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Drybench Patent.

TIRZEPATIDE, NDA 217806

The patents and exclusivities FDA's Orange Book lists for NDA 217806 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 appTIRZEPATIDE in the molecule app

Listed protection

Listed dates run from 8 Nov 2026 to 22 Jul 2039, each by its own rule; no one date stands for this product.

Earliest listed date
8 Nov 2026NP exclusivityRule R3 · Products 001, 002, 003, 004, 005, 006 · exclusivity.txt lines 1,945, 1,949, 1,953, 1,957, 1,961, 1,965
Latest listed date
22 Jul 2039US 12,616,740, use patentRule R1 · Products 001, 002, 003, 004, 005, 006, 007, 008, 009, 010, 011, 012, 013, 014, 015, 016, 017, 018, 019, 020, 021, 022, 023, 024 · patent.txt lines 20,407, 20,424, 20,441, 20,458, 20,475, 20,492, 20,509, 20,526, 20,543, 20,560, 20,577, 20,594, 20,608, 20,620, 20,632, 20,644, 20,656, 20,668, 20,680, 20,692, 20,704, 20,716, 20,728, 20,740
Latest substance patent
13 May 2036US 9,474,780, substance and product patentRule R1 · Products 001, 002, 003, 004, 005, 006, 007, 008, 009, 010, 011, 012, 013, 014, 015, 016, 017, 018, 019, 020, 021, 022, 023, 024 · patent.txt lines 20,410, 20,427, 20,444, 20,461, 20,478, 20,495, 20,512, 20,529, 20,546, 20,563, 20,580, 20,597, 20,609, 20,621, 20,633, 20,645, 20,657, 20,669, 20,681, 20,693, 20,705, 20,717, 20,729, 20,741
Latest listed patent
22 Jul 2039US 12,616,740, use patentRule R1 · Products 001, 002, 003, 004, 005, 006, 007, 008, 009, 010, 011, 012, 013, 014, 015, 016, 017, 018, 019, 020, 021, 022, 023, 024 · patent.txt lines 20,407, 20,424, 20,441, 20,458, 20,475, 20,492, 20,509, 20,526, 20,543, 20,560, 20,577, 20,594, 20,608, 20,620, 20,632, 20,644, 20,656, 20,668, 20,680, 20,692, 20,704, 20,716, 20,728, 20,740
Latest exclusivity
20 Dec 2027I-958 exclusivityRule R3 · Products 001, 002, 003, 004, 005, 006, 007, 008, 009, 010, 011, 012, 013, 014, 015, 016, 017, 018, 019, 020, 021, 022, 023, 024 · exclusivity.txt lines 1,942, 1,946, 1,950, 1,954, 1,958, 1,962, 1,966, 1,969, 1,972, 1,975, 1,978, 1,981, 1,984, 1,987, 1,990, 1,993, 1,996, 1,999, 2,002, 2,005, 2,008, 2,011, 2,014, 2,017

300 use-code patents, blocking the coded use only

This page shows only the dates FDA lists. The app also shows NCE-1, the one date it computes, with its qualifications. Open in the app

Products

Each product number FDA lists under NDA 217806, as listed. The sections below name products by these numbers.

  • Product 001 · ZEPBOUND (AUTOINJECTOR)

    Dosage form; route
    SOLUTION;SUBCUTANEOUS
    Strength
    2.5MG/0.5ML (2.5MG/0.5ML)
    Approval date as listed
    8 Nov 2023
    Type as listed
    RX
    Applicant as listed
    ELI LILLY AND CO

  • Product 002 · ZEPBOUND (AUTOINJECTOR)

    Dosage form; route
    SOLUTION;SUBCUTANEOUS
    Strength
    5MG/0.5ML (5MG/0.5ML)
    Approval date as listed
    8 Nov 2023
    Type as listed
    RX
    Applicant as listed
    ELI LILLY AND CO

  • Product 003 · ZEPBOUND (AUTOINJECTOR)

    Dosage form; route
    SOLUTION;SUBCUTANEOUS
    Strength
    7.5MG/0.5ML (7.5MG/0.5ML)
    Approval date as listed
    8 Nov 2023
    Type as listed
    RX
    Applicant as listed
    ELI LILLY AND CO

  • Product 004 · ZEPBOUND (AUTOINJECTOR)

    Dosage form; route
    SOLUTION;SUBCUTANEOUS
    Strength
    10MG/0.5ML (10MG/0.5ML)
    Approval date as listed
    8 Nov 2023
    Type as listed
    RX
    Applicant as listed
    ELI LILLY AND CO

