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Serving leading biopharmaceutical companies globally:

Citi
Fish and Richardson
Cantor Fitzgerald
US Army
Cipla
Baxter
McKesson
Accenture
Dow
Argus Health

Generated: December 10, 2017

DrugPatentWatch Database Preview

Astrazeneca Company Profile

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What is the competitive landscape for ASTRAZENECA, and when can generic versions of ASTRAZENECA drugs launch?

ASTRAZENECA has ninety-four approved drugs.

There are one hundred and forty-four 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 seventy-two patent family members on ASTRAZENECA drugs in seventy-four countries and one hundred and ninety-eight supplementary protection certificates in sixteen countries.

Summary for Astrazeneca

International Patents:2672
US Patents:144
Tradenames:68
Ingredients:58
NDAs:94
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Patent Submitted Product Substance Delist Req. Exclusivity Expiration
AstrazenecaSYMBICORTbudesonide; formoterol fumarate dihydrateAEROSOL, METERED;INHALATION021929-002Jul 21, 2006RXYesYes► Subscribe► Subscribe► SubscribeY► Subscribe
Astrazeneca PharmsALVESCOciclesonideAEROSOL, METERED;INHALATION021658-003Jan 10, 2008RXYesYes► Subscribe► Subscribe► SubscribeYY► Subscribe
Astrazeneca AbBYDUREON PENexenatide syntheticFOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS022200-002Feb 28, 2014RXYesYes► Subscribe► Subscribe► SubscribeY► Subscribe
Astrazeneca AbBYDUREON PENexenatide syntheticFOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS022200-002Feb 28, 2014RXYesYes► Subscribe► Subscribe► Subscribe► Subscribe
AstrazenecaATACAND HCTcandesartan cilexetil; hydrochlorothiazideTABLET;ORAL021093-001Sep 5, 2000ABRXYesNo► Subscribe► Subscribe► Subscribe► Subscribe
Astrazeneca PharmsLYNPARZAolaparibCAPSULE;ORAL206162-001Dec 19, 2014RXYesYes► Subscribe► Subscribe► Subscribe► Subscribe
Astrazeneca AbBYDUREON PENexenatide syntheticFOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS022200-002Feb 28, 2014RXYesYes► Subscribe► Subscribe► SubscribeY► Subscribe
Astrazeneca AbBYETTAexenatide syntheticINJECTABLE;SUBCUTANEOUS021773-001Apr 28, 2005RXYesYes► Subscribe► Subscribe► Subscribe► Subscribe
Astrazeneca LpNEXIUM 24HResomeprazole magnesiumCAPSULE, DELAYED RELEASE;ORAL204655-001Mar 28, 2014OTCYesYes► Subscribe► Subscribe► Subscribe► Subscribe
Astrazeneca PharmsOMNARISciclesonideSPRAY, METERED;NASAL022004-001Oct 20, 2006RXYesYes► Subscribe► Subscribe► SubscribeYY► Subscribe
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Expired Patents for Astrazeneca

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Astrazeneca PharmsNEXIUMesomeprazole magnesiumCAPSULE, DELAYED REL PELLETS;ORAL021153-002Feb 20, 2001► Subscribe► Subscribe
AstrazenecaELAVILamitriptyline hydrochlorideTABLET;ORAL012703-004Approved Prior to Jan 1, 1982► Subscribe► Subscribe
AstrazenecaPLENDILfelodipineTABLET, EXTENDED RELEASE;ORAL019834-002Jul 25, 1991► Subscribe► Subscribe
Astrazeneca PharmsPRILOSEComeprazoleCAPSULE, DELAYED REL PELLETS;ORAL019810-001Sep 14, 1989► Subscribe► Subscribe
Astrazeneca PharmsALVESCOciclesonideAEROSOL, METERED;INHALATION021658-002Jan 10, 2008► Subscribe► Subscribe
Astrazeneca PharmsNEXIUMesomeprazole magnesiumCAPSULE, DELAYED REL PELLETS;ORAL021153-002Feb 20, 2001► Subscribe► Subscribe
AstrazenecaATACANDcandesartan cilexetilTABLET;ORAL020838-001Jun 4, 1998► Subscribe► Subscribe
Astrazeneca PharmsZETONNAciclesonideAEROSOL, METERED;NASAL202129-001Jan 20, 2012► Subscribe► Subscribe
Astrazeneca PharmsCASODEXbicalutamideTABLET;ORAL020498-001Oct 4, 1995► Subscribe► Subscribe
Astrazeneca PharmsPRILOSEComeprazoleCAPSULE, DELAYED REL PELLETS;ORAL019810-002Jan 15, 1998► Subscribe► Subscribe
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Paragraph IV activity for ASTRAZENECA drugs

