Bydureon Patent Expiration

Bydureon is a drug owned by Astrazeneca Ab. It is protected by 46 US drug patents filed from 2013 to 2021. Out of these, 27 drug patents are active and 19 have expired. Based on its patents and exclusivities, its generic launch date is estimated to be May 26, 2030. Details of Bydureon's patents and their expiration are given in the table below.

Drug Patent Number Drug Patent Title Drug Patent Expiry Status
These drug patents protect the active ingredient(API) of the drug. Only drug patent owner can launch products that use this active ingredient until these patents expire.
US7919598 Crystal structures of SGLT2 inhibitors and processes for preparing same
Dec, 2029

(5 years from now)

Active
US6515117 C-aryl glucoside SGLT2 inhibitors and method
Oct, 2025

(9 months from now)

Active
US6414126 C-aryl glucoside SGLT2 inhibitors and method
Oct, 2020

(4 years ago)

Expired
These drug patents focus on the other aspects of the drug like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US8685934 Methods for treating extreme insulin resistance in patients resistant to previous treatment with other anti-diabetic drugs employing an SGLT2 inhibitor and compositions thereof
May, 2030

(5 years from now)

Active
US8361972

(Pediatric)

Pharmaceutical formulations containing an SGLT2 inhibitor
Sep, 2028

(3 years from now)

Active
US7851502 Pharmaceutical formulations containing an SGLT2 inhibitor
Aug, 2028

(3 years from now)

Active
US8439864 Device for administering fluid from a multi-chamber ampoule in incremental steps
Mar, 2028

(3 years from now)

Active
US8716251 Pharmaceutical formulations containing an SGLT2 inhibitor
Mar, 2028

(3 years from now)

Active
US8221786 Pharmaceutical formulations containing an SGLT2 inhibitor
Mar, 2028

(3 years from now)

Active
US8361972 Pharmaceutical formulations containing an SGLT2 inhibitor
Mar, 2028

(3 years from now)

Active
US8216180 Administering apparatus with functional drive element
Jan, 2028

(3 years from now)

Active
US8501698

(Pediatric)

Crystal structures of SGLT2 inhibitors and processes for preparing same
Dec, 2027

(3 years from now)

Active
US8501698 Crystal structures of SGLT2 inhibitors and processes for preparing same
Jun, 2027

(2 years from now)

Active
US9884092

(Pediatric)

Methods for treating diabetes and reducing body weight
Feb, 2027

(2 years from now)

Active
US8906851

(Pediatric)

Method for treating diabetes
Feb, 2027

(2 years from now)

Active
US8329648

(Pediatric)

Methods for treating diabetes and reducing body weight
Feb, 2027

(2 years from now)

Active
US9884092 Methods for treating diabetes and reducing body weight
Aug, 2026

(1 year, 8 months from now)

Active
US8906851 Method for treating diabetes
Aug, 2026

(1 year, 8 months from now)

Active
US8329648 Methods for treating diabetes and reducing body weight
Aug, 2026

(1 year, 8 months from now)

Active
US6515117

(Pediatric)

C-aryl glucoside SGLT2 inhibitors and method
Apr, 2026

(1 year, 3 months from now)

Active
US7456254

(Pediatric)

Polymer-based sustained release device
Dec, 2025

(1 year, 19 days from now)

Active
US7612176

(Pediatric)

Polymer-based sustained release device
Oct, 2025

(10 months from now)

Active
US8461105

(Pediatric)

Polymer-based sustained release device
Oct, 2025

(10 months from now)

Active
US8431685

(Pediatric)

Polymer-based sustained release device
Oct, 2025

(10 months from now)

Active
US7456254 Polymer-based sustained release device
Jun, 2025

(6 months from now)

Active
US7612176 Polymer-based sustained release device
Apr, 2025

(4 months from now)

Active
US8431685 Polymer-based sustained release device
Apr, 2025

(4 months from now)

Active
US8461105 Polymer-based sustained release device
Apr, 2025

(4 months from now)

Active
US9238076

(Pediatric)

Polymer-based sustained release device
Oct, 2024

(a month ago)

Expired
US7563871

(Pediatric)

Polymer-based sustained release device
Oct, 2024

(a month ago)

Expired
US7563871 Polymer-based sustained release device
Apr, 2024

(7 months ago)

Expired
US9238076 Polymer-based sustained release device
Apr, 2024

(7 months ago)

Expired
US6824822

(Pediatric)

Residual solvent extraction method and microparticles produced thereby
Apr, 2023

(1 year, 8 months ago)

Expired
US6824822 Residual solvent extraction method and microparticles produced thereby
Oct, 2022

(2 years ago)

Expired
US7223440

(Pediatric)

Residual solvent extraction method and microparticles produced thereby
Mar, 2022

(2 years ago)

Expired
US7223440 Residual solvent extraction method and microparticles produced thereby
Aug, 2021

(3 years ago)

Expired
US6936590 C-aryl glucoside SGLT2 inhibitors and method
Oct, 2020

(4 years ago)

