liraglutide Pen Injector

Brand(s): Saxenda, Victoza
Category(s): prescription
SPL Type(s): Human Prescription
Master SPL: Novo Nordisk (2015-11-10)
Oldest Current Product: 2010-01-25
License(s): NDA

RxNORM: PEN INJECTOR\LIRAGLUTIDE
FDAOB: SUBCUTANEOUS\SOLUTION\LIRAGLUTIDE RECOMBINANT
SPL Active: SUBCUTANEOUS\INJECTION, SOLUTION\LIRAGLUTIDE
SPL Moiety: SUBCUTANEOUS\INJECTION, SOLUTION\LIRAGLUTIDE

product(s) by strength(s)

3 ml liraglutide 6 mg/ml pen injector

original product(s)(s)

#	id	brand	category	labeler	first marketed	active ingredient(s)	route	dose form	application	spl
1	001694060	Victoza	NDA	Novo Nordisk	2010-01-25	LIRAGLUTIDE	SUBCUTANEOUS	INJECTION, SOLUTION	NDA022341	5a9ef4ea-c76a-4d34-a604-27c5b505f5a4

application(s)

#	id	title	applicant	approved	patent	exclusivity	approved drug
1	NDA022341	VICTOZA	NOVO NORDISK INC	2010-01-25	p8846618, SUBSTANCE p6004297, SUBSTANCE p6268343, A METHOD FOR IMPROVING GLYCEMIC CONTROL IN ADULTS WITH TYPE 2 DIABETES MELLITUS, SUBSTANCE pRE43834, SUBSTANCE p6458924, A METHOD FOR IMPROVING GLYCEMIC CONTROL IN ADULTS WITH TYPE 2 DIABETES MELLITUS, SUBSTANCE p8114833, SUBSTANCE pRE41956, SUBSTANCE p7235627, SUBSTANCE	REVISIONS TO THE PI BASED ON RESULTS FROM STUDY NN2211-1842 [2015-04-06] NEW CHEMICAL ENTITY [2015-01-25]	NDA022341_001
2	NDA206321	SAXENDA	NOVO NORDISK INC	2014-12-23	p9132239, SUBSTANCE p7686786, SUBSTANCE p8846618, SUBSTANCE p8684969, SUBSTANCE p8672898, SUBSTANCE p6899699, SUBSTANCE p8920383, SUBSTANCE p8114833, SUBSTANCE p6268343, METHOD FOR CHRONIC WEIGHT MANAGEMENT BY TREATING OBESITY, SUBSTANCE p6458924, METHOD FOR CHRONIC WEIGHT MANAGEMENT BY TREATING OBESITY, SUBSTANCE p9108002, SUBSTANCE p7235627, SUBSTANCE	NEW CHEMICAL ENTITY [2015-01-25] NEW PRODUCT [2017-01-25]	NDA206321_001

application drug(s)

#	id	category/deprecated	ingredient strength(s)	route	dose form	rld	approved	application
1	NDA022341_001	RX	LIRAGLUTIDE RECOMBINANT (18MG/3ML)	SUBCUTANEOUS	SOLUTION	True	2010-01-25	VICTOZA
2	NDA206321_001	RX	LIRAGLUTIDE RECOMBINANT (18MG/3ML)	SUBCUTANEOUS	SOLUTION	True	2014-12-23	SAXENDA

patent(s)

