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Last Updated: May 21, 2022

BYETTA Drug Patent 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.

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

See drug prices for BYETTA

Drug Sales Revenue Trends for BYETTA

See drug sales revenues for BYETTA

DrugPatentWatch® Estimated Generic Entry Opportunity Date for BYETTA
Generic Entry Date for BYETTA*:
Constraining patent/regulatory exclusivity:
INFORMATION ADDED TO SECTION 8.4 OF THE LABELING TO DESCRIBE THE RESULTS FROM PEDIATRIC STUDIES
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.

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

Paragraph IV (Patent) Challenges for BYETTA
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
BYETTA Injection exenatide synthetic 250 mg/mL, 1.2 mL and 2.4 mL prefilled syringe 021773 1 2014-06-11

US Patents and Regulatory Information for BYETTA

BYETTA is protected by zero US patents and one FDA Regulatory Exclusivity.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of BYETTA is See Plans and Pricing.

This potential generic entry date is based on INFORMATION ADDED TO SECTION 8.4 OF THE LABELING TO DESCRIBE THE RESULTS FROM PEDIATRIC STUDIES.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

FDA Regulatory Exclusivity protecting BYETTA

INFORMATION ADDED TO SECTION 8.4 OF THE LABELING TO DESCRIBE THE RESULTS FROM PEDIATRIC STUDIES
Exclusivity Expiration: See Plans and Pricing

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

International Patents for BYETTA

See the table below for patents covering BYETTA around the world.

Country Patent Number Title Estimated Expiration
World Intellectual Property Organization (WIPO) 9830231 See Plans and Pricing
European Patent Office 1938830 See Plans and Pricing
World Intellectual Property Organization (WIPO) 9907404 See Plans and Pricing
Denmark 1019077 See Plans and Pricing
European Patent Office 1032587 NOUVEAUX COMPOSES AGONISTES DE L'EXENDINE (NOVEL EXENDIN AGONIST COMPOUNDS) See Plans and Pricing
Denmark 1143989 See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for BYETTA

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0996459 C00996459/01 Switzerland See Plans and Pricing FORMER OWNER: AMYLIN PHARMACEUTICALS, INC., US
1140145 SZ 30/2007 Austria See Plans and Pricing PRODUCT NAME: EXENATIDE
0996459 CA 2007 00034 Denmark See Plans and Pricing
0996459 0790031-9 Sweden See Plans and Pricing PRODUCT NAME: EXANATID; REG. NO/DATE: EU/1/06/362/001 20061120
0996459 464 Finland See Plans and Pricing
1734971 122012000028 Germany See Plans and Pricing PRODUCT NAME: BYDUREON-EXENATIDE; REGISTRATION NO/DATE: EU/1/11/696/001-002 20110617
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

Boehringer Ingelheim
Johnson and Johnson
AstraZeneca
Medtronic
Baxter
McKinsey

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.