Orange Book Companion
Orange Book Champion: BYDUREON PEN

Patents whose numbers are in italics have been extended under 35 USC 156. All expiration dates include applicable Sec. 156 and pediatric (PED) extensions.
Products tagged as [GENERIC] have had a generic equivalent approved for at least one strength of the product.


BYDUREON PEN (FOR SUSPENSION, EXTENDED RELEASE) (SUBCUTANEOUS) EXENATIDE SYNTHETIC
Drug Classes: glucagon-like peptide-1 (GLP-1) receptor agonist
NDA Applicant: ASTRAZENECA AB      NDA No.: 022200  Prod. No.: 002 RX (2MG)
PatentsExpirationPatented Use
Pat. No. 6414126 DS* DP* C-aryl glucoside SGLT2 inhibitors and method
Claim Types: Compound; Composition; Formulation; Method of use
Oct 4, 2020U-2139: Treatment of Type 2 diabetes mellitus in combination with exenatide
U-493: Treatment of Type 2 Diabetes Mellitus
Pat. No. 6479065 DP* Process for the preparation of polymer-based sustained release compositions
Claim Types: Formulation; Method of administration
Aug 10, 2020 
Pat. No. 6495164 DP* Preparation of injectable suspensions having improved injectability
Claim Types: Formulation; Process; Method of use; Product-by-process
May 25, 2020 
Pat. No. 6515117 DS* DP* C-aryl glucoside SGLT2 inhibitors and method
Claim Types: Compound; Composition; Formulation; Method of use
Oct 4, 2020U-2139: Treatment of Type 2 diabetes mellitus in combination with exenatide
U-493: Treatment of Type 2 Diabetes Mellitus
Pat. No. 6667061 DP* Preparation of injectable suspensions having improved injectability
Claim Types: Formulation
May 25, 2020 
Pat. No. 6824822 DP* Residual solvent extraction method and microparticles produced thereby
Claim Types: Product-by-process; Process
Oct 9, 2022 
Pat. No. 6872700 Methods for glucagon suppression
Claim Types: Method of use
Jan 14, 2020U-2288: Treatment of Type 2 diabetes mellitus with exenatide as an add-on to basal insulin or basil insulin plus metformin therapy
U-654: Lowering plasma glucagon in a subject in need thereof, including one with Type 2 diabetes, by administering an exendin or analog, such as exendin-4
Pat. No. 6936590 C-aryl glucoside SGLT2 inhibitors and method
Claim Types: Method of use
Oct 4, 2020U-493: Treatment of Type 2 Diabetes Mellitus
Pat. No. 6956026 Use of exendins for the reduction of food intake
Claim Types: Method of use
Jan 7, 2018U-687: Reducing food intake in a subject with Type 2 diabetes by administering an exendin, such as exendin-4
Pat. No. 7223440 DP* Residual solvent extraction method and microparticles produced thereby
Claim Types: Product-by-process; Process
Aug 31, 2021 
Pat. No. 7456254 DP* Polymer-based sustained release device
Claim Types: Formulation; Method of use
Jun 30, 2025U-1223: Method for treating Type 2 diabetes using a sustained-release composition containing exenatide
Pat. No. 7563871 DP* Polymer-based sustained release device
Claim Types: Formulation
Apr 15, 2024 
Pat. No. 7612176 DP* Polymer-based sustained release device
Claim Types: Formulation; Method of use
Apr 13, 2025U-1223: Method for treating Type 2 diabetes using a sustained-release composition containing exenatide
Pat. No. 7741269 Exendins and exendin agonists for weight reduction and obesity
Claim Types: Method of use
Jan 7, 2018U-1224: Reductions in body weight are observed with exenatide
Pat. No. 7851502 DP* Pharmaceutical formulations containing an SGLT2 inhibitor
Claim Types: Formulation
Aug 19, 2028 
Pat. No. 7919598 DS* Crystal structures of SGLT2 inhibitors and processes for preparing same
Claim Types: New polymorph, salt or hydrate; Process
Dec 16, 2029 
Pat. No. 8216180 DP* Administering apparatus with functional drive element
Claim Types: Device
Jan 12, 2028 
