Skip to content

Drybench Patent.

AVATROMBOPAG MALEATE, NDA 210238

The patents and exclusivities FDA's Orange Book lists for NDA 210238 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 appAVATROMBOPAG MALEATE in the molecule app

Listed protection

Listed dates run from 26 Jun 2026 to 24 Jul 2032, each by its own rule; no one date stands for this product.

Earliest listed date
26 Jun 2026ODE-246 exclusivityRule R3 · Product 001
Source lines

exclusivity.txt line 857

Latest listed date
24 Jul 2032ODE-548 exclusivityRule R3 · Product 001
Source lines

exclusivity.txt line 858

Latest substance patent
28 Jul 2027US 7,638,536, substance and product patentRule R1 · Product 001
Source lines

patent.txt line 11,210

Latest listed patent
28 Jul 2027US 7,638,536, substance and product patentRule R1 · Product 001
Source lines

patent.txt line 11,210

Latest exclusivity
24 Jul 2032ODE-548 exclusivityRule R3 · Product 001
Source lines

exclusivity.txt line 858

Listed dates of other NDAs in the same years:2026202720282032

Products

Each product number FDA lists under NDA 210238, as listed. The sections below name products by these numbers.

  • Product 001 · DOPTELET

    Dosage form; route
    TABLET;ORAL
    Strength
    EQ 20MG BASE
    Approval date as listed
    21 May 2018
    Type as listed
    RX
    Applicant as listed
    AKARX 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.

1 entry from 1 row as listed; rows merge only where every cell shown is the same, each with its product numbers.

  • US 7,638,536, substance and product patent

    patent.txt line 11,210
    Expiry as listed
    28 Jul 2027
    Rule
    R1
    Flags
    substance · product
    Product numbers
    001

Listed exclusivities

Each exclusivity FDA lists for NDA 210238, with its code, FDA's definition of the code where the store's code list gives one, and its date as listed.

  • ODE-246 exclusivity

    exclusivity.txt line 857
    Date
    26 Jun 2026
    Rule
    R3
    Definition
    Orphan drug exclusivity (to be checked against FDA's list)
    Product numbers
    001
  • I-974 exclusivity

    exclusivity.txt line 856
    Date
    24 Jul 2028
    Rule
    R3
    Definition
    New indication (to be checked against FDA's list)
    Product numbers
    001
  • ODE-548 exclusivity

    exclusivity.txt line 858
    Date
    24 Jul 2032
    Rule
    R3
    Definition
    Orphan drug exclusivity (to be checked against FDA's list)
    Product numbers
    001

Paragraph IV list rows giving NDA 210238

The rows of FDA's Paragraph IV certifications list as captured on 17 October 2026 whose RLD/NDA cell gives NDA 210238, 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 210238 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