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Last Updated: March 28, 2024

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BYETTA Drug Patent Profile


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Which patents cover Byetta, 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

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Drug Sales Revenue Trends for BYETTA

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DrugPatentWatch® Estimated Loss of Exclusivity (LOE) 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
Boston Medical CenterPhase 1
National Institute on Alcohol Abuse and Alcoholism (NIAAA)Phase 1

See all BYETTA clinical trials

Pharmacology for BYETTA
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 ⤷  Try a Trial.

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: ⤷  Try a Trial

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 Trial ⤷  Try a Trial ⤷  Try a Trial
Astrazeneca Ab BYETTA exenatide synthetic INJECTABLE;SUBCUTANEOUS 021773-002 Apr 28, 2005 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a 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 ⤷  Try a Trial ⤷  Try a Trial
Astrazeneca Ab BYETTA exenatide synthetic INJECTABLE;SUBCUTANEOUS 021773-002 Apr 28, 2005 ⤷  Try a Trial ⤷  Try a Trial
Astrazeneca Ab BYETTA exenatide synthetic INJECTABLE;SUBCUTANEOUS 021773-001 Apr 28, 2005 ⤷  Try a Trial ⤷  Try a Trial
Astrazeneca Ab BYETTA exenatide synthetic INJECTABLE;SUBCUTANEOUS 021773-002 Apr 28, 2005 ⤷  Try a Trial ⤷  Try a Trial
Astrazeneca Ab BYETTA exenatide synthetic INJECTABLE;SUBCUTANEOUS 021773-002 Apr 28, 2005 ⤷  Try a Trial ⤷  Try a Trial
Astrazeneca Ab BYETTA exenatide synthetic INJECTABLE;SUBCUTANEOUS 021773-001 Apr 28, 2005 ⤷  Try a Trial ⤷  Try a Trial
Astrazeneca Ab BYETTA exenatide synthetic INJECTABLE;SUBCUTANEOUS 021773-002 Apr 28, 2005 ⤷  Try a Trial ⤷  Try a Trial
>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
Spain 2425559 ⤷  Try a Trial
Norway 20013469 ⤷  Try a Trial
European Patent Office 1941900 ⤷  Try a Trial
World Intellectual Property Organization (WIPO) 03099314 ⤷  Try a Trial
Spain 2343072 ⤷  Try a Trial
Austria 304864 ⤷  Try a Trial
Austria 381939 ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for BYETTA

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1140145 91343 Luxembourg ⤷  Try a Trial 91343, EXPIRES: 20211120
0996459 C00996459/01 Switzerland ⤷  Try a Trial FORMER OWNER: AMYLIN PHARMACEUTICALS, INC., US
0996459 91342 Luxembourg ⤷  Try a Trial 91342, EXPIRES: 20211120
1140145 CA 2007 00033 Denmark ⤷  Try a Trial PRODUCT NAME: EXENATID, EXENDIN, EXENDINAGONISTER; REG. NO/DATE: EU/1/06/362/001-004 20061120
1734971 C300526 Netherlands ⤷  Try a Trial PRODUCT NAME: EXENATIDE; REGISTRATION NO/DATE: EU/1/11/696/001-002 20110617
1734971 122012000028 Germany ⤷  Try a Trial PRODUCT NAME: BYDUREON-EXENATIDE; REGISTRATION NO/DATE: EU/1/11/696/001-002 20110617
0996459 0790031-9 Sweden ⤷  Try a Trial PRODUCT NAME: EXANATID; REG. NO/DATE: EU/1/06/362/001 20061120
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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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.