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
National Health and Medical Research Council, 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 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	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
>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	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	exenatide synthetic	FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS	022200-001	Jan 27, 2012	⤷ 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
World Intellectual Property Organization (WIPO)	2008116179		⤷ Sign Up
Israel	214181	סולבטים גבישיים וקומפלקסים של נגזרות -1,51)(s-אנהידרו(3--1-c-((פניל)מתיל)פניל)-d-גלוציטול עם חומצות אמינו המשמשים כמעכבי 2sglt עבור הטיפול בסוכרת (Crystalline solvates and complexes of (1s)-1,5-anhydro-1-c-(3-((phenyl)methyl)phenyl)-d-glucitol derivatives with amino acids as sglt2 inhibitors for the treatment of diabetes)	⤷ Sign Up
Croatia	P20110831		⤷ Sign Up
China	101687080	Device for administering a fluid active substance from a multi-chamber ampoule	⤷ Sign Up
Cyprus	1123143		⤷ 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	92182	Luxembourg	⤷ Sign Up	PRODUCT NAME: DAPAGLIFLOZINE ET SES SELS PHARMACEUTIQUEMENT ACCEPTABLES
1734971	122012000028	Germany	⤷ Sign Up	PRODUCT NAME: BYDUREON-EXENATIDE; REGISTRATION NO/DATE: EU/1/11/696/001-002 20110617
1140145	SZ 30/2007	Austria	⤷ Sign Up	PRODUCT NAME: EXENATIDE
1506211	1390017-0	Sweden	⤷ Sign Up	PRODUCT NAME: DAPAGLIFLOZIN OCH FARMACEUTISKT GODTAGBARA SALTER DAERAV; REG. NO/DATE: EU/1/12/795/001 20121112
1506211	PA2013008,C1506211	Lithuania	⤷ Sign Up	PRODUCT NAME: DAPAGLIFLOZINUM; REGISTRATION NO/DATE: EU/1/12/795/001 - EU/1/12/795/010 20121112
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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