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Drybench Patent.

TAZEMETOSTAT HYDROBROMIDE, NDA 211723

The patents and exclusivities FDA's Orange Book lists for NDA 211723 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 appTAZEMETOSTAT HYDROBROMIDE in the molecule app

Listed protection

Listed dates run from 23 Jan 2027 to 3 May 2038, each by its own rule; no one date stands for this product.

Earliest listed date
23 Jan 2027ODE-299 exclusivityRule R3 · Product 001
Source lines

exclusivity.txt line 997

Latest listed date
3 May 2038US 12,168,014, use patentRule R1 · Product 001
Source lines

patent.txt line 13,109

Latest substance patent
23 Jan 2034US 8,410,088, substance and product patentRule R1 · Product 001
Source lines

patent.txt line 13,113

Latest listed patent
3 May 2038US 12,168,014, use patentRule R1 · Product 001
Source lines

patent.txt line 13,109

Latest exclusivity
18 Jun 2027ODE-314 exclusivityRule R3 · Product 001
Source lines

exclusivity.txt line 998

Listed dates of other NDAs in the same years:202720312033203420352038

41 use-code patents, blocking the coded use only

Products

Each product number FDA lists under NDA 211723, as listed. The sections below name products by these numbers.

  • Product 001 · TAZVERIK

    Dosage form; route
    TABLET;ORAL
    Strength
    EQ 200MG BASE
    Approval date as listed
    23 Jan 2020
    Type as listed
    DISCN
    Applicant as listed
    EPIZYME 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.

46 entries from 46 rows as listed; rows merge only where every cell shown is the same, each with its product numbers.

  • US 10,155,002, use patent

    patent.txt line 13,087
    Expiry as listed
    12 Sep 2031
    Rule
    R1
    Flags
    use code U-2736
    Product numbers
    001
  • US 10,420,775, use patent

    patent.txt line 13,094
    Expiry as listed
    12 Sep 2031
    Rule
    R1
    Flags
    use code U-2736
    Product numbers
    001
  • US 10,420,775, use patent

    patent.txt line 13,095
    Expiry as listed
    12 Sep 2031
    Rule
    R1
    Flags
    use code U-2852
    Product numbers
    001
  • US 10,420,775, use patent

    patent.txt line 13,096
    Expiry as listed
    12 Sep 2031
    Rule
    R1
    Flags
    use code U-2853
    Product numbers
    001
  • US 11,052,093, substance and product and use patent

    patent.txt line 13,099
    Expiry as listed
    12 Sep 2031
    Rule
    R1
    Flags
    substance · product · use code U-2736
    Product numbers
    001
  • US 11,052,093, substance and product and use patent

    patent.txt line 13,100
    Expiry as listed
    12 Sep 2031
    Rule
    R1
    Flags
    substance · product · use code U-2852
    Product numbers
    001
  • US 11,052,093, substance and product and use patent

    patent.txt line 13,101
    Expiry as listed
    12 Sep 2031
    Rule
    R1
    Flags
    substance · product · use code U-2853
    Product numbers
    001
  • US 12,161,645, use patent

    patent.txt line 13,105
    Expiry as listed
    12 Sep 2031
    Rule
    R1
    Flags
    use code U-2853
    Product numbers
    001
  • US 12,168,015, substance and product patent

    patent.txt line 13,110
    Expiry as listed
    12 Sep 2031
    Rule
    R1
    Flags
    substance · product
    Product numbers
    001
  • US 12,168,016, use patent

    patent.txt line 13,111
    Expiry as listed
    12 Sep 2031
    Rule
    R1
    Flags
    use code U-2736
    Product numbers
    001
  • US 12,168,016, use patent

    patent.txt line 13,112
    Expiry as listed
    12 Sep 2031
    Rule
    R1
    Flags
    use code U-2853
    Product numbers
    001
  • US 8,691,507, use patent

    patent.txt line 13,114
    Expiry as listed
    12 Sep 2031
    Rule
    R1
    Flags
    use code U-2852
    Product numbers
    001
  • US 8,765,732, use patent

    patent.txt line 13,115
    Expiry as listed
    12 Sep 2031
    Rule
    R1
    Flags
    use code U-2852
    Product numbers
    001
  • US 8,765,732, use patent

    patent.txt line 13,116
    Expiry as listed
    12 Sep 2031
    Rule
    R1
    Flags
    use code U-2853
    Product numbers
    001
  • US 8,895,245, use patent

    patent.txt line 13,117
    Expiry as listed
    12 Sep 2031
    Rule
    R1
    Flags
    use code U-2852
    Product numbers
    001
  • US 9,090,562, substance and product patent

    patent.txt line 13,118
    Expiry as listed
    12 Sep 2031
    Rule
    R1
    Flags
    substance · product
    Product numbers
    001
  • US 9,175,331, use patent

    patent.txt line 13,119
    Expiry as listed
    12 Sep 2031
    Rule
    R1
    Flags
    use code U-2852
    Product numbers
    001
  • US 9,333,217, use patent

    patent.txt line 13,120
    Expiry as listed
    12 Sep 2031
    Rule
    R1
    Flags
    use code U-2852
    Product numbers
    001
  • US 9,334,527, use patent

    patent.txt line 13,121
    Expiry as listed
    12 Sep 2031
    Rule
    R1
    Flags
    use code U-2852
    Product numbers
    001
  • US 9,549,931, use patent

    patent.txt line 13,124
    Expiry as listed
    12 Sep 2031
    Rule
    R1
    Flags
    use code U-2736
    Product numbers
    001
  • US 9,549,931, use patent

    patent.txt line 13,125
    Expiry as listed
    12 Sep 2031
    Rule
    R1
    Flags
    use code U-2852
    Product numbers
    001
  • US 9,549,931, use patent

