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-two 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 forty-five patent family members in forty-eight countries.

One supplier is listed for this compound.

Summary for exenatide synthetic

International Patents:	445
US Patents:	22
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
Karolinska Institutet	Phase 2
Center for Neurology, Stockholm	Phase 2
Monash University	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	exenatide synthetic	FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS	022200-001	Jan 27, 2012		DISCN	Yes	No
Astrazeneca Ab	BYDUREON BCISE	exenatide synthetic	SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS	209210-001	Oct 20, 2017		RX	Yes	Yes					Y
Astrazeneca Ab	BYDUREON BCISE	exenatide synthetic	SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS	209210-001	Oct 20, 2017		RX	Yes	Yes
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
Astrazeneca Ab	BYDUREON	exenatide synthetic	FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS	022200-001	Jan 27, 2012		DISCN	Yes	No					Y

Expired US Patents for exenatide synthetic

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Astrazeneca Ab	BYDUREON BCISE	exenatide synthetic	SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS	209210-001	Oct 20, 2017
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
Astrazeneca Ab	BYDUREON BCISE	exenatide synthetic	SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS	209210-001	Oct 20, 2017
Astrazeneca Ab	BYETTA	exenatide synthetic	INJECTABLE;SUBCUTANEOUS	021773-001	Apr 28, 2005
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
Poland	2508188
Israel	243317
Eurasian Patent Organization	020299	СОСТАВЫ С ЗАМЕДЛЕННЫМ ВЫСВОБОЖДЕНИЕМ, ПОЛУЧЕННЫЕ С ПРИМЕНЕНИЕМ НЕВОДНЫХ НОСИТЕЛЕЙ (SUSTAINED RELEASE FORMULATIONS USING NON-AQUEOUS CARRIERS)
Taiwan	I421245
Spain	2280759
Hungary	229446	C-ARYL GLUCOSIDE SGLT2 INHIBITORS AND THEIR USE

Supplementary Protection Certificates for exenatide synthetic

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1506211	PA 2013 008, C 1506211	Lithuania		PRODUCT NAME: DAPAGLIFLOZINUM; REGISTRATION NO/DATE: EU/1/12/795/001 - EU/1/12/795/010 20121112
1506211	588	Finland
2139494	C202030045	Spain		PRODUCT NAME: SAXAGLIPTINA + DAPAGLIFOZINA; NATIONAL AUTHORISATION NUMBER: EU/1/16/1108; DATE OF AUTHORISATION: 20160715; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/16/1108; DATE OF FIRST AUTHORISATION IN EEA: 20160715
1734971	CA 2012 00015	Denmark		PRODUCT NAME: EXENATIDE; REG. NO/DATE: EU/1/11/696/001-002 20110623
1506211	122014000070	Germany		PRODUCT NAME: KOMBINATION VON DAPAGLIFLOZIN ODER EINEM PHARMAZEUTISCH VERTRAEGLICHEN SALZ DAVON UND METFORMIN ODER EINEM PHARMAZEUTISCH VERTRAEGLICHEN SALZ DAVON, WIE DURCH DAS GRUNDPATENT GESCHUETZT; REGISTRATION NO/DATE: EU/1/13/900 20140116
2139494	SPC/GB20/028	United Kingdom		PRODUCT NAME: SAXAGLIPTIN AND DAPAGLIFLOZIN; REGISTERED: UK EU/1/16/1108 (NI) 20160719; UK PLGB 17901/0339 20160719