Expired
US9198925 Pharmaceutical formulations containing an SGLT2 inhibitor
Oct, 2020

(4 years ago)

Expired
US6479065 Process for the preparation of polymer-based sustained release compositions
Aug, 2020

(4 years ago)

Expired
US6667061 Preparation of injectable suspensions having improved injectability
May, 2020

(4 years ago)

Expired
US6495164 Preparation of injectable suspensions having improved injectability
May, 2020

(4 years ago)

Expired
US6872700 Methods for glucagon suppression
Jan, 2020

(4 years ago)

Expired
US6956026 Use of exendins for the reduction of food intake
Jan, 2018

(6 years ago)

Expired
US7741269 Exendins and exendin agonists for weight reduction and obesity
Jan, 2018

(6 years ago)

Expired
US6858576 Methods for regulating gastrointestinal motility
Jan, 2017

(7 years ago)

Expired
US5424286 Exendin-3 and exendin-4 polypeptides, and pharmaceutical compositions comprising same
Dec, 2016

(8 years ago)

Expired


A patent's expiry date may change depending upon legal activities going on that patent. Critical activities like abandoning of a patent, term extension of a patent or amendment of its claims can increase or decrease the life of a patent hence affecting its expiry date and in turn affecting the generic launch date of that drug. Tracking these ongoing activities on a patent application helps to keep an eye on the latest developments in the patent process of the drug which can give an idea of how early a drug's generic could be available. The next section provides a list of recent legal activities on Bydureon's patents.

Given below is the list of recent legal activities going on the following patents of Bydureon.

Activity Date Patent Number
Patent litigations
Payment of Maintenance Fee, 12th Year, Large Entity 17 Jul, 2024 US8361972
Payment of Maintenance Fee, 12th Year, Large Entity 29 May, 2024 US8329648
Payment of Maintenance Fee, 12th Year, Large Entity 03 Jan, 2024 US8221786
Payment of Maintenance Fee, 12th Year, Large Entity 27 Dec, 2023 US8216180
Payment of Maintenance Fee, 8th Year, Large Entity 19 Jul, 2023 US9238076
Payment of Maintenance Fee, 8th Year, Large Entity 17 May, 2023 US9198925
Payment of Maintenance Fee, 12th Year, Large Entity 21 Sep, 2022 US7919598
Expire Patent 25 Jul, 2022 US7741269 (Litigated)
Payment of Maintenance Fee, 12th Year, Large Entity 01 Jun, 2022 US7851502
Payment of Maintenance Fee, 8th Year, Large Entity 25 May, 2022 US8906851


While patent expiration is one way of estimating the generic date of a drug, if a patent gets invalidated somehow, the generic of the drug may arrive early. Being aware of all relevant patents can help in avoiding legal pitfalls. Given below are details of the litigation history of Bydureon and ongoing litigations to help you estimate the early arrival of Bydureon generic.

Bydureon's Litigations

Bydureon been subject to various legal proceedings, including patent litigations. The earliest legal proceeding was initiated on May 31, 2016, against patent number US6667061. The petitioner Luye Pharma Group Ltd., challenged the validity of this patent, with Alkermes Controlled Therapeutics, Inc. as the respondent. Click below to track the latest information on how companies are challenging Bydureon's patents.

Last updated on December 10, 2024
Patent Proceeding Filing Date Status Respondent Petitioner
Patent litigations
US6667061 May, 2016 FWD Entered
(28 Nov, 2017)
Alkermes Controlled Therapeutics, Inc. Luye Pharma Group Ltd.
US6667061 May, 2016 Terminated-Denied
(30 Nov, 2016)
Alkermes Controlled Therapeutics, Inc. Luye Pharma Group Ltd.


FDA has granted some exclusivities to Bydureon. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Bydureon, regardless of the status of it's patents. These exclusivities hence play a crucial role in delaying the generic launch. Given below are details of the exclusivities granted to Bydureon.

Exclusivity Information

Bydureon holds 7 exclusivities out of which 6 have expired. Its last outstanding exclusivity is set to expire in 2025. Details of Bydureon's exclusivity codes and their expiration dates are given below.


Drug Exclusivity Drug Exclusivity Expiration
New Product(NP) Jan 27, 2015
M(M-162) Sep 24, 2018
M(M-212) Oct 20, 2020
M(M-224) Apr 02, 2021
M(M-240) Feb 15, 2022
New Patient Population(NPP) Jul 22, 2024
Pediatric Exclusivity(PED) Jan 22, 2025

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Several oppositions have been filed on Bydureon's European patents. EP oppositions can significantly impact the timeline for the generic launch of drugs. If an opposition results in the revocation or amendment of a patent, it can shorten the exclusivity period of the original drug. This can lead to an earlier entry of generic versions into the market. To help you estimate the potential early arrival of Bydureon's generic, the next section provides detailed information on ongoing and past EP oppositions related to Bydureon patents.

