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AstraZeneca
McKesson
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Dow
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Mallinckrodt

Last Updated: May 31, 2020

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Astrazeneca Ab Company Profile


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Drugs and US Patents for Astrazeneca Ab

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Astrazeneca Ab QTERNMET XR dapagliflozin; metformin hydrochloride; saxagliptin hydrochloride TABLET, EXTENDED RELEASE;ORAL 210874-001 May 2, 2019 RX Yes No RE44186   Start Trial Y Y   Start Trial
Astrazeneca Ab BYDUREON exenatide synthetic FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS 022200-001 Jan 27, 2012 RX Yes Yes 6,479,065   Start Trial Y   Start Trial
Astrazeneca Ab FARXIGA dapagliflozin TABLET;ORAL 202293-001 Jan 8, 2014 RX Yes No 8,361,972   Start Trial   Start Trial
Astrazeneca Ab BYDUREON BCISE exenatide SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS 209210-001 Oct 20, 2017 RX Yes Yes 6,936,590   Start Trial   Start Trial
Astrazeneca Ab BYDUREON PEN exenatide synthetic FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS 022200-002 Feb 28, 2014 RX Yes Yes 6,515,117   Start Trial Y Y   Start Trial
Astrazeneca Ab QTERN dapagliflozin; saxagliptin hydrochloride TABLET;ORAL 209091-001 Feb 27, 2017 RX Yes Yes 8,361,972   Start Trial   Start Trial
Astrazeneca Ab QTERNMET XR dapagliflozin; metformin hydrochloride; saxagliptin hydrochloride TABLET, EXTENDED RELEASE;ORAL 210874-002 May 2, 2019 RX Yes No 8,628,799   Start Trial Y   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 Astrazeneca Ab

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Astrazeneca Ab FARXIGA dapagliflozin TABLET;ORAL 202293-001 Jan 8, 2014 6,667,061   Start Trial
Astrazeneca Ab SYMLIN pramlintide acetate INJECTABLE;SUBCUTANEOUS 021332-001 Mar 16, 2005 7,271,238   Start Trial
Astrazeneca Ab BYETTA exenatide synthetic INJECTABLE;SUBCUTANEOUS 021773-002 Apr 28, 2005 7,521,423   Start Trial
Astrazeneca Ab SYMLIN pramlintide acetate INJECTABLE;SUBCUTANEOUS 021332-002 Sep 25, 2007 6,114,304   Start Trial
Astrazeneca Ab SYMLIN pramlintide acetate INJECTABLE;SUBCUTANEOUS 021332-001 Mar 16, 2005 5,998,367   Start Trial
Astrazeneca Ab FARXIGA dapagliflozin TABLET;ORAL 202293-002 Jan 8, 2014 6,495,164   Start Trial
Astrazeneca Ab BYDUREON PEN exenatide synthetic FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS 022200-002 Feb 28, 2014 6,872,700   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration
Paragraph IV (Patent) Challenges for ASTRAZENECA AB drugs
Drugname Dosage Strength Tradename Submissiondate
➤ Subscribe Injection 250 mg/mL, 1.2 mL and 2.4 mL prefilled syringe ➤ Subscribe 2014-06-11
➤ Subscribe HydrochlorideExtended-release Tablets 2.5 mg/1000 mg ➤ Subscribe 2018-10-29
➤ Subscribe Extended-release Tablets 5 mg/500 mg, 2.5 mg/1000 mg, and 5 mg/1000 mg ➤ Subscribe 2013-07-31
➤ Subscribe Tablets 2.5 mg and 5 mg ➤ Subscribe 2013-07-31

Supplementary Protection Certificates for Astrazeneca Ab Drugs

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1261586 15/2012 Austria   Start Trial PRODUCT NAME: KOMBINATIONSPRODUKT VON SAXAGLIPTIN UND METFORMIN UND PHARMAZEUTISCH VERTRAEGLICHE SALZE DAVON, BEINHALTEND DIE HYDROCHLORIDSALZE VON SAXAGLIPTIN UND METFORMIN; REGISTRATION NO/DATE: EU/1/11/731/001-EU/1/11/731/012 20111124
1506211 CA 2014 00037 Denmark   Start Trial 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
1734971 C01734971/01 Switzerland   Start Trial PRODUCT NAME: EXENATIDE; REGISTRATION NO/DATE: SWISSMEDIC 61629 17.02.2012
1412357 SPC/GB08/040 United Kingdom   Start Trial PRODUCT NAME: SITAGLIPTIN OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT, IN PARTICULAR THE MONOPHOSPHATE, PLUS METFORMIN OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT, IN PARTICULAR THE HYDROCHLORIDE.; REGISTERED: CH 58450 01-03 20080408; UK EU/1/08/455/001 20080716; UK EU/1/08/455/002 20080716; UK EU/1/08/455/003 20080716; UK EU/1/08/455/004 20080716; UK EU/1/08/455/005 20080716; UK EU/1/08/455/006 20080716; UK EU/1/08/455/007 20080716; UK EU/1/08/455/008 20080716; UK EU/1/08/455/009 20080716; UK EU/1/08/455/010 20080716; UK EU/1/08/455/011 20080716; UK EU/1/08/455/012 20080716; UK EU/1/08/455/013 20080716; UK EU/1/08/455/014 20080716
1734971 248 5006-2012 Slovakia   Start Trial PRODUCT NAME: EXENATID; REGISTRATION NO/DATE: EU/1/11/696/001 - EU/1/11/696/002 20110623
1261586 2010C/008 Belgium   Start Trial PRODUCT NAME: SAXAGLIPTINE ET SES SELS PHARMACEUTIQUEMENT ACCEPTABLES, COMPRENANT LE CHLORHYDRATE DE SAXAGLIPTINE; AUTHORISATION NUMBER AND DATE: EU/1/09/545001 20091005
1734971 2012C/017 Belgium   Start Trial PRODUCT NAME: BYDUREON-EXENATIDE; AUTHORISATION NUMBER AND DATE: EU/1/11/696/001 20110617
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description
Similar Applicant Names
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Serving leading biopharmaceutical companies globally:

AstraZeneca
Express Scripts
Boehringer Ingelheim
Merck
Dow
Medtronic

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