Exenatide synthetic - Generic Drug Details

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What are the generic 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-nine patent family members in forty-eight countries.

One supplier is listed for this compound.

Summary for exenatide synthetic

International Patents:	439
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
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

Anatomical Therapeutic Chemical (ATC) Classes for exenatide synthetic

A10BJ	Glucagon-like peptide-1 (GLP-1) analogues
A10B	BLOOD GLUCOSE LOWERING DRUGS, EXCL. INSULINS
A10	DRUGS USED IN DIABETES
A	Alimentary tract and metabolism

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			Y	⤷ 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	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
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 BCISE	exenatide synthetic	SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS	209210-001	Oct 20, 2017		RX	Yes	Yes	⤷ 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	BYETTA	exenatide synthetic	INJECTABLE;SUBCUTANEOUS	021773-002	Apr 28, 2005	⤷ Sign Up	⤷ Sign Up
Astrazeneca Ab	BYETTA	exenatide synthetic	INJECTABLE;SUBCUTANEOUS	021773-001	Apr 28, 2005	⤷ Sign Up	⤷ Sign Up
Astrazeneca Ab	BYDUREON	exenatide synthetic	FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS	022200-001	Jan 27, 2012	⤷ 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 BCISE	exenatide synthetic	SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS	209210-001	Oct 20, 2017	⤷ Sign Up	⤷ Sign Up
Astrazeneca Ab	BYDUREON	exenatide synthetic	FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS	022200-001	Jan 27, 2012	⤷ Sign Up	⤷ Sign Up
Astrazeneca Ab	BYDUREON BCISE	exenatide synthetic	SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS	209210-001	Oct 20, 2017	⤷ 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
Canada	2653344	SOLVATES CRISTALLINS ET COMPLEXES DE DERIVES DE (IS)-1,5-ANHYDRO-L-C-{3-[(PHENYL)METHYL]PHENYL}-D-GLUCITOL AVEC DES ACIDES AMINES EN TANT QU'INHIBITEURS DE SGLT2 POUR LE TRAITEMENT DU DIABETE (CRYSTALLINE SOLVATES AND COMPLEXES OF (IS) -1, 5-ANHYDRO-1-C- (3- ( (PHENYL) METHYL) PHENYL) -D-GLUCITOL DERIVATIVES WITH AMINO ACIDS ASSGLT2 INHIBITORS FOR THE TREATMENT OF DIABETES)	⤷ Sign Up
China	102164597	Sustained release formulations using non-aqueous carriers	⤷ Sign Up
Israel	148806	C-ARYL GLUCOSIDE DERIVATIVES AND PHARMACEUTICAL COMPOSITIONS CONTAINING THE SAME	⤷ Sign Up
Eurasian Patent Organization	201490902	КРИСТАЛЛИЧЕСКИЕ СОЛЬВАТЫ И КОМПЛЕКСЫ ПРОИЗВОДНЫХ (1S)-1,5-АНГИДРО-1-C-(3-((ФЕНИЛ)МЕТИЛ)ФЕНИЛ)-D-ГЛЮЦИТОЛА С АМИНОКИСЛОТАМИ В КАЧЕСТВЕ ИНГИБИТОРОВ SGLT2 ДЛЯ ЛЕЧЕНИЯ ДИАБЕТА	⤷ Sign Up
Brazil	PI0509946	microcápsulas de liberação prolongada com base em poli(lactìdeo-co-glicolìdeo) compreendendo um polipeptìdeo e um açúcar	⤷ Sign Up
Japan	5980872		⤷ Sign Up
China	105056211	Exendin for treating diabetes and reducing body weight	⤷ 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
2139494	C20200028 00358	Estonia	⤷ Sign Up	PRODUCT NAME: SAKSAGLIPTIIN JA DAPAGLIFLOSIIN;REG NO/DATE: EU/1/16/1108; 19.07.2016
1506211	13C0022	France	⤷ Sign Up	PRODUCT NAME: DAPAGLIFLOZINE ET SES SELS PHARMACEUTIQUEMENT ACCEPTABLES; REGISTRATION NO/DATE: EU/1/12/795/001 20121112
2139494	122020000043	Germany	⤷ Sign Up	PRODUCT NAME: SAXAGLIPTIN UND DAPAGLIFLOZIN; REGISTRATION NO/DATE: EU/1/16/1108 20160715
1506211	1390017-0	Sweden	⤷ Sign Up	PRODUCT NAME: DAPAGLIFLOZIN OCH FARMACEUTISKT GODTAGBARA SALTER DAERAV; REG. NO/DATE: EU/1/12/795/001 20121112
1506211	300677	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	CA 2014 00037	Denmark	⤷ Sign Up	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
1734971	16/2012	Austria	⤷ Sign Up	PRODUCT NAME: EXENATID; REGISTRATION NO/DATE: EU/1/11/696/001-002 (MITTEILUNG) 20110623
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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