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Last Updated: March 28, 2024

EXENATIDE SYNTHETIC - Generic Drug Details


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What are the generic drug 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-one 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 twenty-eight 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
National Health and Medical Research Council, 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 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 ⤷  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 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
>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 BYDUREON PEN exenatide synthetic FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS 022200-002 Feb 28, 2014 ⤷  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 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 BYDUREON PEN exenatide synthetic FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS 022200-002 Feb 28, 2014 ⤷  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
European Patent Office 2508188 Formulations pharmaceutiques contenant un hydrate de propylèneglycol dapagliflozine (Pharmaceutical formulations containing dapagliflozin propylene glycol hydrate) ⤷  Try a Trial
Norway 2013007 ⤷  Try a Trial
Poland 2069374 ⤷  Try a Trial
Portugal 2139494 ⤷  Try a Trial
China 1653075 C-aryl glucoside SGLT2 inhibitors and method ⤷  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
1734971 C01734971/01 Switzerland ⤷  Try a Trial PRODUCT NAME: EXENATIDE; REGISTRATION NO/DATE: SWISSMEDIC 61629 17.02.2012
1734971 CA 2012 00015 Denmark ⤷  Try a Trial PRODUCT NAME: EXENATIDE; REG. NO/DATE: EU/1/11/696/001-002 20110623
2139494 CA 2020 00035 Denmark ⤷  Try a Trial PRODUCT NAME: SAXAGLIPTIN OG DAPAGLIFLOZIN; REG. NO/DATE: EU/1/16/1108 20160719
1734971 91989 Luxembourg ⤷  Try a Trial 91989, EXPIRES: 20260617
1506211 122014000071 Germany ⤷  Try a Trial 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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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