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Drybench Patent.

TIRZEPATIDE, NDA 215866

The patents and exclusivities FDA's Orange Book lists for NDA 215866 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 13 May 2027 to 30 Dec 2041, each by its own rule; no one date stands for this product.

Earliest listed date
13 May 2027NCE 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 1,625, 1,627, 1,629, 1,631, 1,633–1,635, 1,637, 1,639, 1,641, 1,643–1,645, 1,647, 1,649, 1,651, 1,653, 1,655, 1,657, 1,659, 1,661, 1,663, 1,665–1,666
Latest listed date
30 Dec 2041US 12,295,987, 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 17,573, 17,601, 17,629, 17,657, 17,685, 17,713, 17,741, 17,769, 17,797, 17,825, 17,853, 17,881, 17,908, 17,920, 17,932, 17,944, 17,956, 17,968, 17,980, 17,992, 18,004, 18,016, 18,028, 18,040
Latest substance patent
14 Jun 2039US 11,357,820, substance and product patentRule R1 · Products 007, 008, 009, 010, 011, 012 · patent.txt lines 17,739, 17,767, 17,795, 17,823, 17,851, 17,879
Latest listed patent
30 Dec 2041US 12,295,987, 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 17,573, 17,601, 17,629, 17,657, 17,685, 17,713, 17,741, 17,769, 17,797, 17,825, 17,853, 17,881, 17,908, 17,920, 17,932, 17,944, 17,956, 17,968, 17,980, 17,992, 18,004, 18,016, 18,028, 18,040
Latest exclusivity
19 Dec 2028NPP exclusivityRule R3 · Products 001, 002, 003, 004, 007, 008, 009, 010, 013, 014, 015, 016, 017, 018, 019, 020, 021, 022 · exclusivity.txt lines 1,626, 1,628, 1,630, 1,632, 1,636, 1,638, 1,640, 1,642, 1,646, 1,648, 1,650, 1,652, 1,654, 1,656, 1,658, 1,660, 1,662, 1,664

456 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 215866, as listed. The sections below name products by these numbers.

  • Product 001 · MOUNJARO (AUTOINJECTOR)

    Dosage form; route
    SOLUTION;SUBCUTANEOUS
    Strength
    2.5MG/0.5ML (2.5MG/0.5ML)
    Approval date as listed
    13 May 2022
    Type as listed
    RX
    Applicant as listed
    ELI LILLY AND CO

  • Product 002 · MOUNJARO (AUTOINJECTOR)

    Dosage form; route
    SOLUTION;SUBCUTANEOUS
    Strength
    5MG/0.5ML (5MG/0.5ML)
    Approval date as listed
    13 May 2022
    Type as listed
    RX
    Applicant as listed
    ELI LILLY AND CO

  • Product 003 · MOUNJARO (AUTOINJECTOR)

    Dosage form; route
    SOLUTION;SUBCUTANEOUS
    Strength
    7.5MG/0.5ML (7.5MG/0.5ML)
    Approval date as listed
    13 May 2022
    Type as listed
    RX
    Applicant as listed
    ELI LILLY AND CO

  • Product 004 · MOUNJARO (AUTOINJECTOR)

    Dosage form; route
    SOLUTION;SUBCUTANEOUS
    Strength
    10MG/0.5ML (10MG/0.5ML)
    Approval date as listed
    13 May 2022
    Type as listed
    RX
    Applicant as listed
    ELI LILLY AND CO

  • Product 005 · MOUNJARO (AUTOINJECTOR)

    Dosage form; route
    SOLUTION;SUBCUTANEOUS
    Strength
    12.5MG/0.5ML (12.5MG/0.5ML)
    Approval date as listed
    13 May 2022
    Type as listed
    RX
    Applicant as listed
    ELI LILLY AND CO

  • Product 006 · MOUNJARO (AUTOINJECTOR)

    Dosage form; route
    SOLUTION;SUBCUTANEOUS
    Strength
    15MG/0.5ML (15MG/0.5ML)
    Approval date as listed
    13 May 2022
    Type as listed
    RX
    Applicant as listed
    ELI LILLY AND CO

  • Product 007 · MOUNJARO

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

  • Product 008 · MOUNJARO

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

  • Product 009 · MOUNJARO

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

  • Product 010 · MOUNJARO

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

  • Product 011 · MOUNJARO

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

  • Product 012 · MOUNJARO

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

  • Product 013 · MOUNJARO

    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 · MOUNJARO

    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 · MOUNJARO

    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 · MOUNJARO

    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 · MOUNJARO

    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 · MOUNJARO

    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 · MOUNJARO 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 · MOUNJARO 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 · MOUNJARO 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 · MOUNJARO 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 · MOUNJARO 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 · MOUNJARO 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.

