BYDUREON PEN Drug Patent Profile
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Which patents cover Bydureon Pen, and what generic alternatives are available?
Bydureon Pen is a drug marketed by Astrazeneca Ab and is included in one NDA. There are twenty patents protecting this drug.
This drug has four hundred and eight patent family members in forty-eight countries.
The generic ingredient in BYDUREON PEN is exenatide synthetic. There are seven drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the exenatide synthetic profile page.
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Summary for BYDUREON PEN
International Patents: | 408 |
US Patents: | 20 |
Applicants: | 1 |
NDAs: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 1 |
Clinical Trials: | 39 |
Drug Prices: | Drug price information for BYDUREON PEN |
DailyMed Link: | BYDUREON PEN at DailyMed |
Recent Clinical Trials for BYDUREON PEN
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
The University of Texas Health Science Center, Houston | Phase 2 |
University of Washington | Phase 3 |
Dasman Diabetes Institute | Phase 4 |
US Patents and Regulatory Information for BYDUREON PEN
BYDUREON PEN is protected by twenty US patents and two FDA Regulatory Exclusivities.
Patents protecting BYDUREON PEN
C-aryl glucoside SGLT2 inhibitors and method
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Polymer-based sustained release device
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Polymer-based sustained release device
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Polymer-based sustained release device
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Administering apparatus with functional drive element
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Methods for treating diabetes and reducing body weight
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Pharmaceutical formulations containing an SGLT2 inhibitor
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Polymer-based sustained release device
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Device for administering fluid from a multi-chamber ampoule in incremental steps
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Polymer-based sustained release device
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Crystal structures of SGLT2 inhibitors and processes for preparing same
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Mixing device for a two-chamber ampoule
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Ampoule comprising an ampoule holder
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Administering apparatus with functional drive element
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Administering device with holding mechanism
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Method for treating diabetes
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Ampoule comprising an ampoule holder
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Polymer-based sustained release device
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Method for administering a fluid active substance from a multi-chamber ampoule
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Methods for treating diabetes and reducing body weight
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FDA Regulatory Exclusivity protecting BYDUREON PEN
NEW PATIENT POPULATION
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PEDIATRIC EXCLUSIVITY
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Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
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Astrazeneca Ab | BYDUREON PEN | exenatide synthetic | FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS | 022200-002 | Feb 28, 2014 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
Astrazeneca Ab | BYDUREON PEN | exenatide synthetic | FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS | 022200-002 | Feb 28, 2014 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
Astrazeneca Ab | BYDUREON PEN | exenatide synthetic | FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS | 022200-002 | Feb 28, 2014 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
Astrazeneca Ab | BYDUREON PEN | exenatide synthetic | FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS | 022200-002 | Feb 28, 2014 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
Astrazeneca Ab | BYDUREON PEN | exenatide synthetic | FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS | 022200-002 | Feb 28, 2014 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
Astrazeneca Ab | BYDUREON PEN | exenatide synthetic | FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS | 022200-002 | Feb 28, 2014 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
Astrazeneca Ab | BYDUREON PEN | exenatide synthetic | FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS | 022200-002 | Feb 28, 2014 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
>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 PEN
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 | ⤷ Sign Up | ⤷ Sign Up |
Astrazeneca Ab | BYDUREON PEN | exenatide synthetic | FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS | 022200-002 | Feb 28, 2014 | ⤷ Sign Up | ⤷ Sign Up |
Astrazeneca Ab | BYDUREON PEN | exenatide synthetic | FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS | 022200-002 | Feb 28, 2014 | ⤷ Sign Up | ⤷ Sign Up |
Astrazeneca Ab | BYDUREON PEN | exenatide synthetic | FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS | 022200-002 | Feb 28, 2014 | ⤷ Sign Up | ⤷ Sign Up |
Astrazeneca Ab | BYDUREON PEN | exenatide synthetic | FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS | 022200-002 | Feb 28, 2014 | ⤷ Sign Up | ⤷ Sign Up |
Astrazeneca Ab | BYDUREON PEN | exenatide synthetic | FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS | 022200-002 | Feb 28, 2014 | ⤷ Sign Up | ⤷ Sign Up |
Astrazeneca Ab | BYDUREON PEN | exenatide synthetic | FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS | 022200-002 | Feb 28, 2014 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for BYDUREON PEN
See the table below for patents covering BYDUREON PEN around the world.
