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Drybench Patent.

CORTICOTROPIN, NDA 008975

The patents and exclusivities FDA's Orange Book lists for NDA 008975 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 27 Oct 2043 to 27 Oct 2043, each by its own rule; no one date stands for this product.

Earliest listed date
27 Oct 2043US 11,975,047, use patentRule R1 · Product 002
Source lines

patent.txt line 33

Latest listed date
27 Oct 2043US 12,734,217, product and use patentRule R1 · Product 002
Source lines

patent.txt line 131

Latest substance patent
None listed
Latest listed patent
27 Oct 2043US 12,734,217, product and use patentRule R1 · Product 002
Source lines

patent.txt line 131

Latest exclusivity
None listed

Listed dates of other NDAs in the same years:2043

121 use-code patents, blocking the coded use only

Products

Each product number FDA lists under NDA 008975, as listed. The sections below name products by these numbers.

  • Product 001 · PURIFIED CORTROPHIN GEL

    Dosage form; route
    INJECTABLE;INJECTION
    Strength
    40 UNITS/ML
    Approval date as listed
    Approved Prior to Jan 1, 1982
    Type as listed
    DISCN
    Applicant as listed
    ANI PHARMACEUTICALS INC

  • Product 002 · PURIFIED CORTROPHIN GEL

    Dosage form; route
    INJECTABLE;INJECTION
    Strength
    80 UNITS/ML
    Approval date as listed
    Approved Prior to Jan 1, 1982
    Type as listed
    RX
    Applicant as listed
    ANI PHARMACEUTICALS 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.

99 entries from 122 rows as listed; rows merge only where every cell shown is the same, each with its product numbers.

  • US 11,975,047, use patent

    patent.txt line 33
    Expiry as listed
    27 Oct 2043
    Rule
    R1
    Flags
    use code U-3904
    Product numbers
    002

  • US 11,975,047, use patent

    patent.txt line 34
    Expiry as listed
    27 Oct 2043
    Rule
    R1
    Flags
    use code U-3905
    Product numbers
    002

  • US 11,975,047, use patent

    patent.txt line 35
    Expiry as listed
    27 Oct 2043
    Rule
    R1
    Flags
    use code U-3906
    Product numbers
    002

  • US 11,975,047, use patent

    patent.txt line 36
    Expiry as listed
    27 Oct 2043
    Rule
    R1
    Flags
    use code U-3907
    Product numbers
    002

  • US 11,975,047, use patent

    patent.txt line 37
    Expiry as listed
    27 Oct 2043
    Rule
    R1
    Flags
    use code U-3908
    Product numbers
    002

  • US 11,975,047, use patent

    patent.txt line 38
    Expiry as listed
    27 Oct 2043
    Rule
    R1
    Flags
    use code U-3909
    Product numbers
    002

  • US 11,975,047, use patent

    patent.txt line 39
    Expiry as listed
    27 Oct 2043
    Rule
    R1
    Flags
    use code U-3910
    Product numbers
    002

  • US 11,975,047, use patent

    patent.txt line 40
    Expiry as listed
    27 Oct 2043
    Rule
    R1
    Flags
    use code U-3911
    Product numbers
    002

  • US 11,975,047, use patent

    patent.txt line 41
    Expiry as listed
    27 Oct 2043
    Rule
    R1
    Flags
    use code U-3912
    Product numbers
    002

  • US 11,975,047, use patent

    patent.txt line 42
    Expiry as listed
    27 Oct 2043
    Rule
    R1
    Flags
    use code U-3913
    Product numbers
    002

  • US 11,975,047, use patent

    patent.txt line 43
    Expiry as listed
    27 Oct 2043
    Rule
    R1
    Flags
    use code U-3914
    Product numbers
    002

  • US 11,975,047, use patent

    patent.txt line 44
    Expiry as listed
    27 Oct 2043
    Rule
    R1
    Flags
    use code U-3915
    Product numbers
    002

  • US 11,975,047, use patent

    patent.txt line 45
    Expiry as listed
    27 Oct 2043
    Rule
    R1
    Flags
    use code U-3916
    Product numbers
    002

  • US 11,975,047, use patent

    patent.txt line 46
    Expiry as listed
    27 Oct 2043
    Rule
    R1
    Flags
    use code U-3917
    Product numbers
    002

