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Serving leading biopharmaceutical companies globally:

Deloitte
Medtronic
Teva
Covington
Healthtrust
Cipla
Farmers Insurance
QuintilesIMS
Moodys
Harvard Business School

Generated: February 20, 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.
Summary for BYETTA
Drug patent expirations by year for BYETTA
Pharmacology for BYETTA

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 ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Astrazeneca Ab BYETTA exenatide synthetic INJECTABLE;SUBCUTANEOUS 021773-001 Apr 28, 2005 RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Astrazeneca Ab BYETTA exenatide synthetic INJECTABLE;SUBCUTANEOUS 021773-002 Apr 28, 2005 RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Astrazeneca Ab BYETTA exenatide synthetic INJECTABLE;SUBCUTANEOUS 021773-001 Apr 28, 2005 RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Astrazeneca Ab BYETTA exenatide synthetic INJECTABLE;SUBCUTANEOUS 021773-001 Apr 28, 2005 RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Astrazeneca Ab BYETTA exenatide synthetic INJECTABLE;SUBCUTANEOUS 021773-002 Apr 28, 2005 RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Astrazeneca Ab BYETTA exenatide synthetic INJECTABLE;SUBCUTANEOUS 021773-002 Apr 28, 2005 RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Astrazeneca Ab BYETTA exenatide synthetic INJECTABLE;SUBCUTANEOUS 021773-002 Apr 28, 2005 RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
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 ➤ Try a Free Trial ➤ Try a Free Trial
Astrazeneca Ab BYETTA exenatide synthetic INJECTABLE;SUBCUTANEOUS 021773-001 Apr 28, 2005 ➤ Try a Free Trial ➤ Try a Free Trial
Astrazeneca Ab BYETTA exenatide synthetic INJECTABLE;SUBCUTANEOUS 021773-001 Apr 28, 2005 ➤ Try a Free Trial ➤ Try a Free Trial
Astrazeneca Ab BYETTA exenatide synthetic INJECTABLE;SUBCUTANEOUS 021773-002 Apr 28, 2005 ➤ Try a Free Trial ➤ Try a Free Trial
Astrazeneca Ab BYETTA exenatide synthetic INJECTABLE;SUBCUTANEOUS 021773-001 Apr 28, 2005 ➤ Try a Free Trial ➤ Try a Free Trial
Astrazeneca Ab BYETTA exenatide synthetic INJECTABLE;SUBCUTANEOUS 021773-001 Apr 28, 2005 ➤ Try a Free Trial ➤ Try a Free Trial
Astrazeneca Ab BYETTA exenatide synthetic INJECTABLE;SUBCUTANEOUS 021773-002 Apr 28, 2005 ➤ Try a Free Trial ➤ Try a Free Trial
Astrazeneca Ab BYETTA exenatide synthetic INJECTABLE;SUBCUTANEOUS 021773-001 Apr 28, 2005 ➤ Try a Free Trial ➤ Try a Free Trial
Astrazeneca Ab BYETTA exenatide synthetic INJECTABLE;SUBCUTANEOUS 021773-002 Apr 28, 2005 ➤ Try a Free Trial ➤ Try a Free Trial
Astrazeneca Ab BYETTA exenatide synthetic INJECTABLE;SUBCUTANEOUS 021773-002 Apr 28, 2005 ➤ Try a Free Trial ➤ Try a Free Trial
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 Submissiondate
➤ Subscribe Injection 250 mg/mL, 1.2 mL and 2.4 mL prefilled syringe ➤ Subscribe 6/11/2014

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
7,220,721 Exendin agonist peptides ➤ Try a Free Trial
7,521,423 Exendin pharmaceutical compositions ➤ Try a Free Trial
7,153,825 Methods for glucagon suppression using modified exendins ➤ Try a Free Trial
7,906,146 Lyophilized formulations of exendins and exendin agonist analogs ➤ Try a Free Trial
6,858,576 Methods for regulating gastrointestinal motility ➤ Try a Free Trial
8,026,210 Exendins and exendin agonist analogs to regulate gastrointestinal motility ➤ Try a Free Trial
7,696,161 Exendin agonist compounds ➤ Try a Free Trial
7,157,555 Exendin agonist compounds ➤ Try a Free Trial
8,288,338 Exendin and exendin agonists for eating disorders ➤ Try a Free Trial
6,989,366 Exendins, exendin agonists, and methods for their use ➤ Try a Free Trial
Patent No. Title Estimated Patent Expiration

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International Patents for BYETTA

Supplementary Protection Certificates for BYETTA

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2012000028 Germany ➤ Try a Free Trial PRODUCT NAME: BYDUREON-EXENATIDE; REGISTRATION NO/DATE: EU/1/11/696/001-002 20110617
343 Luxembourg ➤ Try a Free Trial 91343, EXPIRES: 20211120
31/2007 Austria ➤ Try a Free Trial PRODUCT NAME: EXENATIDE
2007 00033 Denmark ➤ Try a Free Trial PRODUCT NAME: EXENATID, EXENDIN, EXENDINAGONISTER; REG. NO/DATE: EU/1/06/362/001-004 20061120
342 Luxembourg ➤ Try a Free Trial 91342, EXPIRES: 20211120
1734971/01 Switzerland ➤ Try a Free Trial PRODUCT NAME: EXENATIDE; REGISTRATION NO/DATE: SWISSMEDIC 61629 17.02.2012
90031-9 Sweden ➤ Try a Free Trial PRODUCT NAME: EXANATID; REG. NO/DATE: EU/1/06/362/001 20061120
/2007 Austria ➤ Try a Free Trial PRODUCT NAME: EXENATIDE; REGISTRATION NO/DATE: EU/1/06/362/001-004 20061120
4 Finland ➤ Try a Free Trial
2007 00034 Denmark ➤ Try a Free Trial
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

Johnson and Johnson
Baxter
US Army
Queensland Health
Chinese Patent Office
Federal Trade Commission
Teva
Fish and Richardson
US Department of Justice

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