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Serving leading biopharmaceutical companies globally:

McKesson
US Department of Justice
Novartis
Julphar
Queensland Health
Boehringer Ingelheim
Cantor Fitzgerald
UBS
Federal Trade Commission
Citi

Generated: October 23, 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 three Paragraph IV challenges on ASTRAZENECA drugs in the past three years.

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

Summary for Applicant: Astrazeneca

International Patents:2617
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
SORBITRATE
isosorbide dinitrate
TABLET;SUBLINGUAL016191-002Apr 1, 1996DISCNNoNo► Subscribe► Subscribe► Subscribe
Astrazeneca Pharms
NEXIUM
esomeprazole magnesium
FOR SUSPENSION, DELAYED RELEASE;ORAL022101-001Feb 27, 2008RXYesNo► Subscribe► Subscribe ► Subscribe
Astrazeneca Lp
NEXIUM 24HR
esomeprazole magnesium
CAPSULE, DELAYED RELEASE;ORAL204655-001Mar 28, 2014OTCYesYes► Subscribe► SubscribeY► Subscribe
Astrazeneca
SYMBICORT
budesonide; formoterol fumarate dihydrate
AEROSOL, METERED;INHALATION021929-001Jul 21, 2006RXYesYes► Subscribe► SubscribeY► Subscribe
Astrazeneca Pharms
OMNARIS
ciclesonide
SPRAY, METERED;NASAL022004-001Oct 20, 2006RXYesYes► Subscribe► SubscribeY ► Subscribe
Astrazeneca Ab
XIGDUO XR
dapagliflozin propanediol; metformin hydrochloride
TABLET, EXTENDED RELEASE;ORAL205649-002Oct 29, 2014RXYesNo► Subscribe► SubscribeYY ► Subscribe
Astrazeneca
METAPROTERENOL SULFATE
metaproterenol sulfate
SOLUTION;INHALATION071018-001Jul 27, 1988DISCNNoNo► Subscribe► Subscribe► Subscribe
Astrazeneca
LEXXEL
enalapril maleate; felodipine
TABLET, EXTENDED RELEASE;ORAL020668-001Dec 27, 1996DISCNNoNo► Subscribe► Subscribe► Subscribe
Astrazeneca Pharms
NEXIUM
esomeprazole magnesium
FOR SUSPENSION, DELAYED RELEASE;ORAL021957-002Oct 20, 2006RXYesYes► Subscribe► SubscribeY► Subscribe
Astrazeneca Ab
BYDUREON
exenatide synthetic
FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS022200-001Jan 27, 2012RXYesYes► Subscribe► SubscribeY ► Subscribe
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Expired Patents for Astrazeneca

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Astrazeneca Pharms
TUDORZA PRESSAIR
aclidinium bromide
POWDER, METERED;INHALATION202450-001Jul 23, 2012► Subscribe► Subscribe
Astrazeneca Pharms
SEROQUEL
quetiapine fumarate
TABLET;ORAL020639-004Dec 20, 1998► Subscribe► Subscribe
Astrazeneca Pharms
NEXIUM
esomeprazole magnesium
FOR SUSPENSION, DELAYED RELEASE;ORAL021957-003Dec 15, 2011► Subscribe► Subscribe
Astrazeneca
LEXXEL
enalapril maleate; felodipine
TABLET, EXTENDED RELEASE;ORAL020668-001Dec 27, 1996► Subscribe► Subscribe
Astrazeneca
ATACAND HCT
candesartan cilexetil; hydrochlorothiazide
TABLET;ORAL021093-003May 16, 2008► Subscribe► Subscribe
Astrazeneca Pharms
PULMICORT RESPULES
budesonide
SUSPENSION;INHALATION020929-003Aug 8, 2000► Subscribe► Subscribe
Astrazeneca Pharms
NEXIUM
esomeprazole magnesium
CAPSULE, DELAYED REL PELLETS;ORAL021153-002Feb 20, 2001► Subscribe► Subscribe
Astrazeneca Ab
SYMLIN
pramlintide acetate
INJECTABLE;SUBCUTANEOUS021332-001Mar 16, 2005► Subscribe► Subscribe
Astrazeneca Pharms
PRILOSEC OTC
omeprazole magnesium
TABLET, DELAYED RELEASE;ORAL021229-001Jun 20, 2003► Subscribe► Subscribe
Astrazeneca Ab
SYMLIN
pramlintide acetate
INJECTABLE;SUBCUTANEOUS021332-003Sep 25, 2007► Subscribe► Subscribe
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Paragraph IV activity for ASTRAZENECA drugs

