,935
    Expiry as listed
    14 Aug 2035
    Rule
    R1
    Flags
    product · use code U-2584
    Product numbers
    001, 002, 003, 004, 005, 006
  • US 11,753,401, product and use patent

    patent.txt lines 13,840, 13,860, 13,879, 13,898, 13,917, 13,936
    Expiry as listed
    14 Aug 2035
    Rule
    R1
    Flags
    product · use code U-3018
    Product numbers
    001, 002, 003, 004, 005, 006
  • US 11,807,629, substance and product patent

    patent.txt lines 13,844, 13,863, 13,882, 13,901
    Expiry as listed
    14 Aug 2035
    Rule
    R1
    Flags
    substance · product
    Product numbers
    001, 002, 003, 004
  • US 11,807,629, substance patent

    patent.txt lines 13,920, 13,939
    Expiry as listed
    14 Aug 2035
    Rule
    R1
    Flags
    substance
    Product numbers
    005, 006

Listed exclusivities

Each exclusivity FDA lists for NDA 212306, with its code, FDA's definition of the code where the store's code list gives one, and its date as listed.

  • ODE* exclusivity

    exclusivity.txt lines 1,050, 1,053, 1,056, 1,059, 1,062
    Date
    3 Jul 2026
    Rule
    R3
    Definition
    Orphan drug exclusivity (to be checked against FDA's list)
    Product numbers
    002, 003, 004, 005, 006
  • ODE-257 exclusivity

    exclusivity.txt line 1,046
    Date
    3 Jul 2026
    Rule
    R3
    Definition
    Orphan drug exclusivity (to be checked against FDA's list)
    Product numbers
    001
  • ODE* exclusivity

    exclusivity.txt lines 1,051, 1,054, 1,057, 1,060
    Date
    22 Jun 2027
    Rule
    R3
    Definition
    Orphan drug exclusivity (to be checked against FDA's list)
    Product numbers
    002, 003, 004, 005
  • ODE-310 exclusivity

    exclusivity.txt line 1,047
    Date
    22 Jun 2027
    Rule
    R3
    Definition
    Orphan drug exclusivity (to be checked against FDA's list)
    Product numbers
    001
  • ODE* exclusivity

    exclusivity.txt lines 1,049, 1,052, 1,055, 1,058, 1,061
    Date
    18 Dec 2027
    Rule
    R3
    Definition
    Orphan drug exclusivity (to be checked against FDA's list)
    Product numbers
    002, 003, 004, 005, 006
  • ODE-346 exclusivity

    exclusivity.txt line 1,048
    Date
    18 Dec 2027
    Rule
    R3
    Definition
    Orphan drug exclusivity (to be checked against FDA's list)
    Product numbers
    001

Paragraph IV list rows giving NDA 212306

The rows of FDA's Paragraph IV certifications list as captured on 17 October 2026 whose RLD/NDA cell gives NDA 212306, 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 212306 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