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Last Updated: May 24, 2024

Exenatide synthetic - Generic Drug Details

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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-six patent family members in forty-eight countries.

One supplier is listed for this compound.

Summary for exenatide synthetic

International Patents:	436
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^: ⤷ Sign Up* Constraining patent/regulatory exclusivity: ⤷ Sign Up Dosage: FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS
Generic Entry Dates for exenatide synthetic^: ⤷ Sign Up* 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

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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	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Astrazeneca Ab	BYDUREON	exenatide synthetic	FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS	022200-001	Jan 27, 2012		DISCN	Yes	No	⤷ Sign Up	⤷ Sign Up			Y	⤷ Sign Up
Astrazeneca Ab	BYDUREON PEN	exenatide synthetic	FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS	022200-002	Feb 28, 2014		DISCN	Yes	No	⤷ Sign Up	⤷ Sign Up			Y	⤷ Sign Up
Astrazeneca Ab	BYETTA	exenatide synthetic	INJECTABLE;SUBCUTANEOUS	021773-002	Apr 28, 2005		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Astrazeneca Ab	BYDUREON BCISE	exenatide synthetic	SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS	209210-001	Oct 20, 2017		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up			Y	⤷ Sign Up
Astrazeneca Ab	BYDUREON PEN	exenatide synthetic	FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS	022200-002	Feb 28, 2014		DISCN	Yes	No	⤷ Sign Up	⤷ Sign Up			Y	⤷ Sign Up
Astrazeneca Ab	BYDUREON PEN	exenatide synthetic	FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS	022200-002	Feb 28, 2014		DISCN	Yes	No	⤷ Sign Up	⤷ Sign Up			Y	⤷ Sign Up
>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 PEN	exenatide synthetic	FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS	022200-002	Feb 28, 2014	⤷ Sign Up	⤷ Sign Up
Astrazeneca Ab	BYDUREON PEN	exenatide synthetic	FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS	022200-002	Feb 28, 2014	⤷ Sign Up	⤷ Sign Up
Astrazeneca Ab	BYDUREON PEN	exenatide synthetic	FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS	022200-002	Feb 28, 2014	⤷ Sign Up	⤷ Sign Up
Astrazeneca Ab	BYETTA	exenatide synthetic	INJECTABLE;SUBCUTANEOUS	021773-002	Apr 28, 2005	⤷ Sign Up	⤷ Sign Up
Astrazeneca Ab	BYDUREON BCISE	exenatide synthetic	SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS	209210-001	Oct 20, 2017	⤷ Sign Up	⤷ Sign Up
Astrazeneca Ab	BYDUREON PEN	exenatide synthetic	FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS	022200-002	Feb 28, 2014	⤷ Sign Up	⤷ Sign Up
Astrazeneca Ab	BYDUREON PEN	exenatide synthetic	FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS	022200-002	Feb 28, 2014	⤷ Sign Up	⤷ Sign Up
>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
Brazil	PI0014722	compostos inibidores de sglt2, composição farmacêutica e uso dos referidos compostos	⤷ Sign Up
Japan	5313889		⤷ Sign Up
Cyprus	1116337		⤷ Sign Up
Peru	20120776	ESTRUCTURAS CRISTALINAS DE DAPAGLIFLOZIN Y SUS PROCESOS DE PREPARACION	⤷ Sign Up
South Korea	20140124874	다파글리플로진 프로필렌 글리콜 수화물을 함유하는 제약 제형 (PHARMACEUTICAL FORMULATIONS CONTAINING DAPAGLIFLOZIN PROPYLENE GLYCOL HYDRATE)	⤷ Sign Up
Australia	2003237886	C-ARYL GLUCOSIDE SGLT2 INHIBITORS AND METHOD	⤷ Sign Up
Canada	2929811	PREPARATIONS PHARMACEUTIQUES CONTENANT DE L'HYDRATE DE PROPYLENEGLYCOL DE DAPAGLIFLOZINE (PHARMACEUTICAL FORMULATIONS CONTAINING DAPAGLIFLOZIN PROPYLENE GLYCOL HYDRATE)	⤷ Sign Up
>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	C300677	Netherlands	⤷ Sign Up	PRODUCT NAME: COMBINATIE VAN DAPAGLIFLOZINE OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN EN METFORMINE OF EEN FARMACEITISCH AANVAARDBAAR ZOUT DAARVAN, ZOALS BESCHERMD DOOR HET BASISOCTROOI EP 1506211B1; REGISTRATION NO/DATE: EU/1/13/900 20140121
1506211	92182	Luxembourg	⤷ Sign Up	PRODUCT NAME: DAPAGLIFLOZINE ET SES SELS PHARMACEUTIQUEMENT ACCEPTABLES
1734971	C20120006 00104	Estonia	⤷ Sign Up	PRODUCT NAME: EKSENATIID;REG NO/DATE: K(2011)4479 LOPLIK 23.06.2011
1140145	SZ 30/2007	Austria	⤷ Sign Up	PRODUCT NAME: EXENATIDE
1734971	2012C/017	Belgium	⤷ Sign Up	PRODUCT NAME: EXENATIDE; AUTHORISATION NUMBER AND DATE: EU/1/11/696/001 20110617
1734971	91989	Luxembourg	⤷ Sign Up	91989, EXPIRES: 20260617
1506211	PA2014026	Lithuania	⤷ Sign Up	PRODUCT NAME: DAPAGLIFOZINUM + METFORMINUM; REGISTRATION NO/DATE: EU/1/13/900 20140116
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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