  • Product 005 · ZEPBOUND (AUTOINJECTOR)

    Dosage form; route
    SOLUTION;SUBCUTANEOUS
    Strength
    12.5MG/0.5ML (12.5MG/0.5ML)
    Approval date as listed
    8 Nov 2023
    Type as listed
    RX
    Applicant as listed
    ELI LILLY AND CO

  • Product 006 · ZEPBOUND (AUTOINJECTOR)

    Dosage form; route
    SOLUTION;SUBCUTANEOUS
    Strength
    15MG/0.5ML (15MG/0.5ML)
    Approval date as listed
    8 Nov 2023
    Type as listed
    RX
    Applicant as listed
    ELI LILLY AND CO

  • Product 007 · ZEPBOUND

    Dosage form; route
    SOLUTION;SUBCUTANEOUS
    Strength
    2.5MG/0.5ML (2.5MG/0.5ML)
    Approval date as listed
    28 Mar 2024
    Type as listed
    RX
    Applicant as listed
    ELI LILLY AND CO

  • Product 008 · ZEPBOUND

    Dosage form; route
    SOLUTION;SUBCUTANEOUS
    Strength
    5MG/0.5ML (5MG/0.5ML)
    Approval date as listed
    28 Mar 2024
    Type as listed
    RX
    Applicant as listed
    ELI LILLY AND CO

  • Product 009 · ZEPBOUND

    Dosage form; route
    SOLUTION;SUBCUTANEOUS
    Strength
    7.5MG/0.5ML (7.5MG/0.5ML)
    Approval date as listed
    28 Mar 2024
    Type as listed
    RX
    Applicant as listed
    ELI LILLY AND CO

  • Product 010 · ZEPBOUND

    Dosage form; route
    SOLUTION;SUBCUTANEOUS
    Strength
    10MG/0.5ML (10MG/0.5ML)
    Approval date as listed
    28 Mar 2024
    Type as listed
    RX
    Applicant as listed
    ELI LILLY AND CO

  • Product 011 · ZEPBOUND

    Dosage form; route
    SOLUTION;SUBCUTANEOUS
    Strength
    12.5MG/0.5ML (12.5MG/0.5ML)
    Approval date as listed
    28 Mar 2024
    Type as listed
    RX
    Applicant as listed
    ELI LILLY AND CO

  • Product 012 · ZEPBOUND

    Dosage form; route
    SOLUTION;SUBCUTANEOUS
    Strength
    15MG/0.5ML (15MG/0.5ML)
    Approval date as listed
    28 Mar 2024
    Type as listed
    RX
    Applicant as listed
    ELI LILLY AND CO

  • Product 013 · ZEPBOUND

    Dosage form; route
    SOLUTION;SUBCUTANEOUS
    Strength
    10MG/2.4ML (4.17MG/ML)
    Approval date as listed
    7 Jan 2026
    Type as listed
    RX
    Applicant as listed
    ELI LILLY AND CO

  • Product 014 · ZEPBOUND

    Dosage form; route
    SOLUTION;SUBCUTANEOUS
    Strength
    20MG/2.4ML (8.33MG/ML)
    Approval date as listed
    7 Jan 2026
    Type as listed
    RX
    Applicant as listed
    ELI LILLY AND CO

  • Product 015 · ZEPBOUND

    Dosage form; route
    SOLUTION;SUBCUTANEOUS
    Strength
    30MG/2.4ML (12.5MG/ML)
    Approval date as listed
    7 Jan 2026
    Type as listed
    RX
    Applicant as listed
    ELI LILLY AND CO

  • Product 016 · ZEPBOUND

    Dosage form; route
    SOLUTION;SUBCUTANEOUS
    Strength
    40MG/2.4ML (16.7MG/ML)
    Approval date as listed
    7 Jan 2026
    Type as listed
    RX
    Applicant as listed
    ELI LILLY AND CO

  • Product 017 · ZEPBOUND

    Dosage form; route
    SOLUTION;SUBCUTANEOUS
    Strength
    50MG/2.4ML (20.8MG/ML)
    Approval date as listed
    7 Jan 2026
    Type as listed
    RX
    Applicant as listed
    ELI LILLY AND CO

