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FDA Orange Book · active-ingredient family

Tirzepatide

Tirzepatide: 2 brands, 0 generics; first approved May 13, 2022; on patent until May 13, 2036.

On patent5 exclusivity periods
Generic status & protection

Protected until May 13, 2036 (earliest listed patent expiry).

Earliest patent expiry Latest exclusivity ends
Brands (NDA)
2
Generics (ANDA)
0
Listed patents
10
Next patent expiry
May 13, 2036
in 9 yr 8 mo

Brand (NDA) products

Originator applications
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  • ZEPBOUNDRLDRS
    NDA 217806202424 strengths
    Approved strengths under this FDA application.
    StrengthDosage formRouteStatusTE
    2.5MG/0.5ML (2.5MG/0.5ML)SOLUTIONSUBCUTANEOUSRx-
    5MG/0.5ML (5MG/0.5ML)SOLUTIONSUBCUTANEOUSRx-
    7.5MG/0.5ML (7.5MG/0.5ML)SOLUTIONSUBCUTANEOUSRx-
    10MG/0.5ML (10MG/0.5ML)SOLUTIONSUBCUTANEOUSRx-
    12.5MG/0.5ML (12.5MG/0.5ML)SOLUTIONSUBCUTANEOUSRx-
    15MG/0.5ML (15MG/0.5ML)SOLUTIONSUBCUTANEOUSRx-
    2.5MG/0.5ML (2.5MG/0.5ML)SOLUTIONSUBCUTANEOUSRx-
    5MG/0.5ML (5MG/0.5ML)SOLUTIONSUBCUTANEOUSRx-
    7.5MG/0.5ML (7.5MG/0.5ML)SOLUTIONSUBCUTANEOUSRx-
    10MG/0.5ML (10MG/0.5ML)SOLUTIONSUBCUTANEOUSRx-
    12.5MG/0.5ML (12.5MG/0.5ML)SOLUTIONSUBCUTANEOUSRx-
    15MG/0.5ML (15MG/0.5ML)SOLUTIONSUBCUTANEOUSRx-
    10MG/2.4ML (4.17MG/ML)SOLUTIONSUBCUTANEOUSRx-
    20MG/2.4ML (8.33MG/ML)SOLUTIONSUBCUTANEOUSRx-
    30MG/2.4ML (12.5MG/ML)SOLUTIONSUBCUTANEOUSRx-
    40MG/2.4ML (16.7MG/ML)SOLUTIONSUBCUTANEOUSRx-
    50MG/2.4ML (20.8MG/ML)SOLUTIONSUBCUTANEOUSRx-
    60MG/2.4ML (25MG/ML)SOLUTIONSUBCUTANEOUSRx-
    10MG/2.4ML (4.17MG/ML)SOLUTIONSUBCUTANEOUSRx-
    20MG/2.4ML (8.33MG/ML)SOLUTIONSUBCUTANEOUSRx-
    30MG/2.4ML (12.5MG/ML)SOLUTIONSUBCUTANEOUSRx-
    40MG/2.4ML (16.7MG/ML)SOLUTIONSUBCUTANEOUSRx-
    50MG/2.4ML (20.8MG/ML)SOLUTIONSUBCUTANEOUSRx-
    60MG/2.4ML (25MG/ML)SOLUTIONSUBCUTANEOUSRx-
  • MOUNJARORLDRS
    NDA 215866202324 strengths
    Approved strengths under this FDA application.
    StrengthDosage formRouteStatusTE
    2.5MG/0.5ML (2.5MG/0.5ML)SOLUTIONSUBCUTANEOUSRx-
    5MG/0.5ML (5MG/0.5ML)SOLUTIONSUBCUTANEOUSRx-
    7.5MG/0.5ML (7.5MG/0.5ML)SOLUTIONSUBCUTANEOUSRx-
    10MG/0.5ML (10MG/0.5ML)SOLUTIONSUBCUTANEOUSRx-
    12.5MG/0.5ML (12.5MG/0.5ML)SOLUTIONSUBCUTANEOUSRx-
    15MG/0.5ML (15MG/0.5ML)SOLUTIONSUBCUTANEOUSRx-
    2.5MG/0.5ML (2.5MG/0.5ML)SOLUTIONSUBCUTANEOUSRx-
    5MG/0.5ML (5MG/0.5ML)SOLUTIONSUBCUTANEOUSRx-
    7.5MG/0.5ML (7.5MG/0.5ML)SOLUTIONSUBCUTANEOUSRx-
    10MG/0.5ML (10MG/0.5ML)SOLUTIONSUBCUTANEOUSRx-
    12.5MG/0.5ML (12.5MG/0.5ML)SOLUTIONSUBCUTANEOUSRx-
    15MG/0.5ML (15MG/0.5ML)SOLUTIONSUBCUTANEOUSRx-
    10MG/2.4ML (4.17MG/ML)SOLUTIONSUBCUTANEOUSRx-
    20MG/2.4ML (8.33MG/ML)SOLUTIONSUBCUTANEOUSRx-
    30MG/2.4ML (12.5MG/ML)SOLUTIONSUBCUTANEOUSRx-
    40MG/2.4ML (16.7MG/ML)SOLUTIONSUBCUTANEOUSRx-
    50MG/2.4ML (20.8MG/ML)SOLUTIONSUBCUTANEOUSRx-
    60MG/2.4ML (25MG/ML)SOLUTIONSUBCUTANEOUSRx-
    10MG/2.4ML (4.17MG/ML)SOLUTIONSUBCUTANEOUSRx-
    20MG/2.4ML (8.33MG/ML)SOLUTIONSUBCUTANEOUSRx-
    30MG/2.4ML (12.5MG/ML)SOLUTIONSUBCUTANEOUSRx-
    40MG/2.4ML (16.7MG/ML)SOLUTIONSUBCUTANEOUSRx-
    50MG/2.4ML (20.8MG/ML)SOLUTIONSUBCUTANEOUSRx-
    60MG/2.4ML (25MG/ML)SOLUTIONSUBCUTANEOUSRx-