Bydureon's Oppositions Filed in EPO

Bydureon has faced multiple oppositions in the European Patent Office. The earliest opposition was filed on Apr 30, 2015, by Lek Pharmaceuticals D.D.. This opposition was filed on patent number EP07784499A. Click below to reveal the latest opposition data.


Application Filing Date Opposition Party Legal Status
Patent litigations
EP08732695A Dec, 2020 Gedeon Richter Plc. Granted and Under Opposition
EP08732695A Dec, 2020 Galenicum Health S.L.U. Granted and Under Opposition
EP08732695A Dec, 2020 Generics [UK] Limited Granted and Under Opposition
EP08732695A Dec, 2020 Kraus & Weisert Patentanwälte PartGmbB Granted and Under Opposition
EP08732695A Dec, 2020 Stada-Arzneimittel Aktiengesellschaft Granted and Under Opposition
EP08732695A Dec, 2020 Zentiva, k.s. Granted and Under Opposition
EP17203302A Aug, 2020 Generics (U.K.) Limited Granted and Under Opposition
EP10016112A Feb, 2020 Generics (UK) Ltd Granted and Under Opposition
EP10016112A Jan, 2020 Instone, Terry/Appleyard Lees IP LLP/Read, Howard Granted and Under Opposition
EP15181545A Sep, 2018 Generics (U.K.) Limited Granted and Under Opposition
EP08716685A Apr, 2017 SHL Group AB Opposition rejected
EP11180259A Nov, 2015 Teva Pharmaceutical Industries Ltd. Opposition rejected
EP11180259A Nov, 2015 PHARMATHEN S.A. Opposition rejected
EP06801867A Sep, 2015 Teva Pharmaceutical Industries Ltd. Revoked
EP06801867A Sep, 2015 Generics [UK] Ltd (trading as Mylan) Revoked
EP06801867A Sep, 2015 COOLEY LLP Revoked
EP06801867A Sep, 2015 Glaxo Group Limited Revoked
EP06801867A Sep, 2015 PENTAFARMA, Sociedade Técnico-Medicinal, SA Revoked
EP06801867A Aug, 2015 PHARMATHEN S.A. Revoked
EP07784499A Apr, 2015 LEK Pharmaceuticals d.d. Patent maintained as amended


US patents provide insights into the exclusivity only within the United States, but Bydureon is protected by patents in multiple countries. Understanding the full scope of patent protection is crucial in strategizing market entry. By looking at the broader patent landscape, you can identify markets with weaker patent protection which could be ideal generic entry points. The following section offers details on Bydureon's family patents as well as insights into ongoing legal events on those patents.

Bydureon's Family Patents

Bydureon has patent protection in a total of 49 countries. It's US patent count contributes only to 18.7% of its total global patent coverage. 10 countries have all of their patents expired or invalidated which has opened up potential generic launch opportunities in these countries. Click below to unlock the full patent family tree for Bydureon.

Family Patents

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Generic Launch

Generic Release Date:

Bydureon's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be May 26, 2030 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)

Bydureon Generics:

There are no approved generic versions for Bydureon as of now.

Alternative Brands for Bydureon

Bydureon which is used for improving glycemic control in patients with type 2 diabetes mellitus., has several other brand drugs in the same treatment category and using the same active ingredient (Exenatide Synthetic). Given below is the list of those companies and their brand drugs, to help you identify new opportunities, assess competitors, and plan your market strategies more effectively.

Drug Owner Drug Name Treatment Area
Astrazeneca Ab
Byetta

(uses Exenatide Synthetic)

Used for managing type 2 diabetes by stimulating insulin release, reducing food intake, and delaying gastric emptying.
Farxiga used for treating heart failure and type 2 diabetes.
Xigduo Xr used for managing type 2 diabetes mellitus when glycemic control is not achievable with other medications.
Bydureon Pen

(uses Exenatide Synthetic)

used for improving glycemic control in patients with Type 2 diabetes, reducing food intake, delaying gastric motility, reducing body weight, and stimulating insulin release.
Bydureon Bcise

(uses Exenatide Synthetic)

Used for improving glycemic control and reducing food intake in patients with type 2 diabetes.





About Bydureon

Bydureon is a drug owned by Astrazeneca Ab. It is used for improving glycemic control in patients with type 2 diabetes mellitus. Bydureon uses Exenatide Synthetic as an active ingredient. Bydureon was launched by Astrazeneca Ab in 2012.

Approval Date:

Bydureon was approved by FDA for market use on 27 January, 2012.

Active Ingredient:

Bydureon uses Exenatide Synthetic as the active ingredient. Check out other Drugs and Companies using Exenatide Synthetic ingredient

Treatment:

Bydureon is used for improving glycemic control in patients with type 2 diabetes mellitus.

Dosage:

Bydureon is available in for suspension, extended release form for subcutaneous use. Given below is detailed information on Dosage -

Strength Dosage Form Availability Application Pathway
2MG/VIAL FOR SUSPENSION, EXTENDED RELEASE Discontinued SUBCUTANEOUS