  • Product 018 · ZEPBOUND

    Dosage form; route
    SOLUTION;SUBCUTANEOUS
    Strength
    60MG/2.4ML (25MG/ML)
    Approval date as listed
    7 Jan 2026
    Type as listed
    RX
    Applicant as listed
    ELI LILLY AND CO

  • Product 019 · ZEPBOUND KWIKPEN

    Dosage form; route
    SOLUTION;SUBCUTANEOUS
    Strength
    10MG/2.4ML (4.17MG/ML)
    Approval date as listed
    20 Jan 2026
    Type as listed
    RX
    Applicant as listed
    ELI LILLY AND CO

  • Product 020 · ZEPBOUND KWIKPEN

    Dosage form; route
    SOLUTION;SUBCUTANEOUS
    Strength
    20MG/2.4ML (8.33MG/ML)
    Approval date as listed
    20 Jan 2026
    Type as listed
    RX
    Applicant as listed
    ELI LILLY AND CO

  • Product 021 · ZEPBOUND KWIKPEN

    Dosage form; route
    SOLUTION;SUBCUTANEOUS
    Strength
    30MG/2.4ML (12.5MG/ML)
    Approval date as listed
    20 Jan 2026
    Type as listed
    RX
    Applicant as listed
    ELI LILLY AND CO

  • Product 022 · ZEPBOUND KWIKPEN

    Dosage form; route
    SOLUTION;SUBCUTANEOUS
    Strength
    40MG/2.4ML (16.7MG/ML)
    Approval date as listed
    20 Jan 2026
    Type as listed
    RX
    Applicant as listed
    ELI LILLY AND CO

  • Product 023 · ZEPBOUND KWIKPEN

    Dosage form; route
    SOLUTION;SUBCUTANEOUS
    Strength
    50MG/2.4ML (20.8MG/ML)
    Approval date as listed
    20 Jan 2026
    Type as listed
    RX
    Applicant as listed
    ELI LILLY AND CO

  • Product 024 · ZEPBOUND KWIKPEN

    Dosage form; route
    SOLUTION;SUBCUTANEOUS
    Strength
    60MG/2.4ML (25MG/ML)
    Approval date as listed
    20 Jan 2026
    Type as listed
    RX
    Applicant as listed
    ELI LILLY AND CO

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.

17 entries from 348 rows as listed; rows merge only where every cell shown is the same, each with its product numbers.

  • US 9,474,780, substance and product patent

    patent.txt lines 20,410, 20,427, 20,444, 20,461, 20,478, 20,495, 20,512, 20,529, 20,546, 20,563, 20,580, 20,597, 20,609, 20,621, 20,633, 20,645, 20,657, 20,669, 20,681, 20,693, 20,705, 20,717, 20,729, 20,741
    Expiry as listed
    13 May 2036
    Rule
    R1
    Flags
    substance · product
    Product numbers
    001, 002, 003, 004, 005, 006, 007, 008, 009, 010, 011, 012, 013, 014, 015, 016, 017, 018, 019, 020, 021, 022, 023, 024

  • US 11,357,820, product patent

    patent.txt lines 20,394, 20,411, 20,428, 20,445, 20,462, 20,479, 20,496, 20,513, 20,530, 20,547, 20,564, 20,581
    Expiry as listed
    14 Jun 2039
    Rule
    R1
    Flags
    product
    Product numbers
    001, 002, 003, 004, 005, 006, 007, 008, 009, 010, 011, 012

  • US 11,918,623, use patent

    patent.txt lines 20,395, 20,412, 20,429, 20,446, 20,463, 20,480, 20,497, 20,514, 20,531, 20,548, 20,565, 20,582
    Expiry as listed
    14 Jun 2039
    Rule
    R1
    Flags
    use code U-3855
    Product numbers
    001, 002, 003, 004, 005, 006, 007, 008, 009, 010, 011, 012

  • US 12,453,756, product patent

    patent.txt lines 20,400, 20,417, 20,434, 20,451, 20,468, 20,485, 20,502, 20,519, 20,536, 20,553, 20,570, 20,587
    Expiry as listed
    14 Jun 2039
    Rule
    R1
    Flags
    product
    Product numbers
    001, 002, 003, 004, 005, 006, 007, 008, 009, 010, 011, 012

  • US 12,629,404, product and use patent

    patent.txt lines 20,408, 20,425, 20,442, 20,459, 20,476, 20,493, 20,510, 20,527, 20,544, 20,561, 20,578, 20,595
    Expiry as listed
    14 Jun 2039
    Rule
    R1
    Flags
    product · use code U-4531
    Product numbers
    001, 002, 003, 004, 005, 006, 007, 008, 009, 010, 011, 012