  • US 11,975,047, use patent

    patent.txt line 47
    Expiry as listed
    27 Oct 2043
    Rule
    R1
    Flags
    use code U-3918
    Product numbers
    002

  • US 11,975,047, use patent

    patent.txt line 48
    Expiry as listed
    27 Oct 2043
    Rule
    R1
    Flags
    use code U-3919
    Product numbers
    002

  • US 11,975,047, use patent

    patent.txt line 49
    Expiry as listed
    27 Oct 2043
    Rule
    R1
    Flags
    use code U-3920
    Product numbers
    002

  • US 11,975,047, use patent

    patent.txt line 50
    Expiry as listed
    27 Oct 2043
    Rule
    R1
    Flags
    use code U-3921
    Product numbers
    002

  • US 11,975,047, use patent

    patent.txt line 51
    Expiry as listed
    27 Oct 2043
    Rule
    R1
    Flags
    use code U-3922
    Product numbers
    002

  • US 11,975,047, use patent

    patent.txt line 52
    Expiry as listed
    27 Oct 2043
    Rule
    R1
    Flags
    use code U-3923
    Product numbers
    002

  • US 11,975,047, use patent

    patent.txt line 53
    Expiry as listed
    27 Oct 2043
    Rule
    R1
    Flags
    use code U-3924
    Product numbers
    002

  • US 11,975,047, use patent

    patent.txt line 54
    Expiry as listed
    27 Oct 2043
    Rule
    R1
    Flags
    use code U-3925
    Product numbers
    002

  • US 11,975,047, use patent

    patent.txt line 55
    Expiry as listed
    27 Oct 2043
    Rule
    R1
    Flags
    use code U-3926
    Product numbers
    002

  • US 12,102,662, use patent

    patent.txt lines 10, 56
    Expiry as listed
    27 Oct 2043
    Rule
    R1
    Flags
    use code U-3904
    Product numbers
    001, 002

  • US 12,102,662, use patent

    patent.txt lines 11, 57
    Expiry as listed
    27 Oct 2043
    Rule
    R1
    Flags
    use code U-3905
    Product numbers
    001, 002

  • US 12,102,662, use patent

    patent.txt lines 12, 58
    Expiry as listed
    27 Oct 2043
    Rule
    R1
    Flags
    use code U-3906
    Product numbers
    001, 002

  • US 12,102,662, use patent

    patent.txt lines 13, 59
    Expiry as listed
    27 Oct 2043
    Rule
    R1
    Flags
    use code U-3907
    Product numbers
    001, 002

  • US 12,102,662, use patent

    patent.txt lines 14, 60
    Expiry as listed
    27 Oct 2043
    Rule
    R1
    Flags
    use code U-3908
    Product numbers
    001, 002

  • US 12,102,662, use patent

    patent.txt lines 15, 61
    Expiry as listed
    27 Oct 2043
    Rule
    R1
    Flags
    use code U-3909
    Product numbers
    001, 002

  • US 12,102,662, use patent

    patent.txt lines 16, 62
    Expiry as listed
    27 Oct 2043
    Rule
    R1
    Flags
    use code U-3910
    Product numbers
    001, 002

  • US 12,102,662, use patent

    patent.txt lines 17, 63
    Expiry as listed
    27 Oct 2043
    Rule
    R1
    Flags
    use code U-3911
    Product numbers
    001, 002

  • US 12,102,662, use patent

    patent.txt lines 18, 64
    Expiry as listed
    27 Oct 2043
    Rule
    R1
    Flags
    use code U-3912
    Product numbers
    001, 002

  • US 12,102,662, use patent

    patent.txt lines 19, 65
    Expiry as listed
    27 Oct 2043
    Rule
    R1
    Flags
    use code U-3913
    Product numbers
    001, 002

  • US 12,102,662, use patent

    patent.txt lines 20, 66
    Expiry as listed
    27 Oct 2043
    Rule
    R1
    Flags
    use code U-3914
    Product numbers
    001, 002

  • US 12,102,662, use patent

    patent.txt lines 21, 67
    Expiry as listed
    27 Oct 2043
    Rule
    R1
    Flags
    use code U-3915
    Product numbers
    001, 002

  • US 12,102,662, use patent

    patent.txt lines 22, 68
    Expiry as listed
    27 Oct 2043
    Rule
    R1
    Flags
    use code U-3916
    Product numbers
    001, 002

