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Last Updated: March 5, 2024

Exenatide synthetic - Generic Drug Details


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What are the generic sources for exenatide synthetic and what is the scope of patent protection?

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

Exenatide synthetic has four hundred and forty-nine patent family members in forty-eight countries.

One supplier is listed for this compound.

DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for exenatide synthetic
Generic Entry Dates for exenatide synthetic*:
Constraining patent/regulatory exclusivity:
Dosage:
FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS
Generic Entry Dates for exenatide synthetic*:
Constraining patent/regulatory exclusivity:
INFORMATION ADDED TO SECTION 8.4 OF THE LABELING TO DESCRIBE THE RESULTS FROM PEDIATRIC STUDIES
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 exenatide synthetic

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Center for Neurology, StockholmPhase 2
Karolinska InstitutetPhase 2
Neuroscience Trials AustraliaPhase 2

See all exenatide synthetic clinical trials

Pharmacology for exenatide synthetic
Paragraph IV (Patent) Challenges for EXENATIDE SYNTHETIC
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 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 DISCN Yes No ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Astrazeneca Ab BYDUREON BCISE exenatide synthetic SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS 209210-001 Oct 20, 2017 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Astrazeneca Ab BYDUREON exenatide synthetic FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS 022200-001 Jan 27, 2012 DISCN Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Astrazeneca Ab BYDUREON PEN exenatide synthetic FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS 022200-002 Feb 28, 2014 DISCN Yes No ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Astrazeneca Ab BYDUREON exenatide synthetic FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS 022200-001 Jan 27, 2012 DISCN Yes No ⤷  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 exenatide synthetic

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Astrazeneca Ab BYETTA exenatide synthetic INJECTABLE;SUBCUTANEOUS 021773-001 Apr 28, 2005 ⤷  Try a Trial ⤷  Try a Trial
Astrazeneca Ab BYDUREON PEN exenatide synthetic FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS 022200-002 Feb 28, 2014 ⤷  Try a Trial ⤷  Try a Trial
Astrazeneca Ab BYDUREON BCISE exenatide synthetic SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS 209210-001 Oct 20, 2017 ⤷  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
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for exenatide synthetic

Country Patent Number Title Estimated Expiration
New Zealand 589195 CRYSTALLINE SOLVATES AND COMPLEXES OF (1S)-1,5-ANHYDRO-1-C-(3-((PHENYL) METHYL) PHENYL)-D-GLUCITOL DERIVATIVES WITH AMINO ACIDS AS SGLT2 INHIBITORS FOR THE TREATMENT OF DIABETES ⤷  Try a Trial
Japan 5980872 ⤷  Try a Trial
Japan 2010522244 ⤷  Try a Trial
Argentina 061730 ESTRUCTURAS DE CRISTAL DE INHIBIDORES SGLT2 Y PROCESOS PARA PREPARAR LOS MISMOS ⤷  Try a Trial
Israel 160378 RESIDUAL SOLVENT EXTRACTION METHOD AND MICROPARTICLES PRODUCED THEREBY ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for exenatide synthetic

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2139494 C20200028 00358 Estonia ⤷  Try a Trial PRODUCT NAME: SAKSAGLIPTIIN JA DAPAGLIFLOSIIN;REG NO/DATE: EU/1/16/1108; 19.07.2016
1734971 CA 2012 00015 Denmark ⤷  Try a Trial PRODUCT NAME: EXENATIDE; REG. NO/DATE: EU/1/11/696/001-002 20110623
2139494 122020000043 Germany ⤷  Try a Trial PRODUCT NAME: SAXAGLIPTIN UND DAPAGLIFLOZIN; REGISTRATION NO/DATE: EU/1/16/1108 20160715
2139494 34/2020 Austria ⤷  Try a Trial PRODUCT NAME: DAPAGLIFLOZIN PROPYLENGYLKOL HYDRAT/SAXAGLIPTIN; REGISTRATION NO/DATE: EU/1/16/1108 (MITTEILUNG) 20160715
1506211 PA 2013 008, C 1506211 Lithuania ⤷  Try a Trial PRODUCT NAME: DAPAGLIFLOZINUM; REGISTRATION NO/DATE: EU/1/12/795/001 - EU/1/12/795/010 20121112
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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