  • US 12,629,404, product and use patent

    patent.txt lines 20,409, 20,426, 20,443, 20,460, 20,477, 20,494, 20,511, 20,528, 20,545, 20,562, 20,579, 20,596
    Expiry as listed
    14 Jun 2039
    Rule
    R1
    Flags
    product · use code U-4532
    Product numbers
    001, 002, 003, 004, 005, 006, 007, 008, 009, 010, 011, 012

  • US 12,343,382, use patent

    patent.txt lines 20,396, 20,413, 20,430, 20,447, 20,464, 20,481, 20,498, 20,515, 20,532, 20,549, 20,566, 20,583, 20,598, 20,610, 20,622, 20,634, 20,646, 20,658, 20,670, 20,682, 20,694, 20,706, 20,718, 20,730
    Expiry as listed
    22 Jul 2039
    Rule
    R1
    Flags
    use code U-4227
    Product numbers
    001, 002, 003, 004, 005, 006, 007, 008, 009, 010, 011, 012, 013, 014, 015, 016, 017, 018, 019, 020, 021, 022, 023, 024

  • US 12,343,382, use patent

    patent.txt lines 20,397, 20,414, 20,431, 20,448, 20,465, 20,482, 20,499, 20,516, 20,533, 20,550, 20,567, 20,584, 20,599, 20,611, 20,623, 20,635, 20,647, 20,659, 20,671, 20,683, 20,695, 20,707, 20,719, 20,731
    Expiry as listed
    22 Jul 2039
    Rule
    R1
    Flags
    use code U-4228
    Product numbers
    001, 002, 003, 004, 005, 006, 007, 008, 009, 010, 011, 012, 013, 014, 015, 016, 017, 018, 019, 020, 021, 022, 023, 024

  • US 12,343,382, use patent

    patent.txt lines 20,398, 20,415, 20,432, 20,449, 20,466, 20,483, 20,500, 20,517, 20,534, 20,551, 20,568, 20,585, 20,600, 20,612, 20,624, 20,636, 20,648, 20,660, 20,672, 20,684, 20,696, 20,708, 20,720, 20,732
    Expiry as listed
    22 Jul 2039
    Rule
    R1
    Flags
    use code U-4409
    Product numbers
    001, 002, 003, 004, 005, 006, 007, 008, 009, 010, 011, 012, 013, 014, 015, 016, 017, 018, 019, 020, 021, 022, 023, 024

  • US 12,343,382, use patent

    patent.txt lines 20,399, 20,416, 20,433, 20,450, 20,467, 20,484, 20,501, 20,518, 20,535, 20,552, 20,569, 20,586, 20,601, 20,613, 20,625, 20,637, 20,649, 20,661, 20,673, 20,685, 20,697, 20,709, 20,721, 20,733
    Expiry as listed
    22 Jul 2039
    Rule
    R1
    Flags
    use code U-4410
    Product numbers
    001, 002, 003, 004, 005, 006, 007, 008, 009, 010, 011, 012, 013, 014, 015, 016, 017, 018, 019, 020, 021, 022, 023, 024

  • US 12,453,758, use patent

    patent.txt lines 20,401, 20,418, 20,435, 20,452, 20,469, 20,486, 20,503, 20,520, 20,537, 20,554, 20,571, 20,588, 20,602, 20,614, 20,626, 20,638, 20,650, 20,662, 20,674, 20,686, 20,698, 20,710, 20,722, 20,734
    Expiry as listed
    22 Jul 2039
    Rule
    R1
    Flags
    use code U-4308
    Product numbers
    001, 002, 003, 004, 005, 006, 007, 008, 009, 010, 011, 012, 013, 014, 015, 016, 017, 018, 019, 020, 021, 022, 023, 024

  • US 12,453,758, use patent

    patent.txt lines 20,402, 20,419, 20,436, 20,453, 20,470, 20,487, 20,504, 20,521, 20,538, 20,555, 20,572, 20,589, 20,603, 20,615, 20,627, 20,639, 20,651, 20,663, 20,675, 20,687, 20,699, 20,711, 20,723, 20,735
    Expiry as listed
    22 Jul 2039
    Rule
    R1
    Flags
    use code U-4309
    Product numbers
    001, 002, 003, 004, 005, 006, 007, 008, 009, 010, 011, 012, 013, 014, 015, 016, 017, 018, 019, 020, 021, 022, 023, 024

