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 |
Formulation / Manufacturing: | see details |
Drug Prices: | Drug price information for BYDUREON PEN |
DailyMed Link: | BYDUREON PEN at DailyMed |
![BYDUREON PEN drug patent expirations Drug patent expirations by year for BYDUREON PEN](/p/graph/s/t/BYDUREON_PEN-patent-expirations.png)
![Drug Prices for BYDUREON PEN](/p/graph/drug-price/BYDUREON+PEN.png)
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 |
---|---|---|---|
Serbia | 60258 | FARMACEUTSKE FORMULACIJE KOJE SADRŽE HIDRAT PROPILEN GLIKOL DAPAGLIFLOZINA (PHARMACEUTICAL FORMULATIONS CONTAINING DAPAGLIFLOZIN PROPYLENE GLYCOL HYDRATE) | ⤷ Sign Up |
Japan | 4798814 | ⤷ Sign Up | |
Colombia | 6160299 | SOLVATOS CRISTALINOS Y COMPLEJOS DE DERIVADOS DE (1S)-1,5-ANHIDRO-1-C-(3-((FENIL)METIL)FENIL)-D-GLUCITOL CON AMINOÁCIDOS COMO INHIBIDORES SGLT2 PARA EL TRATAMIENTO DE DIABETES. | ⤷ Sign Up |
Mexico | 352480 | FORMULACIONES FARMACEUTICAS QUE CONTIENEN HIDRATO DE PROPILENGLICOL DE DAPAGLIFLOZINA. (PHARMACEUTICAL FORMULATIONS CONTAINING DAPAGLIFLOZIN PROPYLENE GLYCOL HYDRATE.) | ⤷ Sign Up |
Eurasian Patent Organization | 011584 | МИКРОКАПСУЛЫ С ЗАМЕДЛЕННЫМ ВЫСВОБОЖДЕНИЕМ, ОСНОВАННЫЕ НА СОПОЛИМЕРЕ ЛАКТИДА И ГЛИКОЛИДА, ВКЛЮЧАЮЩИЕ ПОЛИПЕПТИД И САХАР (POLY (LACTIDE-GO-GLYCOLIDE)-BASED SUSTAINED RELEASE MUCROCAPSULES COMPRISING A POLYPEPTIDE AND A SUGAR) | ⤷ Sign Up |
Iceland | 7529 | C-arýl glúkósíð SGLT2-tálmar og aðferð | ⤷ Sign Up |
Serbia | 53814 | EKSENDIN ZA LEČENJE ŠEĆERNE BOLESTI I SMANJENJE TELESNE TEŽINE (EXENDIN FOR TREATING DIABETES AND REDUCING BODY WEIGHT) | ⤷ 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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2139494 | 301054 | Netherlands | ⤷ Sign Up | PRODUCT NAME: SAXAGLIPTIN AND DAPAGLIFLOZIN; REGISTRATION NO/DATE: EU/1/16/1108 20160719 |
1506211 | 13C0022 | France | ⤷ Sign Up | PRODUCT NAME: DAPAGLIFLOZINE ET SES SELS PHARMACEUTIQUEMENT ACCEPTABLES; REGISTRATION NO/DATE: EU/1/12/795/001 20121112 |
1734971 | C 2012 010 | Romania | ⤷ Sign Up | PRODUCT NAME: EXENATIDA; NATIONAL AUTHORISATION NUMBER: EU/1/11/696/001, EU/1/11/696/002; DATE OF NATIONAL AUTHORISATION: 20110623; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EMEA EU/1/11/696/001, EMEA EU/1/11/696/002; DATE OF FIRST AUTHORISATION IN EEA: 20110623 |
1506211 | 1390017-0 | Sweden | ⤷ Sign Up | PRODUCT NAME: DAPAGLIFLOZIN OCH FARMACEUTISKT GODTAGBARA SALTER DAERAV; REG. NO/DATE: EU/1/12/795/001 20121112 |
1734971 | 91989 | Luxembourg | ⤷ Sign Up | 91989, EXPIRES: 20260617 |
1506211 | CA 2014 00037 | Denmark | ⤷ Sign Up | PRODUCT NAME: ET KOMBINATIONSPRODUKT AF DAPAGLIFLOZIN ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF, HERUNDER DAPAGLIFLOZINPROPANDIOLMONOHYDRAT OG METFORMIN ELLER SALTE DERAF, HERUNDER METFORMINHYDROCHLORID; REG. NO/DATE: EU/1/13/900 20140116 |
0996459 | CA 2007 00034 | Denmark | ⤷ Sign Up | |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |