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Last Updated: April 19, 2024

EXENATIDE SYNTHETIC - Generic Drug Details

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What are the generic drug sources for exenatide synthetic and what is the scope of patent protection?

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

Generic Entry Dates for EXENATIDE SYNTHETIC^: ⤷ Try a Trial* Constraining patent/regulatory exclusivity: ⤷ Try a Trial Dosage: FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS
Generic Entry Dates for EXENATIDE SYNTHETIC^: ⤷ Try a Trial* 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

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Glossary

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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	⤷ Try a Trial	⤷ Try a Trial			Y	⤷ Try a Trial
Astrazeneca Ab	BYETTA	exenatide synthetic	INJECTABLE;SUBCUTANEOUS	021773-002	Apr 28, 2005		RX	Yes	Yes	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Astrazeneca Ab	BYDUREON PEN	exenatide synthetic	FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS	022200-002	Feb 28, 2014		DISCN	Yes	No	⤷ Try a Trial	⤷ Try a Trial			Y	⤷ Try a Trial
Astrazeneca Ab	BYDUREON PEN	exenatide synthetic	FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS	022200-002	Feb 28, 2014		DISCN	Yes	No	⤷ Try a Trial	⤷ Try a Trial			Y	⤷ Try a Trial
Astrazeneca Ab	BYDUREON PEN	exenatide synthetic	FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS	022200-002	Feb 28, 2014		DISCN	Yes	No	⤷ Try a Trial	⤷ Try a Trial			Y	⤷ Try a Trial
Astrazeneca Ab	BYDUREON PEN	exenatide synthetic	FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS	022200-002	Feb 28, 2014		DISCN	Yes	No	⤷ Try a Trial	⤷ Try a Trial			Y	⤷ Try a Trial
Astrazeneca Ab	BYDUREON PEN	exenatide synthetic	FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS	022200-002	Feb 28, 2014		DISCN	Yes	No	⤷ Try a Trial	⤷ Try a Trial			Y	⤷ Try a 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 SYNTHETIC

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Astrazeneca Ab	BYDUREON	exenatide synthetic	FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS	022200-001	Jan 27, 2012	⤷ Try a Trial	⤷ Try a Trial
Astrazeneca Ab	BYDUREON BCISE	exenatide synthetic	SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS	209210-001	Oct 20, 2017	⤷ Try a Trial	⤷ Try a Trial
Astrazeneca Ab	BYDUREON	exenatide synthetic	FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS	022200-001	Jan 27, 2012	⤷ Try a Trial	⤷ Try a Trial
Astrazeneca Ab	BYDUREON	exenatide synthetic	FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS	022200-001	Jan 27, 2012	⤷ Try a Trial	⤷ Try a Trial
Astrazeneca Ab	BYDUREON BCISE	exenatide synthetic	SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS	209210-001	Oct 20, 2017	⤷ Try a Trial	⤷ Try a Trial
Astrazeneca Ab	BYDUREON BCISE	exenatide synthetic	SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS	209210-001	Oct 20, 2017	⤷ Try a Trial	⤷ Try a Trial
Astrazeneca Ab	BYDUREON PEN	exenatide synthetic	FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS	022200-002	Feb 28, 2014	⤷ Try a Trial	⤷ Try a Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

International Patents for EXENATIDE SYNTHETIC

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Country	Patent Number	Title	Estimated Expiration
Malaysia	148566	CRYSTALLINE SOLVATES AND COMPLEXES OF (IS) -1, 5- ANHYDRO-1 -C-(3-( (PHENYL) METHYL) PHENYL) -D-GLUCITOL DERIVATIVES WITH AMINO ACIDS AS SGLT2 INHIBITORS FOR THE TREATMENT OF DIABETES	⤷ Try a Trial
Russian Federation	2013115635	СПОСОБЫ ПОЛУЧЕНИЯ И ИСПОЛЬЗОВАНИЯ ИНГИБИТОРА SGLT2	⤷ Try a Trial
Norway	20065213		⤷ Try a Trial
Brazil	122017015091	compostos intermediários para inibidores de c-aril glicosídeo sglt2	⤷ Try a Trial
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)	⤷ Try a Trial
Slovenia	2139494		⤷ Try a Trial
Poland	2139494		⤷ Try a Trial
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for EXENATIDE SYNTHETIC

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1506211	1390017-0	Sweden	⤷ Try a Trial	PRODUCT NAME: DAPAGLIFLOZIN OCH FARMACEUTISKT GODTAGBARA SALTER DAERAV; REG. NO/DATE: EU/1/12/795/001 20121112
2139494	C202030045	Spain	⤷ Try a Trial	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
1140145	SZ 30/2007	Austria	⤷ Try a Trial	PRODUCT NAME: EXENATIDE
2139494	34/2020	Austria	⤷ Try a Trial	PRODUCT NAME: DAPAGLIFLOZIN PROPYLENGYLKOL HYDRAT/SAXAGLIPTIN; REGISTRATION NO/DATE: EU/1/16/1108 (MITTEILUNG) 20160715
1734971	C01734971/01	Switzerland	⤷ Try a Trial	PRODUCT NAME: EXENATIDE; REGISTRATION NO/DATE: SWISSMEDIC 61629 17.02.2012
1734971	16/2012	Austria	⤷ Try a Trial	PRODUCT NAME: EXENATID; REGISTRATION NO/DATE: EU/1/11/696/001-002 (MITTEILUNG) 20110623
2139494	132020000000115	Italy	⤷ Try a Trial	PRODUCT NAME: SAXAGLIPTIN E DAPAGLIFLOZIN(QTERN); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/16/1108, 20160719
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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