Skip to content
Drybench

Drybench Patent.

SEMAGLUTIDE, NDA 209637

The patents and exclusivities FDA's Orange Book lists for NDA 209637 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 Jan 2026 to 17 Feb 2041, each by its own rule; no one date stands for this product.

Earliest listed date
20 Jan 2026US 10,357,616, product patentRule R1 · Products 001, 002, 003, 004 · patent.txt lines 10,688, 10,704, 10,721, 10,739
Latest listed date
17 Feb 2041US 11,318,191, product and use patentRule R1 · Products 005, 006, 007 · patent.txt lines 10,757, 10,764, 10,772
Latest substance patent
5 Dec 2031US 8,129,343, substance and product and use patentRule R1 · Product 004 · patent.txt line 10,744
Latest listed patent
17 Feb 2041US 11,318,191, product and use patentRule R1 · Products 005, 006, 007 · patent.txt lines 10,757, 10,764, 10,772
Latest exclusivity
28 Jan 2028I-961 exclusivityRule R3 · Products 001, 002, 003, 004 · exclusivity.txt lines 797–800

52 patents with a delist request, kept in the table · 40 use-code patents, blocking the coded use only

Products

Each product number FDA lists under NDA 209637, as listed. The sections below name products by these numbers.

  • Product 001 · OZEMPIC

    Dosage form; route
    SOLUTION;SUBCUTANEOUS
    Strength
    2MG/1.5ML (1.34MG/ML)
    Approval date as listed
    5 Dec 2017
    Type as listed
    DISCN
    Applicant as listed
    NOVO NORDISK INC

  • Product 002 · OZEMPIC

    Dosage form; route
    SOLUTION;SUBCUTANEOUS
    Strength
    4MG/3ML (1.34MG/ML)
    Approval date as listed
    9 Apr 2019
    Type as listed
    RX
    Applicant as listed
    NOVO NORDISK INC

  • Product 003 · OZEMPIC

    Dosage form; route
    SOLUTION;SUBCUTANEOUS
    Strength
    8MG/3ML (2.68MG/ML)
    Approval date as listed
    28 Mar 2022
    Type as listed
    RX
    Applicant as listed
    NOVO NORDISK INC

  • Product 004 · OZEMPIC

    Dosage form; route
    SOLUTION;SUBCUTANEOUS
    Strength
    2MG/3ML (0.68MG/ML)
    Approval date as listed
    6 Oct 2022
    Type as listed
    RX
    Applicant as listed
    NOVO NORDISK INC

  • Product 005 · OZEMPIC

    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 006 · OZEMPIC

    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 007 · OZEMPIC

    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

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.

30 entries from 92 rows as listed; rows merge only where every cell shown is the same, each with its product numbers.

  • US 10,357,616, product patent

    patent.txt lines 10,688, 10,704, 10,721, 10,739
    Expiry as listed
    20 Jan 2026
    Rule
    R1
    Flags
    product · delist requested
    Product numbers
    001, 002, 003, 004

  • US 10,376,652, product patent

    patent.txt lines 10,689, 10,705, 10,722, 10,740
    Expiry as listed
    20 Jan 2026
    Rule
    R1
    Flags
    product · delist requested
    Product numbers
    001, 002, 003, 004

  • US 9,108,002, product patent

    patent.txt lines 10,694, 10,712, 10,729, 10,747
    Expiry as listed
    20 Jan 2026
    Rule
    R1
    Flags
    product · delist requested
    Product numbers
    001, 002, 003, 004

  • US 9,616,180, product patent

    patent.txt lines 10,697, 10,715, 10,732, 10,750
    Expiry as listed
    20 Jan 2026
    Rule
    R1
    Flags
    product · delist requested
    Product numbers
    001, 002, 003, 004

  • US 9,861,757, product patent

    patent.txt lines 10,700, 10,718, 10,735, 10,753
    Expiry as listed
    20 Jan 2026
    Rule
    R1
    Flags
    product · delist requested
    Product numbers
    001, 002, 003, 004

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

    patent.txt lines 10,692, 10,710
    Expiry as listed
    20 Mar 2026
    Rule
    R1
    Flags
    substance · product · use code U-2202
    Product numbers
    001, 002

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

    patent.txt line 10,727
    Expiry as listed
    20 Mar 2026
    Rule
    R1
    Flags
    substance · product · use code U-3355
    Product numbers
    003

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

    patent.txt line 10,745
    Expiry as listed
    20 Mar 2026
    Rule
    R1
    Flags
    substance · product · use code U-3469
    Product numbers
    004

  • US 10,220,155, product patent

    patent.txt lines 10,686, 10,702, 10,720, 10,737
    Expiry as listed
    17 Jul 2026
    Rule
    R1
    Flags
    product · delist requested
    Product numbers
    001, 002, 003, 004

  • US 11,097,063, product patent

    patent.txt lines 10,690, 10,706, 10,723, 10,741
    Expiry as listed
    17 Jul 2026
    Rule
    R1
    Flags
    product · delist requested
    Product numbers
    001, 002, 003, 004

  • US 8,920,383, product patent

    patent.txt lines 10,693, 10,711, 10,728, 10,746
    Expiry as listed
    17 Jul 2026
    Rule
    R1
    Flags
    product · delist requested
    Product numbers
    001, 002, 003, 004