29 entries from 480 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 and use patent

    patent.txt lines 17,598, 17,626, 17,654, 17,682, 17,710, 17,738, 17,766, 17,794, 17,822, 17,850, 17,878, 17,906, 17,918, 17,930, 17,942, 17,954, 17,966, 17,978, 17,990, 18,002, 18,014, 18,026, 18,038, 18,050
    Expiry as listed
    13 May 2036
    Rule
    R1
    Flags
    substance · product · use code U-4374
    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 17,571, 17,599, 17,627, 17,655, 17,683, 17,711
    Expiry as listed
    14 Jun 2039
    Rule
    R1
    Flags
    product
    Product numbers
    001, 002, 003, 004, 005, 006

  • US 11,357,820, substance and product patent

    patent.txt lines 17,739, 17,767, 17,795, 17,823, 17,851, 17,879
    Expiry as listed
    14 Jun 2039
    Rule
    R1
    Flags
    substance · product
    Product numbers
    007, 008, 009, 010, 011, 012

  • US 12,453,755, use patent

    patent.txt lines 17,580, 17,608, 17,636, 17,664, 17,692, 17,720, 17,748, 17,776, 17,804, 17,832, 17,860, 17,888
    Expiry as listed
    14 Jun 2039
    Rule
    R1
    Flags
    use code U-4375
    Product numbers
    001, 002, 003, 004, 005, 006, 007, 008, 009, 010, 011, 012

  • US 12,453,755, use patent

    patent.txt lines 17,581, 17,609, 17,637, 17,665, 17,693, 17,721, 17,749, 17,777, 17,805, 17,833, 17,861, 17,889
    Expiry as listed
    14 Jun 2039
    Rule
    R1
    Flags
    use code U-4376
    Product numbers
    001, 002, 003, 004, 005, 006, 007, 008, 009, 010, 011, 012

  • US 12,453,755, use patent

    patent.txt lines 17,582, 17,610, 17,638, 17,666, 17,694, 17,722, 17,750, 17,778, 17,806, 17,834, 17,862, 17,890
    Expiry as listed
    14 Jun 2039
    Rule
    R1
    Flags
    use code U-4377
    Product numbers
    001, 002, 003, 004, 005, 006, 007, 008, 009, 010, 011, 012

  • US 12,453,755, use patent

    patent.txt lines 17,583, 17,611, 17,639, 17,667, 17,695, 17,723, 17,751, 17,779, 17,807, 17,835, 17,863, 17,891
    Expiry as listed
    14 Jun 2039
    Rule
    R1
    Flags
    use code U-4378
    Product numbers
    001, 002, 003, 004, 005, 006, 007, 008, 009, 010, 011, 012

  • US 12,453,755, use patent

    patent.txt lines 17,584, 17,612, 17,640, 17,668, 17,696, 17,724, 17,752, 17,780, 17,808, 17,836, 17,864, 17,892
    Expiry as listed
    14 Jun 2039
    Rule
    R1
    Flags
    use code U-4379
    Product numbers
    001, 002, 003, 004, 005, 006, 007, 008, 009, 010, 011, 012

  • US 12,453,755, use patent

    patent.txt lines 17,585, 17,613, 17,641, 17,669, 17,697, 17,725, 17,753, 17,781, 17,809, 17,837, 17,865, 17,893
    Expiry as listed
    14 Jun 2039
    Rule
    R1
    Flags
    use code U-4380
    Product numbers
    001, 002, 003, 004, 005, 006, 007, 008, 009, 010, 011, 012

  • US 12,453,755, use patent

    patent.txt lines 17,586, 17,614, 17,642, 17,670, 17,698, 17,726, 17,754, 17,782, 17,810, 17,838, 17,866, 17,894
    Expiry as listed
    14 Jun 2039
    Rule
    R1
    Flags
    use code U-4381
    Product numbers
    001, 002, 003, 004, 005, 006, 007, 008, 009, 010, 011, 012

  • US 12,453,755, use patent

    patent.txt lines 17,587, 17,615, 17,643, 17,671, 17,699, 17,727, 17,755, 17,783, 17,811, 17,839, 17,867, 17,895
    Expiry as listed
    14 Jun 2039
    Rule
    R1
    Flags
    use code U-4382
    Product numbers
    001, 002, 003, 004, 005, 006, 007, 008, 009, 010, 011, 012

  • US 12,453,755, use patent

    patent.txt lines 17,588, 17,616, 17,644, 17,672, 17,700, 17,728, 17,756, 17,784, 17,812, 17,840, 17,868, 17,896
    Expiry as listed
    14 Jun 2039
    Rule
    R1
    Flags
    use code U-4383
    Product numbers
    001, 002, 003, 004, 005, 006, 007, 008, 009, 010, 011, 012