Drugname Dosage Strength Tradename Submissiondate
zolmitriptanNasal Spray2.5 mg/sprayZOMIG6/9/2016
ticagrelorTablets60 mgBRILINTA9/30/2015
ticagrelorTablets90 mgBRILINTA7/20/2015
roflumilastTablets500 mcgDALIRESP3/2/2015
exenatideInjection250 mg/mL, 1.2 mL and 2.4 mL prefilled syringeBYETTA6/11/2014
zolmitriptanNasal Spray5 mg/sprayZOMIG11/14/2013
saxagliptin hydrochloride and metformin hydrochlorideExtended-release Tablets5 mg/500 mg, 2.5 mg/1000 mg, and 5 mg/1000 mgKOMBIGLYZE XR7/31/2013
saxagliptin hydrochlorideTablets2.5 mg and 5 mgONGLYZA7/31/2013
omeprazole magnesiumDelayed-release Tablets20 mgPRILOSEC OTC3/30/2012
ciclesonideNasal Spray250 mcgOMNARIS2/13/2012
budesonideInhalation Suspension1 mg/2 mLPULMICORT RESPULES5/28/2010
esomeprazole sodiumFor Injection20 mg/vial and 40 mg/vialNEXIUM IV11/23/2009
fulvestrantInjection50 mg/mL, 2.5 mL and 5 mL syringeFASLODEX10/1/2009
candesartan cilexetil and hydrochlorothiazideTablets32 mg/25 mgATACAND HCT3/6/2009
quetiapine fumarateExtended-release Tablets150 mgSEROQUEL XR11/17/2008
quetiapine fumarateExtended-release Tablets50 mgSEROQUEL XR10/17/2008
candesartan cilexetil and hydrochlorothiazideTablets16 mg/12.5 mg and 32 mg/12.5 mgATACAND HCT6/25/2008
quetiapine fumarateExtended-release Tablets400 mgSEROQUEL XR6/18/2008
quetiapine fumarateTablets200 mg and 300 mgSEROQUEL XR6/12/2008
budesonideNasal Spray0.032 mg (32 mcg)/sprayRHINOCORT5/14/2007
omeprazole magnesiumDelayed-release Capsules20 mgPRILOSEC OTC3/19/2007
quetiapine fumarateTablets50 mg, 150 mg and 400 mgSEROQUEL2/12/2007
candesartan cilexetilTablets4 mg, 8 mg, 16 mg and 32 mgATACAND12/22/2006
quetiapine fumarateTablets100 mg, 200 mg and 300 mgSEROQUEL2/21/2006
budesonideInhalation Suspension0.25 mg/2 mL and 0.5 mg/2 mLPULMICORT RESPULES9/15/2005
quetiapine fumarateTablets25 mgSEROQUEL8/12/2005
esomeprazole magnesiumDelayed-release20 mg and 40 mgNEXIUM8/5/2005

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
7,214,687Quinuclidine derivatives and medicinal compositions containing the same► Subscribe
7,196,098Quinuclidine derivatives and medicinal compositions containing the same► Subscribe
8,034,825Chemically modified small molecules► Subscribe
6,747,155 Process► Subscribe
7,745,466Form of S-omeprazole► Subscribe
8,513,279Quinuclidine derivatives and medicinal compositions containing the same► Subscribe
7,875,310Residual solvent extraction method and microparticles produced thereby► Subscribe
8,617,613Polymer-based sustained release device► Subscribe
7,692,006Phthalazinone derivatives► Subscribe
7,906,146Lyophilized formulations of exendins and exendin agonist analogs► 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
Hong Kong1152660► Subscribe
Hong Kong1215171► Subscribe
Cuba20130149► Subscribe
Australia2413600► Subscribe
Japan6169639► Subscribe
Argentina026073► Subscribe
Australia2006225304► Subscribe
Bulgaria61752► Subscribe
TaiwanI259086► Subscribe
South Korea20070043771► 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
00357Netherlands► SubscribePRODUCT NAME: SITAGLIPTINE, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVA ARDBAAR ZOUT, IN HET BIJZONDER HET MONOFOSFAAT, EN METFORMINE DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT, IN HET BIJZONDER HET HYDROCHLORIDE; REGISTRATION NO/DATE: EU/1/08/455/001-014 20080716
8 5006-2012Slovakia► SubscribePRODUCT NAME: EXENATID; REGISTRATION NO/DATE: EU/1/11/696/001 - EU/1/11/696/002 20110623
1506211/02Switzerland► SubscribePRODUCT NAME: DAPAGLIFLOZIN + METFORMIN; REGISTRATION NO/DATE: SWISSMEDIC 65377 16.07.2015
C005/2010Ireland► SubscribeSPC005/2010: 20100702, EXPIRES: 20240930
0526Netherlands► SubscribePRODUCT NAME: EXENATIDE; REGISTRATION NO/DATE: EU/1/11/696/001-002 20110617
00677Netherlands► SubscribePRODUCT NAME: COMBINATIE VAN DAPAGLIFLOZINE OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN EN METFORMINE OF EEN FARMACEITISCH AANVAARDBAAR ZOUT DAARVAN, ZOALS BESCHERMD DOOR HET BASISOCTROOI EP 1506211B1; REGISTRATION NO/DATE: EU/1/13/900 20140121
2013 00002Denmark► Subscribe
2012006Lithuania► SubscribePRODUCT NAME: EXENATIDUM; REGISTRATION NO/DATE: EU/1/11/696/001 - EU/1/11/696/002 20110617
C/GB97/089United Kingdom► SubscribePRODUCT NAME: ZOLMITRIPTAN AND OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT; REGISTERED: UK 12619/0116 19970307
2011004,C1135391Lithuania► SubscribePRODUCT NAME: TICAGRELORUM; REGISTRATION NO/DATE: EU/1/10/655/001 2010 12 03 EU/1/10/655/002 2010 12 03 EU/1/10/655/003 2010 12 03 EU/1/10/655/004 2010 12 03 EU/1/10/655/005 2010 12 03 EU/1/10/655/00 20101203
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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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Serving leading biopharmaceutical companies globally:

AstraZeneca
Covington
US Department of Justice
Colorcon
Harvard Business School
Teva
Healthtrust
Fuji
McKesson
Boehringer Ingelheim

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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