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Last Updated: March 18, 2024

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 FARXIGA dapagliflozin TABLET;ORAL 202293-002 Jan 8, 2014 RX Yes Yes 8,361,972 ⤷  Try a Trial ⤷  Try a Trial
Astrazeneca Ab WAINUA eplontersen sodium SOLUTION;SUBCUTANEOUS 217388-001 Dec 21, 2023 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial
Astrazeneca Ab FARXIGA dapagliflozin TABLET;ORAL 202293-002 Jan 8, 2014 RX Yes Yes 7,919,598 ⤷  Try a Trial Y ⤷  Try a Trial
Astrazeneca Ab FARXIGA dapagliflozin TABLET;ORAL 202293-001 Jan 8, 2014 RX Yes No 7,919,598 ⤷  Try a Trial Y ⤷  Try a Trial
Astrazeneca Ab BYDUREON exenatide synthetic FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS 022200-001 Jan 27, 2012 DISCN Yes No 9,238,076*PED ⤷  Try a Trial Y ⤷  Try a Trial
Astrazeneca Ab FARXIGA dapagliflozin TABLET;ORAL 202293-001 Jan 8, 2014 RX Yes No 8,431,685 ⤷  Try a Trial Y ⤷  Try a Trial
Astrazeneca Ab XIGDUO XR dapagliflozin; metformin hydrochloride TABLET, EXTENDED RELEASE;ORAL 205649-002 Oct 29, 2014 RX Yes No 6,515,117 ⤷  Try a Trial Y 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 ASTRAZENECA AB

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Astrazeneca Ab QTERN dapagliflozin; saxagliptin hydrochloride TABLET;ORAL 209091-002 May 2, 2019 RE44186 ⤷  Try a Trial
Astrazeneca Ab SYMLIN pramlintide acetate INJECTABLE;SUBCUTANEOUS 021332-001 Mar 16, 2005 5,686,411 ⤷  Try a Trial
Astrazeneca Ab BYETTA exenatide synthetic INJECTABLE;SUBCUTANEOUS 021773-001 Apr 28, 2005 6,872,700 ⤷  Try a Trial
Astrazeneca Ab BYDUREON PEN exenatide synthetic FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS 022200-002 Feb 28, 2014 6,479,065 ⤷  Try a Trial
Astrazeneca Ab SYMLIN pramlintide acetate INJECTABLE;SUBCUTANEOUS 021332-002 Sep 25, 2007 6,610,824 ⤷  Try a Trial
Astrazeneca Ab FARXIGA dapagliflozin TABLET;ORAL 202293-002 Jan 8, 2014 6,414,126 ⤷  Try a Trial
Astrazeneca Ab SYMLIN pramlintide acetate INJECTABLE;SUBCUTANEOUS 021332-001 Mar 16, 2005 6,610,824 ⤷  Try a 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 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
➤ Subscribe Injection 250 mg/mL, 1.2 mL and 2.4 mL prefilled syringe ➤ Subscribe 2014-06-11

Supplementary Protection Certificates for ASTRAZENECA AB Drugs

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1734971 C01734971/01 Switzerland ⤷  Try a Trial PRODUCT NAME: EXENATIDE; REGISTRATION NO/DATE: SWISSMEDIC 61629 17.02.2012
1506211 C20130006 00074 Estonia ⤷  Try a Trial PRODUCT NAME: DAPAGLIFLOZIN;REG NO/DATE: K(2012)8378 12.11.2012
2139494 34/2020 Austria ⤷  Try a Trial PRODUCT NAME: DAPAGLIFLOZIN PROPYLENGYLKOL HYDRAT/SAXAGLIPTIN; REGISTRATION NO/DATE: EU/1/16/1108 (MITTEILUNG) 20160715
2498758 2020C/509 Belgium ⤷  Try a Trial PRODUCT NAME: QTRILMET - METFORMINE OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELLE-CI; SAXAGLIPTINE OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELLE-CI; DAPAGLIFLOZINE OU UN SOLVATE PHARMACEUTIQUEMENT ACCEPTABLE DE CELLE-CI; AUTHORISATION NUMBER AND DATE: EU/1/19/1401 20191113
1734971 91989 Luxembourg ⤷  Try a Trial 91989, EXPIRES: 20260617
1506211 136 5005-2013 Slovakia ⤷  Try a Trial PRODUCT NAME: DAPAGLIFLOZIN; FIRST REGISTRATION NO/DATE: EU/1/12/795/001, EU/1/12/795/002, EU/1/12/795/003, EU/1/12/795/004, EU/1/12/795/005, EU/1/12/795/006, EU/1/12/795/007, EU/1/12/795/007, EU/1/12/795/008, EU/1/12/795/009, EU/1/12/795/010 20121112
1532149 PA2012022 Lithuania ⤷  Try a Trial PRODUCT NAME: LINAGLIPTINUM + METFORMINI HYDROCHLORIDUM; REGISTRATION NO/DATE: EU/1/12/780/001 - EU/1/12/780/034 20120720
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description
Similar Applicant Names
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.