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FDA Orange Book · active-ingredient family

Lanreotide acetate

Lanreotide acetate: 2 brands, 1 generic; first approved Aug 30, 2007; generic available.

Generic available
Generic status & protection

Generic available: 1 ANDA application approved.

Brands (NDA)
2
Generics (ANDA)
1
Listed patents
0
Presentations
9

Brand (NDA) products

Originator applications
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  • LANREOTIDE ACETATERLDRS
    NDA 21539520213 strengths
    Approved strengths under this FDA application.
    StrengthDosage formRouteStatusTE
    EQ 60MG BASE/0.2ML (EQ 60MG BASE/0.2ML)SOLUTIONSUBCUTANEOUSRx-
    EQ 90MG BASE/0.3ML (EQ 90MG BASE/0.3ML)SOLUTIONSUBCUTANEOUSRx-
    EQ 120MG BASE/0.5ML (EQ 120MG BASE/0.5ML)SOLUTIONSUBCUTANEOUSRx-
  • SOMATULINE DEPOTRLDRS
    NDA 02207420073 strengths
    Approved strengths under this FDA application.
    StrengthDosage formRouteStatusTE
    EQ 60MG BASE/0.2ML (EQ 60MG BASE/0.2ML)SOLUTIONSUBCUTANEOUSRxAB
    EQ 90MG BASE/0.3ML (EQ 90MG BASE/0.3ML)SOLUTIONSUBCUTANEOUSRxAB
    EQ 120MG BASE/0.5ML (EQ 120MG BASE/0.5ML)SOLUTIONSUBCUTANEOUSRxAB

Generic (ANDA) products (1)

Abbreviated applications
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  • LANREOTIDE ACETATE
    ANDA 21719320243 strengths
    Approved strengths under this FDA application.
    StrengthDosage formRouteStatusTE
    EQ 60MG BASE/0.2ML (EQ 60MG BASE/0.2ML)SOLUTIONSUBCUTANEOUSRxAB
    EQ 90MG BASE/0.3ML (EQ 90MG BASE/0.3ML)SOLUTIONSUBCUTANEOUSRxAB
    EQ 120MG BASE/0.5ML (EQ 120MG BASE/0.5ML)SOLUTIONSUBCUTANEOUSRxAB

Listed patents

Orange Book patent file

No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.

Approval history

FDA approval span
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First approval
19 yr 5 mo ago
Most recent approval
2 yr 6 mo ago

Approvals span 2007–2024 across 3 FDA applications.

Brand (NDA) 267%
Generic (ANDA) 133%

Lanreotide acetate: 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

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  • PubMed
  • ClinicalTrials.gov
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  • Health Canada
  • EMA
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