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Serving leading biopharmaceutical companies globally:

AstraZeneca
Merck
Johnson and Johnson
Fuji
Dow
Chinese Patent Office
Cantor Fitzgerald
Argus Health
QuintilesIMS
Citi

Generated: January 22, 2018

DrugPatentWatch Database Preview

Exenatide - Generic Drug Details

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What are the generic drug sources for exenatide and what is the scope of exenatide freedom to operate?

Exenatide
is the generic ingredient in four branded drugs marketed by Astrazeneca Ab and is included in three NDAs. There are forty-one patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Exenatide has three hundred and thirty-eight patent family members in thirty-two countries.

There are seven drug master file entries for exenatide. One supplier is listed for this compound.
Summary for exenatide
Pharmacology for exenatide

US Patents and Regulatory Information for exenatide

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Astrazeneca Ab BYDUREON PEN exenatide synthetic FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS 022200-002 Feb 28, 2014 RX Yes Yes ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Astrazeneca Ab BYDUREON PEN exenatide synthetic FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS 022200-002 Feb 28, 2014 RX Yes Yes ➤ Subscribe ➤ Subscribe ➤ Subscribe
Astrazeneca Ab BYDUREON PEN exenatide synthetic FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS 022200-002 Feb 28, 2014 RX Yes Yes ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Astrazeneca Ab BYDUREON exenatide synthetic FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS 022200-001 Jan 27, 2012 RX Yes Yes ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Astrazeneca Ab BYDUREON exenatide synthetic FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS 022200-001 Jan 27, 2012 RX Yes Yes ➤ Subscribe ➤ Subscribe ➤ Subscribe
Astrazeneca Ab BYDUREON exenatide synthetic FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS 022200-001 Jan 27, 2012 RX Yes Yes ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Astrazeneca Ab BYDUREON exenatide synthetic FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS 022200-001 Jan 27, 2012 RX Yes Yes ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Astrazeneca Ab BYDUREON PEN exenatide synthetic FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS 022200-002 Feb 28, 2014 RX Yes Yes ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Astrazeneca Ab BYDUREON PEN exenatide synthetic FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS 022200-002 Feb 28, 2014 RX Yes Yes ➤ Subscribe ➤ Subscribe ➤ Subscribe
Astrazeneca Ab BYDUREON PEN exenatide synthetic FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS 022200-002 Feb 28, 2014 RX Yes Yes ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration

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Expired US Patents for exenatide

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Astrazeneca Ab BYDUREON BCISE exenatide SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS 209210-001 Oct 20, 2017 ➤ Subscribe ➤ Subscribe
Astrazeneca Ab BYDUREON BCISE exenatide SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS 209210-001 Oct 20, 2017 ➤ Subscribe ➤ Subscribe
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Non-Orange Book US Patents for exenatide

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
7,700,549 Exendin agonist analogs to treat diabetes ➤ Subscribe
7,407,932 Methods for glucagon suppression using modified exendins ➤ Subscribe
7,799,345 Preparation of injectable suspensions having improved injectability ➤ Subscribe
6,495,164 Preparation of injectable suspensions having improved injectability ➤ Subscribe
7,524,530 Residual solvent extraction method and microparticles produced thereby ➤ Subscribe
7,399,489 Exendin analog formulations ➤ Subscribe
7,138,375 Use of exendins and agonists thereof for lowering plasma lipid ➤ Subscribe
7,220,721 Exendin agonist peptides ➤ Subscribe
7,521,423 Exendin pharmaceutical compositions ➤ Subscribe
6,902,744 Exendin agonist formulations and methods of administration thereof ➤ Subscribe
Patent No. Title Estimated Patent Expiration

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International Patents for exenatide

Supplementary Protection Certificates for exenatide

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
4 Finland ➤ Subscribe
30/2007 Austria ➤ Subscribe PRODUCT NAME: EXENATIDE
2012006 Lithuania ➤ Subscribe PRODUCT NAME: EXENATIDUM; REGISTRATION NO/DATE: EU/1/11/696/001 - EU/1/11/696/002 20110617
2007 00033 Denmark ➤ Subscribe
0996459/01 Switzerland ➤ Subscribe FORMER OWNER: AMYLIN PHARMACEUTICALS, INC., US
0526 Netherlands ➤ Subscribe PRODUCT NAME: EXENATIDE; REGISTRATION NO/DATE: EU/1/11/696/001-002 20110617
2012 00015 Denmark ➤ Subscribe
90031-9 Sweden ➤ Subscribe PRODUCT NAME: EXANATID; REG. NO/DATE: EU/1/06/362/001 20061120
2007 00034 Denmark ➤ Subscribe
8 5006-2012 Slovakia ➤ Subscribe PRODUCT NAME: EXENATID; REGISTRATION NO/DATE: EU/1/11/696/001 - EU/1/11/696/002 20110623
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving leading biopharmaceutical companies globally:

UBS
Federal Trade Commission
Julphar
Express Scripts
Citi
Boehringer Ingelheim
Daiichi Sankyo
Argus Health
Farmers Insurance

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 verifification 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.

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