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Last Updated: January 15, 2021

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BYETTA Drug Profile

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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. 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 2018 were $290mm indicating the motivation for generic entry (peak sales were $1.1bn in 2008).

There have been four 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
National Institute on Alcohol Abuse and Alcoholism (NIAAA)Phase 1
Boston Medical CenterPhase 1

See all BYETTA clinical trials

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
>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 021773-001 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
0996459 0790031-9 Sweden   Start Trial PRODUCT NAME: EXANATID; REG. NO/DATE: EU/1/06/362/001 20061120
1140145 CA 2007 00033 Denmark   Start Trial PRODUCT NAME: EXENATID, EXENDIN, EXENDINAGONISTER; REG. NO/DATE: EU/1/06/362/001-004 20061120
0996459 SZ 31/2007 Austria   Start Trial PRODUCT NAME: EXENATIDE
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Boehringer Ingelheim
Johnson and Johnson
AstraZeneca
Medtronic
Baxter
McKinsey

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