Make Better Decisions - Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Last Updated: October 15, 2019

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 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.

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

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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

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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

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

Supplementary Protection Certificates for BYETTA

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1734971 122012000028 Germany   See Pricing PRODUCT NAME: BYDUREON-EXENATIDE; REGISTRATION NO/DATE: EU/1/11/696/001-002 20110617
1140145 30/2007 Austria   See Pricing PRODUCT NAME: EXENATIDE; REGISTRATION NO/DATE: EU/1/06/362/001-004 20061120
1734971 C300526 Netherlands   See Pricing PRODUCT NAME: EXENATIDE; REGISTRATION NO/DATE: EU/1/11/696/001-002 20110617
1734971 2012C/017 Belgium   See Pricing PRODUCT NAME: BYDUREON-EXENATIDE; AUTHORISATION NUMBER AND DATE: EU/1/11/696/001 20110617
0996459 SZ 31/2007 Austria   See Pricing 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
McKesson
Mallinckrodt
Harvard Business School
McKinsey
Express Scripts

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