exenatide Injection

Brand(s)
Bydureon
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Astrazeneca Pharmaceuticals Lp (2015-09-24)
Oldest Current Product
2012-01-27
License(s)
NDA
RxNORM
INJECTION\EXENATIDE
FDAOB
SUBCUTANEOUS\FOR SUSPENSION, EXTENDED RELEASE\EXENATIDE SYNTHETIC

product(s) by strength(s)

exenatide 2 mg injection

original product(s)(s)

#idbrandcategorylabelerfirst marketedlast marketedactive ingredient(s)dose formapplicationspl
1003106520BydureonNDAAstrazeneca Pharmaceuticals Lp2015-02-01EXENATIDEKITNDA02220071fe88be-b4e6-4c2d-9cc3-8b1864467776
2667800219BydureonNDAAmylin Pharmaceuticals, Llc2012-01-272018-01-31EXENATIDEKITNDA022200a1c8ee2a-6a76-435e-ad38-8a9c99046ad9

application(s)

#idtitleapplicantapprovedpatentexclusivityapproved drugin other drug docs
1NDA022200BYDUREONASTRAZENECA 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 Pen Injector

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldapprovedapplication
1NDA022200_001RXEXENATIDE SYNTHETIC (2MG/VIAL)SUBCUTANEOUSFOR SUSPENSION, EXTENDED RELEASETrue2012-01-27BYDUREON

patent(s)

#idexpiration dateapplication(s)in other drug docs
1p5424286 (view patent)2016-12-01NDA022200, NDA021773exenatide Pen Injector
2p6479065 (view patent)2020-08-10NDA022200exenatide Pen Injector
3p6495164 (view patent)2020-05-25NDA022200, NDA021897exenatide Pen Injector
Naltrexone Injectable Suspension
4p6667061 (view patent)2020-05-25NDA022200, NDA021346, NDA021897exenatide Pen Injector
Risperidone Injectable Suspension
Naltrexone Injectable Suspension
5p6824822 (view patent)2022-10-09NDA022200exenatide Pen Injector
6p6858576 (view patent)2017-01-06NDA022200, NDA021773exenatide Pen Injector
7p6872700 (view patent)2020-01-14NDA022200, NDA021773exenatide Pen Injector
8p6956026 (view patent)2018-01-07NDA022200, NDA021773exenatide Pen Injector
9p7223440 (view patent)2021-08-31NDA022200exenatide Pen Injector
10p7456254 (view patent)2025-06-30NDA022200exenatide Pen Injector
11p7563871 (view patent)2024-04-15NDA022200exenatide Pen Injector
12p7612176 (view patent)2025-04-13NDA022200exenatide Pen Injector
13p7741269 (view patent)2018-01-07NDA022200, NDA021773exenatide Pen Injector
14p8216180 (view patent)2028-01-12NDA022200exenatide Pen Injector
15p8329648 (view patent)2026-08-18NDA022200exenatide Pen Injector
16p8431685 (view patent)2025-04-13NDA022200exenatide Pen Injector
17p8439864 (view patent)2028-03-25NDA022200exenatide Pen Injector
18p8461105 (view patent)2025-04-13NDA022200exenatide Pen Injector
19p8906851 (view patent)2026-08-18NDA022200exenatide Pen Injector

spl(s)

#idtitlecategorytypelabelerlast updateversionproduct(s)in other drug docs
171fe88be-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 Lp2015-09-2411003106520, 003106530exenatide Pen Injector
2a1c8ee2a-6a76-435e-ad38-8a9c99046ad9 (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 suspension) Initial U.S. Approval: 2012prescriptionHuman PrescriptionAmylin Pharmaceuticals, Llc2014-05-229667800219, 667800226

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