  • US 12,102,662, use patent

    patent.txt lines 23, 69
    Expiry as listed
    27 Oct 2043
    Rule
    R1
    Flags
    use code U-3917
    Product numbers
    001, 002

  • US 12,102,662, use patent

    patent.txt lines 24, 70
    Expiry as listed
    27 Oct 2043
    Rule
    R1
    Flags
    use code U-3918
    Product numbers
    001, 002

  • US 12,102,662, use patent

    patent.txt lines 25, 71
    Expiry as listed
    27 Oct 2043
    Rule
    R1
    Flags
    use code U-3919
    Product numbers
    001, 002

  • US 12,102,662, use patent

    patent.txt lines 26, 72
    Expiry as listed
    27 Oct 2043
    Rule
    R1
    Flags
    use code U-3920
    Product numbers
    001, 002

  • US 12,102,662, use patent

    patent.txt lines 27, 73
    Expiry as listed
    27 Oct 2043
    Rule
    R1
    Flags
    use code U-3921
    Product numbers
    001, 002

  • US 12,102,662, use patent

    patent.txt lines 28, 74
    Expiry as listed
    27 Oct 2043
    Rule
    R1
    Flags
    use code U-3922
    Product numbers
    001, 002

  • US 12,102,662, use patent

    patent.txt lines 29, 75
    Expiry as listed
    27 Oct 2043
    Rule
    R1
    Flags
    use code U-3923
    Product numbers
    001, 002

  • US 12,102,662, use patent

    patent.txt lines 30, 76
    Expiry as listed
    27 Oct 2043
    Rule
    R1
    Flags
    use code U-3924
    Product numbers
    001, 002

  • US 12,102,662, use patent

    patent.txt lines 31, 77
    Expiry as listed
    27 Oct 2043
    Rule
    R1
    Flags
    use code U-3925
    Product numbers
    001, 002

  • US 12,102,662, use patent

    patent.txt lines 32, 78
    Expiry as listed
    27 Oct 2043
    Rule
    R1
    Flags
    use code U-3926
    Product numbers
    001, 002

  • US 12,233,105, use patent

    patent.txt line 79
    Expiry as listed
    27 Oct 2043
    Rule
    R1
    Flags
    use code U-3904
    Product numbers
    002

  • US 12,233,105, use patent

    patent.txt line 80
    Expiry as listed
    27 Oct 2043
    Rule
    R1
    Flags
    use code U-3905
    Product numbers
    002

  • US 12,233,105, use patent

    patent.txt line 81
    Expiry as listed
    27 Oct 2043
    Rule
    R1
    Flags
    use code U-3906
    Product numbers
    002

  • US 12,233,105, use patent

    patent.txt line 82
    Expiry as listed
    27 Oct 2043
    Rule
    R1
    Flags
    use code U-3907
    Product numbers
    002

  • US 12,233,105, use patent

    patent.txt line 83
    Expiry as listed
    27 Oct 2043
    Rule
    R1
    Flags
    use code U-3908
    Product numbers
    002

  • US 12,233,105, use patent

    patent.txt line 84
    Expiry as listed
    27 Oct 2043
    Rule
    R1
    Flags
    use code U-3909
    Product numbers
    002

  • US 12,233,105, use patent

    patent.txt line 85
    Expiry as listed
    27 Oct 2043
    Rule
    R1
    Flags
    use code U-3910
    Product numbers
    002

  • US 12,233,105, use patent

    patent.txt line 86
    Expiry as listed
    27 Oct 2043
    Rule
    R1
    Flags
    use code U-3911
    Product numbers
    002

  • US 12,233,105, use patent

    patent.txt line 87
    Expiry as listed
    27 Oct 2043
    Rule
    R1
    Flags
    use code U-3912
    Product numbers
    002

  • US 12,233,105, use patent

    patent.txt line 88
    Expiry as listed
    27 Oct 2043
    Rule
    R1
    Flags
    use code U-3913
    Product numbers
    002

  • US 12,233,105, use patent

    patent.txt line 89
    Expiry as listed
    27 Oct 2043
    Rule
    R1
    Flags
    use code U-3914
    Product numbers
    002

  • US 12,233,105, use patent

    patent.txt line 90
    Expiry as listed
    27 Oct 2043
    Rule
    R1
    Flags
    use code U-3915
    Product numbers
    002

