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Boehringer Ingelheim

Last Updated: December 3, 2022

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 ONGLYZA saxagliptin hydrochloride TABLET;ORAL 022350-001 Jul 31, 2009 RX Yes No 7,951,400 See Plans and Pricing Y See Plans and Pricing
Astrazeneca Ab XIGDUO XR dapagliflozin; metformin hydrochloride TABLET, EXTENDED RELEASE;ORAL 205649-003 Oct 29, 2014 RX Yes No 6,515,117 See Plans and Pricing Y Y See Plans and Pricing
Astrazeneca Ab QTERN dapagliflozin; saxagliptin hydrochloride TABLET;ORAL 209091-002 May 2, 2019 RX Yes No 8,628,799 See Plans and Pricing Y See Plans and Pricing
Astrazeneca Ab BYDUREON BCISE exenatide synthetic SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS 209210-001 Oct 20, 2017 RX Yes Yes 7,612,176*PED See Plans and Pricing Y See Plans and Pricing
Astrazeneca Ab FARXIGA dapagliflozin TABLET;ORAL 202293-002 Jan 8, 2014 RX Yes Yes 10,973,836 See Plans and Pricing See Plans and Pricing
>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 9,198,925 See Plans and Pricing
Astrazeneca Ab BYDUREON exenatide synthetic FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS 022200-001 Jan 27, 2012 7,741,269 See Plans and Pricing
Astrazeneca Ab BYDUREON exenatide synthetic FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS 022200-001 Jan 27, 2012 6,872,700 See Plans and Pricing
Astrazeneca Ab BYETTA exenatide synthetic INJECTABLE;SUBCUTANEOUS 021773-001 Apr 28, 2005 7,521,423 See Plans and Pricing
Astrazeneca Ab XIGDUO XR dapagliflozin; metformin hydrochloride TABLET, EXTENDED RELEASE;ORAL 205649-003 Oct 29, 2014 6,414,126 See Plans and Pricing
>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
1734971 PA2012006 Lithuania See Plans and Pricing PRODUCT NAME: EXENATIDUM; REGISTRATION NO/DATE: EU/1/11/696/001 - EU/1/11/696/002 20110617
1506211 PA2014026 Lithuania See Plans and Pricing PRODUCT NAME: DAPAGLIFOZINUM + METFORMINUM; REGISTRATION NO/DATE: EU/1/13/900 20140116
1261586 2010C/008 Belgium See Plans and Pricing PRODUCT NAME: SAXAGLIPTINE ET SES SELS PHARMACEUTIQUEMENT ACCEPTABLES, COMPRENANT LE CHLORHYDRATE DE SAXAGLIPTINE; AUTHORISATION NUMBER AND DATE: EU/1/09/545001 20091005
1734971 122012000028 Germany See Plans and Pricing PRODUCT NAME: BYDUREON-EXENATIDE; REGISTRATION NO/DATE: EU/1/11/696/001-002 20110617
1412357 PA2008013,C1412357 Lithuania See Plans and Pricing PRODUCT NAME: SITAGLIPTINUM PHOSPHAS MONOHYDRICUS, METFORMINI HYDROCHLORIDUM; REGISTRATION NO/DATE: EU/1/08/455/001 - EU/1/08/455/014 20080716
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description
Similar Applicant Names
Applicants may be listed under multiple names.
Here is a list of applicants with similar names.

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Serving leading biopharmaceutical companies globally:

Express Scripts
AstraZeneca
McKinsey
McKesson
Merck
Moodys

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