Bydureon is a drug owned by Astrazeneca Ab. It is protected by 46 US drug patents filed from 2013 to 2021. Out of these, 29 drug patents are active and 17 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 protects the active chemical substance. Only drug patent owner can launch products that use this active substance. | |||
US6414126 | C-aryl glucoside SGLT2 inhibitors and method |
Oct, 2020
(3 years ago) |
Expired
|
US6515117 | C-aryl glucoside SGLT2 inhibitors and method |
Oct, 2025
(1 year, 2 months from now) | Active |
US7919598 | Crystal structures of SGLT2 inhibitors and processes for preparing same |
Dec, 2029
(5 years from now) | Active |
These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
US5424286 | Exendin-3 and exendin-4 polypeptides, and pharmaceutical compositions comprising same |
Dec, 2016
(7 years ago) |
Expired
|
US6858576 | Methods for regulating gastrointestinal motility |
Jan, 2017
(7 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
|
US6872700 | Methods for glucagon suppression |
Jan, 2020
(4 years ago) |
Expired
|
US6495164 | Preparation of injectable suspensions having improved injectability |
May, 2020
(4 years ago) |
Expired
|
US6667061 | Preparation of injectable suspensions having improved injectability |
May, 2020
(4 years ago) |
Expired
|
US6479065 | Process for the preparation of polymer-based sustained release compositions |
Aug, 2020
(3 years ago) |
Expired
|
US9198925 | Pharmaceutical formulations containing an SGLT2 inhibitor |
Oct, 2020
(3 years ago) |
Expired
|
US6936590 | C-aryl glucoside SGLT2 inhibitors and method |
Oct, 2020
(3 years ago) |
Expired
|
US7223440 | Residual solvent extraction method and microparticles produced thereby |
Aug, 2021
(2 years ago) |
Expired
|
US7223440 (Pediatric) | Residual solvent extraction method and microparticles produced thereby |
Mar, 2022
(2 years ago) |
Expired
|
US6824822 | Residual solvent extraction method and microparticles produced thereby |
Oct, 2022
(1 year, 9 months ago) |
Expired
|
US6824822 (Pediatric) | Residual solvent extraction method and microparticles produced thereby |
Apr, 2023
(1 year, 3 months ago) |
Expired
|
US9238076 | Polymer-based sustained release device |
Apr, 2024
(3 months ago) |
Expired
|
US7563871 | Polymer-based sustained release device |
Apr, 2024
(3 months ago) |
Expired
|
US7563871 (Pediatric) | Polymer-based sustained release device |
Oct, 2024
(2 months from now) | Active |
US9238076 (Pediatric) | Polymer-based sustained release device |
Oct, 2024
(2 months from now) | Active |
US8461105 | Polymer-based sustained release device |
Apr, 2025
(8 months from now) | Active |
US7612176 | Polymer-based sustained release device |
Apr, 2025
(8 months from now) | Active |
US8431685 | Polymer-based sustained release device |
Apr, 2025
(8 months from now) | Active |
US7456254 | Polymer-based sustained release device |
Jun, 2025
(11 months from now) | Active |
US8461105 (Pediatric) | Polymer-based sustained release device |
Oct, 2025
(1 year, 2 months from now) | Active |
US8431685 (Pediatric) | Polymer-based sustained release device |
Oct, 2025
(1 year, 2 months from now) | Active |
US7612176 (Pediatric) | Polymer-based sustained release device |
Oct, 2025
(1 year, 2 months from now) | Active |
US7456254 (Pediatric) | Polymer-based sustained release device |
Dec, 2025
(1 year, 5 months from now) | Active |
US6515117 (Pediatric) | C-aryl glucoside SGLT2 inhibitors and method |
Apr, 2026
(1 year, 8 months from now) | Active |
US8329648 | Methods for treating diabetes and reducing body weight |
Aug, 2026
(2 years from now) | Active |
US8906851 | Method for treating diabetes |
Aug, 2026
(2 years from now) | Active |
US9884092 | Methods for treating diabetes and reducing body weight |
Aug, 2026
(2 years from now) | Active |
US9884092 (Pediatric) | Methods for treating diabetes and reducing body weight |
Feb, 2027
(2 years from now) | Active |
US8329648 (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 |
US8501698 | Crystal structures of SGLT2 inhibitors and processes for preparing same |
Jun, 2027
(2 years from now) | Active |
US8501698 (Pediatric) | Crystal structures of SGLT2 inhibitors and processes for preparing same |
Dec, 2027
(3 years from now) | Active |
US8216180 | Administering apparatus with functional drive element |
Jan, 2028
(3 years from now) | Active |
US8221786 | Pharmaceutical formulations containing an SGLT2 inhibitor |
Mar, 2028
(3 years from now) | Active |
US8716251 | 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 |
US8439864 | Device for administering fluid from a multi-chamber ampoule in incremental steps |
Mar, 2028
(3 years from now) | Active |
US7851502 | Pharmaceutical formulations containing an SGLT2 inhibitor |
Aug, 2028
(4 years from now) | Active |
US8361972 (Pediatric) | Pharmaceutical formulations containing an SGLT2 inhibitor |
Sep, 2028
(4 years from now) | Active |
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 |
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.
Latest Legal Activities on Bydureon's Patents
Given below is the list of recent legal activities going on the following patents of Bydureon.
Event | Date | Patent/Publication |
---|---|---|
![]() | ||
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 |
FDA has granted several 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 |
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 |
---|---|---|---|
![]() | |||
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
![Family Patents](/_nuxt/img/family_patents.217b832.png)
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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.
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.
Market Authorisation 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 |