  • US 12,233,105, use patent

    patent.txt line 91
    Expiry as listed
    27 Oct 2043
    Rule
    R1
    Flags
    use code U-3916
    Product numbers
    002

  • US 12,233,105, use patent

    patent.txt line 92
    Expiry as listed
    27 Oct 2043
    Rule
    R1
    Flags
    use code U-3917
    Product numbers
    002

  • US 12,233,105, use patent

    patent.txt line 93
    Expiry as listed
    27 Oct 2043
    Rule
    R1
    Flags
    use code U-3918
    Product numbers
    002

  • US 12,233,105, use patent

    patent.txt line 94
    Expiry as listed
    27 Oct 2043
    Rule
    R1
    Flags
    use code U-3919
    Product numbers
    002

  • US 12,233,105, use patent

    patent.txt line 95
    Expiry as listed
    27 Oct 2043
    Rule
    R1
    Flags
    use code U-3920
    Product numbers
    002

  • US 12,233,105, use patent

    patent.txt line 96
    Expiry as listed
    27 Oct 2043
    Rule
    R1
    Flags
    use code U-3921
    Product numbers
    002

  • US 12,233,105, use patent

    patent.txt line 97
    Expiry as listed
    27 Oct 2043
    Rule
    R1
    Flags
    use code U-3922
    Product numbers
    002

  • US 12,233,105, use patent

    patent.txt line 98
    Expiry as listed
    27 Oct 2043
    Rule
    R1
    Flags
    use code U-3923
    Product numbers
    002

  • US 12,233,105, use patent

    patent.txt line 99
    Expiry as listed
    27 Oct 2043
    Rule
    R1
    Flags
    use code U-3924
    Product numbers
    002

  • US 12,233,105, use patent

    patent.txt line 100
    Expiry as listed
    27 Oct 2043
    Rule
    R1
    Flags
    use code U-3925
    Product numbers
    002

  • US 12,233,105, use patent

    patent.txt line 101
    Expiry as listed
    27 Oct 2043
    Rule
    R1
    Flags
    use code U-3926
    Product numbers
    002

  • US 12,324,787, product patent

    patent.txt line 102
    Expiry as listed
    27 Oct 2043
    Rule
    R1
    Flags
    product
    Product numbers
    002

  • US 12,440,542, product and use patent

    patent.txt line 103
    Expiry as listed
    27 Oct 2043
    Rule
    R1
    Flags
    product · use code U-3904
    Product numbers
    002

  • US 12,440,542, product and use patent

    patent.txt line 104
    Expiry as listed
    27 Oct 2043
    Rule
    R1
    Flags
    product · use code U-3905
    Product numbers
    002

  • US 12,440,542, product and use patent

    patent.txt line 105
    Expiry as listed
    27 Oct 2043
    Rule
    R1
    Flags
    product · use code U-3906
    Product numbers
    002

  • US 12,440,542, product and use patent

    patent.txt line 106
    Expiry as listed
    27 Oct 2043
    Rule
    R1
    Flags
    product · use code U-3907
    Product numbers
    002

  • US 12,440,542, product and use patent

    patent.txt line 107
    Expiry as listed
    27 Oct 2043
    Rule
    R1
    Flags
    product · use code U-3908
    Product numbers
    002

  • US 12,440,542, product and use patent

    patent.txt line 108
    Expiry as listed
    27 Oct 2043
    Rule
    R1
    Flags
    product · use code U-3909
    Product numbers
    002

  • US 12,440,542, product and use patent

    patent.txt line 109
    Expiry as listed
    27 Oct 2043
    Rule
    R1
    Flags
    product · use code U-3910
    Product numbers
    002

  • US 12,440,542, product and use patent

    patent.txt line 110
    Expiry as listed
    27 Oct 2043
    Rule
    R1
    Flags
    product · use code U-3911
    Product numbers
    002

  • US 12,440,542, product and use patent

    patent.txt line 111
    Expiry as listed
    27 Oct 2043
    Rule
    R1
    Flags
    product · use code U-3912
    Product numbers
    002

  • US 12,440,542, product and use patent

    patent.txt line 112
    Expiry as listed
    27 Oct 2043
    Rule
    R1
    Flags
    product · use code U-3913
    Product numbers
    002