Patent & exclusivity timeline

Protection horizon
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202620282030203220342036203820402042TodayExclusivity NP: 2026-11-08Exclusivity NPExclusivity NCE: 2027-05-13Exclusivity NCEExclusivity M-82: 2027-10-18Exclusivity M-82Exclusivity I-958: 2027-12-20Exclusivity I-958Exclusivity NPP: 2028-12-19Exclusivity NPPPatent 9474780: 2036-05-13Patent 9474780Patent 12453755: 2039-06-14Patent 12453755Patent 12629404: 2039-06-14Patent 12629404Patent 11357820: 2039-06-14Patent 11357820Patent 12453756: 2039-06-14Patent 12453756Patent 11918623: 2039-06-14Patent 11918623Patent 12343382: 2039-07-22Patent 12343382Patent 12616740: 2039-07-22Patent 12616740Patent 12453758: 2039-07-22Patent 12453758Patent 12295987: 2041-12-30Patent 12295987
Patent expiryExclusivity endToday

Marketing exclusivity

Hatch-Waxman
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  • NPNew product exclusivity (3 years)

    in 5 d

  • NCENew chemical entity exclusivity (5 years)

    in 6 mo

  • M-82New use / labeling-change exclusivity (3 years)

    in 1 yr

  • I-958New indication exclusivity (3 years)

    in 1 yr 2 mo

  • NPPNew patient population exclusivity (3 years)

    in 2 yr 2 mo

Listed patents

Orange Book patent file
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Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
PatentExpiresInType
9474780in 9 yr 8 mo
SubstanceProductU-4374
12453755in 12 yr 10 mo
U-4386
12629404in 12 yr 10 mo
ProductU-4533
11357820in 12 yr 10 mo
SubstanceProduct
12453756in 12 yr 10 mo
Product
11918623in 12 yr 10 mo
U-3855
12343382in 12 yr 11 mo
U-4229
12616740in 12 yr 11 mo
U-4500
12453758in 12 yr 11 mo
U-4311
12295987in 15 yr 5 mo
U-4193

Approval history

FDA approval span
Ask AI
First approval
4 yr 7 mo ago
Most recent approval
10 mo ago

Approvals span 2022–2026 across 2 FDA applications.

Brand (NDA) 2100%
Generic (ANDA) 00%

Tirzepatide: frequently asked questions

Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.

Built directly from the FDA Orange Book data file (products, patents, and exclusivity). TE codes, RLD/RS flags, patent expirations, and exclusivity dates match the official FDA record. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.

Related FDA reference tools

Assyro Intelligence

Ask anything about Tirzepatide

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  • ClinicalTrials.gov
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  • Health Canada
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