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Last Updated: January 25, 2020

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BYDUREON BCISE Drug Profile

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Which patents cover Bydureon Bcise, and when can generic versions of Bydureon Bcise launch?

Bydureon Bcise is a drug marketed by Astrazeneca Ab and is included in one NDA. There are twenty-one patents protecting this drug.

This drug has four hundred and ninety-one patent family members in forty-seven countries.

The generic ingredient in BYDUREON BCISE is exenatide. There are seven drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the exenatide profile page.

US ANDA Litigation and Generic Entry Outlook for Bydureon Bcise

Bydureon Bcise was eligible for patent challenges on December 31, 1968.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be October 4, 2030. This may change due to patent challenges or generic licensing.

There have been seven patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

Indicators of Generic Entry

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Drug patent expirations by year for BYDUREON BCISE
Drug Prices for BYDUREON BCISE

See drug prices for BYDUREON BCISE

Generic Entry Opportunity Date for BYDUREON BCISE
Generic Entry Date for BYDUREON BCISE*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
SUSPENSION, EXTENDED RELEASE;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 BYDUREON BCISE

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

SponsorPhase
Dasman Diabetes InstitutePhase 4
Peking Union Medical College HospitalPhase 4
Consano Clinical Research, LLCPhase 4

See all BYDUREON BCISE clinical trials

Recent Litigation for BYDUREON BCISE

Identify potential future generic entrants

District Court Litigation
Case NameDate
Alkermes Pharma Ireland Limited v. Luye Pharma Group Ltd.2019-07-17
AstraZeneca AB v. Zydus Pharmaceuticals (USA) Inc.2018-05-01
MITSUBISHI TANABE PHARMA CORPORATION v. LUPIN LIMITED2018-01-09

See all BYDUREON BCISE litigation

PTAB Litigation
PetitionerDate
Luye Pharma Group Ltd.2016-05-31

See all BYDUREON BCISE litigation

Pharmacology for BYDUREON BCISE

US Patents and Regulatory Information for BYDUREON BCISE

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 BCISE exenatide SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS 209210-001 Oct 20, 2017 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Astrazeneca Ab BYDUREON BCISE exenatide SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS 209210-001 Oct 20, 2017 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Astrazeneca Ab BYDUREON BCISE exenatide SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS 209210-001 Oct 20, 2017 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Astrazeneca Ab BYDUREON BCISE exenatide SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS 209210-001 Oct 20, 2017 RX Yes Yes   Start Trial   Start Trial   Start Trial
Astrazeneca Ab BYDUREON BCISE exenatide SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS 209210-001 Oct 20, 2017 RX Yes Yes   Start Trial   Start Trial   Start 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 BYDUREON BCISE

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

Supplementary Protection Certificates for BYDUREON BCISE

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1734971 300526 Netherlands   Start Trial PRODUCT NAME: EXENATIDE; REGISTRATION NO/DATE: EU/1/11/696/001-002 20110617
1506211 92182 Luxembourg   Start Trial PRODUCT NAME: DAPAGLIFLOZINE ET SES SELS PHARMACEUTIQUEMENT ACCEPTABLES
1506211 1390017-0 Sweden   Start Trial PRODUCT NAME: DAPAGLIFLOZIN OCH FARMACEUTISKT GODTAGBARA SALTER DAERAV; REG. NO/DATE: EU/1/12/795/001 20121112
1506211 DO 136; 5005-2013 Slovakia   Start Trial PRODUCT NAME: DAPAGLIFOZIN:REGISTRATION NO/DATE: EU/1/12/795/001-010 20121112; FORMER OWNER: BRISTOL
1506211 C300585 Netherlands   Start Trial PRODUCT NAME: DAPAGLIFLOZINE, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT; REGISTRATION NO/DATE: EU/1/12/795/001-010 20121112
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Moodys
McKesson
Mallinckrodt
Johnson and Johnson
Boehringer Ingelheim
AstraZeneca

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