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Last Updated: October 18, 2019

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Exenatide - Generic Drug Details

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What are the generic drug sources for exenatide and what is the scope of 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-six patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Exenatide has four hundred and eighty-two patent family members in forty-seven countries.

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

Recent Clinical Trials for exenatide

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

SponsorPhase
University of Colorado, DenverPhase 2/Phase 3
Central Hospital, Nancy, FrancePhase 4
Peking Union Medical College HospitalPhase 4

See all exenatide clinical trials

Recent Litigation for exenatide

Identify potential future generic entrants

District Court Litigation
Case NameDate
Alkermes Pharma Ireland Limited v. Luye Pharma Group Ltd.2019-07-17
AstraZeneca AB v. Zydus Pharmaceuticals (USA) Inc.2018-05-01
MITSUBISHI TANABE PHARMA CORPORATION v. LUPIN LIMITED2018-01-09

See all exenatide litigation

PTAB Litigation
PetitionerDate
Luye Pharma Group Ltd.2016-05-31

See all exenatide litigation

Pharmacology for exenatide
Synonyms for exenatide
141732-76-5
141758-74-9
286014-72-0
335149-21-8
9P1872D4OL
AC 2993
AKOS015994651
AKOS034831545
Bydureon
Bydureon Pen
CHEBI:64073
DA 3091
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
ITCA 650
LY 2148568
MolPort-009-194-177
PT302
SCHEMBL14634818
SCHEMBL20509814
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 PEN exenatide synthetic FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS 022200-002 Feb 28, 2014 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Astrazeneca Ab BYDUREON BCISE exenatide SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS 209210-001 Oct 20, 2017 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Astrazeneca Ab BYETTA exenatide synthetic INJECTABLE;SUBCUTANEOUS 021773-002 Apr 28, 2005 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Astrazeneca Ab BYDUREON BCISE exenatide SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS 209210-001 Oct 20, 2017 RX Yes Yes   Start Trial   Start Trial   Start Trial
>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 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   Start Trial   Start Trial
Astrazeneca Ab BYDUREON BCISE exenatide SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS 209210-001 Oct 20, 2017   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Supplementary Protection Certificates for exenatide

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0996459 SZ 31/2007 Austria   Start Trial PRODUCT NAME: EXENATIDE
1506211 13C0022 France   Start Trial PRODUCT NAME: DAPAGLIFLOZINE ET SES SELS PHARMACEUTIQUEMENT ACCEPTABLES; REGISTRATION NO/DATE: EU/1/12/795/001 20121112
1506211 PA2013008,C1506211 Lithuania   Start Trial PRODUCT NAME: DAPAGLIFLOZINUM; REGISTRATION NO/DATE: EU/1/12/795/001 - EU/1/12/795/010 20121112
1734971 C01734971/01 Switzerland   Start Trial PRODUCT NAME: EXENATIDE; REGISTRATION NO/DATE: SWISSMEDIC 61629 17.02.2012
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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AstraZeneca

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