insulin degludec Pen Injector

Brand(s)
Tresiba
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Novo Nordisk (2015-09-25)
Oldest Current Product
2015-09-25
License(s)
NDA
RxNORM
PEN INJECTOR\INSULIN DEGLUDEC
FDAOB
SUBCUTANEOUS\SOLUTION\INSULIN DEGLUDEC
SPL Active
SUBCUTANEOUS\INJECTION, SOLUTION\INSULIN DEGLUDEC
SPL Moiety
SUBCUTANEOUS\INJECTION, SOLUTION\INSULIN DEGLUDEC

product(s) by strength(s)

3 ml insulin degludec 100 unt/ml pen injector

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1001692660TresibaNDANovo Nordisk2015-09-25INSULIN DEGLUDECSUBCUTANEOUSINJECTION, SOLUTIONNDA203314456c5e87-3dfd-46fa-8ac0-c6128d4c97c6

3 ml insulin degludec 200 unt/ml pen injector

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1001692550TresibaNDANovo Nordisk2015-09-25INSULIN DEGLUDECSUBCUTANEOUSINJECTION, SOLUTIONNDA203314456c5e87-3dfd-46fa-8ac0-c6128d4c97c6

application(s)

#idtitleapplicantapprovedpatentexclusivityapproved drug
1NDA203314TRESIBANOVO NORDISK INC2015-09-25p9132239, SUBSTANCE
p7686786, SUBSTANCE
p8684969, SUBSTANCE
p7615532, SUBSTANCE
p8672898, SUBSTANCE
p6899699, SUBSTANCE
p8920383, SUBSTANCE
p9108002, SUBSTANCE
NEW CHEMICAL ENTITY [2020-09-25]NDA203314_001, NDA203314_002

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldapprovedapplication
1NDA203314_001RXINSULIN DEGLUDEC (300 UNITS/3ML)SUBCUTANEOUSSOLUTIONFalse2015-09-25TRESIBA
2NDA203314_002RXINSULIN DEGLUDEC (600 UNITS/3ML)SUBCUTANEOUSSOLUTIONTrue2015-09-25TRESIBA

patent(s)

#idexpiration dateapplication(s)in other drug docs
1p6899699 (view patent)2022-01-02NDA203314, NDA020986, NDA021148, NDA021536, NDA203313, NDA206321Insulin, Aspart, Human Cartridge
insulin detemir Pen Injector
Insulin, Aspart, Human Pen Injector
Somatropin Injectable Solution
Somatropin Prefilled Syringe
liraglutide Pen Injector
insulin detemir Injectable Solution
Insulin, Aspart, Human Injectable Solution
2p7615532 (view patent)2025-05-25NDA203314, NDA203313
3p7686786 (view patent)2026-08-03NDA203314, NDA020986, NDA021148, NDA021536, NDA203313, NDA206321Insulin, Aspart, Human Cartridge
insulin detemir Pen Injector
Insulin, Aspart, Human Pen Injector
Somatropin Injectable Solution
Somatropin Prefilled Syringe
liraglutide Pen Injector
insulin detemir Injectable Solution
Insulin, Aspart, Human Injectable Solution
4p8672898 (view patent)2022-01-02NDA203314, NDA020986, NDA021148, NDA021536, NDA203313, NDA206321Insulin, Aspart, Human Cartridge
insulin detemir Pen Injector
Insulin, Aspart, Human Pen Injector
Somatropin Injectable Solution
Somatropin Prefilled Syringe
liraglutide Pen Injector
insulin detemir Injectable Solution
Insulin, Aspart, Human Injectable Solution
5p8684969 (view patent)2025-10-20NDA203314, NDA020986, NDA021148, NDA021536, NDA203313, NDA206321Insulin, Aspart, Human Cartridge
insulin detemir Pen Injector
Insulin, Aspart, Human Pen Injector
Somatropin Injectable Solution
Somatropin Prefilled Syringe
liraglutide Pen Injector
insulin detemir Injectable Solution
Insulin, Aspart, Human Injectable Solution
6p8920383 (view patent)2026-07-17NDA203314, NDA020986, NDA021148, NDA021536, NDA203313, NDA206321Insulin, Aspart, Human Cartridge
insulin detemir Pen Injector
Insulin, Aspart, Human Pen Injector
Somatropin Injectable Solution
Somatropin Prefilled Syringe
liraglutide Pen Injector
insulin detemir Injectable Solution
Insulin, Aspart, Human Injectable Solution
7p9108002 (view patent)2026-01-20NDA203314, NDA020986, NDA021148, NDA021536, NDA203313, NDA206321Insulin, Aspart, Human Cartridge
insulin detemir Pen Injector
Insulin, Aspart, Human Pen Injector
Somatropin Injectable Solution
Somatropin Prefilled Syringe
liraglutide Pen Injector
insulin detemir Injectable Solution
Insulin, Aspart, Human Injectable Solution
8p9132239 (view patent)2032-02-01NDA203314, NDA020986, NDA021148, NDA021536, NDA203313, NDA206321Insulin, Aspart, Human Cartridge
insulin detemir Pen Injector
Insulin, Aspart, Human Pen Injector
Somatropin Injectable Solution
Somatropin Prefilled Syringe
liraglutide Pen Injector
insulin detemir Injectable Solution
Insulin, Aspart, Human Injectable Solution

spl(s)

#idtitlecategorytypelabelerlast updateversionproduct(s)
1456c5e87-3dfd-46fa-8ac0-c6128d4c97c6 (view SPL)These highlights do not include all the information needed to use TRESIBA safely and effectively. See full prescribing information for TRESIBA. TRESIBA (insulin degludec injection), for subcutaneous use Initial U.S. Approval: 2015prescriptionHuman PrescriptionNovo Nordisk2015-09-251001692550, 001692660

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