  • US 12,453,758, use patent

    patent.txt lines 20,403, 20,420, 20,437, 20,454, 20,471, 20,488, 20,505, 20,522, 20,539, 20,556, 20,573, 20,590, 20,604, 20,616, 20,628, 20,640, 20,652, 20,664, 20,676, 20,688, 20,700, 20,712, 20,724, 20,736
    Expiry as listed
    22 Jul 2039
    Rule
    R1
    Flags
    use code U-4310
    Product numbers
    001, 002, 003, 004, 005, 006, 007, 008, 009, 010, 011, 012, 013, 014, 015, 016, 017, 018, 019, 020, 021, 022, 023, 024

  • US 12,453,758, use patent

    patent.txt lines 20,404, 20,421, 20,438, 20,455, 20,472, 20,489, 20,506, 20,523, 20,540, 20,557, 20,574, 20,591, 20,605, 20,617, 20,629, 20,641, 20,653, 20,665, 20,677, 20,689, 20,701, 20,713, 20,725, 20,737
    Expiry as listed
    22 Jul 2039
    Rule
    R1
    Flags
    use code U-4311
    Product numbers
    001, 002, 003, 004, 005, 006, 007, 008, 009, 010, 011, 012, 013, 014, 015, 016, 017, 018, 019, 020, 021, 022, 023, 024

  • US 12,616,740, use patent

    patent.txt lines 20,405, 20,422, 20,439, 20,456, 20,473, 20,490, 20,507, 20,524, 20,541, 20,558, 20,575, 20,592, 20,606, 20,618, 20,630, 20,642, 20,654, 20,666, 20,678, 20,690, 20,702, 20,714, 20,726, 20,738
    Expiry as listed
    22 Jul 2039
    Rule
    R1
    Flags
    use code U-4497
    Product numbers
    001, 002, 003, 004, 005, 006, 007, 008, 009, 010, 011, 012, 013, 014, 015, 016, 017, 018, 019, 020, 021, 022, 023, 024

  • US 12,616,740, use patent

    patent.txt lines 20,406, 20,423, 20,440, 20,457, 20,474, 20,491, 20,508, 20,525, 20,542, 20,559, 20,576, 20,593, 20,607, 20,619, 20,631, 20,643, 20,655, 20,667, 20,679, 20,691, 20,703, 20,715, 20,727, 20,739
    Expiry as listed
    22 Jul 2039
    Rule
    R1
    Flags
    use code U-4498
    Product numbers
    001, 002, 003, 004, 005, 006, 007, 008, 009, 010, 011, 012, 013, 014, 015, 016, 017, 018, 019, 020, 021, 022, 023, 024

  • US 12,616,740, use patent

    patent.txt lines 20,407, 20,424, 20,441, 20,458, 20,475, 20,492, 20,509, 20,526, 20,543, 20,560, 20,577, 20,594, 20,608, 20,620, 20,632, 20,644, 20,656, 20,668, 20,680, 20,692, 20,704, 20,716, 20,728, 20,740
    Expiry as listed
    22 Jul 2039
    Rule
    R1
    Flags
    use code U-4499
    Product numbers
    001, 002, 003, 004, 005, 006, 007, 008, 009, 010, 011, 012, 013, 014, 015, 016, 017, 018, 019, 020, 021, 022, 023, 024

Listed exclusivities

Each exclusivity FDA lists for NDA 217806, with its code, FDA's definition of the code where the store's code list gives one, and its date as listed.

  • NP exclusivity

    exclusivity.txt lines 1,945, 1,949, 1,953, 1,957, 1,961, 1,965
    Date
    8 Nov 2026
    Rule
    R3
    Definition
    New product (to be checked against FDA's list)
    Product numbers
    001, 002, 003, 004, 005, 006

  • NCE exclusivity

    exclusivity.txt lines 1,944, 1,948, 1,952, 1,956, 1,960, 1,964, 1,968, 1,971, 1,974, 1,977, 1,980, 1,983, 1,986, 1,989, 1,992, 1,995, 1,998, 2,001, 2,004, 2,007, 2,010, 2,013, 2,016, 2,019
    Date
    13 May 2027
    Rule
    R3
    Definition
    New chemical entity (to be checked against FDA's list)
    Product numbers
    001, 002, 003, 004, 005, 006, 007, 008, 009, 010, 011, 012, 013, 014, 015, 016, 017, 018, 019, 020, 021, 022, 023, 024

