Viewing data from:

LIRAGLUTIDE

ANDA

LIRAGLUTIDE | A215503 | HIKMA PHARMACEUTICALS USA INC

1 strength0 unique patents0 unique exclusivities

Reference Listed Drug: VICTOZA(TE code: AP1)

Hatch-Waxman Litigation

1 case on OB patents from PACER

Case	Court	Filed	Status	Judge
Novo Nordisk Inc. et al v. Hikma Pharmaceuticals USA Inc. 1:2021cv01783 4 patentsANDA 215503Liraglutide	D. Del.	2021-12-21	Terminated 2023-01-17	—

Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).

API Supply Chain18 active DMFs3 inactive

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

CHENGDU SHENGNUO BIOPHARM CO LTDLIRAGLUTIDE

DMF 293022015

ALP PHARM BEIJING CO LTDLIRAGLUTIDE

DMF 297112015

HYBIO PHARMACEUTICAL CO LTDLIRAGLUTIDE NON-STERILE BULK DRUG SUBSTANCE

DMF 300952015

BACHEM AGLIRAGLUTIDE DRUG SUBSTANCE

DMF 304672016

BACHEM AMERICAS INCLIRAGLUTIDE

DMF 333662020

SINOPEP-ALLSINO BIOPHARMACEUTICAL CO LTDLIRAGLUTIDE

DMF 341042019

SHENZHEN JYMED TECHNOLOGY CO LTDLIRAGLUTIDE

DMF 341712019

DR REDDYS LABORATORIES LTDLIRAGLUTIDE

DMF 347552020

FRESENIUS KABI IPSUM SRLLIRAGLUTIDE

DMF 352422022

HANGZHOU JIUYUAN GENE ENGINEERING CO LTDLIRAGLUTIDE

DMF 353492021

POLYPEPTIDE LABORATORIES INCLIRAGLUTIDE

DMF 358602021

BIOCON LTDLIRAGLUTIDE

DMF 359682021

ZHEJIANG PEPTITES BIOTECH CO LTDLIRAGLUTIDE

DMF 359722021

SUN PHARMACEUTICAL INDUSTRIES LTDLIRAGLUTIDE

DMF 365492021

SCINOPHARM TAIWAN LTDLIRAGLUTIDE

DMF 370092022

AURO PEPTIDES LTDLIRAGLUTIDE

DMF 377932023

CHONGQING CHEN'AN BIOPHARMACEUTICAL CO LTDLIRAGLUTIDE

DMF 386812023

ASYMCHEM LIFE SCIENCE TIANJIN CO LTDLIRAGLUTIDE

DMF 390922023

CHENGDU SHENGNUO BIOPHARM CO LTDInactiveLIRAGLUTIDE

DMF 285132014

SINOPEP-ALLSINO BIOPHARMACEUTICAL CO LTDInactiveLIRAGLUTIDE

DMF 330962018

AMPHASTAR NANJING PHARMACEUTICALS INCInactiveLIRAGLUTIDE

DMF 339122019

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

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Feb 10, 2025	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 18MG/3ML (6MG/ML)

AP1

0 patents0 exclusivities▴

SOLUTION;SUBCUTANEOUS | Approved: Dec 23, 2024

No patent or exclusivity listings for this strength.