    patent.txt line 13,126
    Expiry as listed
    12 Sep 2031
    Rule
    R1
    Flags
    use code U-2853
    Product numbers
    001
  • US 9,855,275, use patent

    patent.txt line 13,128
    Expiry as listed
    12 Sep 2031
    Rule
    R1
    Flags
    use code U-2736
    Product numbers
    001
  • US 9,949,999, use patent

    patent.txt line 13,132
    Expiry as listed
    12 Sep 2031
    Rule
    R1
    Flags
    use code U-2851
    Product numbers
    001
  • US 10,245,269, use patent

    patent.txt line 13,088
    Expiry as listed
    11 Apr 2033
    Rule
    R1
    Flags
    use code U-2737
    Product numbers
    001
  • US 10,245,269, use patent

    patent.txt line 13,089
    Expiry as listed
    11 Apr 2033
    Rule
    R1
    Flags
    use code U-2851
    Product numbers
    001
  • US 10,245,269, use patent

    patent.txt line 13,090
    Expiry as listed
    11 Apr 2033
    Rule
    R1
    Flags
    use code U-2854
    Product numbers
    001
  • US 10,821,113, substance and product patent

    patent.txt line 13,098
    Expiry as listed
    11 Apr 2033
    Rule
    R1
    Flags
    substance · product
    Product numbers
    001
  • US 11,491,163, use patent

    patent.txt line 13,102
    Expiry as listed
    11 Apr 2033
    Rule
    R1
    Flags
    use code U-2736
    Product numbers
    001
  • US 11,491,163, use patent

    patent.txt line 13,103
    Expiry as listed
    11 Apr 2033
    Rule
    R1
    Flags
    use code U-2852
    Product numbers
    001
  • US 11,491,163, use patent

    patent.txt line 13,104
    Expiry as listed
    11 Apr 2033
    Rule
    R1
    Flags
    use code U-2853
    Product numbers
    001
  • US 9,394,283, substance and product and use patent

    patent.txt line 13,122
    Expiry as listed
    11 Apr 2033
    Rule
    R1
    Flags
    substance · product · use code U-2852
    Product numbers
    001
  • US 9,394,283, substance and product and use patent

    patent.txt line 13,123
    Expiry as listed
    11 Apr 2033
    Rule
    R1
    Flags
    substance · product · use code U-2853
    Product numbers
    001
  • US 8,410,088, substance and product patent

    patent.txt line 13,113
    Expiry as listed
    23 Jan 2034
    Rule
    R1
    Flags
    substance · product
    Product numbers
    001
  • US 12,162,865, use patent

    patent.txt line 13,106
    Expiry as listed
    12 Jun 2034
    Rule
    R1
    Flags
    use code U-2736
    Product numbers
    001
  • US 9,688,665, use patent

    patent.txt line 13,127
    Expiry as listed
    22 Aug 2034
    Rule
    R1
    Flags
    use code U-2736
    Product numbers
    001
  • US 10,369,155, use patent

    patent.txt line 13,091
    Expiry as listed
    16 Oct 2035
    Rule
    R1
    Flags
    use code U-2736
    Product numbers
    001
  • US 10,369,155, use patent

    patent.txt line 13,092
    Expiry as listed
    16 Oct 2035
    Rule
    R1
    Flags
    use code U-2852
    Product numbers
    001
  • US 10,369,155, use patent

    patent.txt line 13,093
    Expiry as listed
    16 Oct 2035
    Rule
    R1
    Flags
    use code U-2853
    Product numbers
    001
  • US 9,889,138, use patent

    patent.txt line 13,129
    Expiry as listed
    16 Oct 2035
    Rule
    R1
    Flags
    use code U-2736
    Product numbers
    001
  • US 9,889,138, use patent

    patent.txt line 13,130
    Expiry as listed
    16 Oct 2035
    Rule
    R1
    Flags
    use code U-2852
    Product numbers
    001
  • US 9,889,138, use patent

    patent.txt line 13,131
    Expiry as listed
    16 Oct 2035
    Rule
    R1
    Flags
    use code U-2853
    Product numbers
    001
  • US 10,786,511, product patent

    patent.txt line 13,097
    Expiry as listed
    19 Dec 2035
    Rule
    R1
    Flags
    product
    Product numbers
    001
  • US 12,168,014, use patent

    patent.txt line 13,107
    Expiry as listed
    3 May 2038
    Rule
    R1
    Flags
    use code U-2736
    Product numbers
    001
  • US 12,168,014, use patent

    patent.txt line 13,108
    Expiry as listed
    3 May 2038
    Rule
    R1
    Flags
    use code U-2852
    Product numbers
    001
  • US 12,168,014, use patent

    patent.txt line 13,109
    Expiry as listed
    3 May 2038
    Rule
    R1
    Flags
    use code U-2853
    Product numbers
    001

Listed exclusivities

Each exclusivity FDA lists for NDA 211723, with its code, FDA's definition of the code where the store's code list gives one, and its date as listed.

  • ODE-299 exclusivity

    exclusivity.txt line 997
    Date
    23 Jan 2027
    Rule
    R3
    Definition
    Orphan drug exclusivity (to be checked against FDA's list)
    Product numbers
    001
  • ODE-314 exclusivity

    exclusivity.txt line 998
    Date
    18 Jun 2027
    Rule
    R3
    Definition
    Orphan drug exclusivity (to be checked against FDA's list)
    Product numbers
    001

Paragraph IV list rows giving NDA 211723

The rows of FDA's Paragraph IV certifications list as captured on 17 October 2026 whose RLD/NDA cell gives NDA 211723, 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 211723 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