Make Better Decisions - Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Serving leading biopharmaceutical companies globally:

Colorcon
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Last Updated: October 20, 2019

DrugPatentWatch Database Preview

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 eighty-two 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.

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
Peking Union Medical College HospitalPhase 4
Consano Clinical Research, LLCPhase 4
Xiangya Hospital of Central South UniversityPhase 3

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

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   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
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
>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
1506211 PA2014026 Lithuania   Start Trial PRODUCT NAME: DAPAGLIFOZINUM + METFORMINUM; REGISTRATION NO/DATE: EU/1/13/900 20140116
1140145 SZ 30/2007 Austria   Start Trial PRODUCT NAME: EXENATIDE
1506211 18/2013 Austria   Start Trial PRODUCT NAME: DAPAGLIFLOZIN UND PHARMAZEUTISCH VERTRAEGLICHE SALZE DAVON; REGISTRATION NO/DATE: EU/1/12/795/001 - EU/1/12/795/010 20121112
1506211 CA 2013 00019 Denmark   Start Trial
1506211 13C0022 France   Start Trial PRODUCT NAME: DAPAGLIFLOZINE ET SES SELS PHARMACEUTIQUEMENT ACCEPTABLES; REGISTRATION NO/DATE: EU/1/12/795/001 20121112
1734971 248 5006-2012 Slovakia   Start Trial PRODUCT NAME: EXENATID; REGISTRATION NO/DATE: EU/1/11/696/001 - EU/1/11/696/002 20110623
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:

Mallinckrodt
Johnson and Johnson
Merck
Colorcon
Baxter
Moodys

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