BYDUREON Drug Patent Profile

When do Bydureon patents expire, and what generic alternatives are available?

Bydureon is a drug marketed by Astrazeneca Ab and is included in two NDAs. There are twenty-two patents protecting this drug.

This drug has three hundred and eighty-four patent family members in forty-eight countries.

The generic ingredient in BYDUREON is exenatide synthetic. There are seven drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the exenatide synthetic profile page.

DrugPatentWatch^® Generic Entry Outlook for Bydureon

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be December 20, 2027. This may change due to patent challenges or generic licensing.

There have been eight patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

Indicators of Generic Entry

Summary for BYDUREON

International Patents:	384
US Patents:	13
Applicants:	1
NDAs:	2
Raw Ingredient (Bulk) Api Vendors:	31
Clinical Trials:	39
Patent Applications:	8
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for BYDUREON
Drug Sales Revenues:	Drug sales revenues for BYDUREON
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for BYDUREON
What excipients (inactive ingredients) are in BYDUREON?	BYDUREON excipients list
DailyMed Link:	BYDUREON at DailyMed

See drug prices for BYDUREON

See drug sales revenues for BYDUREON

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for BYDUREON

NDA:

022200

Dosage:

FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for BYDUREON

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
The University of Texas Health Science Center, Houston	Phase 2
University of Washington	Phase 3
Dasman Diabetes Institute	Phase 4

See all BYDUREON clinical trials

Anatomical Therapeutic Chemical (ATC) Classes for BYDUREON

A10BJ	Glucagon-like peptide-1 (GLP-1) analogues
A10B	BLOOD GLUCOSE LOWERING DRUGS, EXCL. INSULINS
A10	DRUGS USED IN DIABETES
A	Alimentary tract and metabolism

US Patents and Regulatory Information for BYDUREON

BYDUREON is protected by thirteen US patents and three FDA Regulatory Exclusivities.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Patents protecting BYDUREON

FDA Regulatory Exclusivity protecting BYDUREON

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Astrazeneca Ab	BYDUREON PEN	exenatide synthetic	FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS	022200-002	Feb 28, 2014		DISCN	Yes	No					Y
Astrazeneca Ab	BYDUREON BCISE	exenatide synthetic	SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS	209210-001	Oct 20, 2017		RX	Yes	Yes
Astrazeneca Ab	BYDUREON PEN	exenatide synthetic	FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS	022200-002	Feb 28, 2014		DISCN	Yes	No					Y
Astrazeneca Ab	BYDUREON PEN	exenatide synthetic	FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS	022200-002	Feb 28, 2014		DISCN	Yes	No					Y

Expired US Patents for BYDUREON

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Astrazeneca Ab	BYDUREON	exenatide synthetic	FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS	022200-001	Jan 27, 2012
Astrazeneca Ab	BYDUREON	exenatide synthetic	FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS	022200-001	Jan 27, 2012
Astrazeneca Ab	BYDUREON	exenatide synthetic	FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS	022200-001	Jan 27, 2012
Astrazeneca Ab	BYDUREON	exenatide synthetic	FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS	022200-001	Jan 27, 2012

International Patents for BYDUREON

When does loss-of-exclusivity occur for BYDUREON?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Argentina

Australia

Brazil

Canada

Chile

China

Colombia

Croatia

Cyprus

Denmark

Eurasian Patent Organization

European Patent Office

Hong Kong

Israel

Japan

Malaysia

Mexico

New Zealand

Norway

Peru

Philippines

Poland

Portugal

Serbia

Singapore

Slovenia

South Africa

South Korea

Spain

Taiwan

Ukraine

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering BYDUREON around the world.

Country	Patent Number	Title	Estimated Expiration
Slovenia	2069374
China	101065116	Poly (lactide-co-glycolide)-based sustained release microcapsules comprising a polypeptide and a sugar
Serbia	60258	FARMACEUTSKE FORMULACIJE KOJE SADRŽE HIDRAT PROPILEN GLIKOL DAPAGLIFLOZINA (PHARMACEUTICAL FORMULATIONS CONTAINING DAPAGLIFLOZIN PROPYLENE GLYCOL HYDRATE)
Taiwan	I411453

Supplementary Protection Certificates for BYDUREON

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1734971	C01734971/01	Switzerland		PRODUCT NAME: EXENATIDE; REGISTRATION NO/DATE: SWISSMEDIC 61629 17.02.2012
2139494	2020C/533	Belgium		PRODUCT NAME: QTERN -SAXAGLIPTINE ET DAPAGLIFLOZINE; AUTHORISATION NUMBER AND DATE: EU/1/16/1108 20160719
1506211	122014000070	Germany		PRODUCT NAME: KOMBINATION VON DAPAGLIFLOZIN ODER EINEM PHARMAZEUTISCH VERTRAEGLICHEN SALZ DAVON UND METFORMIN ODER EINEM PHARMAZEUTISCH VERTRAEGLICHEN SALZ DAVON, WIE DURCH DAS GRUNDPATENT GESCHUETZT; REGISTRATION NO/DATE: EU/1/13/900 20140116
1506211	PA 2013 008, C 1506211	Lithuania		PRODUCT NAME: DAPAGLIFLOZINUM; REGISTRATION NO/DATE: EU/1/12/795/001 - EU/1/12/795/010 20121112