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Serving hundreds of leading biopharmaceutical companies globally:

US Department of Justice
Daiichi Sankyo
McKesson
US Army
Fish and Richardson
AstraZeneca
Julphar
Deloitte
Mallinckrodt

Generated: August 15, 2018

DrugPatentWatch Database Preview

Exenatide - Generic Drug Details

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What are the generic drug sources for exenatide and what is the scope of exenatide freedom to operate?

Exenatide is the generic ingredient in four branded drugs marketed by Astrazeneca Ab and is included in three NDAs. There are thirty-eight patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Exenatide has three hundred and thirty-eight patent family members in thirty-two countries.

There are seven drug master file entries for exenatide. One supplier is listed for this compound.

Pharmacology for exenatide
Synonyms for exenatide
141758-74-9
286014-72-0
335149-21-8
9P1872D4OL
AC 2993
AC002993
AC2993A
AKOS015994651
AM000935
AM015948
Bydureon
Bydureon Pen
Byetta
CHEBI:64073
CS-1174
DA 3091
Ex4
exenatida
Exenatide [USAN:INN:BAN:JAN]
Exenatide; Exendin-4
exenatidum
Exendin 3 (Heloderma horridum), 2-glycine-3-L-glutamic acid-
Exendin 4
Exendin-4
H-His-Gly-Glu-Gly-xiThr-Phe-xiThr-Ser-Asp-Leu-Ser-Lys-Gln-Met-Glu-Glu-Glu-Ala-Val-Arg-Leu-Phe-xiIle-Glu-Trp-Leu-Lys-Asn-Gly-Gly-Pro-Ser-Ser-Gly-Ala-Pro-Pro-Pro-Ser-NH2
Heloderma suspectum gila monster exendin-4
His-Gly-Glu-Gly-Thr-Phe-Thr-Ser-Asp-Leu-Ser-Lys-Gln-Met-Glu-Glu-Glu-Ala-Val-Arg-Leu-Phe-Ile-Glu-Trp-Leu-Lys-Asn-Gly-Gly-Pro-Ser-Ser-Gly-Ala-Pro-Pro-Pro-Ser-NH2
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 exenatide

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 exenatide synthetic FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS 022200-001 Jan 27, 2012 RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Astrazeneca Ab BYETTA exenatide synthetic INJECTABLE;SUBCUTANEOUS 021773-001 Apr 28, 2005 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 ➤ 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 exenatide synthetic FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS 022200-001 Jan 27, 2012 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
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 exenatide

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Astrazeneca Ab BYDUREON BCISE exenatide SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS 209210-001 Oct 20, 2017 ➤ Try a Free Trial ➤ Try a Free Trial
Astrazeneca Ab BYDUREON BCISE exenatide SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS 209210-001 Oct 20, 2017 ➤ 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 exenatide

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
8,389,472 Exendin-4 to treat nonalcoholic steatohepatitis and nonalcoholic fatty liver disease ➤ Try a Free Trial
6,858,576 Methods for regulating gastrointestinal motility ➤ Try a Free Trial
6,989,366 Exendins, exendin agonists, and methods for their use ➤ Try a Free Trial
7,115,569 Exendins, exendin agonists, and methods for their use ➤ Try a Free Trial
7,138,375 Use of exendins and agonists thereof for lowering plasma lipid ➤ Try a Free Trial
7,157,555 Exendin agonist compounds ➤ Try a Free Trial
Patent No. Title Estimated Patent Expiration

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Supplementary Protection Certificates for exenatide

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0526 Netherlands ➤ Try a Free Trial PRODUCT NAME: EXENATIDE; REGISTRATION NO/DATE: EU/1/11/696/001-002 20110617
2007 00033 Denmark ➤ Try a Free Trial PRODUCT NAME: EXENATID, EXENDIN, EXENDINAGONISTER; REG. NO/DATE: EU/1/06/362/001-004 20061120
342 Luxembourg ➤ Try a Free Trial 91342, EXPIRES: 20211120
8 5006-2012 Slovakia ➤ Try a Free Trial PRODUCT NAME: EXENATID; REGISTRATION NO/DATE: EU/1/11/696/001 - EU/1/11/696/002 20110623
2012 00015 Denmark ➤ Try a Free Trial
0996459/01 Switzerland ➤ Try a Free Trial FORMER OWNER: AMYLIN PHARMACEUTICALS, INC., US
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

QuintilesIMS
Mallinckrodt
Julphar
Covington
Dow
Chinese Patent Office
Deloitte
Cantor Fitzgerald
Johnson and Johnson

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.