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Serving hundreds of leading biopharmaceutical companies globally:

Mallinckrodt
UBS
McKinsey
Julphar
McKesson
Baxter
Federal Trade Commission
Healthtrust
Argus Health

Generated: April 19, 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.
Summary for exenatide
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 ➤ 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 ➤ 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 exenatide synthetic FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS 022200-001 Jan 27, 2012 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
6,495,164 Preparation of injectable suspensions having improved injectability ➤ Try a Free Trial
8,617,613 Polymer-based sustained release device ➤ Try a Free Trial
7,858,740 Exendin agonist compounds ➤ Try a Free Trial
8,026,210 Exendins and exendin agonist analogs to regulate gastrointestinal motility ➤ 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
2012000028 Germany ➤ Try a Free Trial PRODUCT NAME: BYDUREON-EXENATIDE; REGISTRATION NO/DATE: EU/1/11/696/001-002 20110617
2007 00034 Denmark ➤ Try a Free Trial
0526 Netherlands ➤ Try a Free Trial PRODUCT NAME: EXENATIDE; REGISTRATION NO/DATE: EU/1/11/696/001-002 20110617
/2012 Austria ➤ Try a Free Trial PRODUCT NAME: EXENATID; REGISTRATION NO/DATE: EU/1/11/696/001-002 (MITTEILUNG) 20110623
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

Cantor Fitzgerald
Teva
Moodys
Dow
Chinese Patent Office
Fuji
Citi
QuintilesIMS
Cipla

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.