Country | Patent Number | Title | Estimated Expiration |
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Hungary | E062284 | ⤷ Sign Up | |
Hong Kong | 1205689 | 乳酸-羥基乙酸 共聚物為基礎、含有多肽和糖的持續釋放微膠囊 (POLY(LACTIDE-CO-GLYCOLIDE)-BASED SUSTAINED RELEASE MICROCAPSULES COMPRISING A POLYPEPTIDE AND A SUGAR. (-)) | ⤷ Sign Up |
Russian Federation | 2002109477 | С-арилглюкозидные ингибиторы SGTL2 | ⤷ Sign Up |
Brazil | 122017015091 | compostos intermediários para inibidores de c-aril glicosídeo sglt2 | ⤷ Sign Up |
Hungary | 0300393 | C-aril glükozid SGLT2 inhibitorok és alkalmazásuk, valamint ezeket tartalmazó gyógyszerkészítmények (C-ARYL GLUCOSIDE SGLT2 INHIBITORS AND THEIR USE AND PHARMACEUTICAL COMPOSITIONS CONTAINING THEM) | ⤷ Sign Up |
Russian Federation | 2017131447 | СПОСОБЫ ПОЛУЧЕНИЯ И ИСПОЛЬЗОВАНИЯ ИНГИБИТОРА SGLT2 | ⤷ Sign Up |
Portugal | 2069374 | ⤷ Sign Up | |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for BYDUREON PEN
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
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1506211 | 1390017-0 | Sweden | ⤷ Sign Up | PRODUCT NAME: DAPAGLIFLOZIN OCH FARMACEUTISKT GODTAGBARA SALTER DAERAV; REG. NO/DATE: EU/1/12/795/001 20121112 |
1734971 | 2012C/017 | Belgium | ⤷ Sign Up | PRODUCT NAME: EXENATIDE; AUTHORISATION NUMBER AND DATE: EU/1/11/696/001 20110617 |
1506211 | C 2014 029 | Romania | ⤷ Sign Up | PRODUCT NAME: COMBINATIE DE DAPAGLIFLOZIN SAU O SARE ACCEPTABILAFARMACEUTIC A ACESTUIA SI METFORMINA SAU O SARE ACCEPTABILA FARMACEUTIC A ACESTEIA; NATIONAL AUTHORISATION NUMBER: EU/1/13/900; DATE OF NATIONAL AUTHORISATION: 20140116; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/13/900; DATE OF FIRST AUTHORISATION IN EEA: 20140116 |
1506211 | 92496 | Luxembourg | ⤷ Sign Up | 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 |
1734971 | 248 5006-2012 | Slovakia | ⤷ Sign Up | PRODUCT NAME: EXENATID; REGISTRATION NO/DATE: EU/1/11/696/001 - EU/1/11/696/002 20110623 |
1506211 | 132014902277722 | Italy | ⤷ Sign Up | PRODUCT NAME: UNA COMBINAZIONE DI DAPAGLIFLOZIN O UN SUO SALE FARMACEUTICAMENTE ACCETTABILE E METFORMINA O UN SUO SALE FARMACEUTICAMENTE ACCETTABILE COME PROTETTI DAL BREVETTO DI BASE EP1506211(XIGDUO); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/13/900, 20140116 |
1506211 | 18/2013 | Austria | ⤷ Sign Up | PRODUCT NAME: DAPAGLIFLOZIN UND PHARMAZEUTISCH VERTRAEGLICHE SALZE DAVON; 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 |