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Serving hundreds of leading biopharmaceutical companies globally:

Boehringer Ingelheim
McKesson
Cipla
Healthtrust
Cantor Fitzgerald
Harvard Business School

Generated: June 19, 2019

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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 Pharms TAGRISSO osimertinib mesylate TABLET;ORAL 208065-002 Nov 13, 2015 RX Yes Yes 9,732,058 ➤ Sign Up Y Y ➤ Sign Up
Astrazeneca Ab XIGDUO XR dapagliflozin; metformin hydrochloride TABLET, EXTENDED RELEASE;ORAL 205649-004 Oct 29, 2014 RX Yes Yes 8,685,934 ➤ Sign Up ➤ Sign Up
Astrazeneca TONOCARD tocainide hydrochloride TABLET;ORAL 018257-001 Nov 9, 1984 DISCN No No ➤ Sign Up ➤ Sign Up
Astrazeneca Ab BYDUREON PEN exenatide synthetic FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS 022200-002 Feb 28, 2014 RX Yes Yes 8,439,864 ➤ Sign Up Y ➤ Sign Up
Astrazeneca Pharms LYNPARZA olaparib TABLET;ORAL 208558-002 Aug 17, 2017 RX Yes Yes 7,449,464 ➤ Sign Up Y Y ➤ Sign Up
Astrazeneca XYLOCAINE W/ EPINEPHRINE epinephrine; lidocaine hydrochloride INJECTABLE;INJECTION 010418-010 Approved Prior to Jan 1, 1982 DISCN No No ➤ Sign Up ➤ Sign Up
Astrazeneca Ab KOMBIGLYZE XR metformin hydrochloride; saxagliptin hydrochloride TABLET, EXTENDED RELEASE;ORAL 200678-001 Nov 5, 2010 RX Yes No ➤ Sign Up ➤ 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 Pharms NEXIUM esomeprazole magnesium CAPSULE, DELAYED REL PELLETS;ORAL 021153-001 Feb 20, 2001 5,690,960*PED ➤ Sign Up
Astrazeneca Pharms ALVESCO ciclesonide AEROSOL, METERED;INHALATION 021658-002 Jan 10, 2008 6,036,942 ➤ Sign Up
Astrazeneca SYMBICORT budesonide; formoterol fumarate dihydrate AEROSOL, METERED;INHALATION 021929-001 Jul 21, 2006 6,123,924*PED ➤ Sign Up
Astrazeneca PLENDIL felodipine TABLET, EXTENDED RELEASE;ORAL 019834-001 Jul 25, 1991 4,803,081*PED ➤ Sign Up
Astrazeneca Ab FARXIGA dapagliflozin TABLET;ORAL 202293-001 Jan 8, 2014 7,741,269 ➤ Sign Up
Astrazeneca LEXXEL enalapril maleate; felodipine TABLET, EXTENDED RELEASE;ORAL 020668-001 Dec 27, 1996 4,472,380 ➤ Sign Up
Astrazeneca Pharms NEXIUM IV esomeprazole sodium INJECTABLE;INTRAVENOUS 021689-002 Mar 31, 2005 5,877,192*PED ➤ 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 Delayed-release for Oral Suspension 2.5 mg and 5 mg ➤ Subscribe 2018-09-24
➤ Subscribe Nasal Spray 250 mcg ➤ Subscribe 2012-02-13
➤ Subscribe Nasal Spray 0.032 mg (32 mcg)/spray ➤ Subscribe 2007-05-14
➤ Subscribe Inhalation Suspension 1 mg/2 mL ➤ Subscribe 2010-05-28
➤ Subscribe Nasal Spray 5 mg/spray ➤ Subscribe 2013-11-14
➤ Subscribe Delayed-release Tablets 20 mg ➤ Subscribe 2012-03-30
➤ Subscribe Extended-release Tablets 400 mg ➤ Subscribe 2008-06-18
➤ Subscribe Tablets 60 mg ➤ Subscribe 2015-09-30
➤ Subscribe Tablets 200 mg and 300 mg ➤ Subscribe 2008-06-12
➤ Subscribe Tablets 12.5 mg and 25 mg ➤ Subscribe 2018-09-17
➤ Subscribe Injection 250 mg/mL, 1.2 mL and 2.4 mL prefilled syringe ➤ Subscribe 2014-06-11
➤ Subscribe Tablets 50 mg, 150 mg and 400 mg ➤ Subscribe 2007-02-12
➤ Subscribe HydrochlorideExtended-release Tablets 2.5 mg/1000 mg ➤ Subscribe 2018-10-29
➤ Subscribe Delayed-release 20 mg and 40 mg ➤ Subscribe 2005-08-05
➤ 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 Injection 50 mg/mL, 2.5 mL and 5 mL syringe ➤ Subscribe 2009-10-01
➤ Subscribe Delayed-release Capsules 20 mg ➤ Subscribe 2007-03-19
➤ Subscribe Nasal Spray 2.5 mg/spray ➤ Subscribe 2016-06-09
➤ Subscribe Tablets 90 mg ➤ Subscribe 2015-07-20
➤ Subscribe Extended-release Tablets 150 mg ➤ Subscribe 2008-11-17
➤ Subscribe Tablets 500 mcg ➤ Subscribe 2015-03-02
➤ Subscribe Extended-release Tablets 50 mg ➤ Subscribe 2008-10-17
➤ Subscribe Tablets 25 mg ➤ Subscribe 2005-08-12
➤ Subscribe Extended-release Tablets 5 mg/500 mg, 2.5 mg/1000 mg, and 5 mg/1000 mg ➤ Subscribe 2013-07-31
➤ Subscribe Tablets 100 mg, 200 mg and 300 mg ➤ Subscribe 2006-02-21
➤ 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
1734971 16/2012 Austria ➤ Sign Up PRODUCT NAME: EXENATID; REGISTRATION NO/DATE: EU/1/11/696/001-002 (MITTEILUNG) 20110623
1734971 2012C/017 Belgium ➤ Sign Up PRODUCT NAME: BYDUREON-EXENATIDE; AUTHORISATION NUMBER AND DATE: EU/1/11/696/001 20110617
0823900 PA2009009,C0823900 Lithuania ➤ Sign Up PRODUCT NAME: GEFITINIBUM; REGISTRATION NO/DATE: EU/1/09/526/001 20090624
1200431 SPC/GB13/006 United Kingdom ➤ Sign Up PRODUCT NAME: ACLIDINIUM SALT WITH PHARMACEUTICALLY ACCEPTABLE ANION OF A MONO OR POLYVALENT ACID ESPECIALLY AS ACLIDINIUM BROMIDE; REGISTERED: UK EU/1/12/778/001 20120720; UK EU/1/12/778/002 20120720; UK EU/1/12/778/003 20120720; UK EU/1/12/781/001 20120720; UK EU/1/12/781/002 20120720; UK EU/1/12/781/003 20120720
0823900 0990043-2.L Sweden ➤ Sign Up PRODUCT NAME: GEFITINIB ELLER ETT FARMACEUTISKT GODTAGBART SALT DAERAV; NAT. REG. NO/DATE: EU/1/09/526/001 20090624; FIRST REG.: CH ZD1839 20040302
1261586 C01261586/01 Switzerland ➤ Sign Up FORMER OWNER: BRISTOL-MYERS SQUIBB COMPANY, US
0290047 SPC/GB97/078 United Kingdom ➤ Sign Up 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
Patent Number 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.

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Serving hundreds of leading biopharmaceutical companies globally:

Healthtrust
Boehringer Ingelheim
Colorcon
Federal Trade Commission
QuintilesIMS
US Department of Justice

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.