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.

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.

Activity	Date	Patent Number
Critical Events This Week
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 Critical	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.

Patent	Proceeding Filing Date	Status	Respondent	Petitioner
Live updates
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.

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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
Live updates
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.

Full family tree

Generic Launch

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.