  • US 12,440,542, product and use patent

    patent.txt line 113
    Expiry as listed
    27 Oct 2043
    Rule
    R1
    Flags
    product · use code U-3914
    Product numbers
    002

  • US 12,440,542, product and use patent

    patent.txt line 114
    Expiry as listed
    27 Oct 2043
    Rule
    R1
    Flags
    product · use code U-3915
    Product numbers
    002

  • US 12,440,542, product and use patent

    patent.txt line 115
    Expiry as listed
    27 Oct 2043
    Rule
    R1
    Flags
    product · use code U-3916
    Product numbers
    002

  • US 12,440,542, product and use patent

    patent.txt line 116
    Expiry as listed
    27 Oct 2043
    Rule
    R1
    Flags
    product · use code U-3917
    Product numbers
    002

  • US 12,440,542, product and use patent

    patent.txt line 117
    Expiry as listed
    27 Oct 2043
    Rule
    R1
    Flags
    product · use code U-3918
    Product numbers
    002

  • US 12,440,542, product and use patent

    patent.txt line 118
    Expiry as listed
    27 Oct 2043
    Rule
    R1
    Flags
    product · use code U-3919
    Product numbers
    002

  • US 12,440,542, product and use patent

    patent.txt line 119
    Expiry as listed
    27 Oct 2043
    Rule
    R1
    Flags
    product · use code U-3920
    Product numbers
    002

  • US 12,440,542, product and use patent

    patent.txt line 120
    Expiry as listed
    27 Oct 2043
    Rule
    R1
    Flags
    product · use code U-3921
    Product numbers
    002

  • US 12,440,542, product and use patent

    patent.txt line 121
    Expiry as listed
    27 Oct 2043
    Rule
    R1
    Flags
    product · use code U-3922
    Product numbers
    002

  • US 12,440,542, product and use patent

    patent.txt line 122
    Expiry as listed
    27 Oct 2043
    Rule
    R1
    Flags
    product · use code U-3923
    Product numbers
    002

  • US 12,440,542, product and use patent

    patent.txt line 123
    Expiry as listed
    27 Oct 2043
    Rule
    R1
    Flags
    product · use code U-3924
    Product numbers
    002

  • US 12,440,542, product and use patent

    patent.txt line 124
    Expiry as listed
    27 Oct 2043
    Rule
    R1
    Flags
    product · use code U-3925
    Product numbers
    002

  • US 12,440,542, product and use patent

    patent.txt line 125
    Expiry as listed
    27 Oct 2043
    Rule
    R1
    Flags
    product · use code U-3926
    Product numbers
    002

  • US 12,734,217, product and use patent

    patent.txt line 126
    Expiry as listed
    27 Oct 2043
    Rule
    R1
    Flags
    product · use code U-3904
    Product numbers
    002

  • US 12,734,217, product and use patent

    patent.txt line 127
    Expiry as listed
    27 Oct 2043
    Rule
    R1
    Flags
    product · use code U-3905
    Product numbers
    002

  • US 12,734,217, product and use patent

    patent.txt line 128
    Expiry as listed
    27 Oct 2043
    Rule
    R1
    Flags
    product · use code U-3907
    Product numbers
    002

  • US 12,734,217, product and use patent

    patent.txt line 129
    Expiry as listed
    27 Oct 2043
    Rule
    R1
    Flags
    product · use code U-3912
    Product numbers
    002

  • US 12,734,217, product and use patent

    patent.txt line 130
    Expiry as listed
    27 Oct 2043
    Rule
    R1
    Flags
    product · use code U-3916
    Product numbers
    002

  • US 12,734,217, product and use patent

    patent.txt line 131
    Expiry as listed
    27 Oct 2043
    Rule
    R1
    Flags
    product · use code U-3924
    Product numbers
    002

Listed exclusivities

Each exclusivity FDA lists for NDA 008975, 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 008975.

Paragraph IV list rows giving NDA 008975

The rows of FDA's Paragraph IV certifications list as captured on 17 October 2026 whose RLD/NDA cell gives NDA 008975, 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 008975 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

  • Product 001: approval date "Approved Prior to Jan 1, 1982" is text FDA wrote; no ISO date.
  • Product 002: approval date "Approved Prior to Jan 1, 1982" is text FDA wrote; no ISO date.
  • 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