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Last Updated: February 29, 2020

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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 two patents protecting this drug and one Paragraph IV challenge.

This drug has seventy-four patent family members in nineteen countries.

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.

US ANDA Litigation and Generic Entry Outlook for Byetta

Byetta was eligible for patent challenges on April 28, 2009.

Annual sales in 2017 were $217mm indicating the motivation for generic entry (peak sales were $1.1bn in 2008).

There have been five patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

Indicators of Generic Entry

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Drug patent expirations by year for BYETTA
Drug Prices for BYETTA

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Drug Sales Revenue Trends for BYETTA

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Recent Clinical Trials for BYETTA

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

SponsorPhase
Consano Clinical Research, LLCPhase 4
Boston Medical CenterPhase 1
National Institute on Alcohol Abuse and Alcoholism (NIAAA)Phase 1

See all BYETTA clinical trials

Recent Litigation for BYETTA

Identify potential future generic entrants

District Court Litigation
Case NameDate
AstraZeneca Pharmaceuticals LP v. Amneal Pharmaceuticals LLC2015-12-09
Sanofi-Aventis US LLC v. AstraZeneca Pharmaceuticals LP2015-07-31
Teva Pharmaceuticals USA Inc. v. AstraZeneca Pharmaceuticals LP2015-01-19

See all BYETTA litigation

PTAB Litigation
PetitionerDate
Sanofi-Aventis U.S. LLC2015-12-16

See all BYETTA litigation

Pharmacology for BYETTA
Paragraph IV (Patent) Challenges for BYETTA
Tradename Dosage Ingredient NDA Submissiondate
BYETTA INJECTABLE;SUBCUTANEOUS exenatide synthetic 021773 2014-06-11

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

Supplementary Protection Certificates for BYETTA

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1140145 30/2007 Austria   Start Trial PRODUCT NAME: EXENATIDE; REGISTRATION NO/DATE: EU/1/06/362/001-004 20061120
1734971 300526 Netherlands   Start Trial PRODUCT NAME: EXENATIDE; REGISTRATION NO/DATE: EU/1/11/696/001-002 20110617
1734971 122012000028 Germany   Start Trial PRODUCT NAME: BYDUREON-EXENATIDE; REGISTRATION NO/DATE: EU/1/11/696/001-002 20110617
1140145 SZ 30/2007 Austria   Start Trial PRODUCT NAME: EXENATIDE
1734971 C300526 Netherlands   Start Trial PRODUCT NAME: EXENATIDE; REGISTRATION NO/DATE: EU/1/11/696/001-002 20110617
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Merck
Moodys
Dow
Harvard Business School
Medtronic
Baxter

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