Insulin Glargine Pen Injector

Brand(s): Lantus, Toujeo
Category(s): prescription
SPL Type(s): Human Prescription
Master SPL: Sanofi-Aventis U.S. Llc (2015-10-15)
Oldest Current Product: 2007-04-04
License(s): NDA

RxNORM: PEN INJECTOR\INSULIN GLARGINE
FDAOB: INJECTION\INJECTION\INSULIN GLARGINE RECOMBINANT\rdfq
SUBCUTANEOUS\SOLUTION\INSULIN GLARGINE RECOMBINANT
SPL Active: SUBCUTANEOUS\INJECTION, SOLUTION\INSULIN GLARGINE
SPL Moiety: SUBCUTANEOUS\INJECTION, SOLUTION\INSULIN GLARGINE

product(s) by strength(s)

3 ml insulin glargine 100 unt/ml pen injector

original product(s)(s)

#	id	brand	category	labeler	first marketed	active ingredient(s)	route	dose form	application	spl
1	000882219	Lantus	NDA	Sanofi-Aventis U.S. Llc	2009-09-23	INSULIN GLARGINE	SUBCUTANEOUS	INJECTION, SOLUTION	NDA021081	d5e07a0c-7e14-4756-9152-9fea485d654a

relabeler product(s)(s)

#	id	brand	category	labeler	first marketed	active ingredient(s)	route	dose form	equivalent product	application	spl
1	548685765	Lantus	NDA	Physicians Total Care, Inc.	2007-04-04	INSULIN GLARGINE	SUBCUTANEOUS	INJECTION, SOLUTION	000882220	NDA021081	b861fdd9-e134-436e-8c0c-a60dd0006dd3
2	548686231	Lantus	NDA	Physicians Total Care, Inc.	2011-02-07	INSULIN GLARGINE	SUBCUTANEOUS	INJECTION, SOLUTION	000882219	NDA021081	b861fdd9-e134-436e-8c0c-a60dd0006dd3

1.5 ml insulin glargine 300 unt/ml pen injector

original product(s)(s)

#	id	brand	category	labeler	first marketed	active ingredient(s)	route	dose form	application	spl
1	000245869	Toujeo	NDA	Sanofi-Aventis U.S. Llc	2015-02-25	INSULIN GLARGINE	SUBCUTANEOUS	INJECTION, SOLUTION	NDA206538	c9561d96-124d-48ca-982f-0aa1575bff36

application(s)

#	id	title	applicant	approved	patent	exclusivity	approved drug	in other drug docs
1	NDA021081	LANTUS	SANOFI AVENTIS US LLC	2000-04-20	p9011391, SUBSTANCE p8603044, SUBSTANCE p5656722, TREATMENT OF DIABETES MELLITUS, SUBSTANCE p8992486, SUBSTANCE p7918833, SUBSTANCE p8512297, SUBSTANCE p7713930, SUBSTANCE p8679069, SUBSTANCE p8556864, SUBSTANCE p7476652, SUBSTANCE		NDA021081_001, NDA021081_002	Insulin Glargine Injectable Solution
2	NDA206538	TOUJEO SOLOSTAR	SANOFI US SERVICES INC	2015-02-25	p8603044, SUBSTANCE p8992486, SUBSTANCE p7918833, SUBSTANCE p8556864, SUBSTANCE p9011391, SUBSTANCE p8679069, SUBSTANCE p8512297, SUBSTANCE	NEW PRODUCT [2018-02-25]	NDA206538_001

application drug(s)

#	id	category/deprecated	ingredient strength(s)	route	dose form	rld	approved	application
1	NDA021081_001	RX	INSULIN GLARGINE RECOMBINANT (100 UNITS/ML)		INJECTION	True	2000-04-20	LANTUS
2	NDA021081_002	RX	INSULIN GLARGINE RECOMBINANT (300 UNITS/3ML)		INJECTION	True	2007-04-27	LANTUS
3	NDA206538_001	RX	INSULIN GLARGINE RECOMBINANT (300 UNITS/ML)	SUBCUTANEOUS	SOLUTION	True	2015-02-25	TOUJEO SOLOSTAR

patent(s)

