Deeper Knowledge, Faster

  • Identify first generic entrants
  • Uncover prior art in expired and abandoned patents
  • Obtain formulation and manufacturing information
➤ Start Trial

or, See Plans & Pricing

Upgrade to enjoy subscriber-only features like email alerts and data export. See the Plans and Pricing

Serving leading biopharmaceutical companies globally:

Farmers Insurance
Novartis
Argus Health
Chinese Patent Office
Citi
US Department of Justice
Accenture
Cipla
US Army
QuintilesIMS

Generated: January 22, 2018

DrugPatentWatch Database Preview

EXENATIDE SYNTHETIC - Generic Drug Details

« Back to Dashboard

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

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

Exenatide synthetic has five hundred and sixty-two patent family members in forty-six countries.

There are seven drug master file entries for exenatide synthetic. Three suppliers are listed for this compound.
Summary for EXENATIDE SYNTHETIC
Pharmacology for EXENATIDE SYNTHETIC

US Patents and Regulatory Information for EXENATIDE SYNTHETIC

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 ➤ Subscribe
Astrazeneca Ab BYETTA exenatide synthetic INJECTABLE;SUBCUTANEOUS 021773-001 Apr 28, 2005 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 ➤ 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 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 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 BYETTA exenatide synthetic INJECTABLE;SUBCUTANEOUS 021773-001 Apr 28, 2005 RX Yes Yes ➤ Subscribe ➤ Subscribe ➤ Subscribe
Astrazeneca Ab BYETTA exenatide synthetic INJECTABLE;SUBCUTANEOUS 021773-002 Apr 28, 2005 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

This preview shows a limited data set. Subscribe for full access, or try a Free Trial

Expired US Patents for EXENATIDE SYNTHETIC

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Astrazeneca Ab BYETTA exenatide synthetic INJECTABLE;SUBCUTANEOUS 021773-002 Apr 28, 2005 ➤ Subscribe ➤ Subscribe
Astrazeneca Ab BYDUREON PEN exenatide synthetic FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS 022200-002 Feb 28, 2014 ➤ Subscribe ➤ Subscribe
Astrazeneca Ab BYETTA exenatide synthetic INJECTABLE;SUBCUTANEOUS 021773-001 Apr 28, 2005 ➤ Subscribe ➤ Subscribe
Astrazeneca Ab BYDUREON exenatide synthetic FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS 022200-001 Jan 27, 2012 ➤ Subscribe ➤ Subscribe
Astrazeneca Ab BYDUREON PEN exenatide synthetic FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS 022200-002 Feb 28, 2014 ➤ Subscribe ➤ Subscribe
Astrazeneca Ab BYETTA exenatide synthetic INJECTABLE;SUBCUTANEOUS 021773-001 Apr 28, 2005 ➤ Subscribe ➤ Subscribe
Astrazeneca Ab BYETTA exenatide synthetic INJECTABLE;SUBCUTANEOUS 021773-001 Apr 28, 2005 ➤ Subscribe ➤ Subscribe
Astrazeneca Ab BYETTA exenatide synthetic INJECTABLE;SUBCUTANEOUS 021773-002 Apr 28, 2005 ➤ Subscribe ➤ Subscribe
Astrazeneca Ab BYETTA exenatide synthetic INJECTABLE;SUBCUTANEOUS 021773-002 Apr 28, 2005 ➤ Subscribe ➤ Subscribe
Astrazeneca Ab BYDUREON PEN exenatide synthetic FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS 022200-002 Feb 28, 2014 ➤ Subscribe ➤ Subscribe
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

This preview shows a limited data set. Subscribe for full access, or try a Free Trial

Non-Orange Book US Patents for EXENATIDE SYNTHETIC

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
7,138,375 Use of exendins and agonists thereof for lowering plasma lipid ➤ Subscribe
8,389,472 Exendin-4 to treat nonalcoholic steatohepatitis and nonalcoholic fatty liver disease ➤ Subscribe
6,296,842 Process for the preparation of polymer-based sustained release compositions ➤ Subscribe
7,115,569 Exendins, exendin agonists, and methods for their use ➤ Subscribe
7,696,161 Exendin agonist compounds ➤ Subscribe
7,858,740 Exendin agonist compounds ➤ Subscribe
8,617,613 Polymer-based sustained release device ➤ Subscribe
8,293,871 Poly(lactide-co-glycolide) based sustained release microcapsules comprising a polypeptide and a sugar ➤ Subscribe
7,419,952 Use of exendins and agonists thereof to treat diabetes ➤ Subscribe
8,288,338 Exendin and exendin agonists for eating disorders ➤ Subscribe
Patent No. Title Estimated Patent Expiration

This preview shows a limited data set. Subscribe for full access, or try a Free Trial

International Patents for EXENATIDE SYNTHETIC

Supplementary Protection Certificates for EXENATIDE SYNTHETIC

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0996459/01 Switzerland ➤ Subscribe FORMER OWNER: AMYLIN PHARMACEUTICALS, INC., US
0120006 00104 Estonia ➤ Subscribe PRODUCT NAME: EKSENATIID;REG NO/DATE: K(2011)4479 LOPLIK 23.06.2011
2012 00015 Denmark ➤ Subscribe
1734971/01 Switzerland ➤ Subscribe PRODUCT NAME: EXENATIDE; REGISTRATION NO/DATE: SWISSMEDIC 61629 17.02.2012
2014000071 Germany ➤ Subscribe PRODUCT NAME: KOMBINATION VON DAPAGLIFLOZIN ODER EINEM PHARMAZEUTISCH VERTRAEGLICHEN SALZ DAVON, UND METFORMIN ODER EINEM PHARMAZEUTISCH VERTRAEGLICHEN SALZ DAVON, GESCHUETZT DURCH DAS GRUNDPATENT EP 1 506 211; REGISTRATION NO/DATE: EU/1/13/900 20140116
0526 Netherlands ➤ Subscribe PRODUCT NAME: EXENATIDE; REGISTRATION NO/DATE: EU/1/11/696/001-002 20110617
2014026 Lithuania ➤ Subscribe PRODUCT NAME: DAPAGLIFOZINUM + METFORMINUM; REGISTRATION NO/DATE: EU/1/13/900 20140116
2014026,C1506211 Lithuania ➤ Subscribe PRODUCT NAME: DAPAGLIFLOZINUM + METFORMINUM; REGISTRATION NO/DATE: EU/1/13/900 20140116
496 Luxembourg ➤ Subscribe PRODUCT NAME: COMBINAISON DE DAPAGLIFLOZINE OU D UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELLE-CI ET DE METFORMINE OU D UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELLE-CI,TELLE QUE PROTEGEE PAR LE BREVET DE BASE EP1506211 B1
C0022 France ➤ Subscribe PRODUCT NAME: DAPAGLIFLOZINE ET SES SELS PHARMACEUTIQUEMENT ACCEPTABLES; REGISTRATION NO/DATE: EU/1/12/795/001 20121112
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

This preview shows a limited data set. Subscribe for full access, or try a Free Trial

For more information try a trial or see the plans and pricing

Serving leading biopharmaceutical companies globally:

Chubb
Queensland Health
Citi
US Army
UBS
Fuji
Farmers Insurance
Baxter
Teva

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.

botpot