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SEMAGLUTIDE, NDA 215256

The patents and exclusivities FDA's Orange Book lists for NDA 215256 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 appSEMAGLUTIDE in the molecule app

Listed protection

Listed dates run from 20 Mar 2026 to 17 Feb 2041, each by its own rule; no one date stands for this product.

Earliest listed date
20 Mar 2026US 8,536,122, substance and product patentRule R1 · Products 001, 002, 003, 004, 005 · patent.txt lines 16,609, 16,617, 16,625, 16,633, 16,643
Latest listed date
17 Feb 2041US 11,318,191, product and use patentRule R1 · Products 007, 008, 009, 010, 011 · patent.txt lines 16,656, 16,668, 16,680, 16,692, 16,704
Latest substance patent
5 Dec 2031US 8,129,343, substance and product patentRule R1 · Products 001, 002, 003, 004, 005, 006, 007, 008, 009, 010, 011, 012 · patent.txt lines 16,608, 16,616, 16,624, 16,632, 16,642, 16,651, 16,663, 16,675, 16,687, 16,699, 16,711, 16,716
Latest listed patent
17 Feb 2041US 11,318,191, product and use patentRule R1 · Products 007, 008, 009, 010, 011 · patent.txt lines 16,656, 16,668, 16,680, 16,692, 16,704
Latest exclusivity
19 Mar 2029NS exclusivityRule R3 · Product 006 · exclusivity.txt line 1,513

98 use-code patents, blocking the coded use only

Products

Each product number FDA lists under NDA 215256, as listed. The sections below name products by these numbers.

  • Product 001 · WEGOVY

    Dosage form; route
    SOLUTION;SUBCUTANEOUS
    Strength
    0.25MG/0.5ML (0.25MG/0.5ML)
    Approval date as listed
    4 Jun 2021
    Type as listed
    RX
    Applicant as listed
    NOVO NORDISK INC

  • Product 002 · WEGOVY

    Dosage form; route
    SOLUTION;SUBCUTANEOUS
    Strength
    0.5MG/0.5ML (0.5MG/0.5ML)
    Approval date as listed
    4 Jun 2021
    Type as listed
    RX
    Applicant as listed
    NOVO NORDISK INC

  • Product 003 · WEGOVY

    Dosage form; route
    SOLUTION;SUBCUTANEOUS
    Strength
    1MG/0.5ML (1MG/0.5ML)
    Approval date as listed
    4 Jun 2021
    Type as listed
    RX
    Applicant as listed
    NOVO NORDISK INC

  • Product 004 · WEGOVY

    Dosage form; route
    SOLUTION;SUBCUTANEOUS
    Strength
    1.7MG/0.75ML (1.7MG/0.75ML)
    Approval date as listed
    4 Jun 2021
    Type as listed
    RX
    Applicant as listed
    NOVO NORDISK INC

  • Product 005 · WEGOVY

    Dosage form; route
    SOLUTION;SUBCUTANEOUS
    Strength
    2.4MG/0.75ML (2.4MG/0.75ML)
    Approval date as listed
    4 Jun 2021
    Type as listed
    RX
    Applicant as listed
    NOVO NORDISK INC

  • Product 006 · WEGOVY HD

    Dosage form; route
    SOLUTION;SUBCUTANEOUS
    Strength
    7.2MG/0.75ML (7.2MG/0.75ML)
    Approval date as listed
    19 Mar 2026
    Type as listed
    RX
    Applicant as listed
    NOVO NORDISK INC

  • Product 007 · WEGOVY

    Dosage form; route
    SOLUTION;SUBCUTANEOUS
    Strength
    0.25MG/0.5ML (0.25MG/0.5ML)
    Approval date as listed
    5 May 2026
    Type as listed
    RX
    Applicant as listed
    NOVO NORDISK INC

  • Product 008 · WEGOVY

    Dosage form; route
    SOLUTION;SUBCUTANEOUS
    Strength
    0.5MG/0.5ML (0.5MG/0.5ML)
    Approval date as listed
    5 May 2026
    Type as listed
    RX
    Applicant as listed
    NOVO NORDISK INC

  • Product 009 · WEGOVY

    Dosage form; route
    SOLUTION;SUBCUTANEOUS
    Strength
    1MG/0.5ML (1MG/0.5ML)
    Approval date as listed
    5 May 2026
    Type as listed
    RX
    Applicant as listed
    NOVO NORDISK INC

