Register entryShortage reported

Novo Nordisk Inc.

Registered sites
11
Drug products
124
Live patents
252
Countries
2
Base
Denmark
Authorisation

Registered operations

What the FDA has registered these sites to do. This is the regulatory record, not a marketing claim.

Analytical testingActive ingredient (API) manufactureLabellingFinished drug manufacturePackaging
Sites

Facilities

11
SiteLocationOperationsFEI
Novo Nordisk A/SBagsvaerdDenmarkAnalytical testing, Active ingredient (API) manufacture, Finished drug manufacture3000151819
Novo Nordisk A/S - HaxGentofteDenmarkAnalytical testing, Active ingredient (API) manufacture, Labelling, Finished drug manufacture, Packaging3002807748
Novo Nordisk A/S - 25a-BHilleroedDenmarkAnalytical testing, Active ingredient (API) manufacture, Labelling, Finished drug manufacture, Packaging3003131673
Novo Nordisk A/SKalundborgDenmarkAnalytical testing, Active ingredient (API) manufacture, Labelling, Finished drug manufacture, Packaging3002807751
Novo Nordisk Pharmatech A/SKogeDenmarkActive ingredient (API) manufacture3008618737
Novo Nordisk A/S - G8, X9 M.Fl.MalovDenmarkAnalytical testing, Labelling, Finished drug manufacture, Packaging3003037054
Novo Nordisk A/S - KvVaerloseDenmarkLabelling, Finished drug manufacture, Packaging3015545250
Novo Nordisk Pharmaceutical Industries, LPClayton, NCUnited StatesAnalytical testing, Active ingredient (API) manufacture, Labelling, Finished drug manufacture, Packaging1000158576
Novo Nordisk Pharmaceutical Industries, LPDurham, NCUnited StatesAnalytical testing, Labelling, Finished drug manufacture, Packaging3016799712
Novo Nordisk Pharmaceutical Industries, LPPetersburg, VAUnited StatesAnalytical testing3033953703
Novo Nordisk US Bio Production Inc.West Lebanon, NHUnited StatesAnalytical testing, Active ingredient (API) manufacture3012593913
Alert

Products in shortage

5
DrugPresentationAvailability
Liraglutide InjectionVictoza, Injection, 6 mg/1 mL (NDC 0169-4060-12)Limited Availability
Liraglutide InjectionVictoza, Injection, 6 mg/1 mL (NDC 0169-4060-13)Limited Availability
Liraglutide InjectionLiraglutide, Injection, 6 mg/1 mL (NDC 0480-3667-20)Available
Liraglutide InjectionLiraglutide, Injection, 6 mg/1 mL (NDC 0480-3667-22)Available
Liraglutide InjectionSaxenda, Injection, 6 mg/1 mL (NDC 0169-2800-15)Available
Exclusivity

Patents

252

Unexpired Orange Book patents where this company is the application holder.

ProductActive ingredientExpiry
OZEMPICSEMAGLUTIDEDec 2031
OZEMPICSEMAGLUTIDEDec 2031
OZEMPICSEMAGLUTIDEJun 2033
OZEMPICSEMAGLUTIDEJun 2033
OZEMPICSEMAGLUTIDEMay 2034
OZEMPICSEMAGLUTIDEApr 2037
OZEMPICSEMAGLUTIDEAug 2038
OZEMPICSEMAGLUTIDEOct 2038
OZEMPICSEMAGLUTIDEFeb 2039
OZEMPICSEMAGLUTIDEFeb 2041
RIVFLOZANEDOSIRAN SODIUMOct 2035
RIVFLOZANEDOSIRAN SODIUMOct 2035
RIVFLOZANEDOSIRAN SODIUMOct 2038
RYBELSUSSEMAGLUTIDEDec 2031
RYBELSUSSEMAGLUTIDEDec 2031
RYBELSUSSEMAGLUTIDEMar 2033
RYBELSUSSEMAGLUTIDEJun 2033
RYBELSUSSEMAGLUTIDEMay 2034
SAXENDALIRAGLUTIDEJan 2037
SAXENDALIRAGLUTIDEJul 2037
VICTOZALIRAGLUTIDEJan 2037
VICTOZALIRAGLUTIDEJul 2037
WEGOVYSEMAGLUTIDEDec 2031
WEGOVYSEMAGLUTIDEDec 2031
WEGOVYSEMAGLUTIDEJun 2033
WEGOVYSEMAGLUTIDEJun 2033
WEGOVYSEMAGLUTIDEMay 2034
WEGOVYSEMAGLUTIDEApr 2037
WEGOVYSEMAGLUTIDEAug 2038
WEGOVYSEMAGLUTIDEOct 2038
WEGOVYSEMAGLUTIDEFeb 2039
WEGOVYSEMAGLUTIDEMay 2040
WEGOVYSEMAGLUTIDEFeb 2041
WEGOVY FLEXTOUCHSEMAGLUTIDEDec 2031
WEGOVY FLEXTOUCHSEMAGLUTIDEJun 2033
WEGOVY FLEXTOUCHSEMAGLUTIDEOct 2038
WEGOVY FLEXTOUCHSEMAGLUTIDEMay 2040
WEGOVY HDSEMAGLUTIDEDec 2031
WEGOVY HDSEMAGLUTIDEJun 2033
WEGOVY HDSEMAGLUTIDEAug 2038
WEGOVY HDSEMAGLUTIDEOct 2038
WEGOVY HDSEMAGLUTIDEFeb 2041
Catalogue

Marketed products

124

Showing 124 of 124.