Pat. No. 8221786 DP* Pharmaceutical formulations containing an SGLT2 inhibitor
Claim Types: Formulation
Mar 21, 2028 
Pat. No. 8329648 Methods for treating diabetes and reducing body weight
Claim Types: Method of use
Aug 18, 2026U-1313: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus
Pat. No. 8361972 Pharmaceutical formulations containing an SGLT2 inhibitor
Claim Types: Method of use
Mar 21, 2028U-2139: Treatment of Type 2 diabetes mellitus in combination with exenatide
U-493: Treatment of Type 2 Diabetes Mellitus
Pat. No. 8431685 DP* Polymer-based sustained release device
Claim Types: Formulation; Method of use
Apr 13, 2025U-412: Treatment of Type 2 diabetes
Pat. No. 8439864 DP* Device for administering fluid from a multi-chamber ampoule in incremental steps
Claim Types: Device
Mar 25, 2028 
Pat. No. 8461105 DP* Polymer-based sustained release device
Claim Types: Formulation; Method of use
Apr 13, 2025U-412: Treatment of Type 2 diabetes
Pat. No. 8501698 DP* Crystal structures of SGLT2 inhibitors and processes for preparing same
Claim Types: New polymorph, salt or hydrate; Composition; Formulation; Method of use
Jun 20, 2027U-493: Treatment of Type 2 Diabetes Mellitus
Pat. No. 8685934 Methods for treating extreme insulin resistance in patients resistant to previous treatment with other anti-diabetic drugs employing an SGLT2 inhibitor and compositions thereof
Claim Types: Method of use
May 26, 2030U-1522: Treatment of Type 2 diabetes mellitus in a patient, wherein glycemic control (HBA1C < 7.0%) is not achievable using one or more of insulin, metformin, pioglitazone, or rosiglitazone
Pat. No. 8690837 DP* Mixing device for a two-chamber ampoule
Claim Types: Device
May 19, 2029 
Pat. No. 8716251 DP* Pharmaceutical formulations containing an SGLT2 inhibitor
Claim Types: Formulation
Mar 21, 2028 
Pat. No. 8721615 DP* Ampoule comprising an ampoule holder
Claim Types:
Device
Jan 18, 2030 
Pat. No. 8758292 DP* Administering apparatus with functional drive element
Claim Types: Device
Nov 12, 2027 
Pat. No. 8827963 DP* Administering device with holding mechanism
Claim Types: Device
Feb 4, 2029 
Pat. No. 8906851 Method for treating diabetes
Claim Types: Method of use
Aug 18, 2026U-1313: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus
Pat. No. 8998876 DP* Ampoule comprising an ampoule holder
Claim Types: Device
Jan 7, 2030 
Pat. No. 9198925 Pharmaceutical formulations containing an SGLT2 inhibitor
Claim Types: Method of use
Oct 4, 2020U-2139: Treatment of Type 2 diabetes mellitus in combination with exenatide
U-493: Treatment of Type 2 Diabetes Mellitus
Pat. No. 9238076 DP* Polymer-based sustained release device
Claim Types: Formulation; Method of use
Apr 15, 2024U-412: Treatment of Type 2 diabetes
Pat. No. 9320853 DP* Method for administering a fluid active substance from a multi-chamber ampoule
Claim Types: Device; Process
Mar 25, 2028 
Pat. No. 9884092 Methods for treating diabetes and reducing body weight
Claim Types: Method of use
Aug 18, 2026U-1313: As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus
U-2154: Reducing fasting plasma glucose in a human in need thereof using a sustained-release composition containing Exendin-4
U-2155: Reducing body weight in a human in need thereof using a sustained-release composition containing Exendin-4
U-2156: Reducing HBA1C in a human in need thereof using a sustained-release composition containing Exendin-4
ExclusivityExpirationExclusivity Description
Exclusivity Code: M - MiscellaneousApr 2, 2021M-224: Information 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


DS*=Drug Substance; DP*=Drug Product - patent submitted for the product after Aug. 18, 2003.
Last edited: 22 September 2018
2001-2018 Bruce A. Pokras, All rights reserved worldwide