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
- LANREOTIDE ACETATERLDRSINVAGEN PHARMSNDA 21539520213 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 60MG BASE/0.2ML (EQ 60MG BASE/0.2ML) SOLUTION SUBCUTANEOUS Rx — EQ 90MG BASE/0.3ML (EQ 90MG BASE/0.3ML) SOLUTION SUBCUTANEOUS Rx — EQ 120MG BASE/0.5ML (EQ 120MG BASE/0.5ML) SOLUTION SUBCUTANEOUS Rx — - IPSEN PHARMANDA 02207420073 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 60MG BASE/0.2ML (EQ 60MG BASE/0.2ML) SOLUTION SUBCUTANEOUS Rx AB EQ 90MG BASE/0.3ML (EQ 90MG BASE/0.3ML) SOLUTION SUBCUTANEOUS Rx AB EQ 120MG BASE/0.5ML (EQ 120MG BASE/0.5ML) SOLUTION SUBCUTANEOUS Rx AB
Generic (ANDA) products (1)
Abbreviated applications
- LANREOTIDE ACETATEINVAGEN PHARMSANDA 21719320243 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 60MG BASE/0.2ML (EQ 60MG BASE/0.2ML) SOLUTION SUBCUTANEOUS Rx AB EQ 90MG BASE/0.3ML (EQ 90MG BASE/0.3ML) SOLUTION SUBCUTANEOUS Rx AB EQ 120MG BASE/0.5ML (EQ 120MG BASE/0.5ML) SOLUTION SUBCUTANEOUS Rx AB
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
First approval
19 yr 5 mo ago
Most recent approval
2 yr 5 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
- FDA Purple BookLicensed biologics, biosimilars, interchangeables, BLA records, and exclusivity dates.
- FDA BiosimilarsFDA-approved biosimilars and interchangeable biosimilars, by reference product.
- 510(k) Predicate DatabaseSearch FDA 510(k) clearances and map predicate-device lineage.
- FDA 483 DatabaseFDA Form 483 observations and inspection records by firm, date, and citation.