BrandGeneric nameFormCategory
AlhemoconcizumabINJECTION, SOLUTIONBLA
AlhemoconcizumabINJECTION, SOLUTIONBLA
AlhemoconcizumabINJECTION, SOLUTIONBLA
AwiqliInsulin icodec-abaeINJECTION, SOLUTIONBLA
AwiqliInsulin icodec-abaeINJECTION, SOLUTIONBLA
AwiqliInsulin icodec-abaeINJECTION, SOLUTIONBLA
-Benzalkonium ChlorideGELBULK INGREDIENT
-Benzalkonium ChlorideSOLUTIONBULK INGREDIENT
-DegludecPOWDERBULK INGREDIENT
ESPEROCTantihemophilic factor (recombinant), glycopegylated-exeiKITBLA
ESPEROCTantihemophilic factor (recombinant), glycopegylated-exeiKITBLA
ESPEROCTantihemophilic factor (recombinant), glycopegylated-exeiKITBLA
ESPEROCTantihemophilic factor (recombinant), glycopegylated-exeiKITBLA
ESPEROCTantihemophilic factor (recombinant), glycopegylated-exeiKITBLA
ESPEROCTantihemophilic factor (recombinant), glycopegylated-exeiKITBLA
ESPEROCTantihemophilic factor (recombinant), glycopegylated-exeiKITBLA
Fiaspinsulin aspart injectionINJECTION, SOLUTIONBLA
Fiaspinsulin aspart injectionINJECTION, SOLUTIONBLA
Fiaspinsulin aspart injectionINJECTION, SOLUTIONBLA
Fiaspinsulin aspartINJECTION, SOLUTIONBLA
-Insulin AspartCRYSTALBULK INGREDIENT
-Insulin AspartCRYSTALBULK INGREDIENT
Insulin Aspartinsulin aspartINJECTION, SOLUTIONBLA
Insulin Aspartinsulin aspartINJECTION, SOLUTIONBLA
Insulin Aspartinsulin aspartINJECTION, SOLUTIONBLA
Insulin Aspart Protamine and Insulin Aspart Mix 70/30insulin aspartINJECTION, SUSPENSIONBLA
Insulin Aspart Protamine and Insulin Aspart Mix 70/30insulin aspartINJECTION, SUSPENSIONBLA
Insulin Degludecinsulin degludecINJECTION, SOLUTIONBLA
Insulin Degludecinsulin degludecINJECTION, SOLUTIONBLA
Insulin Degludecinsulin degludecINJECTION, SOLUTIONBLA
-Insulin DetemirCRYSTALBULK INGREDIENT
-Insulin DetemirCRYSTALBULK INGREDIENT
Insulin Diluting Medium for NovoLogwater injectionINJECTION, SOLUTIONBLA
Levemirinsulin detemirINJECTION, SOLUTIONBLA
-LiraglutidePOWDERBULK INGREDIENT
MacrilenMacimorelin acetateGRANULE, FOR SOLUTIONNDA
NOVOEIGHTantihemophilic factor recombinantKITBLA
NOVOEIGHTantihemophilic factor recombinantKITBLA
NOVOEIGHTantihemophilic factor recombinantKITBLA
NOVOEIGHTantihemophilic factor recombinantKITBLA
NOVOEIGHTantihemophilic factor recombinantKITBLA
NOVOEIGHTantihemophilic factor recombinantKITBLA
NOVOLOGinsulin aspartINJECTION, SOLUTIONBLA
NOVOLOGinsulin aspartINJECTION, SOLUTIONBLA
NOVOLOGinsulin aspartINJECTION, SOLUTIONBLA
NOVOLOGinsulin aspartINJECTION, SOLUTIONBLA
NOVOLOGinsulin aspartINJECTION, SOLUTIONBLA
NOVOLOGinsulin aspartINJECTION, SOLUTIONBLA
NorditropinsomatropinINJECTION, SOLUTIONBLA
NorditropinsomatropinINJECTION, SOLUTIONBLA
NorditropinsomatropinINJECTION, SOLUTIONBLA
NorditropinsomatropinINJECTION, SOLUTIONBLA
NovoLog Mix 70/30insulin aspartINJECTION, SUSPENSIONBLA
NovoLog Mix 70/30insulin aspartINJECTION, SUSPENSIONBLA
NovoLog Mix 70/30insulin aspartINJECTION, SUSPENSIONBLA
NovoLog Mix 70/30insulin aspartINJECTION, SUSPENSIONBLA
NovoSeven RTCoagulation Factor VIIa (Recombinant)KITBLA
NovoSeven RTCoagulation Factor VIIa (Recombinant)KITBLA
NovoSeven RTCoagulation Factor VIIa (Recombinant)KITBLA
NovoSeven RTCoagulation Factor VIIa (Recombinant)KITBLA
NovoSeven RTCoagulation Factor VIIa (Recombinant)KITBLA
NovoSeven RTCoagulation Factor VIIa (Recombinant)KITBLA
