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 three hundred and ninety-seven 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: | 397 |
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
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
Pharmaceutical formulations containing an SGLT2 inhibitor
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
Device for administering fluid from a multi-chamber ampoule in incremental steps
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
Crystal structures of SGLT2 inhibitors and processes for preparing same
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Mixing device for a two-chamber ampoule
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
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 | |||
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 | |||
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
International Patents for BYDUREON PEN
See the table below for patents covering BYDUREON PEN around the world.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
New Zealand | 536605 | C-aryl glucoside inhibitors of sodium dependent glucose transporters found in the intestine and kidney (SGLT2) | ⤷ Try a Trial |
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. (-)) | ⤷ Try a Trial |
European Patent Office | 2139494 | PRÉPARATIONS PHARMACEUTIQUES CONTENANT DE L'HYDRATE DE PROPYLÈNEGLYCOL DE DAPAGLIFLOZINE (PHARMACEUTICAL FORMULATIONS CONTAINING DAPAGLIFLOZIN PROPYLENE GLYCOL HYDRATE) | ⤷ Try a Trial |
Australia | 2011200663 | Exendin for treating diabetes and reducing body weight | ⤷ Try a Trial |
Denmark | 1246638 | ⤷ Try a Trial | |
Cyprus | 1112348 | ⤷ Try a Trial | |
Taiwan | 200904405 | Pharmaceutical formulations containing an SGLT2 inhibitor | ⤷ 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 |
0996459 | 0790031-9 | Sweden | ⤷ Try a Trial | PRODUCT NAME: EXANATID; REG. NO/DATE: EU/1/06/362/001 20061120 |
1506211 | C 2013 012 | Romania | ⤷ Try a Trial | PRODUCT NAME: DAPAGLIFLOZIN SI SARURILE ACCEPTABILE FARMACEUTIC ALEACESTUIA (2S, 3R, 4R, 5S, 6R)-2-[4-CLOR-3-(4-ETOXIBENZIL)FENIL]-6-(HIDROXIMETIL)TETRAHIDRO-2H-PIRAN-3,4,5-TRIOL; NATIONAL AUTHORISATION NUMBER: RO EU/1/12/795/001, RO EU/1/12/795/002, RO EU/1/12/795/003, RO EU/1/12/795/004, RO EU/1/12/795/005, RO EU/1/12/795/006, RO EU/1/12/795/007, RO EU/1/12/795/008, RO EU/1/12/795/009, RO EU/1/12/795/001/010; DATE OF NATIONAL AUTHORISATION: 20121112; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EMEA EU/1/12/795/001, EMEA EU/1/12/795/002, EMEA EU/1/12/795/003, EMEA EU/1/12/795/004, EMEA EU/1/12/795/005, EMEA EU/1/12/795/006, EMEA EU/1/12/795/007, EMEA EU/1/12/795/008 [...] |
1140145 | 91343 | Luxembourg | ⤷ Try a Trial | 91343, EXPIRES: 20211120 |
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 |
2139494 | CA 2020 00035 | Denmark | ⤷ Try a Trial | PRODUCT NAME: SAXAGLIPTIN OG DAPAGLIFLOZIN; REG. NO/DATE: EU/1/16/1108 20160719 |
0996459 | CA 2007 00034 | Denmark | ⤷ Try a Trial | |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |