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OLODATEROL HYDROCHLORIDE; TIOTROPIUM BROMIDE, NDA 206756

The patents and exclusivities FDA's Orange Book lists for NDA 206756 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.

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Listed protection

Listed dates run from 10 Oct 2026 to 16 Oct 2030, each by its own rule; no one date stands for this product.

Earliest listed date
10 Oct 2026US 7,396,341, product patentRule R1 · Product 001 · patent.txt line 6,757
Latest listed date
16 Oct 2030US 8,733,341, product patentRule R1 · Product 001 · patent.txt line 6,761
Latest substance patent
19 Jan 2027US 7,727,984, substance patentRule R1 · Product 001 · patent.txt line 6,758
Latest listed patent
16 Oct 2030US 8,733,341, product patentRule R1 · Product 001 · patent.txt line 6,761
Latest exclusivity
None listed

4 patents with a delist request, kept in the table

Products

Each product number FDA lists under NDA 206756, as listed. The sections below name products by these numbers.

  • Product 001 · STIOLTO RESPIMAT

    Dosage form; route
    SPRAY, METERED;INHALATION
    Strength
    EQ 0.0025MG BASE/INH;EQ 0.0025MG BASE/INH
    Approval date as listed
    21 May 2015
    Type as listed
    RX
    Applicant as listed
    BOEHRINGER INGELHEIM 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.

7 entries from 7 rows as listed; rows merge only where every cell shown is the same, each with its product numbers.

  • US 7,396,341, product patent

    patent.txt line 6,757
    Expiry as listed
    10 Oct 2026
    Rule
    R1
    Flags
    product · delist requested
    Product numbers
    001

  • US 7,727,984, substance patent

    patent.txt line 6,758
    Expiry as listed
    19 Jan 2027
    Rule
    R1
    Flags
    substance
    Product numbers
    001

  • US 9,027,967, product patent

    patent.txt line 6,762
    Expiry as listed
    31 Mar 2027
    Rule
    R1
    Flags
    product · delist requested
    Product numbers
    001

  • US 7,396,341 with pediatric exclusivity, as listed

    patent.txt line 6,756
    Expiry as listed
    10 Apr 2027
    Rule
    R2
    Flags
    product · pediatric, as listed by FDA (from the base row)
    Product numbers
    001

  • US 7,837,235, product patent

    patent.txt line 6,760
    Expiry as listed
    13 Mar 2028
    Rule
    R1
    Flags
    product · delist requested
    Product numbers
    001

  • US 7,837,235 with pediatric exclusivity, as listed

    patent.txt line 6,759
    Expiry as listed
    13 Sep 2028
    Rule
    R2
    Flags
    product · pediatric, as listed by FDA (from the base row)
    Product numbers
    001

  • US 8,733,341, product patent

    patent.txt line 6,761
    Expiry as listed
    16 Oct 2030
    Rule
    R1
    Flags
    product · delist requested
    Product numbers
    001

Listed exclusivities

Each exclusivity FDA lists for NDA 206756, 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 206756.

Paragraph IV list rows giving NDA 206756

The rows of FDA's Paragraph IV certifications list as captured on 17 October 2026 whose RLD/NDA cell gives NDA 206756, 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 206756

  • Tiotropium Bromide and Olodaterol Hydrochloride · Inhalation Spray · 2.5 mcg/2.5 mcg per spray

    RLD/NDA as listed: Stiolto Respimat 206756
    First PIV submission
    24 May 2024
    ANDAs
    1
    180-day status
    blank
    Decision posted
    blank
    First applicant approval
    blank
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    16 Oct 2030

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