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Last Updated: April 19, 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 XIGDUO XR dapagliflozin; metformin hydrochloride TABLET, EXTENDED RELEASE;ORAL 205649-004 Oct 29, 2014 RX Yes Yes 6,515,117 ⤷  Try a Trial Y Y ⤷  Try a Trial
Astrazeneca Ab QTERN dapagliflozin; saxagliptin hydrochloride TABLET;ORAL 209091-002 May 2, 2019 RX Yes No 6,515,117 ⤷  Try a Trial Y Y ⤷  Try a Trial
Astrazeneca Ab BYDUREON exenatide synthetic FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS 022200-001 Jan 27, 2012 DISCN Yes No 7,563,871*PED ⤷  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 Astrazeneca Ab

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Astrazeneca Ab BYDUREON BCISE exenatide synthetic SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS 209210-001 Oct 20, 2017 6,667,061 ⤷  Try a Trial
Astrazeneca Ab BYDUREON exenatide synthetic FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS 022200-001 Jan 27, 2012 6,479,065 ⤷  Try a Trial
Astrazeneca Ab XIGDUO XR dapagliflozin; metformin hydrochloride TABLET, EXTENDED RELEASE;ORAL 205649-001 Oct 29, 2014 9,198,925 ⤷  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 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
➤ Subscribe HydrochlorideExtended-release Tablets 2.5 mg/1000 mg ➤ Subscribe 2018-10-29

Supplementary Protection Certificates for Astrazeneca Ab Drugs

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2435024 122021000026 Germany ⤷  Try a Trial PRODUCT NAME: GLYCOPYRROLAT MIT FORMOTEROL MIT BUDESONID, ODER SALZE, ESTER, SOLVATE, ENANTIOMERE UND MISCHUNGEN VON ENANTIOMEREN DERSELBEN; REGISTRATION NO/DATE: EU/1/20/1498 20201209
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
2435024 21C1020 France ⤷  Try a Trial PRODUCT NAME: COMBINAISON DE FORMOTEROL (Y COMPRIS LES SELS, ESTERS, SOLVATES OU ENANTIOMERES PHARMACEUTIQUEMENT ACCEPTABLES DE CELUI-CI), GLYCOPYRROLATE (Y COMPRIS LES SELS, ESTERS, SOLVATES OU ENANTIOMERES PHARMACEUTIQUEMENT ACCEPTABLES DE CELUI-CI) ET BUDESONIDE (Y COMPRIS LES SELS, ESTERS, SOLVATES OU ENANTIOMERES PHARMACEUTIQUEMENT ACCEPTABLES DE CELUI-CI); REGISTRATION NO/DATE: EU/1/20/1498 20201210
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description
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