  • US 9,775,953, product patent

    patent.txt lines 10,699, 10,717, 10,734, 10,752
    Expiry as listed
    17 Jul 2026
    Rule
    R1
    Flags
    product · delist requested
    Product numbers
    001, 002, 003, 004

  • US RE46363, product patent

    patent.txt lines 10,701, 10,719, 10,736, 10,754
    Expiry as listed
    3 Aug 2026
    Rule
    R1
    Flags
    product · delist requested
    Product numbers
    001, 002, 003, 004

  • US 9,687,611, product patent

    patent.txt lines 10,698, 10,716, 10,733, 10,751
    Expiry as listed
    27 Feb 2027
    Rule
    R1
    Flags
    product · delist requested
    Product numbers
    001, 002, 003, 004

  • US 9,457,154, product patent

    patent.txt lines 10,696, 10,714, 10,731, 10,749
    Expiry as listed
    29 Sep 2027
    Rule
    R1
    Flags
    product · delist requested
    Product numbers
    001, 002, 003, 004

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

    patent.txt lines 10,691, 10,709
    Expiry as listed
    5 Dec 2031
    Rule
    R1
    Flags
    substance · product · use code U-2202
    Product numbers
    001, 002

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

    patent.txt lines 10,726, 10,761, 10,768, 10,777
    Expiry as listed
    5 Dec 2031
    Rule
    R1
    Flags
    substance · product · use code U-3355
    Product numbers
    003, 005, 006, 007

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

    patent.txt line 10,744
    Expiry as listed
    5 Dec 2031
    Rule
    R1
    Flags
    substance · product · use code U-3469
    Product numbers
    004

  • US 9,132,239, product patent

    patent.txt lines 10,695, 10,713, 10,730, 10,748
    Expiry as listed
    1 Feb 2032
    Rule
    R1
    Flags
    product · delist requested
    Product numbers
    001, 002, 003, 004

  • US 10,335,462, use patent

    patent.txt lines 10,687, 10,703
    Expiry as listed
    21 Jun 2033
    Rule
    R1
    Flags
    use code U-2580
    Product numbers
    001, 002

  • US 10,335,462, product and use patent

    patent.txt line 10,738
    Expiry as listed
    21 Jun 2033
    Rule
    R1
    Flags
    product · use code U-2580
    Product numbers
    004

  • US 10,335,462, use patent

    patent.txt line 10,769
    Expiry as listed
    21 Jun 2033
    Rule
    R1
    Flags
    use code U-1852
    Product numbers
    007

  • US 12,569,543, use patent

    patent.txt lines 10,708, 10,725, 10,743, 10,760, 10,767, 10,776
    Expiry as listed
    28 Apr 2037
    Rule
    R1
    Flags
    use code U-4446
    Product numbers
    002, 003, 004, 005, 006, 007

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

    patent.txt lines 10,755, 10,762, 10,770
    Expiry as listed
    24 Aug 2038
    Rule
    R1
    Flags
    product · use code U-1852
    Product numbers
    005, 006, 007

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

    patent.txt lines 10,758, 10,765, 10,773
    Expiry as listed
    24 Aug 2038
    Rule
    R1
    Flags
    product · use code U-1852
    Product numbers
    005, 006, 007

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

    patent.txt lines 10,759, 10,766, 10,774
    Expiry as listed
    24 Aug 2038
    Rule
    R1
    Flags
    product · use code U-1852
    Product numbers
    005, 006, 007

  • US 12,295,988, use patent

    patent.txt lines 10,707, 10,742, 10,775
    Expiry as listed
    10 Oct 2038
    Rule
    R1
    Flags
    use code U-1852
    Product numbers
    002, 004, 007

  • US 12,295,988, use patent

    patent.txt line 10,724
    Expiry as listed
    10 Oct 2038
    Rule
    R1
    Flags
    use code U-2628
    Product numbers
    003

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

    patent.txt lines 10,756, 10,763, 10,771
    Expiry as listed
    17 Feb 2041
    Rule
    R1
    Flags
    product · use code U-1852
    Product numbers
    005, 006, 007

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

    patent.txt lines 10,757, 10,764, 10,772
    Expiry as listed
    17 Feb 2041
    Rule
    R1
    Flags
    product · use code U-4561
    Product numbers
    005, 006, 007

Listed exclusivities

Each exclusivity FDA lists for NDA 209637, with its code, FDA's definition of the code where the store's code list gives one, and its date as listed.

  • I-961 exclusivity

    exclusivity.txt lines 797–800
    Date
    28 Jan 2028
    Rule
    R3
    Definition
    New indication (to be checked against FDA's list)
    Product numbers
    001, 002, 003, 004

Paragraph IV list rows giving NDA 209637

The rows of FDA's Paragraph IV certifications list as captured on 17 October 2026 whose RLD/NDA cell gives NDA 209637, 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 209637

  • Semaglutide · Injection · 2 mg/1.5 mL and 4 mg/3 mL

    RLD/NDA as listed: Ozempic 209637
    First PIV submission
    6 Dec 2021
    ANDAs
    7
    180-day status
    blank
    Decision posted
    blank
    First applicant approval
    blank
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    21 Jun 2033

  • Semaglutide · Injection · 2 mg/3 mL

    RLD/NDA as listed: Ozempic 209637
    First PIV submission
    11 Apr 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)
    21 Jun 2033

  • Semaglutide · Injection · 8 mg/3 mL

    RLD/NDA as listed: Ozempic 209637
    First PIV submission
    21 Dec 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)
    1 Feb 2032

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