  • Product 010 · WEGOVY

    Dosage form; route
    SOLUTION;SUBCUTANEOUS
    Strength
    1.7MG/0.75ML (1.7MG/0.75ML)
    Approval date as listed
    5 May 2026
    Type as listed
    RX
    Applicant as listed
    NOVO NORDISK INC

  • Product 011 · WEGOVY

    Dosage form; route
    SOLUTION;SUBCUTANEOUS
    Strength
    2.4MG/0.75ML (2.4MG/0.75ML)
    Approval date as listed
    5 May 2026
    Type as listed
    RX
    Applicant as listed
    NOVO NORDISK INC

  • Product 012 · WEGOVY FLEXTOUCH

    Dosage form; route
    SOLUTION;SUBCUTANEOUS
    Strength
    9.6MG/3ML (3.2MG/ML)
    Approval date as listed
    18 Jun 2026
    Type as listed
    RX
    Applicant as listed
    NOVO NORDISK 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.

19 entries from 115 rows as listed; rows merge only where every cell shown is the same, each with its product numbers.

  • US 8,536,122, substance and product patent

    patent.txt lines 16,609, 16,617, 16,625, 16,633, 16,643
    Expiry as listed
    20 Mar 2026
    Rule
    R1
    Flags
    substance · product
    Product numbers
    001, 002, 003, 004, 005

  • US 8,129,343, substance and product patent

    patent.txt lines 16,608, 16,616, 16,624, 16,632, 16,642, 16,651, 16,663, 16,675, 16,687, 16,699, 16,711, 16,716
    Expiry as listed
    5 Dec 2031
    Rule
    R1
    Flags
    substance · product
    Product numbers
    001, 002, 003, 004, 005, 006, 007, 008, 009, 010, 011, 012

  • US 9,764,003, use patent

    patent.txt lines 16,610, 16,618, 16,626, 16,634, 16,644, 16,664, 16,676, 16,688, 16,700, 16,712, 16,717
    Expiry as listed
    21 Jun 2033
    Rule
    R1
    Flags
    use code U-3161
    Product numbers
    001, 002, 003, 004, 005, 007, 008, 009, 010, 011, 012

  • US 9,764,003, use patent

    patent.txt line 16,652
    Expiry as listed
    21 Jun 2033
    Rule
    R1
    Flags
    use code U-4418
    Product numbers
    006

  • US 12,569,543, use patent

    patent.txt lines 16,662, 16,674, 16,686, 16,698, 16,710
    Expiry as listed
    28 Apr 2037
    Rule
    R1
    Flags
    use code U-4443
    Product numbers
    007, 008, 009, 010, 011

  • US 10,888,605, product and use patent

    patent.txt lines 16,603, 16,611, 16,619, 16,627, 16,635, 16,653, 16,665, 16,677, 16,689, 16,701
    Expiry as listed
    24 Aug 2038
    Rule
    R1
    Flags
    product · use code U-3162
    Product numbers
    001, 002, 003, 004, 005, 007, 008, 009, 010, 011

  • US 10,888,605, product and use patent

    patent.txt line 16,645
    Expiry as listed
    24 Aug 2038
    Rule
    R1
    Flags
    product · use code U-4418
    Product numbers
    006

  • US 11,752,198, product and use patent

    patent.txt lines 16,606, 16,614, 16,622, 16,630, 16,638, 16,658, 16,670, 16,682, 16,694, 16,706
    Expiry as listed
    24 Aug 2038
    Rule
    R1
    Flags
    product · use code U-3162
    Product numbers
    001, 002, 003, 004, 005, 007, 008, 009, 010, 011

  • US 11,752,198, product and use patent

    patent.txt line 16,647
    Expiry as listed
    24 Aug 2038
    Rule
    R1
    Flags
    product · use code U-4418
    Product numbers
    006

  • US 12,214,017, product and use patent

    patent.txt lines 16,607, 16,615, 16,623, 16,631, 16,640, 16,660, 16,672, 16,684, 16,696, 16,708
    Expiry as listed
    24 Aug 2038
    Rule
    R1
    Flags
    product · use code U-3162
    Product numbers
    001, 002, 003, 004, 005, 007, 008, 009, 010, 011

  • US 12,214,017, product and use patent

    patent.txt line 16,649
    Expiry as listed
    24 Aug 2038
    Rule
    R1
    Flags
    product · use code U-4418
    Product numbers
    006

