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  • Patent information is published on or after the submission date as defined in 21 CFR 314.53(d)(5).
  • Patent listings published prior to August 18, 2003, only identify method-of-use claims. The listed patents may include drug substance and/or drug product claims that are not indicated in the listing.
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Patent and Exclusivity for: N022200

Product 002
EXENATIDE SYNTHETIC (BYDUREON PEN) FOR SUSPENSION, EXTENDED RELEASE 2MG

Patent Data

Product No Patent No Patent Expiration Drug Substance Drug Product Patent Use Code Delist Requested Submission Date
002 6515117 10/04/2025 DS DP
U-2588 AS AN ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN ADULTS WITH TYPE 2 DIABETES MELLITUS IN COMBINATION WITH DAPAGLIFLOZIN AND METFORMIN
11/15/2017
002 6824822 10/09/2022 DP
03/28/2014
002 7223440 08/31/2021 DP
03/28/2014
002 7456254 06/30/2025 DP
U-2588 AS AN ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN ADULTS WITH TYPE 2 DIABETES MELLITUS IN COMBINATION WITH DAPAGLIFLOZIN AND METFORMIN
U-2589 AS AN ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN ADULTS WITH TYPE 2 DIABETES MELLITUS IN COMBINATION WITH BASAL INSULIN OR BASAL INSULIN PLUS METFORMIN
U-2590 AS AN ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN ADULTS WITH TYPE 2 DIABETES MELLITUS IN COMBINATION WITH METFORMIN, A SULFONYLUREA, A THIAZOLIDINEDIONE, OR COMBINATION OF ANY TWO OF THESE THERAPIES
U-2592 IMPROVING GLYCEMIC CONTROL IN ADULTS WITH TYPE 2 DIABETES MELLITUS BY ADMINISTERING A SUSTAINED-RELEASE EXENATIDE FORMULATION AS AN ADJUNCT TO DIET AND EXERCISE
03/28/2014
002 7563871 04/15/2024 DP
03/28/2014
002 7612176 04/13/2025 DP
U-2588 AS AN ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN ADULTS WITH TYPE 2 DIABETES MELLITUS IN COMBINATION WITH DAPAGLIFLOZIN AND METFORMIN
U-2589 AS AN ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN ADULTS WITH TYPE 2 DIABETES MELLITUS IN COMBINATION WITH BASAL INSULIN OR BASAL INSULIN PLUS METFORMIN
U-2590 AS AN ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN ADULTS WITH TYPE 2 DIABETES MELLITUS IN COMBINATION WITH METFORMIN, A SULFONYLUREA, A THIAZOLIDINEDIONE, OR COMBINATION OF ANY TWO OF THESE THERAPIES
U-2592 IMPROVING GLYCEMIC CONTROL IN ADULTS WITH TYPE 2 DIABETES MELLITUS BY ADMINISTERING A SUSTAINED-RELEASE EXENATIDE FORMULATION AS AN ADJUNCT TO DIET AND EXERCISE
03/28/2014
002 8216180 01/12/2028 DP
03/28/2014
002 8329648 08/18/2026
U-2588 AS AN ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN ADULTS WITH TYPE 2 DIABETES MELLITUS IN COMBINATION WITH DAPAGLIFLOZIN AND METFORMIN
U-2589 AS AN ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN ADULTS WITH TYPE 2 DIABETES MELLITUS IN COMBINATION WITH BASAL INSULIN OR BASAL INSULIN PLUS METFORMIN
U-2590 AS AN ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN ADULTS WITH TYPE 2 DIABETES MELLITUS IN COMBINATION WITH METFORMIN, A SULFONYLUREA, A THIAZOLIDINEDIONE, OR COMBINATION OF ANY TWO OF THESE THERAPIES
U-2593 IMPROVING GLYCEMIC CONTROL IN ADULTS WITH TYPE 2 DIABETES MELLITUS BY ADMINISTERING AN EXENATIDE FORMULATION ONCE WEEKLY AS AN ADJUNCT TO DIET AND EXERCISE TO ACHIEVE A MEAN STEADY STATE PLASMA CONCENTRATION OF EXENATIDE AT LEAST 170 PG/ML
