Skip to content
Drybench

Drybench Patent.

TAPENTADOL HYDROCHLORIDE, NDA 022304

The patents and exclusivities FDA's Orange Book lists for NDA 022304 as captured on 14 October 2026, each date named by its rule and its rows, and the rows of FDA's Paragraph IV list that give this NDA's number, as captured on 17 October 2026. 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 appTAPENTADOL HYDROCHLORIDE in the molecule app

Listed protection

Listed dates run from 3 Jul 2026 to 3 Jan 2027, each by its own rule; no one date stands for this product.

Earliest listed date
3 Jul 2026NPP exclusivityRule R3 · Products 001, 002, 003 · exclusivity.txt lines 185, 187, 189
Latest listed date
3 Jan 2027PED exclusivityRule R3 · Products 001, 002, 003 · exclusivity.txt lines 186, 188, 190
Latest substance patent
None listed
Latest listed patent
None listed
Latest exclusivity
3 Jan 2027PED exclusivityRule R3 · Products 001, 002, 003 · exclusivity.txt lines 186, 188, 190

Products

Each product number FDA lists under NDA 022304, as listed. The sections below name products by these numbers.

  • Product 001 · NUCYNTA

    Dosage form; route
    TABLET;ORAL
    Strength
    EQ 50MG BASE
    Approval date as listed
    20 Nov 2008
    Type as listed
    RX
    Applicant as listed
    COLLEGIUM PHARMACEUTICAL INC

  • Product 002 · NUCYNTA

    Dosage form; route
    TABLET;ORAL
    Strength
    EQ 75MG BASE
    Approval date as listed
    20 Nov 2008
    Type as listed
    RX
    Applicant as listed
    COLLEGIUM PHARMACEUTICAL INC

  • Product 003 · NUCYNTA

    Dosage form; route
    TABLET;ORAL
    Strength
    EQ 100MG BASE
    Approval date as listed
    20 Nov 2008
    Type as listed
    RX
    Applicant as listed
    COLLEGIUM PHARMACEUTICAL 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.

The Orange Book capture of 14 October 2026 lists no patent for NDA 022304.

Listed exclusivities

Each exclusivity FDA lists for NDA 022304, with its code, FDA's definition of the code where the store's code list gives one, and its date as listed.

  • NPP exclusivity

    exclusivity.txt lines 185, 187, 189
    Date
    3 Jul 2026
    Rule
    R3
    Definition
    New patient population (to be checked against FDA's list)
    Product numbers
    001, 002, 003

  • PED exclusivity

    exclusivity.txt lines 186, 188, 190
    Date
    3 Jan 2027
    Rule
    R3
    Definition
    Pediatric exclusivity (to be checked against FDA's list)
    Product numbers
    001, 002, 003

Paragraph IV list rows giving NDA 022304

The rows of FDA's Paragraph IV certifications list as captured on 17 October 2026 whose RLD/NDA cell gives NDA 022304, each cell as listed.

FDA's Paragraph IV list names no patent number, so it does not say which of the patents on this page an applicant certified against.

The list gives the last qualifying patent's expiry without pediatric exclusivity; in the app's Patents view, the Orange Book lists any *PED period as a separate row with its own date. The two dates describe different things. A blank cell is one FDA left blank in its list. Dates are FDA's own; the last qualifying patent expiry is not recomputed from the Orange Book.

Rows whose RLD/NDA cell we could not read as exactly one NDA number are kept apart on the list page; some may concern this product.

Rows on FDA's Paragraph IV list whose RLD/NDA cell gives NDA 022304

  • Tapentadol Hydrochloride · Tablets · 50 mg, 75 mg, and 100 mg

    RLD/NDA as listed: Nucynta 22304
    First PIV submission
    20 Nov 2012
    ANDAs
    4
    180-day status
    Extinguished
    Decision posted
    7 Jul 2025
    First applicant approval
    blank
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    27 Jun 2025

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