BYDUREON PEN Drug Patent Profile

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Which patents cover Bydureon Pen, and what generic alternatives are available?

Bydureon Pen is a drug marketed by Astrazeneca Ab and is included in one NDA. There are twenty patents protecting this drug.

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

The generic ingredient in BYDUREON PEN 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.

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Summary for BYDUREON PEN

International Patents:	408
US Patents:	20
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	39
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for BYDUREON PEN
DailyMed Link:	BYDUREON PEN at DailyMed

Drug patent expirations by year for BYDUREON PEN

Recent Clinical Trials for BYDUREON PEN

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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 PEN clinical trials

US Patents and Regulatory Information for BYDUREON PEN

BYDUREON PEN is protected by twenty US patents and two FDA Regulatory Exclusivities.

Patents protecting BYDUREON PEN

C-aryl glucoside SGLT2 inhibitors and method
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Polymer-based sustained release device
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Administering apparatus with functional drive element
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Methods for treating diabetes and reducing body weight
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Pharmaceutical formulations containing an SGLT2 inhibitor
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Polymer-based sustained release device
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Device for administering fluid from a multi-chamber ampoule in incremental steps
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Polymer-based sustained release device
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Crystal structures of SGLT2 inhibitors and processes for preparing same
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Mixing device for a two-chamber ampoule
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Ampoule comprising an ampoule holder
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Administering apparatus with functional drive element
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Administering device with holding mechanism
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Method for treating diabetes
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Ampoule comprising an ampoule holder
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Polymer-based sustained release device
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Method for administering a fluid active substance from a multi-chamber ampoule
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Methods for treating diabetes and reducing body weight
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FDA Regulatory Exclusivity protecting BYDUREON PEN

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PEDIATRIC EXCLUSIVITY
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Glossary

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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	⤷ Sign Up	⤷ Sign Up			Y	⤷ Sign Up
Astrazeneca Ab	BYDUREON PEN	exenatide synthetic	FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS	022200-002	Feb 28, 2014		DISCN	Yes	No	⤷ Sign Up	⤷ Sign Up			Y	⤷ Sign Up
Astrazeneca Ab	BYDUREON PEN	exenatide synthetic	FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS	022200-002	Feb 28, 2014		DISCN	Yes	No	⤷ Sign Up	⤷ Sign Up			Y	⤷ Sign Up
Astrazeneca Ab	BYDUREON PEN	exenatide synthetic	FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS	022200-002	Feb 28, 2014		DISCN	Yes	No	⤷ Sign Up	⤷ Sign Up			Y	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

Expired US Patents for BYDUREON PEN

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Astrazeneca Ab	BYDUREON PEN	exenatide synthetic	FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS	022200-002	Feb 28, 2014	⤷ Sign Up	⤷ Sign Up
Astrazeneca Ab	BYDUREON PEN	exenatide synthetic	FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS	022200-002	Feb 28, 2014	⤷ Sign Up	⤷ Sign Up
Astrazeneca Ab	BYDUREON PEN	exenatide synthetic	FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS	022200-002	Feb 28, 2014	⤷ Sign Up	⤷ Sign Up
Astrazeneca Ab	BYDUREON PEN	exenatide synthetic	FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS	022200-002	Feb 28, 2014	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

International Patents for BYDUREON PEN

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

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Country	Patent Number	Title	Estimated Expiration
Taiwan	I310770		⤷ Sign Up
Austria	E531374		⤷ Sign Up
Australia	2006283517	Exendin for treating diabetes and reducing body weight	⤷ Sign Up
World Intellectual Property Organization (WIPO)	2008002824		⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for BYDUREON PEN

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1506211	C 2013 012	Romania	⤷ Sign Up	PRODUCT NAME: DAPAGLIFLOZIN SI SARURILE ACCEPTABILE FARMACEUTIC ALEACESTUIA (2S, 3R, 4R, 5S, 6R)-2-[4-CLOR-3-(4-ETOXIBENZIL)FENIL]-6-(HIDROXIMETIL)TETRAHIDRO-2H-PIRAN-3,4,5-TRIOL; NATIONAL AUTHORISATION NUMBER: RO EU/1/12/795/001, RO EU/1/12/795/002, RO EU/1/12/795/003, RO EU/1/12/795/004, RO EU/1/12/795/005, RO EU/1/12/795/006, RO EU/1/12/795/007, RO EU/1/12/795/008, RO EU/1/12/795/009, RO EU/1/12/795/001/010; DATE OF NATIONAL AUTHORISATION: 20121112; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EMEA EU/1/12/795/001, EMEA EU/1/12/795/002, EMEA EU/1/12/795/003, EMEA EU/1/12/795/004, EMEA EU/1/12/795/005, EMEA EU/1/12/795/006, EMEA EU/1/12/795/007, EMEA EU/1/12/795/008 [...]
1506211	PA2013008	Lithuania	⤷ Sign Up	PRODUCT NAME: DAPAGLIFLOZINUM; REGISTRATION NO/DATE: EU/1/12/795/001 - EU/1/12/795/010 20121112
1734971	PA2012006	Lithuania	⤷ Sign Up	PRODUCT NAME: EXENATIDUM; REGISTRATION NO/DATE: EU/1/11/696/001 - EU/1/11/696/002 20110617
1734971	CA 2012 00015	Denmark	⤷ Sign Up	PRODUCT NAME: EXENATIDE; REG. NO/DATE: EU/1/11/696/001-002 20110623
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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Summary for BYDUREON PEN

Recent Clinical Trials for BYDUREON PEN

Patents protecting BYDUREON PEN

FDA Regulatory Exclusivity protecting BYDUREON PEN

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