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)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1001694060VictozaNDANovo Nordisk2010-01-25LIRAGLUTIDESUBCUTANEOUSINJECTION, SOLUTIONNDA0223415a9ef4ea-c76a-4d34-a604-27c5b505f5a4

application(s)

#idtitleapplicantapprovedpatentexclusivityapproved drug
1NDA022341VICTOZANOVO NORDISK INC2010-01-25p8846618, 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
2NDA206321SAXENDANOVO NORDISK INC2014-12-23p9132239, 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)

#idcategory/deprecatedingredient strength(s)routedose formrldapprovedapplication
1NDA022341_001RXLIRAGLUTIDE RECOMBINANT (18MG/3ML)SUBCUTANEOUSSOLUTIONTrue2010-01-25VICTOZA
2NDA206321_001RXLIRAGLUTIDE RECOMBINANT (18MG/3ML)SUBCUTANEOUSSOLUTIONTrue2014-12-23SAXENDA

patent(s)

#idexpiration dateapplication(s)in other drug docs
1p6004297 (view patent)2019-01-28NDA022341, NDA020986, NDA021148, NDA021172, NDA021536Insulin, 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
2p6268343 (view patent)2022-08-22NDA022341, NDA206321
3p6458924 (view patent)2017-08-22NDA022341, NDA206321
4p6899699 (view patent)2022-01-02NDA206321, NDA020986, NDA021148, NDA021536, NDA203313, NDA203314insulin 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
5p7235627 (view patent)2017-08-22NDA022341, NDA206321
6p7686786 (view patent)2026-08-03NDA206321, NDA020986, NDA021148, NDA021536, NDA203313, NDA203314insulin 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
7p8114833 (view patent)2025-08-13NDA022341, NDA206321
8p8672898 (view patent)2022-01-02NDA206321, NDA020986, NDA021148, NDA021536, NDA203313, NDA203314insulin 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
9p8684969 (view patent)2025-10-20NDA206321, NDA020986, NDA021148, NDA021536, NDA203313, NDA203314insulin 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
10p8846618 (view patent)2022-06-27NDA022341, NDA206321
11p8920383 (view patent)2026-07-17NDA206321, NDA020986, NDA021148, NDA021536, NDA203313, NDA203314insulin 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
12p9108002 (view patent)2026-01-20NDA206321, NDA020986, NDA021148, NDA021536, NDA203313, NDA203314insulin 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
13p9132239 (view patent)2032-02-01NDA206321, NDA020986, NDA021148, NDA021536, NDA203313, NDA203314insulin 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
14pRE41956 (view patent)2021-01-21NDA022341, NDA020986, NDA021148, NDA021172, NDA021536Insulin, 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
15pRE43834 (view patent)2019-01-28NDA022341, NDA020986, NDA021148, NDA021172, NDA021536Insulin, 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)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
13946d389-0926-4f77-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: 2010prescriptionHuman PrescriptionNovo NordiskAPI MANUFACTURE, MANUFACTURE2015-11-104001692800
25a9ef4ea-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: 2010prescriptionHuman PrescriptionNovo NordiskAPI MANUFACTURE, MANUFACTURE2015-11-1015001694060

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