#	id	expiration date	application(s)	in other drug docs
1	p5656722 (view patent)	2014-08-12	NDA021081	Insulin Glargine Injectable Solution
2	p7476652 (view patent)	2023-07-23	NDA021081	Insulin Glargine Injectable Solution
3	p7713930 (view patent)	2023-06-13	NDA021081	Insulin Glargine Injectable Solution
4	p7918833 (view patent)	2027-09-23	NDA021081, NDA206538, NDA021629	Insulin, Glulisine, Human Injectable Solution Insulin, Glulisine, Human Pen Injector Insulin Glargine Injectable Solution
5	p8512297 (view patent)	2024-09-15	NDA021081, NDA206538, NDA021629	Insulin, Glulisine, Human Injectable Solution Insulin, Glulisine, Human Pen Injector Insulin Glargine Injectable Solution
6	p8556864 (view patent)	2024-03-03	NDA021081, NDA206538, NDA021629	Insulin, Glulisine, Human Injectable Solution Insulin, Glulisine, Human Pen Injector Insulin Glargine Injectable Solution
7	p8603044 (view patent)	2024-03-02	NDA021081, NDA206538, NDA021629	Insulin, Glulisine, Human Injectable Solution Insulin, Glulisine, Human Pen Injector Insulin Glargine Injectable Solution
8	p8679069 (view patent)	2025-04-12	NDA021081, NDA206538, NDA021629	Insulin, Glulisine, Human Injectable Solution Insulin, Glulisine, Human Pen Injector Insulin Glargine Injectable Solution
9	p8992486 (view patent)	2024-06-05	NDA021081, NDA206538, NDA021629	Insulin, Glulisine, Human Injectable Solution Insulin, Glulisine, Human Pen Injector Insulin Glargine Injectable Solution
10	p9011391 (view patent)	2024-03-26	NDA021081, NDA206538, NDA021629	Insulin, Glulisine, Human Injectable Solution Insulin, Glulisine, Human Pen Injector Insulin Glargine Injectable Solution

spl(s)

#	id	title	category	type	labeler	labeler act	last update	version	product(s)	in other drug docs
1	b861fdd9-e134-436e-8c0c-a60dd0006dd3 (view SPL)	These highlights do not include all the information needed to use LANTUS safely and effectively. See full prescribing information for LANTUS. LANTUS (insulin glargine [rDNA origin] injection) solution for subcutaneous injection Initial U.S. Approval: 2000	prescription	Human Prescription	Physicians Total Care, Inc.	relabel	2010-01-05	2	548685765, 548686231, 548684626	Insulin Glargine Injectable Solution
2	c9561d96-124d-48ca-982f-0aa1575bff36 (view SPL)	These highlights do not include all the information needed to use TOUJEO safely and effectively. See full prescribing information for TOUJEO. TOUJEO (insulin glargine injection) U-300, for subcutaneous useInitial U.S. Approval: 2015	prescription	Human Prescription	Sanofi-Aventis U.S. Llc	ANALYSIS, LABEL, MANUFACTURE, PACK	2015-10-15	7	000245869
3	d5e07a0c-7e14-4756-9152-9fea485d654a (view SPL)	These highlights do not include all the information needed to use LANTUS safely and effectively. See full prescribing information for LANTUS. LANTUS (insulin glargine injection) solution for subcutaneous injectionInitial U.S. Approval: 2000	prescription	Human Prescription	Sanofi-Aventis U.S. Llc	ANALYSIS, LABEL, MANUFACTURE, PACK	2015-08-05	22	000882219, 000882220	Insulin Glargine Injectable Solution

Data from: FDAOB, FDAPB, LOINC, MTHSPL, NDFRT, NCIT, RxNORM, UNII