  • US 12,453,755, use patent

    patent.txt lines 17,589, 17,617, 17,645, 17,673, 17,701, 17,729, 17,757, 17,785, 17,813, 17,841, 17,869, 17,897
    Expiry as listed
    14 Jun 2039
    Rule
    R1
    Flags
    use code U-4384
    Product numbers
    001, 002, 003, 004, 005, 006, 007, 008, 009, 010, 011, 012

  • US 12,453,755, use patent

    patent.txt lines 17,590, 17,618, 17,646, 17,674, 17,702, 17,730, 17,758, 17,786, 17,814, 17,842, 17,870, 17,898
    Expiry as listed
    14 Jun 2039
    Rule
    R1
    Flags
    use code U-4385
    Product numbers
    001, 002, 003, 004, 005, 006, 007, 008, 009, 010, 011, 012

  • US 12,453,755, use patent

    patent.txt lines 17,591, 17,619, 17,647, 17,675, 17,703, 17,731, 17,759, 17,787, 17,815, 17,843, 17,871, 17,899
    Expiry as listed
    14 Jun 2039
    Rule
    R1
    Flags
    use code U-4386
    Product numbers
    001, 002, 003, 004, 005, 006, 007, 008, 009, 010, 011, 012

  • US 12,453,756, product patent

    patent.txt lines 17,592, 17,620, 17,648, 17,676, 17,704, 17,732, 17,760, 17,788, 17,816, 17,844, 17,872, 17,900
    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 17,596, 17,624, 17,652, 17,680, 17,708, 17,736, 17,764, 17,792, 17,820, 17,848, 17,876, 17,904
    Expiry as listed
    14 Jun 2039
    Rule
    R1
    Flags
    product · use code U-4533
    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 17,597, 17,625, 17,653, 17,681, 17,709, 17,737, 17,765, 17,793, 17,821, 17,849, 17,877, 17,905
    Expiry as listed
    14 Jun 2039
    Rule
    R1
    Flags
    product · use code U-4534
    Product numbers
    001, 002, 003, 004, 005, 006, 007, 008, 009, 010, 011, 012

  • US 12,343,382, use patent

    patent.txt lines 17,574, 17,602, 17,630, 17,658, 17,686, 17,714, 17,742, 17,770, 17,798, 17,826, 17,854, 17,882, 17,909, 17,921, 17,933, 17,945, 17,957, 17,969, 17,981, 17,993, 18,005, 18,017, 18,029, 18,041
    Expiry as listed
    22 Jul 2039
    Rule
    R1
    Flags
    use code U-4229
    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 17,575, 17,603, 17,631, 17,659, 17,687, 17,715, 17,743, 17,771, 17,799, 17,827, 17,855, 17,883, 17,910, 17,922, 17,934, 17,946, 17,958, 17,970, 17,982, 17,994, 18,006, 18,018, 18,030, 18,042
    Expiry as listed
    22 Jul 2039
    Rule
    R1
    Flags
    use code U-4230
    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 17,576, 17,604, 17,632, 17,660, 17,688, 17,716, 17,744, 17,772, 17,800, 17,828, 17,856, 17,884, 17,911, 17,923, 17,935, 17,947, 17,959, 17,971, 17,983, 17,995, 18,007, 18,019, 18,031, 18,043
    Expiry as listed
    22 Jul 2039
    Rule
    R1
    Flags
    use code U-4231
    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 17,577, 17,605, 17,633, 17,661, 17,689, 17,717, 17,745, 17,773, 17,801, 17,829, 17,857, 17,885, 17,912, 17,924, 17,936, 17,948, 17,960, 17,972, 17,984, 17,996, 18,008, 18,020, 18,032, 18,044
    Expiry as listed
    22 Jul 2039
    Rule
    R1
    Flags
    use code U-4232
    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 17,578, 17,606, 17,634, 17,662, 17,690, 17,718, 17,746, 17,774, 17,802, 17,830, 17,858, 17,886, 17,913, 17,925, 17,937, 17,949, 17,961, 17,973, 17,985, 17,997, 18,009, 18,021, 18,033, 18,045
    Expiry as listed
    22 Jul 2039
    Rule
    R1
    Flags
    use code U-4400
    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 17,579, 17,607, 17,635, 17,663, 17,691, 17,719, 17,747, 17,775, 17,803, 17,831, 17,859, 17,887, 17,914, 17,926, 17,938, 17,950, 17,962, 17,974, 17,986, 17,998, 18,010, 18,022, 18,034, 18,046
    Expiry as listed
    22 Jul 2039
    Rule
    R1
    Flags
    use code U-4401
    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 17,593, 17,621, 17,649, 17,677, 17,705, 17,733, 17,761, 17,789, 17,817, 17,845, 17,873, 17,901, 17,915, 17,927, 17,939, 17,951, 17,963, 17,975, 17,987, 17,999, 18,011, 18,023, 18,035, 18,047
    Expiry as listed
    22 Jul 2039
    Rule
    R1
    Flags
    use code U-4500
    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 17,594, 17,622, 17,650, 17,678, 17,706, 17,734, 17,762, 17,790, 17,818, 17,846, 17,874, 17,902, 17,916, 17,928, 17,940, 17,952, 17,964, 17,976, 17,988, 18,000, 18,012, 18,024, 18,036, 18,048
    Expiry as listed
    22 Jul 2039
    Rule
    R1
    Flags
    use code U-4501
    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 17,595, 17,623, 17,651, 17,679, 17,707, 17,735, 17,763, 17,791, 17,819, 17,847, 17,875, 17,903, 17,917, 17,929, 17,941, 17,953, 17,965, 17,977, 17,989, 18,001, 18,013, 18,025, 18,037, 18,049
    Expiry as listed
    22 Jul 2039
    Rule
    R1
    Flags
    use code U-4502
    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 12,295,987, use patent