  • US 12,029,779, use patent

    patent.txt lines 16,639, 16,659, 16,671, 16,683, 16,695, 16,707, 16,714
    Expiry as listed
    10 Oct 2038
    Rule
    R1
    Flags
    use code U-3162
    Product numbers
    005, 007, 008, 009, 010, 011, 012

  • US 12,029,779, use patent

    patent.txt line 16,648
    Expiry as listed
    10 Oct 2038
    Rule
    R1
    Flags
    use code U-4418
    Product numbers
    006

  • US 12,551,536, use patent

    patent.txt lines 16,641, 16,650, 16,661, 16,673, 16,685, 16,697, 16,709, 16,715
    Expiry as listed
    10 Oct 2038
    Rule
    R1
    Flags
    use code U-4418
    Product numbers
    005, 006, 007, 008, 009, 010, 011, 012

  • US 11,478,533, use patent

    patent.txt lines 16,605, 16,613, 16,621, 16,629, 16,637, 16,657, 16,669, 16,681, 16,693, 16,705, 16,713
    Expiry as listed
    13 May 2040
    Rule
    R1
    Flags
    use code U-3861
    Product numbers
    001, 002, 003, 004, 005, 007, 008, 009, 010, 011, 012

  • US 11,318,191, product and use patent

    patent.txt lines 16,604, 16,612, 16,620, 16,628, 16,636, 16,654, 16,666, 16,678, 16,690, 16,702
    Expiry as listed
    17 Feb 2041
    Rule
    R1
    Flags
    product · use code U-3162
    Product numbers
    001, 002, 003, 004, 005, 007, 008, 009, 010, 011

  • US 11,318,191, product and use patent

    patent.txt line 16,646
    Expiry as listed
    17 Feb 2041
    Rule
    R1
    Flags
    product · use code U-4418
    Product numbers
    006

  • US 11,318,191, product and use patent

    patent.txt lines 16,655, 16,667, 16,679, 16,691, 16,703
    Expiry as listed
    17 Feb 2041
    Rule
    R1
    Flags
    product · use code U-4443
    Product numbers
    007, 008, 009, 010, 011

  • US 11,318,191, product and use patent

    patent.txt lines 16,656, 16,668, 16,680, 16,692, 16,704
    Expiry as listed
    17 Feb 2041
    Rule
    R1
    Flags
    product · use code U-4560
    Product numbers
    007, 008, 009, 010, 011

Listed exclusivities

Each exclusivity FDA lists for NDA 215256, with its code, FDA's definition of the code where the store's code list gives one, and its date as listed.

  • D-190 exclusivity

    exclusivity.txt line 1,508
    Date
    21 Jul 2026
    Rule
    R3
    Definition
    New dosing schedule (to be checked against FDA's list)
    Product numbers
    004

  • I-935 exclusivity

    exclusivity.txt lines 1,502, 1,504, 1,506, 1,509, 1,511, 1,514
    Date
    8 Mar 2027
    Rule
    R3
    Definition
    New indication (to be checked against FDA's list)
    Product numbers
    001, 002, 003, 004, 005, 012

  • I-973 exclusivity

    exclusivity.txt lines 1,503, 1,505, 1,507, 1,510, 1,512, 1,515
    Date
    15 Aug 2028
    Rule
    R3
    Definition
    New indication (to be checked against FDA's list)
    Product numbers
    001, 002, 003, 004, 005, 012

  • NS exclusivity

    exclusivity.txt line 1,513
    Date
    19 Mar 2029
    Rule
    R3
    Definition
    New strength (to be checked against FDA's list)
    Product numbers
    006

Paragraph IV list rows giving NDA 215256

The rows of FDA's Paragraph IV certifications list as captured on 17 October 2026 whose RLD/NDA cell gives NDA 215256, 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 215256

  • Semaglutide · Injection · 0.25 mg/0.5 mL 0.5 mg/0.5 mL 1 mg/0.5 mL 1.7 mg/0.75 mL 2.4 mg/0.75 mL

    RLD/NDA as listed: Wegovy 215256
    First PIV submission
    20 Oct 2022
    ANDAs
    1
    180-day status
    blank
    Decision posted
    blank
    First applicant approval
    blank
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    17 Feb 2041

  • Semaglutide · Injection · 7.2 mg/0.75 mL

    RLD/NDA as listed: Wegovy HD 215256
    First PIV submission
    22 Jun 2026
    ANDAs
    1
    180-day status
    blank
    Decision posted
    blank
    First applicant approval
    blank
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    17 Feb 2041

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