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LANREOTIDE ACETATE

NDA

LANREOTIDE ACETATE | N215395 | INVAGEN PHARMACEUTICALS INC

3 strengths0 unique patents0 unique exclusivities

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

No ANDA patent litigation cases (NOS 835) matched from PACER

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

Medicare Part D Spending

CMS annual spending data for Lanreotide Acetate (2023)

Total Spending

$6.9M

Total Claims

714

Beneficiaries

122

Avg Cost/Unit

$18397.50

Spending Trend

$1.6M(2022)→$6.9M(2023)

YoY Change:+7.2%

5yr CAGR:+7.2%

Source: CMS Medicare Part D Spending by Drug (2023). Shows gross drug cost under Part D.

Medicare Part B Spending

CMS physician-administered drug spending for Lanreotide Acetate (J1930) (2023)

Total Spending

$368.4M

Total Claims

56,081

Beneficiaries

6,804

ASP Price

—

Spending Trend

$368.4M(2023)→$61.4M(2023)

HCPCS: J1930 — Injection, lanreotide, 1 mg

Source: CMS Medicare Part B Spending by Drug (2023). Shows physician-administered drug costs.

API Supply Chain12 active DMFs1 inactive

12 active API suppliers hold Drug Master Files for this ingredient.

ALP PHARM BEIJING CO LTDLANREOTIDE ACETATE

DMF 243782010

SINOPEP-ALLSINO BIOPHARMACEUTICAL CO LTDLANREOTIDE ACETATE

DMF 296932016

BACHEM AMERICAS INCLANREOTIDE ACETATE

DMF 333362019

SUN PHARMACEUTICAL INDUSTRIES LTDLANREOTIDE ACETATE

DMF 365472023

BCN PEPTIDES SALANREOTIDE

DMF 392542023

SICHUAN FRONTIER BIOPHARMACEUTICAL CO LTDLANREOTIDE ACETATE

DMF 394832024

CHENGDU SHENGNUO BIOPHARM CO LTDLANREOTIDE ACETATE

DMF 396732024

DR REDDYS LABORATORIES LTDLANREOTIDE ACETATE

DMF 397682024

SICHUAN DUORUI BIOPHARMACEUTICAL CO LTDLANREOTIDE ACETATE

DMF 414462025

RELIANCE LIFE SCIENCES PVT LTDLANREOTIDE ACETATE

DMF 421302025

PIRAMAL PHARMA LTDLANREOTIDE

DMF 423102025

SICHUAN HUIYU PHARMACEUTICAL CO LTDLANREOTIDE ACETATE

DMF 423182025

IPSEN MANUFACTURING IRELAND LTDInactiveLANREOTIDE (BIM 23014C)

DMF 89741991

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

3 letters from Drugs@FDA

Date	Submission	Document
Sep 17, 2024	SUPPL -7	View Letter (PDF)
Jul 15, 2024	SUPPL -8	View Letter (PDF)
Dec 21, 2021	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (3)

Sort:

#001 — EQ 60MG BASE/0.2ML (EQ 60MG BASE/0.2ML)

RLD

0 patents0 exclusivities▴

SOLUTION;SUBCUTANEOUS | Approved: Dec 17, 2021

No patent or exclusivity listings for this strength.

#002 — EQ 90MG BASE/0.3ML (EQ 90MG BASE/0.3ML)

RLD

0 patents0 exclusivities▾

SOLUTION;SUBCUTANEOUS | Approved: Dec 17, 2021

#003 — EQ 120MG BASE/0.5ML (EQ 120MG BASE/0.5ML)

RLD

0 patents0 exclusivities▾

SOLUTION;SUBCUTANEOUS | Approved: Dec 17, 2021