#	id	expiration date	application(s)	in other drug docs
1	p6004297 (view patent)	2019-01-28	NDA022341, NDA020986, NDA021148, NDA021172, NDA021536	Insulin, Aspart, Human Cartridge insulin detemir Pen Injector Insulin, Aspart, Human Pen Injector Somatropin Injectable Solution Somatropin Prefilled Syringe insulin detemir Injectable Solution Insulin, Aspart Protamine, Human / Insulin, Aspart, Human Pen Injector Insulin, Aspart, Human Injectable Solution Insulin, Aspart Protamine, Human / Insulin, Aspart, Human Injectable Suspension
2	p6268343 (view patent)	2022-08-22	NDA022341, NDA206321
3	p6458924 (view patent)	2017-08-22	NDA022341, NDA206321
4	p6899699 (view patent)	2022-01-02	NDA206321, NDA020986, NDA021148, NDA021536, NDA203313, NDA203314	insulin degludec Pen Injector Insulin, Aspart, Human Cartridge insulin detemir Pen Injector Insulin, Aspart, Human Pen Injector Somatropin Injectable Solution Somatropin Prefilled Syringe insulin detemir Injectable Solution Insulin, Aspart, Human Injectable Solution
5	p7235627 (view patent)	2017-08-22	NDA022341, NDA206321
6	p7686786 (view patent)	2026-08-03	NDA206321, NDA020986, NDA021148, NDA021536, NDA203313, NDA203314	insulin degludec Pen Injector Insulin, Aspart, Human Cartridge insulin detemir Pen Injector Insulin, Aspart, Human Pen Injector Somatropin Injectable Solution Somatropin Prefilled Syringe insulin detemir Injectable Solution Insulin, Aspart, Human Injectable Solution
7	p8114833 (view patent)	2025-08-13	NDA022341, NDA206321
8	p8672898 (view patent)	2022-01-02	NDA206321, NDA020986, NDA021148, NDA021536, NDA203313, NDA203314	insulin degludec Pen Injector Insulin, Aspart, Human Cartridge insulin detemir Pen Injector Insulin, Aspart, Human Pen Injector Somatropin Injectable Solution Somatropin Prefilled Syringe insulin detemir Injectable Solution Insulin, Aspart, Human Injectable Solution
9	p8684969 (view patent)	2025-10-20	NDA206321, NDA020986, NDA021148, NDA021536, NDA203313, NDA203314	insulin degludec Pen Injector Insulin, Aspart, Human Cartridge insulin detemir Pen Injector Insulin, Aspart, Human Pen Injector Somatropin Injectable Solution Somatropin Prefilled Syringe insulin detemir Injectable Solution Insulin, Aspart, Human Injectable Solution
10	p8846618 (view patent)	2022-06-27	NDA022341, NDA206321
11	p8920383 (view patent)	2026-07-17	NDA206321, NDA020986, NDA021148, NDA021536, NDA203313, NDA203314	insulin degludec Pen Injector Insulin, Aspart, Human Cartridge insulin detemir Pen Injector Insulin, Aspart, Human Pen Injector Somatropin Injectable Solution Somatropin Prefilled Syringe insulin detemir Injectable Solution Insulin, Aspart, Human Injectable Solution
12	p9108002 (view patent)	2026-01-20	NDA206321, NDA020986, NDA021148, NDA021536, NDA203313, NDA203314	insulin degludec Pen Injector Insulin, Aspart, Human Cartridge insulin detemir Pen Injector Insulin, Aspart, Human Pen Injector Somatropin Injectable Solution Somatropin Prefilled Syringe insulin detemir Injectable Solution Insulin, Aspart, Human Injectable Solution
13	p9132239 (view patent)	2032-02-01	NDA206321, NDA020986, NDA021148, NDA021536, NDA203313, NDA203314	insulin degludec Pen Injector Insulin, Aspart, Human Cartridge insulin detemir Pen Injector Insulin, Aspart, Human Pen Injector Somatropin Injectable Solution Somatropin Prefilled Syringe insulin detemir Injectable Solution Insulin, Aspart, Human Injectable Solution
14	pRE41956 (view patent)	2021-01-21	NDA022341, NDA020986, NDA021148, NDA021172, NDA021536	Insulin, Aspart, Human Cartridge insulin detemir Pen Injector Insulin, Aspart, Human Pen Injector Somatropin Injectable Solution Somatropin Prefilled Syringe insulin detemir Injectable Solution Insulin, Aspart Protamine, Human / Insulin, Aspart, Human Pen Injector Insulin, Aspart, Human Injectable Solution Insulin, Aspart Protamine, Human / Insulin, Aspart, Human Injectable Suspension
15	pRE43834 (view patent)	2019-01-28	NDA022341, NDA020986, NDA021148, NDA021172, NDA021536	Insulin, Aspart, Human Cartridge insulin detemir Pen Injector Insulin, Aspart, Human Pen Injector Somatropin Injectable Solution Somatropin Prefilled Syringe insulin detemir Injectable Solution Insulin, Aspart Protamine, Human / Insulin, Aspart, Human Pen Injector Insulin, Aspart, Human Injectable Solution Insulin, Aspart Protamine, Human / Insulin, Aspart, Human Injectable Suspension

spl(s)

#	id	title	category	type	labeler	labeler act	last update	version	product(s)
1	3946d389-0926-4f77-a708-0acb8153b143 (view SPL)	These highlights do not include all the information needed to use SAXENDA safely and effectively. See full prescribing information for SAXENDA. SAXENDA (liraglutide [rDNA origin] injection), solution for subcutaneous useInitial U.S. Approval: 2010	prescription	Human Prescription	Novo Nordisk	API MANUFACTURE, MANUFACTURE	2015-11-10	4	001692800
2	5a9ef4ea-c76a-4d34-a604-27c5b505f5a4 (view SPL)	These highlights do not include all the information needed to use Victoza safely and effectively. See full prescribing information for Victoza.Victoza (liraglutide [rDNA origin] injection), solution for subcutaneous useInitial U.S. Approval: 2010	prescription	Human Prescription	Novo Nordisk	API MANUFACTURE, MANUFACTURE	2015-11-10	15	001694060

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