U-2594 REDUCING FASTING PLASMA GLUCOSE IN ADULTS WITH TYPE 2 DIABETES MELLITUS BY ADMINISTERING AN EXENATIDE FORMULATION ONCE WEEKLY AS AN ADJUNCT TO DIET AND EXERCISE TO ACHIEVE A MEAN STEADY STATE PLASMA CONCENTRATION OF EXENATIDE AT LEAST 170 PG/ML
U-2595 REDUCING BODY WEIGHT IN ADULTS WITH TYPE 2 DIABETES MELLITUS BY ADMINISTERING AN EXENATIDE FORMULATION ONCE WEEKLY AS AN ADJUNCT TO DIET AND EXERCISE TO ACHIEVE A MEAN STEADY STATE PLASMA CONCENTRATION OF EXENATIDE AT LEAST 170 PG/ML
U-2596 REDUCING HBA1C IN ADULTS WITH TYPE 2 DIABETES MELLITUS BY ADMINISTERING AN EXENATIDE FORMULATION ONCE WEEKLY AS AN ADJUNCT TO DIET AND EXERCISE TO ACHIEVE A MEAN STEADY STATE PLASMA CONCENTRATION OF EXENATIDE AT LEAST 170 PG/ML
03/28/2014
002 8361972 03/21/2028
U-2588 AS AN ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN ADULTS WITH TYPE 2 DIABETES MELLITUS IN COMBINATION WITH DAPAGLIFLOZIN AND METFORMIN
11/15/2017
002 8431685 04/13/2025 DP
U-2588 AS AN ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN ADULTS WITH TYPE 2 DIABETES MELLITUS IN COMBINATION WITH DAPAGLIFLOZIN AND METFORMIN
U-2589 AS AN ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN ADULTS WITH TYPE 2 DIABETES MELLITUS IN COMBINATION WITH BASAL INSULIN OR BASAL INSULIN PLUS METFORMIN
U-2590 AS AN ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN ADULTS WITH TYPE 2 DIABETES MELLITUS IN COMBINATION WITH METFORMIN, A SULFONYLUREA, A THIAZOLIDINEDIONE, OR COMBINATION OF ANY TWO OF THESE THERAPIES
U-2598 IMPROVING GLYCEMIC CONTROL IN ADULTS WITH TYPE 2 DIABETES MELLITUS BY ADMINISTERING AN INJECTABLE SUSTAINED RELEASE FORMULATION OF EXENATIDE AS AN ADJUNCT TO DIET AND EXERCISE
03/28/2014
002 8439864 03/25/2028 DP
03/28/2014
002 8461105 04/13/2025 DP
U-2588 AS AN ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN ADULTS WITH TYPE 2 DIABETES MELLITUS IN COMBINATION WITH DAPAGLIFLOZIN AND METFORMIN
U-2589 AS AN ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN ADULTS WITH TYPE 2 DIABETES MELLITUS IN COMBINATION WITH BASAL INSULIN OR BASAL INSULIN PLUS METFORMIN
U-2590 AS AN ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN ADULTS WITH TYPE 2 DIABETES MELLITUS IN COMBINATION WITH METFORMIN, A SULFONYLUREA, A THIAZOLIDINEDIONE, OR COMBINATION OF ANY TWO OF THESE THERAPIES
U-2598 IMPROVING GLYCEMIC CONTROL IN ADULTS WITH TYPE 2 DIABETES MELLITUS BY ADMINISTERING AN INJECTABLE SUSTAINED RELEASE FORMULATION OF EXENATIDE AS AN ADJUNCT TO DIET AND EXERCISE
03/28/2014
002 8501698 06/20/2027 DP
U-2588 AS AN ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN ADULTS WITH TYPE 2 DIABETES MELLITUS IN COMBINATION WITH DAPAGLIFLOZIN AND METFORMIN
11/15/2017
002 8690837 05/19/2029 DP
11/15/2017
002 8721615 01/18/2030 DP
11/15/2017
002 8758292 11/12/2027 DP
11/15/2017
002 8827963 02/04/2029 DP
11/15/2017
002 8906851 08/18/2026
U-2588 AS AN ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN ADULTS WITH TYPE 2 DIABETES MELLITUS IN COMBINATION WITH DAPAGLIFLOZIN AND METFORMIN
U-2589 AS AN ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN ADULTS WITH TYPE 2 DIABETES MELLITUS IN COMBINATION WITH BASAL INSULIN OR BASAL INSULIN PLUS METFORMIN
