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Serving hundreds of leading biopharmaceutical companies globally:

McKesson
Chinese Patent Office
Mallinckrodt
McKinsey
Express Scripts
Colorcon
QuintilesIMS
Covington
US Army

Generated: October 23, 2018

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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-two approved drugs.

There are one hundred and forty-five US patents protecting ASTRAZENECA drugs.

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 Ab BYDUREON exenatide synthetic FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS 022200-001 Jan 27, 2012 RX Yes Yes 8,906,851 ➤ Sign Up ➤ Sign Up
Astrazeneca Ab FARXIGA dapagliflozin TABLET;ORAL 202293-002 Jan 8, 2014 RX Yes Yes 8,431,685 ➤ Sign Up Y ➤ Sign Up
Astrazeneca Ab FARXIGA dapagliflozin TABLET;ORAL 202293-002 Jan 8, 2014 RX Yes Yes 9,238,076 ➤ Sign Up Y ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration

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Expired US Patents for ASTRAZENECA

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Astrazeneca Ab SYMLIN pramlintide acetate INJECTABLE;SUBCUTANEOUS 021332-001 Mar 16, 2005 6,608,029 ➤ Sign Up
Astrazeneca PLENDIL felodipine TABLET, EXTENDED RELEASE;ORAL 019834-004 Sep 22, 1994 4,264,611*PED ➤ Sign Up
Astrazeneca IRESSA gefitinib TABLET;ORAL 021399-001 May 5, 2003 5,616,582 ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Paragraph IV (Patent) Challenges for ASTRAZENECA drugs
Drugname Dosage Strength Tradename Submissiondate
➤ Subscribe Extended-release Tablets 150 mg ➤ Subscribe 2008-11-17
➤ Subscribe Tablets 50 mg, 150 mg and 400 mg ➤ Subscribe 2007-02-12
➤ Subscribe Extended-release Tablets 50 mg ➤ Subscribe 2008-10-17
➤ Subscribe Extended-release Tablets 5 mg/500 mg, 2.5 mg/1000 mg, and 5 mg/1000 mg ➤ Subscribe 2013-07-31
➤ Subscribe Delayed-release 20 mg and 40 mg ➤ Subscribe 2005-08-05
➤ Subscribe Nasal Spray 250 mcg ➤ Subscribe 2012-02-13
➤ Subscribe Inhalation Suspension 1 mg/2 mL ➤ Subscribe 2010-05-28
➤ Subscribe Nasal Spray 0.032 mg (32 mcg)/spray ➤ Subscribe 2007-05-14
➤ Subscribe Delayed-release Tablets 20 mg ➤ Subscribe 2012-03-30
➤ Subscribe Nasal Spray 5 mg/spray ➤ Subscribe 2013-11-14
➤ Subscribe Tablets 60 mg ➤ Subscribe 2015-09-30
➤ Subscribe Extended-release Tablets 400 mg ➤ Subscribe 2008-06-18
➤ Subscribe Tablets 25 mg ➤ Subscribe 2005-08-12
➤ Subscribe Tablets 200 mg and 300 mg ➤ Subscribe 2008-06-12
➤ Subscribe Tablets 100 mg, 200 mg and 300 mg ➤ Subscribe 2006-02-21
➤ Subscribe Injection 250 mg/mL, 1.2 mL and 2.4 mL prefilled syringe ➤ Subscribe 2014-06-11
➤ Subscribe Tablets 2.5 mg and 5 mg ➤ Subscribe 2013-07-31
➤ Subscribe For Injection 20 mg/vial and 40 mg/vial ➤ Subscribe 2009-11-23
➤ Subscribe Inhalation Suspension 0.25 mg/2 mL and 0.5 mg/2 mL ➤ Subscribe 2005-09-15
➤ Subscribe Delayed-release Capsules 20 mg ➤ Subscribe 2007-03-19
➤ Subscribe Injection 50 mg/mL, 2.5 mL and 5 mL syringe ➤ Subscribe 2009-10-01
➤ Subscribe Tablets 90 mg ➤ Subscribe 2015-07-20
➤ Subscribe Nasal Spray 2.5 mg/spray ➤ Subscribe 2016-06-09
➤ Subscribe Tablets 500 mcg ➤ Subscribe 2015-03-02

Supplementary Protection Certificates for ASTRAZENECA Drugs

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
00483 Netherlands ➤ Sign Up PRODUCT NAME: NAXOPREN EN ESOMEPRAZOL ALS MAGNESIUMTRIHYFRAAT; NAT. REGISTRATION NO/DATE: RVG 106235 20101118; FIRST REGISTRATION: PL 17091/0263 - 0001 20110524
90002-2 Sweden ➤ Sign Up PRODUCT NAME: AKLIDINIUMSALT MED FARMACEUTISKT ACCEPTABEL ANJON AV EN- ELLER FLERVAERD SYRA, SPECIELLT AKLIDINIUMBROMID; REG. NO/DATE: EU/1/12/778/001 20120720
2008013 Lithuania ➤ Sign Up PRODUCT NAME: SITAGLIPTINUM PHOSPHAS MONOHYDRICUS, METFORMINI HYDROCHLORIDUM; REG. NO/DATE: EU/1/08/455/001-014 20080716
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Similar Applicant Names
Applicants may be listed under multiple names.
Here is a list of applicants with similar names.

For more information try a trial or see the plans and pricing

Serving hundreds of leading biopharmaceutical companies globally:

Cerilliant
Deloitte
McKinsey
Farmers Insurance
Cipla
Fuji
UBS
Merck
Accenture

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 verifification 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.