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Last Updated: May 10, 2024

Astrazeneca Company Profile


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What is the competitive landscape for ASTRAZENECA, and what generic alternatives to ASTRAZENECA drugs are available?

ASTRAZENECA has ninety-three approved drugs.

There are one hundred and twenty-five US patents protecting ASTRAZENECA drugs. There is one tentative approval on ASTRAZENECA drugs.

There are two thousand one hundred and ninety-four patent family members on ASTRAZENECA drugs in seventy countries and three hundred and forty-six supplementary protection certificates in twenty countries.

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 LOKELMA sodium zirconium cyclosilicate FOR SUSPENSION;ORAL 207078-002 May 18, 2018 RX Yes Yes 10,398,730 ⤷  Try a Trial ⤷  Try a Trial
Astrazeneca ISOETHARINE HYDROCHLORIDE isoetharine hydrochloride SOLUTION;INHALATION 089617-001 Jun 13, 1991 DISCN No No ⤷  Try a Trial ⤷  Try a Trial
Astrazeneca TAGRISSO osimertinib mesylate TABLET;ORAL 208065-001 Nov 13, 2015 RX Yes No 8,946,235 ⤷  Try a Trial Y Y ⤷  Try a Trial
Astrazeneca CALQUENCE acalabrutinib CAPSULE;ORAL 210259-001 Oct 31, 2017 RX Yes Yes 9,796,721 ⤷  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 6,515,117*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

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Astrazeneca Ab BYDUREON PEN exenatide synthetic FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS 022200-002 Feb 28, 2014 9,198,925 ⤷  Try a Trial
Astrazeneca PRILOSEC omeprazole CAPSULE, DELAYED REL PELLETS;ORAL 019810-002 Jan 15, 1998 4,853,230*PED ⤷  Try a Trial
Astrazeneca Ab FARXIGA dapagliflozin TABLET;ORAL 202293-001 Jan 8, 2014 6,479,065 ⤷  Try a Trial
Astrazeneca SEROQUEL quetiapine fumarate TABLET;ORAL 020639-007 Oct 4, 2005 4,879,288*PED ⤷  Try a Trial
Astrazeneca PRILOSEC omeprazole CAPSULE, DELAYED REL PELLETS;ORAL 019810-003 Oct 5, 1995 4,853,230*PED ⤷  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 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
➤ 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

Supplementary Protection Certificates for Astrazeneca Drugs

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0480717 SPC/GB98/025 United Kingdom ⤷  Try a Trial PRODUCT NAME: MONTELUKAST, OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, PREFERABLY MONTELUKAST SODIUM; REGISTERED: FI 12766 19970825; FI 12767 19970825; UK 00025/0357 19980115; UK 00025/0358 19980115
1506211 42/2014 Austria ⤷  Try a Trial PRODUCT NAME: KOMBINATION VON DAPAGLIFLOZIN ODER EINES PHARMAZEUTISCH VERTRAEGLICHEN SALZES DAVON UND METFORMIN UND EINES PHARMAZEUTISCH VERTRAEGLICHEN SALZES DAVON; REGISTRATION NO/DATE: EU/1/13/900 (MITTEILUNG) 20140121
1506211 18/2013 Austria ⤷  Try a Trial PRODUCT NAME: DAPAGLIFLOZIN UND PHARMAZEUTISCH VERTRAEGLICHE SALZE DAVON; REGISTRATION NO/DATE: EU/1/12/795/001 - EU/1/12/795/010 20121112
0806968 SPC/GB07/011 United Kingdom ⤷  Try a Trial PRODUCT NAME: GADOFOSVESET TRISODIUM; REGISTERED: UK EU/1/05/313/001 20051003; UK EU/1/05/313/002 20051003; UK EU/1/05/313/003 20051003; UK EU/1/05/313/004 20051003; UK EU/1/05/313/005 20051003; UK EU/1/05/313/006 20051003; UK EU/1/05/313/007 20051003; UK EU/1/05/313/008 20051003; UK EU/1/05/313/009 20051003
1633724 PA2015016 Lithuania ⤷  Try a Trial PRODUCT NAME: OLAPARIBUM; REGISTRATION NO/DATE: EU/1/14/959 20141216
>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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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.