BYDUREON PEN Drug Patent Profile
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Which patents cover Bydureon Pen, and when can generic versions of Bydureon Pen launch?
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 five 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.
DrugPatentWatch® Generic Entry Outlook for Bydureon Pen
Indicators of Generic Entry
Summary for BYDUREON PEN
International Patents: | 405 |
US Patents: | 20 |
Applicants: | 1 |
NDAs: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 26 |
Clinical Trials: | 39 |
Patent Applications: | 7 |
Formulation / Manufacturing: | see details |
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 |
Anatomical Therapeutic Chemical (ATC) Classes for BYDUREON PEN
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
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Polymer-based sustained release device
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Polymer-based sustained release device
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Polymer-based sustained release device
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Administering apparatus with functional drive element
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Patent Expiration: ⤷ Try a Trial
Methods for treating diabetes and reducing body weight
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Pharmaceutical formulations containing an SGLT2 inhibitor
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Patent Expiration: ⤷ Try a Trial
Polymer-based sustained release device
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Device for administering fluid from a multi-chamber ampoule in incremental steps
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Patent Expiration: ⤷ Try a Trial
Polymer-based sustained release device
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Crystal structures of SGLT2 inhibitors and processes for preparing same
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Patent Expiration: ⤷ Try a Trial
Mixing device for a two-chamber ampoule
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Patent Expiration: ⤷ Try a Trial
Ampoule comprising an ampoule holder
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Patent Expiration: ⤷ Try a Trial
Administering apparatus with functional drive element
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Administering device with holding mechanism
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Method for treating diabetes
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Ampoule comprising an ampoule holder
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Polymer-based sustained release device
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Method for administering a fluid active substance from a multi-chamber ampoule
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Methods for treating diabetes and reducing body weight
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
FDA Regulatory Exclusivity protecting BYDUREON PEN
NEW PATIENT POPULATION
Exclusivity Expiration: ⤷ Try a Trial
PEDIATRIC EXCLUSIVITY
Exclusivity Expiration: ⤷ 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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
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 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 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 | ⤷ 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 | 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 BYDUREON PEN
See the table below for patents covering BYDUREON PEN around the world.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
European Patent Office | 0996459 | UTILISATION D'EXENDINES ET DE LEURS AGONISTES POUR REDUIRE LA CONSOMMATION ALIMENTAIRE (USE OF EXENDINS AND AGONISTS THEREOF FOR THE REDUCTION OF FOOD INTAKE) | ⤷ Try a Trial |
Bulgaria | 107288 | ⤷ Try a Trial | |
South Korea | 20070011506 | POLYMER-BASED SUSTAINED RELEASE DEVICE | ⤷ Try a Trial |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for BYDUREON PEN
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
1734971 | 122012000028 | Germany | ⤷ Try a Trial | PRODUCT NAME: BYDUREON-EXENATIDE; REGISTRATION NO/DATE: EU/1/11/696/001-002 20110617 |
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 |
1506211 | 13C0022 | France | ⤷ Try a Trial | PRODUCT NAME: DAPAGLIFLOZINE ET SES SELS PHARMACEUTIQUEMENT ACCEPTABLES; REGISTRATION NO/DATE: EU/1/12/795/001 20121112 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |