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Serving leading biopharmaceutical companies globally:

McKinsey
Accenture
AstraZeneca
Cerilliant
Mallinckrodt
Covington
Teva
Medtronic
US Army
Moodys

Generated: November 20, 2017

DrugPatentWatch Database Preview

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 thirty-seven US patents protecting ASTRAZENECA drugs and there have been four Paragraph IV challenges on ASTRAZENECA drugs in the past three years.

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

Summary for ASTRAZENECA

International Patents:2630
US Patents:137
Tradenames:67
Ingredients:57
NDAs:93
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Astrazeneca Pharms
IRESSA
gefitinib
TABLET;ORAL206995-001Jul 13, 2015RXYesYes► Subscribe► SubscribeYY ► Subscribe
Astrazeneca Ab
XIGDUO XR
dapagliflozin propanediol; metformin hydrochloride
TABLET, EXTENDED RELEASE;ORAL205649-003Oct 29, 2014RXYesNo► Subscribe► Subscribe ► Subscribe
Astrazeneca Lp
NEXIUM 24HR
esomeprazole magnesium
CAPSULE, DELAYED RELEASE;ORAL204655-001Mar 28, 2014OTCYesYes► Subscribe► SubscribeY► Subscribe
Astrazeneca Pharms
NEXIUM
esomeprazole magnesium
CAPSULE, DELAYED REL PELLETS;ORAL021153-002Feb 20, 2001ABRXYesYes► Subscribe► SubscribeY► Subscribe
Astrazeneca Ab
XIGDUO XR
dapagliflozin propanediol; metformin hydrochloride
TABLET, EXTENDED RELEASE;ORAL205649-005Jul 28, 2017RXYesNo► Subscribe► Subscribe ► Subscribe
Astrazeneca
SORBITRATE
isosorbide dinitrate
TABLET;ORAL088124-001Aug 21, 1990DISCNNoNo► Subscribe► Subscribe► Subscribe
Astrazeneca Pharms
SEROQUEL
quetiapine fumarate
TABLET;ORAL020639-006Oct 4, 2005ABRXYesNo► Subscribe► Subscribe► Subscribe
Astrazeneca Ab
BYDUREON
exenatide synthetic
FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS022200-001Jan 27, 2012RXYesYes► Subscribe► SubscribeY ► Subscribe
Astrazeneca Pharms
BEVESPI AEROSPHERE
formoterol fumarate; glycopyrrolate
AEROSOL, METERED;INHALATION208294-001Apr 25, 2016RXYesYes► Subscribe► Subscribe ► Subscribe
Astrazeneca Pharms
NEXIUM
esomeprazole magnesium
FOR SUSPENSION, DELAYED RELEASE;ORAL021957-002Oct 20, 2006RXYesYes► Subscribe► SubscribeY► Subscribe
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Expired Patents for Astrazeneca

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Astrazeneca
PLENDIL
felodipine
TABLET, EXTENDED RELEASE;ORAL019834-002Jul 25, 1991► Subscribe► Subscribe
Astrazeneca
DURANEST
etidocaine hydrochloride
INJECTABLE;INJECTION017751-005Approved Prior to Jan 1, 1982► Subscribe► Subscribe
Astrazeneca
DURANEST
epinephrine; etidocaine hydrochloride
INJECTABLE;INJECTION017751-004Approved Prior to Jan 1, 1982► Subscribe► Subscribe
Astrazeneca Ab
SYMLIN
pramlintide acetate
INJECTABLE;SUBCUTANEOUS021332-003Sep 25, 2007► Subscribe► Subscribe
Astrazeneca Pharms
SEROQUEL
quetiapine fumarate
TABLET;ORAL020639-003Sep 26, 1997► Subscribe► Subscribe
Astrazeneca
DURANEST
epinephrine bitartrate; etidocaine hydrochloride
INJECTABLE;INJECTION017751-007Approved Prior to Jan 1, 1982► Subscribe► Subscribe
Astrazeneca
ATACAND HCT
candesartan cilexetil; hydrochlorothiazide
TABLET;ORAL021093-002Sep 5, 2000► Subscribe► Subscribe
Astrazeneca
SEROQUEL XR
quetiapine fumarate
TABLET, EXTENDED RELEASE;ORAL022047-005Aug 11, 2008► Subscribe► Subscribe
Astrazeneca
ATACAND HCT
candesartan cilexetil; hydrochlorothiazide
TABLET;ORAL021093-003May 16, 2008► Subscribe► Subscribe
Astrazeneca Ab
BYETTA
exenatide synthetic
INJECTABLE;SUBCUTANEOUS021773-002Apr 28, 2005► Subscribe► Subscribe
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Paragraph IV activity for ASTRAZENECA drugs

Drugname Dosage Strength Tradename Submissiondate
zolmitriptan
Nasal Spray2.5 mg/spray
ZOMIG
6/9/2016
ticagrelor
Tablets60 mg
BRILINTA
9/30/2015
ticagrelor
Tablets90 mg
BRILINTA
7/20/2015
roflumilast
Tablets500 mcg
DALIRESP
3/2/2015
exenatide
Injection250 mg/mL, 1.2 mL and 2.4 mL prefilled syringe
BYETTA
6/11/2014
zolmitriptan
Nasal Spray5 mg/spray
ZOMIG
11/14/2013
saxagliptin hydrochloride and metformin hydrochloride
Extended-release Tablets5 mg/500 mg, 2.5 mg/1000 mg, and 5 mg/1000 mg
KOMBIGLYZE XR
7/31/2013
saxagliptin hydrochloride
Tablets2.5 mg and 5 mg
ONGLYZA
7/31/2013
omeprazole magnesium
Delayed-release Tablets20 mg
PRILOSEC OTC
3/30/2012
ciclesonide
Nasal Spray250 mcg
OMNARIS
2/13/2012
budesonide
Inhalation Suspension1 mg/2 mL
PULMICORT RESPULES
5/28/2010
esomeprazole sodium
For Injection20 mg/vial and 40 mg/vial
NEXIUM IV
11/23/2009
fulvestrant
Injection50 mg/mL, 2.5 mL and 5 mL syringe
FASLODEX
10/1/2009
candesartan cilexetil and hydrochlorothiazide
Tablets32 mg/25 mg
ATACAND HCT
3/6/2009
quetiapine fumarate
Extended-release Tablets150 mg
SEROQUEL XR
11/17/2008
quetiapine fumarate
Extended-release Tablets50 mg
SEROQUEL XR
10/17/2008
candesartan cilexetil and hydrochlorothiazide
Tablets16 mg/12.5 mg and 32 mg/12.5 mg
ATACAND HCT
6/25/2008
quetiapine fumarate
Extended-release Tablets400 mg
SEROQUEL XR
6/18/2008
quetiapine fumarate
Tablets200 mg and 300 mg
SEROQUEL XR
6/12/2008
budesonide
Nasal Spray0.032 mg (32 mcg)/spray
RHINOCORT
5/14/2007
omeprazole magnesium
Delayed-release Capsules20 mg
PRILOSEC OTC
3/19/2007
quetiapine fumarate
Tablets50 mg, 150 mg and 400 mg
SEROQUEL
2/12/2007
candesartan cilexetil
Tablets4 mg, 8 mg, 16 mg and 32 mg
ATACAND
12/22/2006
quetiapine fumarate
Tablets100 mg, 200 mg and 300 mg
SEROQUEL
2/21/2006
budesonide
Inhalation Suspension0.25 mg/2 mL and 0.5 mg/2 mL
PULMICORT RESPULES
9/15/2005
quetiapine fumarate
Tablets25 mg
SEROQUEL
8/12/2005
esomeprazole magnesium
Delayed-release20 mg and 40 mg
NEXIUM
8/5/2005

Non-Orange Book Patents for Astrazeneca

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
8,617,613Polymer-based sustained release device► Subscribe
5,998,367 Pramlintide pro H-amylin salts and compositions► Subscribe
8,758,292Administering apparatus with functional drive element► Subscribe
7,470,791Process for the preparation of roflumilast► Subscribe
7,819,075Inhaler device counter► Subscribe
9,453,039Crystal structures of SGLT2 inhibitors and processes for preparing same► Subscribe
7,407,932Methods for glucagon suppression using modified exendins► Subscribe
7,524,530Residual solvent extraction method and microparticles produced thereby► Subscribe
5,795,861 Methods for regulating gastrointestinal motility► Subscribe
7,371,406Preparation of injectable suspensions having improved injectability► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.

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International Patent Family for Astrazeneca Drugs

Country Document Number Estimated Expiration
World Intellectual Property Organization (WIPO)2007024700► Subscribe
CroatiaP20050399► Subscribe
South Korea20060026125► Subscribe
Portugal707580► Subscribe
Norway20024295► Subscribe
China104321055► Subscribe
South Korea20000070186► Subscribe
Czech Republic296301► Subscribe
European Patent Office1014993► Subscribe
Germany60114145► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

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Supplementary Protection Certificates for Astrazeneca Drugs

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
132Luxembourg► SubscribePRODUCT NAME: SEL D ACLIDINIUM AVEC ANION D UN ACIDE MONO OU POLYVALENT PHARMACEUTIQUEMENT ACCEPTABLE PARTICULIEREMENT LE BROMURE D ACLIDINIUM
4Finland► Subscribe
00483Netherlands► SubscribePRODUCT NAME: NAXOPREN EN ESOMEPRAZOL ALS MAGNESIUMTRIHYFRAAT; NAT. REGISTRATION NO/DATE: RVG 106235 20101118; FIRST REGISTRATION: PL 17091/0263 - 0001 20110524
C0001France► SubscribePRODUCT NAME: SEL D'ACLIDINIUM AVEC UN ANION PHARMACEUTIQUEMENT ACCEPTABLE D'UN ACIDE MONO OU POLYVALENT, EN PARTICULIER LE BROMURE D'ACLIDINIUM; REGISTRATION NO/DATE: EU/1/12/778/001-003 20120720
C/GB10/001United Kingdom► SubscribePRODUCT NAME: SAXAGLIPTIN AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF INCLUDING SAXAGLIPTIN HYDROCHLORIDE; REGISTERED: UK EU/1/09/545/001 20091001; UK EU/1/09/545/002 20091001; UK EU/1/09/545/003 20091001; UK EU/1/09/545/004 20091001; UK EU/1/09/545/005 20091001; UK EU/1/09/545/006 20091001; UK EU/1/09/545/007 20091001; UK EU/1/09/545/008 20091001; UK EU/1/09/545/009 20091001; UK EU/1/09/545/010 20091001
342Luxembourg► Subscribe91342, EXPIRES: 20211120
12/048Ireland► SubscribePRODUCT NAME: A COMBINATION PRODUCT COMPRISING ASPIRIN AND ESOMEPRAZOLE MAGNESIUM TRIHYDRATE; NAT REGISTRATION NO/DATE: PA 970/063/001 20120831; FIRST REGISTRATION NO/DATE: 5402359; 5402367 5402375 20110812
C/GB10/040United Kingdom► SubscribePRODUCT NAME: ROFLUMILAST, ROFLUMILAST-N-OXIDE AND THE SALTS OF THESE COMPOUNDS.; REGISTERED: UK EU/1/10/636/001 20100705; UK EU/1/10/636/002 20100705; UK EU/1/10/636/003 20100705
90027-7Sweden► SubscribePRODUCT NAME: NALOXEGOL; REG. NO/DATE: EU/1/14/962 20141210
15/016Ireland► SubscribePRODUCT NAME: OLAPARIB, AND SALTS AND SOLVATES THEREOF; REGISTRATION NO/DATE: EU/1/14/959/001 20141216
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Similar Applicant Names

Individual applicants are sometimes listed under multiple names.
Here is a list of applicants with similar names.

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

Serving leading biopharmaceutical companies globally:

Cantor Fitzgerald
Daiichi Sankyo
Queensland Health
Moodys
Argus Health
AstraZeneca
Farmers Insurance
Fish and Richardson
Mallinckrodt
Colorcon

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.

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