exenatide Pen Injector

Brand(s)
Bydureon, Byetta
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Astrazeneca Pharmaceuticals Lp (2015-09-24)
Oldest Current Product
2014-09-08
License(s)
NDA
RxNORM
PEN INJECTOR\EXENATIDE
FDAOB
SUBCUTANEOUS\FOR SUSPENSION, EXTENDED RELEASE\EXENATIDE SYNTHETIC
SUBCUTANEOUS\INJECTION\EXENATIDE SYNTHETIC
SPL Active
SUBCUTANEOUS\INJECTION, SUSPENSION, EXTENDED RELEASE\EXENATIDE
SUBCUTANEOUS\INJECTION\EXENATIDE
SPL Moiety
SUBCUTANEOUS\INJECTION, SUSPENSION, EXTENDED RELEASE\EXENATIDE
SUBCUTANEOUS\INJECTION\EXENATIDE

product(s) by strength(s)

60 actuat exenatide 0.005 mg/actuat pen injector

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1003106512ByettaNDAAstrazeneca Pharmaceuticals Lp2014-12-10EXENATIDESUBCUTANEOUSINJECTIONNDA02177353d03c03-ebf7-418d-88a8-533eabd2ee4f

60 actuat exenatide 0.01 mg/actuat pen injector

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1003106524ByettaNDAAstrazeneca Pharmaceuticals Lp2014-12-12EXENATIDESUBCUTANEOUSINJECTIONNDA02177353d03c03-ebf7-418d-88a8-533eabd2ee4f

0.65 ml exenatide 3.08 mg/ml pen injector

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1003106530BydureonNDAAstrazeneca Pharmaceuticals Lp2014-09-08EXENATIDESUBCUTANEOUSINJECTION, SUSPENSION, EXTENDED RELEASENDA02220071fe88be-b4e6-4c2d-9cc3-8b1864467776

application(s)

#idtitleapplicantapprovedpatentexclusivityapproved drugin other drug docs
1NDA021773BYETTAASTRAZENECA AB2005-04-28p6872700, LOWERING PLASMA GLUCAGON IN A SUBJECT IN NEED THEREOF
p7521423, SUBSTANCE
p7741269, TREATING TYPE 2 DIABETES MELLITUS WITH EXENATIDE BY STIMULATING INSULIN RELEASE/ USE OF EXENATIDE MAY RESULT IN REDUCTION IN BODY WEIGHT/ STIMULATING INSULIN RELEASE BY ADMINISTERING EXENATIDE
p7297761, SUBSTANCE
p5424286, TREATING TYPE 2 DIABETES MELLITUS WITH EXENATIDE BY STIMULATING INSULIN RELEASE/ STIMULATING INSULIN RELEASE BY ADMINISTERING EXENATIDE
p6858576, REDUCING GASTRIC MOTILITY OR DELAYING GASTRIC EMPTYING BY ADMINISTERING AN EXENDIN/ TREATING TYPE 2 DIABETES MELLITUS WITH EXENATIDE BY STIMULATING INSULIN RELEASE
p6902744, SUBSTANCE
p6956026, REDUCING FOOD INTAKE IN A SUBJECT WITH TYPE 2 DIABETES BY ADMINISTERING AN EXENDIN/ USE OF EXENATIDE MAY RESULT IN REDUCTION IN APPETITE. / USE OF EXENATIDE MAY RESULT IN REDUCTION IN BODY WEIGHT
LABELING CHANGES BASED ON STUDY HW80-EW-GWCI ENTITLED A PLACEBO AND POSITIVE CONTROLLED STUDY OF THE ELECTROPHYSIOLOGICAL EFFECTS OF A SINGLE 10 MCG DOSE OF EXENATIDE ON THE 12 LEAD ELECTROCARDIOGRAM QT INTERVAL IN HEALTHY SUBJECTS [2014-10-19]
LABELING CHANGES BASED ON STUDY H80-US-GWCO ENTITLED A RANDOMIZED TRIAL COMPARING EXENATIDE WITH PLACEBO IN SUBJECTS WITH TYPE 2 DIABETES ON INSULIN GLARGINE WITH OR WITHOUT ORAL ANTIHYPERGLYCEMIC MEDICATIONS [2014-10-19]
LABELING CHANGES BASED ON STUDY H80-EW-GWDM [2017-11-24]
NDA021773_001, NDA021773_002
2NDA022200BYDUREONASTRAZENECA AB2012-01-27p7456254, METHOD FOR TREATING TYPE 2 DIABETES USING A SUSTAINED-RELEASE COMPOSITION CONTAINING EXENATIDE, SUBSTANCE
p8439864, SUBSTANCE
p6872700, LOWERING PLASMA GLUCAGON IN A SUBJECT IN NEED THEREOF
p8461105, TREATMENT OF TYPE 2 DIABETES, SUBSTANCE
p8906851, AS AN ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN ADULTS WITH TYPE 2 DIABETES MELLITUS
p7741269, REDUCTIONS IN BODY WEIGHT ARE OBSERVED WITH EXENATIDE
p6858576, REDUCING GASTRIC MOTILITY OR DELAYING GASTRIC EMPTYING BY ADMINISTERING AN EXENDIN
p6824822, SUBSTANCE
p7563871, SUBSTANCE
p6667061, SUBSTANCE
p6479065, SUBSTANCE
p8329648, AS AN ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN ADULTS WITH TYPE 2 DIABETES MELLITUS
p5424286, TREATING TYPE 2 DIABETES MELLITUS WITH EXENATIDE BY STIMULATING INSULIN RELEASE
p7612176, METHOD FOR TREATING TYPE 2 DIABETES USING A SUSTAINED-RELEASE COMPOSITION CONTAINING EXENATIDE, SUBSTANCE
p8216180, SUBSTANCE
p6495164, SUBSTANCE
p7223440, SUBSTANCE
p6956026, REDUCING FOOD INTAKE IN A SUBJECT WITH TYPE 2 DIABETES BY ADMINISTERING AN EXENDIN
p8431685, TREATMENT OF TYPE 2 DIABETES, SUBSTANCE
INCLUSION OF EFFICACY AND SAFETY DATA TO THE PRESCRIBING INFORMATION OF BYDUREON BASED ON STUDY GWDE [2018-09-24]
NEW PRODUCT [2015-01-27]
NDA022200_001exenatide Injection

