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Serving 500+ biopharmaceutical companies globally:

Fuji
US Department of Justice
Dow
Express Scripts
Covington
Citi
US Army
Cerilliant
Daiichi Sankyo
Teva

Generated: September 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-six 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 five hundred and sixty-four patent family members on ASTRAZENECA drugs in seventy-three countries.

Summary for Applicant: ASTRAZENECA

Patents:136
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 Ab
XIGDUO XR
dapagliflozin propanediol; metformin hydrochloride
TABLET, EXTENDED RELEASE;ORAL205649-003Oct 29, 2014RXYesNo► Subscribe► SubscribeY ► Subscribe
Astrazeneca Pharms
BEVESPI AEROSPHERE
formoterol fumarate; glycopyrrolate
AEROSOL, METERED;INHALATION208294-001Apr 25, 2016RXYesYes► Subscribe► SubscribeY ► Subscribe
Astrazeneca Ab
BYETTA
exenatide synthetic
INJECTABLE;SUBCUTANEOUS021773-002Apr 28, 2005RXYesYes► Subscribe► Subscribe► Subscribe
Astrazeneca Pharms
NEXIUM
esomeprazole magnesium
CAPSULE, DELAYED REL PELLETS;ORAL021153-001Feb 20, 2001ABRXYesNo► Subscribe► SubscribeY► Subscribe
Astrazeneca Ab
BYDUREON
exenatide synthetic
FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS022200-001Jan 27, 2012RXYesYes► Subscribe► SubscribeY ► Subscribe
Astrazeneca Ab
XIGDUO XR
dapagliflozin propanediol; metformin hydrochloride
TABLET, EXTENDED RELEASE;ORAL205649-001Oct 29, 2014RXYesNo► Subscribe► SubscribeY ► Subscribe
Astrazeneca Ab
BYDUREON PEN
exenatide synthetic
FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS022200-002Feb 28, 2014RXYesYes► Subscribe► Subscribe ► Subscribe
Astrazeneca Ab
FARXIGA
dapagliflozin propanediol
TABLET;ORAL202293-001Jan 8, 2014RXYesNo► Subscribe► Subscribe► Subscribe
Astrazeneca Ab
XIGDUO XR
dapagliflozin propanediol; metformin hydrochloride
TABLET, EXTENDED RELEASE;ORAL205649-004Oct 29, 2014RXYesYes► Subscribe► Subscribe ► Subscribe
Astrazeneca Pharms
DALIRESP
roflumilast
TABLET;ORAL022522-001Feb 28, 2011RXYesYes► Subscribe► SubscribeYY ► Subscribe
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Expired Patents for Astrazeneca

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Astrazeneca Ab
SYMLIN
pramlintide acetate
INJECTABLE;SUBCUTANEOUS021332-002Sep 25, 2007► Subscribe► Subscribe
Astrazeneca
SYMBICORT
budesonide; formoterol fumarate dihydrate
AEROSOL, METERED;INHALATION021929-001Jul 21, 2006► Subscribe► Subscribe
Astrazeneca Ab
BYDUREON PEN
exenatide synthetic
FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS022200-002Feb 28, 2014► Subscribe► Subscribe
Astrazeneca Pharms
PRILOSEC
omeprazole
CAPSULE, DELAYED REL PELLETS;ORAL019810-003Oct 5, 1995► Subscribe► Subscribe
Astrazeneca
ATACAND HCT
candesartan cilexetil; hydrochlorothiazide
TABLET;ORAL021093-001Sep 5, 2000► Subscribe► Subscribe
Astrazeneca Lp
NEXIUM 24HR
esomeprazole magnesium
CAPSULE, DELAYED RELEASE;ORAL204655-001Mar 28, 2014► Subscribe► Subscribe
Astrazeneca Pharms
PRILOSEC
omeprazole
CAPSULE, DELAYED REL PELLETS;ORAL019810-002Jan 15, 1998► Subscribe► Subscribe
Astrazeneca
LEXXEL
enalapril maleate; felodipine
TABLET, EXTENDED RELEASE;ORAL020668-002Oct 28, 1998► Subscribe► Subscribe
Astrazeneca Pharms
SEROQUEL
quetiapine fumarate
TABLET;ORAL020639-002Sep 26, 1997► Subscribe► Subscribe
Astrazeneca Pharms
PRILOSEC
omeprazole
CAPSULE, DELAYED REL PELLETS;ORAL019810-003Oct 5, 1995► 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
7,371,406Preparation of injectable suspensions having improved injectability► Subscribe
7,875,310Residual solvent extraction method and microparticles produced thereby► Subscribe
5,795,861 Methods for regulating gastrointestinal motility► Subscribe
9,169,235Phthalazinone derivatives► Subscribe
7,407,934Methods for regulating postprandial blood glucose► Subscribe
8,129,405Quinuclidine derivatives and medicinal compositions containing the same► Subscribe
6,610,824 Amylin agonist peptides and uses therefor► Subscribe
7,153,825Methods for glucagon suppression using modified exendins► Subscribe
6,030,682 Container for aerosol formulation► Subscribe
5,290,539 Device for delivering an aerosol► 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
European Patent Office1569673► Subscribe
Luxembourg92182► Subscribe
Slovakia3892000► Subscribe
Czech Republic20021285► Subscribe
Finland114154► Subscribe
South Korea101691268► Subscribe
South Africa200203077► Subscribe
Israel165119► Subscribe
Japan2008504924► Subscribe
Bulgaria65799► 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
2012 00035Denmark► SubscribePRODUCT NAME: ET KOMBINATIONSPRODUKT AF NAPROXEN OG ESOMEPRAZOL MAGNESIUM TRIHYDRAT; NAT. REG. NO/DATE: 49583 20120327; FIRST REG. NO/DATE: GB PL 17901/0263-001 20101105
2014 00062Denmark► SubscribePRODUCT NAME: SAXAGLIPTIN OG FARMACEUTISK SALTE DERAF, HERUNDER SAXAGLIPTIN HYDROCHLORID; REG. NO/DATE: EU/1/09/545/001-015 20091001
2010 00007Denmark► Subscribe
C005/2010Ireland► SubscribeSPC005/2010: 20100702, EXPIRES: 20240930
31/2007Austria► SubscribePRODUCT NAME: EXENATIDE
90034-8Sweden► SubscribePRODUCT NAME: ROFLUMILAST OCH SALTER DAERAV; REG. NO/DATE: EU/1/10/636/001 20100705
709Luxembourg► Subscribe91709, EXPIRES: 20190702
2012 00035Denmark► Subscribe
77; 5006-2008Slovakia► SubscribePRODUCT NAME: SITAGLIPTIN A METFORMIN; REGISTRATION NO/DATE: EU/1/08/455/001-014 20080716
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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 500+ biopharmaceutical companies globally:

Baxter
Cantor Fitzgerald
Deloitte
Julphar
Fuji
UBS
Colorcon
AstraZeneca
Boehringer Ingelheim
McKesson

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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ISSN: 2162-2639

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