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Last Updated: March 29, 2024

Astrazeneca Company Profile


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Summary for Astrazeneca

Drugs and US Patents for Astrazeneca

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Astrazeneca SYMBICORT budesonide; formoterol fumarate dihydrate AEROSOL, METERED;INHALATION 021929-001 Jul 21, 2006 AB RX Yes Yes 8,528,545*PED ⤷  Try a Trial Y ⤷  Try a Trial
Astrazeneca CALQUENCE acalabrutinib CAPSULE;ORAL 210259-001 Oct 31, 2017 RX Yes Yes 10,167,291 ⤷  Try a Trial Y ⤷  Try a Trial
Astrazeneca Ab WAINUA eplontersen sodium SOLUTION;SUBCUTANEOUS 217388-001 Dec 21, 2023 RX Yes Yes 9,181,549 ⤷  Try a Trial Y ⤷  Try a Trial
Astrazeneca DYCLONE dyclonine hydrochloride SOLUTION;TOPICAL 009925-001 Approved Prior to Jan 1, 1982 DISCN Yes No ⤷  Try a Trial ⤷  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

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Astrazeneca Ab ONGLYZA saxagliptin hydrochloride TABLET;ORAL 022350-001 Jul 31, 2009 6,395,767 ⤷  Try a Trial
Astrazeneca Ab SYMLIN pramlintide acetate INJECTABLE;SUBCUTANEOUS 021332-002 Sep 25, 2007 7,407,934 ⤷  Try a Trial
Astrazeneca PRILOSEC omeprazole CAPSULE, DELAYED REL PELLETS;ORAL 019810-003 Oct 5, 1995 5,629,305*PED ⤷  Try a Trial
Astrazeneca DURANEST etidocaine hydrochloride INJECTABLE;INJECTION 017751-003 Approved Prior to Jan 1, 1982 3,812,147 ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration
Paragraph IV (Patent) Challenges for ASTRAZENECA drugs
Drugname Dosage Strength Tradename Submissiondate
➤ Subscribe Delayed-release Capsules 20 mg ➤ Subscribe 2007-03-19
➤ Subscribe Extended-release Tablets 400 mg ➤ Subscribe 2008-06-18
➤ Subscribe Tablets 200 mg and 300 mg ➤ Subscribe 2008-06-12
➤ Subscribe Tablets 90 mg ➤ Subscribe 2015-07-20
➤ Subscribe Tablets 500 mcg ➤ Subscribe 2015-03-02
➤ Subscribe Nasal Spray 0.032 mg (32 mcg)/spray ➤ Subscribe 2007-05-14
➤ Subscribe Tablets 50 mg, 150 mg and 400 mg ➤ Subscribe 2007-02-12
➤ Subscribe Delayed-release for Oral Suspension 2.5 mg and 5 mg ➤ Subscribe 2018-09-24
➤ Subscribe Injection 250 mg/mL, 1.2 mL and 2.4 mL prefilled syringe ➤ Subscribe 2014-06-11
➤ Subscribe Injection 50 mg/mL, 2.5 mL and 5 mL syringe ➤ Subscribe 2009-10-01
➤ Subscribe HydrochlorideExtended-release Tablets 2.5 mg/1000 mg ➤ Subscribe 2018-10-29
➤ Subscribe Inhalation Suspension 1 mg/2 mL ➤ Subscribe 2010-05-28
➤ Subscribe Delayed-release Tablets 20 mg ➤ Subscribe 2012-03-30
➤ Subscribe Extended-release Tablets 150 mg ➤ Subscribe 2008-11-17
➤ Subscribe Extended-release Tablets 50 mg ➤ Subscribe 2008-10-17
➤ Subscribe Tablets 60 mg ➤ Subscribe 2015-09-30
➤ Subscribe Tablets 25 mg ➤ Subscribe 2005-08-12
➤ Subscribe Delayed-release 20 mg and 40 mg ➤ Subscribe 2005-08-05
➤ Subscribe Tablets 100 mg, 200 mg and 300 mg ➤ Subscribe 2006-02-21
➤ Subscribe For Injection 20 mg/vial and 40 mg/vial ➤ Subscribe 2009-11-23
➤ Subscribe Extended-release Tablets 5 mg/500 mg, 2.5 mg/1000 mg, and 5 mg/1000 mg ➤ Subscribe 2013-07-31
➤ Subscribe Inhalation Suspension 0.25 mg/2 mL and 0.5 mg/2 mL ➤ Subscribe 2005-09-15
➤ Subscribe Tablets 2.5 mg and 5 mg ➤ Subscribe 2013-07-31

Supplementary Protection Certificates for Astrazeneca Drugs

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1633724 2015C/024 Belgium ⤷  Try a Trial PRODUCT NAME: OLAPARIB ET LES SELS ET SOLVATES DE CELUI-CI; AUTHORISATION NUMBER AND DATE: EU/1/14/959 20141218
2734522 LUC00202 Luxembourg ⤷  Try a Trial PRODUCT NAME: ACALABRUTINIB OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI; AUTHORISATION NUMBER AND DATE: EU/1/20/1479 20201106
0290047 SPC/GB97/078 United Kingdom ⤷  Try a Trial PRODUCT NAME: MANGAFODIPIR AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF, IN PARTICULAR MANGAFODIPIR TRISODIUM; REGISTERED: UK EU/1/97/040/001 19970522; UK EU/1/97/040/002 19970522
1633724 CR 2015 00012 Denmark ⤷  Try a Trial PRODUCT NAME: OLAPARIB, OG SALTE OG SOLVATER DERAF; REG. NO/DATE: EU/1/14/959/001 20141216
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description
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