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Serving 500+ biopharmaceutical companies globally:

Queensland Health
Cerilliant
Accenture
Cipla
McKesson
QuintilesIMS
Julphar
Express Scripts
Citi
US Department of Justice

Generated: August 21, 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 eighty-nine approved drugs.

There are one hundred and twenty-five 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 three hundred and eight patent family members on ASTRAZENECA drugs in seventy-three countries.

Summary for Applicant: Astrazeneca

Patents:125
Tradenames:64
Ingredients:56
NDAs:89
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Astrazeneca
SYMBICORT
budesonide; formoterol fumarate dihydrate
AEROSOL, METERED;INHALATION021929-002Jul 21, 2006RXYesYes► Subscribe► SubscribeY► Subscribe
Astrazeneca Ab
QTERN
dapagliflozin propanediol; saxagliptin hydrochloride
TABLET;ORAL209091-001Feb 27, 2017RXYesYes► Subscribe► SubscribeY ► Subscribe
Astrazeneca
SYMBICORT
budesonide; formoterol fumarate dihydrate
AEROSOL, METERED;INHALATION021929-002Jul 21, 2006RXYesYes► Subscribe► SubscribeY► Subscribe
Astrazeneca Pharms
PULMICORT RESPULES
budesonide
SUSPENSION;INHALATION020929-001Aug 8, 2000ANRXYesNo► Subscribe► SubscribeY► Subscribe
Astrazeneca Ab
KOMBIGLYZE XR
metformin hydrochloride; saxagliptin hydrochloride
TABLET, EXTENDED RELEASE;ORAL200678-001Nov 5, 2010RXYesNo► Subscribe► Subscribe► Subscribe
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Expired Patents for Astrazeneca

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Astrazeneca Pharms
NEXIUM
esomeprazole magnesium
CAPSULE, DELAYED REL PELLETS;ORAL021153-002Feb 20, 2001► Subscribe► Subscribe
Astrazeneca Pharms
NEXIUM
esomeprazole magnesium
CAPSULE, DELAYED REL PELLETS;ORAL021153-001Feb 20, 2001► Subscribe► Subscribe
Astrazeneca Lp
NEXIUM 24HR
esomeprazole magnesium
CAPSULE, DELAYED RELEASE;ORAL204655-001Mar 28, 2014► Subscribe► Subscribe
Astrazeneca Pharms
SEROQUEL
quetiapine fumarate
TABLET;ORAL020639-001Sep 26, 1997► Subscribe► Subscribe
Astrazeneca
ATACAND HCT
candesartan cilexetil; hydrochlorothiazide
TABLET;ORAL021093-001Sep 5, 2000► 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
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
7,223,725Exendin agonist compounds► Subscribe
6,677,455 Potassium salt of S-omeprazole► Subscribe
9,169,235Phthalazinone derivatives► Subscribe
7,819,075Inhaler device counter► 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
Argentina047799► Subscribe
Japan4951217► Subscribe
Lithuania2435025► Subscribe
Denmark1032587► Subscribe
Hungary220041► 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
2014000070Germany► SubscribePRODUCT NAME: KOMBINATION VON DAPAGLIFLOZIN ODER EINEM PHARMAZEUTISCH VERTRAEGLICHEN SALZ DAVON, UND METFORMIN ODER EINEM PHARMAZEUTISCH VERTRAEGLICHEN SALZ DAVON, GESCHUETZT DURCH DAS GRUNDPATENT EP 1 506 211; REGISTRATION NO/DATE: EU/1/13/900 20140116
6 5005-2013Slovakia► SubscribePRODUCT NAME: DAPAGLIFLOZIN; FIRST REGISTRATION NO/DATE: EU/1/12/795/001, EU/1/12/795/002, EU/1/12/795/003, EU/1/12/795/004, EU/1/12/795/005, EU/1/12/795/006, EU/1/12/795/007, EU/1/12/795/007, EU/1/12/795/008, EU/1/12/795/009, EU/1/12/795/010 20121112
702Luxembourg► SubscribePRODUCT NAME: NALOXEGOL OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI (MOVENTIG); FIRST REGISTRATION: 20141210
2008013,C1412357Lithuania► SubscribePRODUCT NAME: SITAGLIPTINUM PHOSPHAS MONOHYDRICUS, METFORMINI HYDROCHLORIDUM; REGISTRATION NO/DATE: EU/1/08/455/001 - EU/1/08/455/014 20080716
C/GB14/085United Kingdom► SubscribePRODUCT NAME: SAXAGLIPTIN; REGISTERED: UK EU/1/09/545/001-010 20091005
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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:

Healthtrust
Johnson and Johnson
Chubb
Boehringer Ingelheim
Moodys
McKinsey
Teva
Julphar
QuintilesIMS
Fish and Richardson

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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