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Drybench Patent.

DEFERIPRONE, NDA 212269

The patents and exclusivities FDA's Orange Book lists for NDA 212269 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 30 Apr 2028 to 25 Oct 2038, each by its own rule; no one date stands for this product.

Earliest listed date
30 Apr 2028ODE-417 exclusivityRule R3 · Product 001
Source lines

exclusivity.txt line 1,029

Latest listed date
25 Oct 2038US 11,723,874, use patentRule R1 · Product 001
Source lines

patent.txt line 13,649

Latest substance patent
None listed
Latest listed patent
25 Oct 2038US 11,723,874, use patentRule R1 · Product 001
Source lines

patent.txt line 13,649

Latest exclusivity
30 Apr 2028ODE-421 exclusivityRule R3 · Product 001
Source lines

exclusivity.txt line 1,031

Listed dates of other NDAs in the same years:20282038

4 use-code patents, blocking the coded use only

Products

Each product number FDA lists under NDA 212269, as listed. The sections below name products by these numbers.

  • Product 001 · FERRIPROX

    Dosage form; route
    TABLET;ORAL
    Strength
    1GM
    Approval date as listed
    19 May 2020
    Type as listed
    RX
    Applicant as listed
    CHIESI USA 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.

6 entries from 6 rows as listed; rows merge only where every cell shown is the same, each with its product numbers.

  • US 10,780,055, product and use patent

    patent.txt line 13,644
    Expiry as listed
    25 Oct 2038
    Rule
    R1
    Flags
    product · use code U-3083
    Product numbers
    001
  • US 10,940,115, product and use patent

    patent.txt line 13,645
    Expiry as listed
    25 Oct 2038
    Rule
    R1
    Flags
    product · use code U-3083
    Product numbers
    001
  • US 10,940,116, product patent

    patent.txt line 13,646
    Expiry as listed
    25 Oct 2038
    Rule
    R1
    Flags
    product
    Product numbers
    001
  • US 11,357,731, use patent

    patent.txt line 13,647
    Expiry as listed
    25 Oct 2038
    Rule
    R1
    Flags
    use code U-3083
    Product numbers
    001
  • US 11,458,103, product patent

    patent.txt line 13,648
    Expiry as listed
    25 Oct 2038
    Rule
    R1
    Flags
    product
    Product numbers
    001
  • US 11,723,874, use patent

    patent.txt line 13,649
    Expiry as listed
    25 Oct 2038
    Rule
    R1
    Flags
    use code U-3083
    Product numbers
    001

Listed exclusivities

Each exclusivity FDA lists for NDA 212269, with its code, FDA's definition of the code where the store's code list gives one, and its date as listed.

  • ODE-417 exclusivity

    exclusivity.txt line 1,029
    Date
    30 Apr 2028
    Rule
    R3
    Definition
    Orphan drug exclusivity (to be checked against FDA's list)
    Product numbers
    001
  • ODE-420 exclusivity

    exclusivity.txt line 1,030
    Date
    30 Apr 2028
    Rule
    R3
    Definition
    Orphan drug exclusivity (to be checked against FDA's list)
    Product numbers
    001
  • ODE-421 exclusivity

    exclusivity.txt line 1,031
    Date
    30 Apr 2028
    Rule
    R3
    Definition
    Orphan drug exclusivity (to be checked against FDA's list)
    Product numbers
    001

Paragraph IV list rows giving NDA 212269

The rows of FDA's Paragraph IV certifications list as captured on 17 October 2026 whose RLD/NDA cell gives NDA 212269, 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 212269 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