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Serving hundreds of leading biopharmaceutical companies globally:

AstraZeneca
Queensland Health
McKesson
Cipla
Julphar
Teva
Baxter
Healthtrust
Dow

Generated: July 21, 2018

DrugPatentWatch Database Preview

BYETTA Drug Profile

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When do Byetta patents expire, and what generic alternatives are available?

Byetta is a drug marketed by Astrazeneca Ab and is included in one NDA. There are four patents protecting this drug and one Paragraph IV challenge.

This drug has one hundred and fifty-eight patent family members in twenty-one countries.

The generic ingredient in BYETTA is exenatide synthetic. There are seven drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the exenatide synthetic profile page.
Drug patent expirations by year for BYETTA
Generic Entry Opportunity Date for BYETTA
Generic Entry Date for BYETTA*:
Constraining patent/regulatory exclusivity:
NDA:
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.

Pharmacology for BYETTA
Synonyms for BYETTA
141758-74-9
286014-72-0
335149-21-8
9P1872D4OL
AC 2993
AC002993
AC2993A
AKOS015994651
Bydureon
Bydureon Pen
CS-1174
DA 3091
Exenatide
Exenatide [USAN:INN:BAN:JAN]
Exenatide; Exendin-4
Exendin 3 (Heloderma horridum), 2-glycine-3-L-glutamic acid-
Exendin 4
Exendin-4
HS-2012
HSDB 7789
HY-13443
ITCA 650
LY 2148568
MolPort-009-194-177
PT302
SCHEMBL14634818
UNII-9P1872D4OL
Y-100006

US Patents and Regulatory Information for 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 ➤ Sign Up ➤ Sign Up ➤ Sign Up
Astrazeneca Ab BYETTA exenatide synthetic INJECTABLE;SUBCUTANEOUS 021773-001 Apr 28, 2005 RX Yes Yes ➤ 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 Y ➤ Sign Up
Astrazeneca Ab BYETTA exenatide synthetic INJECTABLE;SUBCUTANEOUS 021773-001 Apr 28, 2005 RX Yes Yes ➤ Sign Up ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration

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

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Paragraph IV (Patent) Challenges for BYETTA
Drugname Dosage Strength RLD Date
➤ Subscribe Injection 250 mg/mL, 1.2 mL and 2.4 mL prefilled syringe ➤ Subscribe ➤ Sign Up

Non-Orange Book US Patents for BYETTA

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
7,138,375 Use of exendins and agonists thereof for lowering plasma lipid ➤ Sign Up
7,700,549 Exendin agonist analogs to treat diabetes ➤ Sign Up
8,263,550 Exendin agonist compounds ➤ Sign Up
7,419,952 Use of exendins and agonists thereof to treat diabetes ➤ Sign Up
Patent No. Title Estimated Patent Expiration

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Supplementary Protection Certificates for BYETTA

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
342 Luxembourg ➤ Sign Up 91342, EXPIRES: 20211120
31/2007 Austria ➤ Sign Up PRODUCT NAME: EXENATIDE
00526 Netherlands ➤ Sign Up PRODUCT NAME: EXENATIDE; REGISTRATION NO/DATE: EU/1/11/696/001-002 20110617
30/2007 Austria ➤ Sign Up PRODUCT NAME: EXENATIDE
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

Fuji
McKinsey
Harvard Business School
Baxter
Accenture
Chubb
Cipla
Queensland Health
Colorcon

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