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldapprovedapplication
1NDA021773_001RXEXENATIDE SYNTHETIC (300MCG/1.2ML)SUBCUTANEOUSINJECTIONTrue2005-04-28BYETTA
2NDA021773_002RXEXENATIDE SYNTHETIC (600MCG/2.4ML)SUBCUTANEOUSINJECTIONTrue2005-04-28BYETTA
3NDA022200_001RXEXENATIDE SYNTHETIC (2MG/VIAL)SUBCUTANEOUSFOR SUSPENSION, EXTENDED RELEASETrue2012-01-27BYDUREON

patent(s)

#idexpiration dateapplication(s)in other drug docs
1p5424286 (view patent)2016-12-01NDA021773, NDA022200exenatide Injection
2p6479065 (view patent)2020-08-10NDA022200exenatide Injection
3p6495164 (view patent)2020-05-25NDA022200, NDA021897exenatide Injection
Naltrexone Injectable Suspension
4p6667061 (view patent)2020-05-25NDA022200, NDA021346, NDA021897exenatide Injection
Risperidone Injectable Suspension
Naltrexone Injectable Suspension
5p6824822 (view patent)2022-10-09NDA022200exenatide Injection
6p6858576 (view patent)2017-01-06NDA021773, NDA022200exenatide Injection
7p6872700 (view patent)2020-01-14NDA021773, NDA022200exenatide Injection
8p6902744 (view patent)2020-01-14NDA021773
9p6956026 (view patent)2018-01-07NDA021773, NDA022200exenatide Injection
10p7223440 (view patent)2021-08-31NDA022200exenatide Injection
11p7297761 (view patent)2017-10-15NDA021773
12p7456254 (view patent)2025-06-30NDA022200exenatide Injection
13p7521423 (view patent)2017-10-15NDA021773
14p7563871 (view patent)2024-04-15NDA022200exenatide Injection
15p7612176 (view patent)2025-04-13NDA022200exenatide Injection
16p7741269 (view patent)2018-01-07NDA021773, NDA022200exenatide Injection
17p8216180 (view patent)2028-01-12NDA022200exenatide Injection
18p8329648 (view patent)2026-08-18NDA022200exenatide Injection
19p8431685 (view patent)2025-04-13NDA022200exenatide Injection
20p8439864 (view patent)2028-03-25NDA022200exenatide Injection
21p8461105 (view patent)2025-04-13NDA022200exenatide Injection
22p8906851 (view patent)2026-08-18NDA022200exenatide Injection

spl(s)

#idtitlecategorytypelabelerlast updateversionproduct(s)in other drug docs
153d03c03-ebf7-418d-88a8-533eabd2ee4f (view SPL)These highlights do not include all the information needed to use BYETTA safely and effectively. See full prescribing information for BYETTA. BYETTA (exenatide) InjectionInitial U.S. Approval: 2005prescriptionHuman PrescriptionAstrazeneca Pharmaceuticals Lp2015-02-252003106512, 003106524
271fe88be-b4e6-4c2d-9cc3-8b1864467776 (view SPL)These highlights do not include all the information needed to use BYDUREON safely and effectively. See full prescribing information for BYDUREON. BYDUREON (exenatide extended-release) for injectable suspensionInitial U.S. Approval: 2012prescriptionHuman PrescriptionAstrazeneca Pharmaceuticals Lp2015-09-2411003106530, 003106520exenatide Injection
3751747da-7c1f-41ad-b1a6-a6d920f70599 (view SPL)These highlights do not include all the information needed to use BYETTA safely and effectively. See full prescribing information for BYETTA. BYETTA (exenatide) InjectionInitial U.S. Approval: 2005prescriptionHuman PrescriptionAmylin Pharmaceuticals, Llc2014-08-1520667800210, 667800212

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