Drugname Dosage Strength Tradename Submissiondate
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
Tablets2.5 mg and 5 mg
ONGLYZA
7/31/2013
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
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
9,320,853Method for administering a fluid active substance from a multi-chamber ampoule► Subscribe
8,802,699Quinuclidine derivatives and medicinal compositions containing the same► Subscribe
6,030,604 Formulation for inhalation► Subscribe
9,149,539Crystalline naloxol-PEG conjugate► Subscribe
8,617,613Polymer-based sustained release device► Subscribe
8,071,579DNA damage repair inhibitors for the treatment of cancer► Subscribe
5,424,394 Synthetic preparation of amylin and amylin analogues► Subscribe
6,395,767 Cyclopropyl-fused pyrrolidine-based inhibitors of dipeptidyl peptidase IV and method► Subscribe
8,535,715Bilayer tablet formulations► Subscribe
7,897,617Quinuclidine derivatives and medicinal compositions containing the same► 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
Norway317518► Subscribe
Denmark1135391► Subscribe
New Zealand336592► Subscribe
Eurasian Patent Organization006015► Subscribe
South Africa9808516► Subscribe
South Korea100822602► Subscribe
Peru03492008► Subscribe
BrazilPI0513360► Subscribe
Yugoslavia28102► Subscribe
Cuba20130047► 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
00737Netherlands► SubscribePRODUCT NAME: NALOXEGOL ALSMEDE DOOR HET BASISOCTROOI; REGISTRATION NO/DATE: EU/1/14/962 20141208
128Luxembourg► SubscribePRODUCT NAME: 8-(3-AMINOPIPERIDIN-1-YL)-7-BUT-2-INYL-3-METHYL-1-(4-METHYLCHINAZOLIN-2-YLMETHYL)-3, 7-DIHYDROPURIN-2, 6-DION, LES ENANTIOMERES ET LEURS SELS, EN PARTICULIER LA LINAGLIPTINE COMBINEE AVEC DU CHLORHYDRATE DE METFORMINE. LINAGLIPTINE
2013001Lithuania► SubscribePRODUCT NAME: ACLIDINII BROMIDUM; REGISTRATION NO/DATE: EU/1/12/778/001 - EU/1/12/778/003, 2012 07 20 EU/1/12/781/001 - EU/1/12/781/003 20120720
2015016Lithuania► SubscribePRODUCT NAME: OLAPARIBUM; REGISTRATION NO/DATE: EU/1/14/959 20141216
2014 00062Denmark► SubscribePRODUCT NAME: SAXAGLIPTIN OG FARMACEUTISK SALTE DERAF, HERUNDER SAXAGLIPTIN HYDROCHLORID; REG. NO/DATE: EU/1/09/545/001-015 20091005
680Luxembourg► SubscribePRODUCT NAME: OLAPARIB AINSI QUE DES SELS ET DES SOLVATES DE CELUI-CI. FIRST REGISTRATION: 20141218
702Luxembourg► SubscribePRODUCT NAME: NALOXEGOL OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI (MOVENTIG); FIRST REGISTRATION: 20141210
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
00C/015Belgium► SubscribePRODUCT NAME: QUETIAPINE FUMARAT (EQUIV. MET 25MG QUETIAPINE BASE); REGISTRATION NO/DATE: 624 S 309 F 3 20000207; FIRST REGISTRATION: GB PL 12619/0113 19970731
2010010,C1606261Lithuania► SubscribePRODUCT NAME: ROFLUMILASTUM; REGISTRATION NO/DATE: EU/1/10/636/001-003 20100705
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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:

Fuji
Chinese Patent Office
Chubb
Mallinckrodt
Farmers Insurance
Baxter
Covington
Citi
Fish and Richardson
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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