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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 patent protection?

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-eight patent family members in forty-seven countries.

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

Summary for exenatide

International Patents:	488
US Patents:	36
Tradenames:	4
Applicants:	1
NDAs:	3
Drug Master File Entries:	7
Suppliers / Packagers:	1
Bulk Api Vendors:	17
Clinical Trials:	272
Patent Applications:	7
Formulation / Manufacturing:	see details
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for exenatide
DailyMed Link:	exenatide at DailyMed

Recent Clinical Trials for exenatide

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

Sponsor	Phase
Dasman Diabetes Institute	Phase 4
University of Colorado, Denver	Phase 2/Phase 3
Central Hospital, Nancy, France	Phase 4

See all exenatide clinical trials

Recent Litigation for exenatide

Identify potential future generic entrants

District Court Litigation

Case Name	Date
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 LIMITED	2018-01-09

See all exenatide litigation

PTAB Litigation

Petitioner	Date
Luye Pharma Group Ltd.	2016-05-31

See all exenatide litigation

Pharmacology for exenatide

Drug Class	GLP-1 Receptor Agonist
Mechanism of Action	Glucagon-like Peptide-1 (GLP-1) Agonists

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	BYETTA	exenatide synthetic	INJECTABLE;SUBCUTANEOUS	021773-001	Apr 28, 2005		RX	Yes	Yes			Y
Astrazeneca Ab	BYDUREON PEN	exenatide synthetic	FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS	022200-002	Feb 28, 2014		RX	Yes	Yes			Y
Astrazeneca Ab	BYDUREON BCISE	exenatide	SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS	209210-001	Oct 20, 2017		RX	Yes	Yes			Y		Y
Astrazeneca Ab	BYDUREON PEN	exenatide synthetic	FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS	022200-002	Feb 28, 2014		RX	Yes	Yes			Y
Astrazeneca Ab	BYDUREON BCISE	exenatide	SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS	209210-001	Oct 20, 2017		RX	Yes	Yes			Y		Y
Astrazeneca Ab	BYDUREON BCISE	exenatide	SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS	209210-001	Oct 20, 2017		RX	Yes	Yes
Astrazeneca Ab	BYDUREON BCISE	exenatide	SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS	209210-001	Oct 20, 2017		RX	Yes	Yes			Y

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
Astrazeneca Ab	BYDUREON BCISE	exenatide	SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS	209210-001	Oct 20, 2017

International Patents for exenatide

Country	Patent Number	Estimated Expiration
Australia	2013205769
Slovenia	2069374
Denmark	1246638
Portugal	1971362
World Intellectual Property Organization (WIPO)	03020245
European Patent Office	2283820
European Patent Office	1609478

Supplementary Protection Certificates for exenatide

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1506211	2013/013	Ireland		PRODUCT NAME: DAPAGLIFLOZIN AND PHARACEUTICALLY ACCEPTABLE SALTS THREOF; REGISTRATION NO/DATE: EU/1/12/795/001-010 20121112
1140145	CA 2007 00033	Denmark		PRODUCT NAME: EXENATID, EXENDIN, EXENDINAGONISTER; REG. NO/DATE: EU/1/06/362/001-004 20061120
1734971	2012C/017	Belgium		PRODUCT NAME: BYDUREON-EXENATIDE; AUTHORISATION NUMBER AND DATE: EU/1/11/696/001 20110617
1506211	CR 2014 00037	Denmark		PRODUCT NAME: ET KOMBINATIONSPRODUKT AF DAPAGLIFLOZIN ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF, HERUNDER DAPAGLIFLOZINPROPANDIOLMONOHYDRAT OG METFORMIN ELLER SALTE DERAF, HERUNDER METFORMINHYDROCHLORID; REG. NO/DATE: EU/1/13/900 20140116
1506211	PA2013008	Lithuania		PRODUCT NAME: DAPAGLIFLOZINUM; REGISTRATION NO/DATE: EU/1/12/795/001 - EU/1/12/795/010 20121112
1506211	SPC/GB13/021	United Kingdom		PRODUCT NAME: DAPAGLIFLOZIN AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF; REGISTERED: UK EU/1/12/795/001 20121114; UK EU/1/12/795/002 20121114; UK EU/1/12/795/003 20121114; UK EU/1/12/795/004 20121114; UK EU/1/12/795/005 20121114; UK EU/1/12/795/006 20121114; UK EU/1/12/795/007 20121114; UK EU/1/12/795/008 20121114; UK EU/1/12/795/009 20121114; UK EU/1/12/795/010 20121114
1734971	CA 2012 00015	Denmark