    patent.txt lines 17,572, 17,600, 17,628, 17,656, 17,684, 17,712, 17,740, 17,768, 17,796, 17,824, 17,852, 17,880, 17,907, 17,919, 17,931, 17,943, 17,955, 17,967, 17,979, 17,991, 18,003, 18,015, 18,027, 18,039
    Expiry as listed
    30 Dec 2041
    Rule
    R1
    Flags
    use code U-4192
    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 12,295,987, use patent

    patent.txt lines 17,573, 17,601, 17,629, 17,657, 17,685, 17,713, 17,741, 17,769, 17,797, 17,825, 17,853, 17,881, 17,908, 17,920, 17,932, 17,944, 17,956, 17,968, 17,980, 17,992, 18,004, 18,016, 18,028, 18,040
    Expiry as listed
    30 Dec 2041
    Rule
    R1
    Flags
    use code U-4193
    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 215866, with its code, FDA's definition of the code where the store's code list gives one, and its date as listed.

  • NCE exclusivity

    exclusivity.txt lines 1,625, 1,627, 1,629, 1,631, 1,633–1,635, 1,637, 1,639, 1,641, 1,643–1,645, 1,647, 1,649, 1,651, 1,653, 1,655, 1,657, 1,659, 1,661, 1,663, 1,665–1,666
    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

  • NPP exclusivity

    exclusivity.txt lines 1,626, 1,628, 1,630, 1,632, 1,636, 1,638, 1,640, 1,642, 1,646, 1,648, 1,650, 1,652, 1,654, 1,656, 1,658, 1,660, 1,662, 1,664
    Date
    19 Dec 2028
    Rule
    R3
    Definition
    New patient population (to be checked against FDA's list)
    Product numbers
    001, 002, 003, 004, 007, 008, 009, 010, 013, 014, 015, 016, 017, 018, 019, 020, 021, 022

Paragraph IV list rows giving NDA 215866

The rows of FDA's Paragraph IV certifications list as captured on 17 October 2026 whose RLD/NDA cell gives NDA 215866, 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 215866

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

    RLD/NDA as listed: Mounjaro (Autoinjector) 215866
    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)
    30 Dec 2041

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

    RLD/NDA as listed: Mounjaro Kwikpen 215866
    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)
    30 Dec 2041

  • Tirzepatide · Subcutaneous Solution · 12.5 mg/0.5 mL

    RLD/NDA as listed: Mounjaro 215866
    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)
    30 Dec 2041

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

    RLD/NDA as listed: Mounjaro (Autoinjector) 215866
    First PIV submission
    13 May 2026
    ANDAs
    13
    180-day status
    blank
    Decision posted
    blank
    First applicant approval
    blank
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    30 Dec 2041

  • Tirzepatide · Subcutaneous Solution · 2.5 mg/0.5 mL 5mg/0.5 mL 7.5 mg/0.5 mL 10 mg/0.5 mL 15 mg/0.5 mL

    RLD/NDA as listed: Mounjaro 215866
    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)
    30 Dec 2041

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

    RLD/NDA as listed: Mounjaro Kwikpen 215866
    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)
    30 Dec 2041

  • Tirzepatide · Subcutaneous Solution · 7.5 mg/0.5 mL

    RLD/NDA as listed: Mounjaro (Autoinjector) 215866
    First PIV submission
    13 May 2026
    ANDAs
    13
    180-day status
    blank
    Decision posted
    blank
    First applicant approval
    blank
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    30 Dec 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