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Serving hundreds of leading biopharmaceutical companies globally:

QuintilesIMS
Accenture
US Department of Justice
Citi
Mallinckrodt
Chubb
US Army
McKinsey
Cerilliant

Generated: July 18, 2018

DrugPatentWatch Database Preview

BYDUREON PEN Drug 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 thirty-six patents protecting this drug.

This drug has five hundred and fifty-seven patent family members in forty-six countries.

The generic ingredient in BYDUREON PEN is exenatide synthetic. There are seven drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the exenatide synthetic profile page.
Summary for BYDUREON PEN
International Patents:557
US Patents:36
Applicants:1
NDAs:1
Suppliers / Packagers: 1
Bulk Api Vendors: 14
Clinical Trials: 27
Formulation / Manufacturing:see details
DailyMed Link:BYDUREON PEN at DailyMed
Drug patent expirations by year for BYDUREON PEN
Pharmacology for BYDUREON PEN
Synonyms for BYDUREON PEN
141758-74-9
286014-72-0
335149-21-8
9P1872D4OL
AC 2993
AC002993
AC2993A
AKOS015994651
Bydureon
Byetta
CS-1174
DA 3091
Exenatide
Exenatide [USAN:INN:BAN:JAN]
Exenatide; Exendin-4
Exendin 3 (Heloderma horridum), 2-glycine-3-L-glutamic acid-
Exendin 4
Exendin-4
HS-2012
HSDB 7789
HY-13443
ITCA 650
LY 2148568
MolPort-009-194-177
PT302
SCHEMBL14634818
UNII-9P1872D4OL
Y-100006

US Patents and Regulatory Information for BYDUREON PEN

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 RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Astrazeneca Ab BYDUREON PEN exenatide synthetic FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS 022200-002 Feb 28, 2014 RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Astrazeneca Ab BYDUREON PEN exenatide synthetic FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS 022200-002 Feb 28, 2014 RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Astrazeneca Ab BYDUREON PEN exenatide synthetic FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS 022200-002 Feb 28, 2014 RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration

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Expired US Patents for BYDUREON PEN

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 ➤ Try a Free Trial ➤ Try a Free Trial
Astrazeneca Ab BYDUREON PEN exenatide synthetic FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS 022200-002 Feb 28, 2014 ➤ Try a Free Trial ➤ Try a Free Trial
Astrazeneca Ab BYDUREON PEN exenatide synthetic FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS 022200-002 Feb 28, 2014 ➤ Try a Free Trial ➤ Try a Free Trial
Astrazeneca Ab BYDUREON PEN exenatide synthetic FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS 022200-002 Feb 28, 2014 ➤ Try a Free Trial ➤ Try a Free Trial
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Non-Orange Book US Patents for BYDUREON PEN

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
7,407,932 Methods for glucagon suppression using modified exendins ➤ Try a Free Trial
7,223,725 Exendin agonist compounds ➤ Try a Free Trial
7,521,423 Exendin pharmaceutical compositions ➤ Try a Free Trial
7,524,530 Residual solvent extraction method and microparticles produced thereby ➤ Try a Free Trial
Patent No. Title Estimated Patent Expiration

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Supplementary Protection Certificates for BYDUREON PEN

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0140021 00131 Estonia ➤ Try a Free Trial PRODUCT NAME: DAPAGLIFLOSIIN/METFORMIIN;REG NO/DATE: K(2014)308 (LOPLIK) 21.01.2014
00526 Netherlands ➤ Try a Free Trial PRODUCT NAME: EXENATIDE; REGISTRATION NO/DATE: EU/1/11/696/001-002 20110617
1734971/01 Switzerland ➤ Try a Free Trial PRODUCT NAME: EXENATIDE; REGISTRATION NO/DATE: SWISSMEDIC 61629 17.02.2012
0120006 00104 Estonia ➤ Try a Free Trial PRODUCT NAME: EKSENATIID;REG NO/DATE: K(2011)4479 LOPLIK 23.06.2011
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

Cantor Fitzgerald
Covington
Moodys
Express Scripts
Healthtrust
Argus Health
Chubb
Mallinckrodt
McKesson

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