  • M-82 exclusivity

    exclusivity.txt lines 1,943, 1,947, 1,951, 1,955, 1,959, 1,963, 1,967, 1,970, 1,973, 1,976, 1,979, 1,982, 1,985, 1,988, 1,991, 1,994, 1,997, 2,000, 2,003, 2,006, 2,009, 2,012, 2,015, 2,018
    Date
    18 Oct 2027
    Rule
    R3
    Definition
    Miscellaneous (to be checked against FDA's list)
    Product numbers
    001, 002, 003, 004, 005, 006, 007, 008, 009, 010, 011, 012, 013, 014, 015, 016, 017, 018, 019, 020, 021, 022, 023, 024

  • I-958 exclusivity

    exclusivity.txt lines 1,942, 1,946, 1,950, 1,954, 1,958, 1,962, 1,966, 1,969, 1,972, 1,975, 1,978, 1,981, 1,984, 1,987, 1,990, 1,993, 1,996, 1,999, 2,002, 2,005, 2,008, 2,011, 2,014, 2,017
    Date
    20 Dec 2027
    Rule
    R3
    Definition
    New indication (to be checked against FDA's list)
    Product numbers
    001, 002, 003, 004, 005, 006, 007, 008, 009, 010, 011, 012, 013, 014, 015, 016, 017, 018, 019, 020, 021, 022, 023, 024

Paragraph IV list rows giving NDA 217806

The rows of FDA's Paragraph IV certifications list as captured on 17 October 2026 whose RLD/NDA cell gives NDA 217806, 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 217806

  • Tirzepatide · Subcutaneous Solution · 10 mg/0.5 mL 12.5 mg/0.5 mL 15 mg/0.5 mL

    RLD/NDA as listed: Zepbound (Autoinjector) 217806
    First PIV submission
    13 May 2026
    ANDAs
    11
    180-day status
    blank
    Decision posted
    blank
    First applicant approval
    blank
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    22 Jul 2039

  • Tirzepatide · Subcutaneous Solution · 10 mg/2.4 mL and 60 mg/2.4 mL

    RLD/NDA as listed: Zepbound Kwikpen 217806
    First PIV submission
    26 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)
    22 Jul 2039

  • Tirzepatide · Subcutaneous Solution · 12.5 mg/0.5 mL

    RLD/NDA as listed: Zepbound 217806
    First PIV submission
    13 May 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)
    22 Jul 2039

  • Tirzepatide · Subcutaneous Solution · 2.5 mg/0.5 mL 5 mg/0.5 mL

    RLD/NDA as listed: Zepbound 217806
    First PIV submission
    13 May 2026
    ANDAs
    3
    180-day status
    blank
    Decision posted
    blank
    First applicant approval
    blank
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    22 Jul 2039

  • Tirzepatide · Subcutaneous Solution · 2.5 mg/0.5 mL 5 mg/0.5 mL

    RLD/NDA as listed: Zepbound (Autoinjector) 217806
    First PIV submission
    13 May 2026
    ANDAs
    12
    180-day status
    blank
    Decision posted
    blank
    First applicant approval
    blank
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    22 Jul 2039

  • Tirzepatide · Subcutaneous Solution · 20 mg/2.4 mL and 30 mg/2.4 mL

    RLD/NDA as listed: Zepbound Kwikpen 217806
    First PIV submission
    24 Aug 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)
    22 Jul 2039

  • Tirzepatide · Subcutaneous Solution · 40 mg/2.4 mL and 50 mg/2.4 mL

    RLD/NDA as listed: Zepbound Kwikpen 217806
    First PIV submission
    26 Aug 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)
    22 Jul 2039

  • Tirzepatide · Subcutaneous Solution · 7.5 mg/0.5 mL

    RLD/NDA as listed: Zepbound (Autoinjector) 217806
    First PIV submission
    13 May 2026
    ANDAs
    12
    180-day status
    blank
    Decision posted
    blank
    First applicant approval
    blank
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    22 Jul 2039

  • Tirzepatide · Subcutaneous Solution · 7.5 mg/0.5 mL 10 mg/0.5 mL 15 mg/0.5 mL

    RLD/NDA as listed: Zepbound 217806
    First PIV submission
    13 May 2026
    ANDAs
    2
    180-day status
    blank
    Decision posted
    blank
    First applicant approval
    blank
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    22 Jul 2039

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