EXENATIDE SYNTHETIC - Generic Drug Details

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

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

Exenatide synthetic has four hundred and thirty-five patent family members in forty-eight countries.

One supplier is listed for this compound.

Summary for EXENATIDE SYNTHETIC

International Patents:	435
US Patents:	21
Tradenames:	4
Applicants:	1
NDAs:	3
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	7
Clinical Trials:	7
Patent Applications:	6,452
Formulation / Manufacturing:	see details
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for EXENATIDE SYNTHETIC
DailyMed Link:	EXENATIDE SYNTHETIC at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for EXENATIDE SYNTHETIC

Dosage:

FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS

Constraining patent/regulatory exclusivity:

INFORMATION ADDED TO SECTION 8.4 OF THE LABELING TO DESCRIBE THE RESULTS FROM PEDIATRIC STUDIES

Dosage:

INJECTABLE;SUBCUTANEOUS

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for EXENATIDE SYNTHETIC

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

Sponsor	Phase
Center for Neurology, Stockholm	Phase 2
Karolinska Institutet	Phase 2
Neuroscience Trials Australia	Phase 2

See all EXENATIDE SYNTHETIC clinical trials

Pharmacology for EXENATIDE SYNTHETIC

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

Paragraph IV (Patent) Challenges for EXENATIDE SYNTHETIC

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
BYETTA	Injection	exenatide synthetic	250 mg/mL, 1.2 mL and 2.4 mL prefilled syringe	021773	1	2014-06-11

US Patents and Regulatory Information for EXENATIDE SYNTHETIC

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		DISCN	Yes	No					Y
Astrazeneca Ab	BYDUREON PEN	exenatide synthetic	FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS	022200-002	Feb 28, 2014		DISCN	Yes	No					Y
Astrazeneca Ab	BYDUREON	exenatide synthetic	FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS	022200-001	Jan 27, 2012		DISCN	Yes	No					Y
Astrazeneca Ab	BYDUREON PEN	exenatide synthetic	FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS	022200-002	Feb 28, 2014		DISCN	Yes	No

Expired US Patents for EXENATIDE SYNTHETIC

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Astrazeneca Ab	BYETTA	exenatide synthetic	INJECTABLE;SUBCUTANEOUS	021773-001	Apr 28, 2005
Astrazeneca Ab	BYETTA	exenatide synthetic	INJECTABLE;SUBCUTANEOUS	021773-002	Apr 28, 2005
Astrazeneca Ab	BYDUREON	exenatide synthetic	FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS	022200-001	Jan 27, 2012
Astrazeneca Ab	BYDUREON	exenatide synthetic	FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS	022200-001	Jan 27, 2012

International Patents for EXENATIDE SYNTHETIC

Country	Patent Number	Title	Estimated Expiration
Ukraine	77306	С-АРИЛ ГЛЮКОЗИДНЫЕ ИНГИБИТОРЫ SGLT2 И СПОСОБ ИХ ПРИМЕНЕНИЯ;С-АРИЛ ГЛЮКОЗИДНІ SGLT2 ІНГІБІТОРИ ТА СПОСІБ ЇХ ЗАСТОСУВАННЯ (C-ARYL GLUCOSIDE SGLT2 INHIBITORS AND METHOD FOR THEIR USE)
Mexico	PA06011990	MICROCAPSULAS DE LIBERACION SOSTENIDA A BASE DE POLI(LACTIDO-CO-GLICOLIDO) QUE COMPRENDEN UN POLIPEPTIDO Y UN AZUCAR. (POLY (LACTIDE-CO-GLYCOLIDE)-BASED SUSTAINED RELEASE MICROCAPSULES COMPRISING A POLYPEPTIDE AND A SUGAR.)
Brazil	122017015098	formulações farmacêuticas de liberação imediata que contêm hidrato de propileno glicol de dapagliflozina
Poland	2347762

Supplementary Protection Certificates for EXENATIDE SYNTHETIC

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1734971	C01734971/01	Switzerland		PRODUCT NAME: EXENATIDE; REGISTRATION NO/DATE: SWISSMEDIC 61629 17.02.2012
1506211	122014000071	Germany		PRODUCT NAME: KOMBINATION VON DAPAGLIFLOZIN ODER EINEM PHARMAZEUTISCH VERTRAEGLICHEN SALZ DAVON, UND METFORMIN ODER EINEM PHARMAZEUTISCH VERTRAEGLICHEN SALZ DAVON, GESCHUETZT DURCH DAS GRUNDPATENT EP 1 506 211; REGISTRATION NO/DATE: EU/1/13/900 20140116
1506211	13C0022	France		PRODUCT NAME: DAPAGLIFLOZINE ET SES SELS PHARMACEUTIQUEMENT ACCEPTABLES; REGISTRATION NO/DATE: EU/1/12/795/001 20121112
0996459	SZ 31/2007	Austria		PRODUCT NAME: EXENATIDE