BYETTA Drug Patent Profile

When do Byetta patents expire, and when can generic versions of Byetta launch?

Byetta is a drug marketed by Astrazeneca Ab and is included in one NDA.

The generic ingredient in BYETTA is exenatide synthetic. There are seven drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the exenatide synthetic profile page.

Summary for BYETTA

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	22
Clinical Trials:	123
Patent Applications:	7
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for BYETTA
Drug Sales Revenues:	Drug sales revenues for BYETTA
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for BYETTA
What excipients (inactive ingredients) are in BYETTA?	BYETTA excipients list
DailyMed Link:	BYETTA at DailyMed

See drug prices for BYETTA

See drug sales revenues for BYETTA

DrugPatentWatch^® Estimated Generic Entry Opportunity Date for BYETTA

Constraining patent/regulatory exclusivity:

INFORMATION ADDED TO SECTION 8.4 OF THE LABELING TO DESCRIBE THE RESULTS FROM PEDIATRIC STUDIES

NDA:

021773

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 BYETTA

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Consano Clinical Research, LLC	Phase 4
National Institute on Alcohol Abuse and Alcoholism (NIAAA)	Phase 1
Boston Medical Center	Phase 1

See all BYETTA clinical trials

Anatomical Therapeutic Chemical (ATC) Classes for BYETTA

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 BYETTA

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 BYETTA

BYETTA is protected by zero US patents and one FDA Regulatory Exclusivity.

This potential generic entry date is based on INFORMATION ADDED TO SECTION 8.4 OF THE LABELING TO DESCRIBE THE RESULTS FROM PEDIATRIC STUDIES.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

FDA Regulatory Exclusivity protecting BYETTA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Astrazeneca Ab	BYETTA	exenatide synthetic	INJECTABLE;SUBCUTANEOUS	021773-001	Apr 28, 2005		RX	Yes	Yes
Astrazeneca Ab	BYETTA	exenatide synthetic	INJECTABLE;SUBCUTANEOUS	021773-002	Apr 28, 2005		RX	Yes	Yes

Expired US Patents for BYETTA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Astrazeneca Ab	BYETTA	exenatide synthetic	INJECTABLE;SUBCUTANEOUS	021773-002	Apr 28, 2005
Astrazeneca Ab	BYETTA	exenatide synthetic	INJECTABLE;SUBCUTANEOUS	021773-002	Apr 28, 2005
Astrazeneca Ab	BYETTA	exenatide synthetic	INJECTABLE;SUBCUTANEOUS	021773-001	Apr 28, 2005
Astrazeneca Ab	BYETTA	exenatide synthetic	INJECTABLE;SUBCUTANEOUS	021773-001	Apr 28, 2005
Astrazeneca Ab	BYETTA	exenatide synthetic	INJECTABLE;SUBCUTANEOUS	021773-001	Apr 28, 2005
Astrazeneca Ab	BYETTA	exenatide synthetic	INJECTABLE;SUBCUTANEOUS	021773-001	Apr 28, 2005

International Patents for BYETTA

See the table below for patents covering BYETTA around the world.

Country	Patent Number	Title	Estimated Expiration
World Intellectual Property Organization (WIPO)	9830231
European Patent Office	1938830
World Intellectual Property Organization (WIPO)	9907404
Denmark	1019077
European Patent Office	1032587	NOUVEAUX COMPOSES AGONISTES DE L'EXENDINE (NOVEL EXENDIN AGONIST COMPOUNDS)
Denmark	1143989

Supplementary Protection Certificates for BYETTA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0996459	C00996459/01	Switzerland		FORMER OWNER: AMYLIN PHARMACEUTICALS, INC., US
1140145	SZ 30/2007	Austria		PRODUCT NAME: EXENATIDE
0996459	CA 2007 00034	Denmark
0996459	0790031-9	Sweden		PRODUCT NAME: EXANATID; REG. NO/DATE: EU/1/06/362/001 20061120
0996459	464	Finland
1734971	122012000028	Germany		PRODUCT NAME: BYDUREON-EXENATIDE; REGISTRATION NO/DATE: EU/1/11/696/001-002 20110617