NovoSeven RTCoagulation Factor VIIa (Recombinant)KITBLA
NovoSeven RTCoagulation Factor VIIa (Recombinant)KITBLA
Novolin 70/30Human InsulinINJECTION, SUSPENSIONBLA
Novolin 70/30Human InsulinINJECTION, SUSPENSIONBLA
Novolin NHuman InsulinINJECTION, SUSPENSIONBLA
Novolin NHuman InsulinINJECTION, SUSPENSIONBLA
Novolin RHuman InsulinINJECTION, SOLUTIONBLA
Novolin RHuman InsulinINJECTION, SOLUTIONBLA
OZEMPICoral semaglutideTABLETNDA
OZEMPICoral semaglutideTABLETNDA
OZEMPICoral semaglutideTABLETNDA
OzempicsemaglutideINJECTION, SOLUTIONNDA
OzempicsemaglutideINJECTION, SOLUTIONNDA
OzempicsemaglutideINJECTION, SOLUTIONNDA
REBINYNcoagulation factor IX recombinant, GlycoPEGylatedKITBLA
REBINYNcoagulation factor IX recombinant, GlycoPEGylatedKITBLA
REBINYNcoagulation factor IX recombinant, GlycoPEGylatedKITBLA
REBINYNcoagulation factor IX recombinant, GlycoPEGylatedKITBLA
RIVFLOZAnedosiranINJECTION, SOLUTIONNDA
RIVFLOZAnedosiranINJECTION, SOLUTIONNDA
RIVFLOZAnedosiranINJECTION, SOLUTIONNDA
RYBELSUSoral semaglutideTABLETNDA
RYBELSUSoral semaglutideTABLETNDA
RYBELSUSoral semaglutideTABLETNDA
SOGROYAsomapacitan-becoINJECTION, SOLUTIONBLA
SOGROYAsomapacitan-becoINJECTION, SOLUTIONBLA
SOGROYAsomapacitan-becoINJECTION, SOLUTIONBLA
SaxendaliraglutideINJECTION, SOLUTIONNDA
-SemaglutidePOWDERBULK INGREDIENT
-SemaglutideINJECTION, SOLUTIONDRUG FOR FURTHER PROCESSING
-SemaglutideINJECTION, SOLUTIONDRUG FOR FURTHER PROCESSING
-SemaglutideINJECTION, SOLUTIONDRUG FOR FURTHER PROCESSING
-SemaglutideINJECTION, SOLUTIONDRUG FOR FURTHER PROCESSING
-SemaglutideINJECTION, SOLUTIONDRUG FOR FURTHER PROCESSING
-SemaglutidePOWDERBULK INGREDIENT
-Semaglutide SNACTABLETDRUG FOR FURTHER PROCESSING
-Semaglutide SNACTABLETDRUG FOR FURTHER PROCESSING
-Semaglutide SNACTABLETDRUG FOR FURTHER PROCESSING
TRETTENCoagulation Factor XIII A-Subunit (Recombinant)KITBLA
Tresibainsulin degludecINJECTION, SOLUTIONBLA
Tresibainsulin degludecINJECTION, SOLUTIONBLA
Tresibainsulin degludecINJECTION, SOLUTIONBLA
VagifemestradiolINSERTNDA
VictozaliraglutideINJECTIONNDA
WEGOVYsemaglutideTABLETNDA
WEGOVYsemaglutideTABLETNDA
WEGOVYsemaglutideTABLETNDA
WEGOVYsemaglutideTABLETNDA
WEGOVYsemaglutideINJECTION, SOLUTIONNDA
WEGOVYsemaglutideINJECTION, SOLUTIONNDA
WEGOVYsemaglutideINJECTION, SOLUTIONNDA
WEGOVYsemaglutideINJECTION, SOLUTIONNDA
WEGOVYsemaglutideINJECTION, SOLUTIONNDA
WEGOVYsemaglutideINJECTION, SOLUTIONNDA
WEGOVYsemaglutideINJECTION, SOLUTIONNDA
Xultophy 100/3.6insulin degludec and liraglutideINJECTION, SOLUTIONBLA
ZegaloguedasiglucagonINJECTION, SOLUTIONNDA
ZegaloguedasiglucagonINJECTION, SOLUTIONNDA
-insulin recombinant humanCRYSTALBULK INGREDIENT
-insulin recombinant humanCRYSTALBULK INGREDIENT
-semaglutideINJECTION, SOLUTIONDRUG FOR FURTHER PROCESSING
-semaglutideINJECTION, SOLUTIONDRUG FOR FURTHER PROCESSING
Provenance

Facility and operations data from the FDA Drug Establishments Current Registration Site. Product data from the openFDA National Drug Code Directory. Patent and exclusivity data from the FDA Orange Book. Shortage data from the FDA drug shortage database. Contact details the FDA publishes for registered establishments are deliberately not reproduced here. This entry is compiled from public records and has not been claimed by the company.