U-2590 AS AN ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN ADULTS WITH TYPE 2 DIABETES MELLITUS IN COMBINATION WITH METFORMIN, A SULFONYLUREA, A THIAZOLIDINEDIONE, OR COMBINATION OF ANY TWO OF THESE THERAPIES
U-2593 IMPROVING GLYCEMIC CONTROL IN ADULTS WITH TYPE 2 DIABETES MELLITUS BY ADMINISTERING AN EXENATIDE FORMULATION ONCE WEEKLY AS AN ADJUNCT TO DIET AND EXERCISE TO ACHIEVE A MEAN STEADY STATE PLASMA CONCENTRATION OF EXENATIDE AT LEAST 170 PG/ML
01/06/2015
002 8998876 01/07/2030 DP
11/15/2017
002 9238076 04/15/2024 DP
U-2588 AS AN ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN ADULTS WITH TYPE 2 DIABETES MELLITUS IN COMBINATION WITH DAPAGLIFLOZIN AND METFORMIN
U-2589 AS AN ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN ADULTS WITH TYPE 2 DIABETES MELLITUS IN COMBINATION WITH BASAL INSULIN OR BASAL INSULIN PLUS METFORMIN
U-2590 AS AN ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN ADULTS WITH TYPE 2 DIABETES MELLITUS IN COMBINATION WITH METFORMIN, A SULFONYLUREA, A THIAZOLIDINEDIONE, OR COMBINATION OF ANY TWO OF THESE THERAPIES
U-2599 IMPROVING GLYCEMIC CONTROL IN ADULTS WITH TYPE 2 DIABETES MELLITUS BY ADMINISTERING AN EXENATIDE FORMULATION AS AN ADJUNCT TO DIET AND EXERCISE TO PROVIDE A RELEASE PROFILE HAVING A RATIO OF C-MAX TO C-AVG OF ABOUT 3 OR LESS
02/17/2016
002 9320853 03/25/2028 DP
11/15/2017
002 9884092 08/18/2026
U-2588 AS AN ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN ADULTS WITH TYPE 2 DIABETES MELLITUS IN COMBINATION WITH DAPAGLIFLOZIN AND METFORMIN
U-2589 AS AN ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN ADULTS WITH TYPE 2 DIABETES MELLITUS IN COMBINATION WITH BASAL INSULIN OR BASAL INSULIN PLUS METFORMIN
U-2590 AS AN ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN ADULTS WITH TYPE 2 DIABETES MELLITUS IN COMBINATION WITH METFORMIN, A SULFONYLUREA, A THIAZOLIDINEDIONE, OR COMBINATION OF ANY TWO OF THESE THERAPIES
U-2593 IMPROVING GLYCEMIC CONTROL IN ADULTS WITH TYPE 2 DIABETES MELLITUS BY ADMINISTERING AN EXENATIDE FORMULATION ONCE WEEKLY AS AN ADJUNCT TO DIET AND EXERCISE TO ACHIEVE A MEAN STEADY STATE PLASMA CONCENTRATION OF EXENATIDE AT LEAST 170 PG/ML
U-2594 REDUCING FASTING PLASMA GLUCOSE IN ADULTS WITH TYPE 2 DIABETES MELLITUS BY ADMINISTERING AN EXENATIDE FORMULATION ONCE WEEKLY AS AN ADJUNCT TO DIET AND EXERCISE TO ACHIEVE A MEAN STEADY STATE PLASMA CONCENTRATION OF EXENATIDE AT LEAST 170 PG/ML
U-2595 REDUCING BODY WEIGHT IN ADULTS WITH TYPE 2 DIABETES MELLITUS BY ADMINISTERING AN EXENATIDE FORMULATION ONCE WEEKLY AS AN ADJUNCT TO DIET AND EXERCISE TO ACHIEVE A MEAN STEADY STATE PLASMA CONCENTRATION OF EXENATIDE AT LEAST 170 PG/ML
U-2596 REDUCING HBA1C IN ADULTS WITH TYPE 2 DIABETES MELLITUS BY ADMINISTERING AN EXENATIDE FORMULATION ONCE WEEKLY AS AN ADJUNCT TO DIET AND EXERCISE TO ACHIEVE A MEAN STEADY STATE PLASMA CONCENTRATION OF EXENATIDE AT LEAST 170 PG/ML
03/06/2018

Exclusivity Data

Product No Exclusivity Code Exclusivity Expiration
002
M-224INFORMATION ADDED TO THE LABELING REGARDING THE SAFETY AND EFFICACY OF EXENATIDE EXTENDED RELEASE AS ADD-ON IN PATIENTS WITH TYPE 2 DIABETES WHO HAVE INADEQUATE GLYCEMIC CONTROL ON BASAL INSULIN GLARGINE WITH OR WITHOUT METFORMIN
COMPETITIVE GENERIC THERAPY
04/02/2021

 

 


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