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Serving leading biopharmaceutical companies globally:

Cerilliant
Covington
Merck
UBS
Johnson and Johnson
McKesson
Chubb
Daiichi Sankyo
Citi
US Army

Generated: October 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 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 Pharms
LYNPARZA
olaparib
TABLET;ORAL208558-001Aug 17, 2017RXYesNo► Subscribe► Subscribe► Subscribe
Astrazeneca Ab
KOMBIGLYZE XR
metformin hydrochloride; saxagliptin hydrochloride
TABLET, EXTENDED RELEASE;ORAL200678-003Nov 5, 2010RXYesNo► Subscribe► Subscribe► Subscribe
Astrazeneca Pharms
EPANOVA
omega-3-carboxylic acids
CAPSULE;ORAL205060-001May 5, 2014RXYesYes► Subscribe► SubscribeY ► Subscribe
Astrazeneca Pharms
LYNPARZA
olaparib
CAPSULE;ORAL206162-001Dec 19, 2014RXYesYes► Subscribe► Subscribe► Subscribe
Astrazeneca
DURANEST
epinephrine bitartrate; etidocaine hydrochloride
INJECTABLE;INJECTION017751-006Approved Prior to Jan 1, 1982DISCNYesNo► Subscribe► Subscribe► Subscribe
Astrazeneca Pharms
EPANOVA
omega-3-carboxylic acids
CAPSULE;ORAL205060-001May 5, 2014RXYesYes► Subscribe► SubscribeY ► Subscribe
Astrazeneca
XYLOCAINE
lidocaine hydrochloride
INJECTABLE;INJECTION010418-005Approved Prior to Jan 1, 1982DISCNNoNo► Subscribe► Subscribe► Subscribe
Astrazeneca
PULMICORT FLEXHALER
budesonide
POWDER, METERED;INHALATION021949-001Jul 12, 2006RXYesNo► Subscribe► SubscribeY ► Subscribe
Astrazeneca Pharms
OMNARIS
ciclesonide
SPRAY, METERED;NASAL022004-001Oct 20, 2006RXYesYes► Subscribe► Subscribe ► Subscribe
Astrazeneca Ab
XIGDUO XR
dapagliflozin propanediol; metformin hydrochloride
TABLET, EXTENDED RELEASE;ORAL205649-003Oct 29, 2014RXYesNo► 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
PRILOSEC OTC
omeprazole magnesium
TABLET, DELAYED RELEASE;ORAL021229-001Jun 20, 2003► Subscribe► Subscribe
Astrazeneca Pharms
NEXIUM
esomeprazole magnesium
CAPSULE, DELAYED REL PELLETS;ORAL021153-001Feb 20, 2001► Subscribe► Subscribe
Astrazeneca
DURANEST
etidocaine hydrochloride
INJECTABLE;INJECTION017751-003Approved Prior to Jan 1, 1982► Subscribe► Subscribe
Astrazeneca Ab
SYMLIN
pramlintide acetate
INJECTABLE;SUBCUTANEOUS021332-001Mar 16, 2005► Subscribe► Subscribe
Astrazeneca
ATACAND
candesartan cilexetil
TABLET;ORAL020838-004Jun 4, 1998► Subscribe► Subscribe
Astrazeneca Pharms
NEXIUM
esomeprazole magnesium
FOR SUSPENSION, DELAYED RELEASE;ORAL021957-003Dec 15, 2011► Subscribe► Subscribe
Astrazeneca
TONOCARD
tocainide hydrochloride
TABLET;ORAL018257-002Nov 9, 1984► Subscribe► Subscribe
Astrazeneca Pharms
NEXIUM
esomeprazole magnesium
CAPSULE, DELAYED REL PELLETS;ORAL021153-001Feb 20, 2001► Subscribe► Subscribe
Astrazeneca Pharms
PRILOSEC
omeprazole
CAPSULE, DELAYED REL PELLETS;ORAL019810-003Oct 5, 1995► Subscribe► Subscribe
Astrazeneca Pharms
SEROQUEL
quetiapine fumarate
TABLET;ORAL020639-007Oct 4, 2005► 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
8,263,550Exendin agonist compounds► Subscribe
2,006,189,587► Subscribe
6,641,800 Pressurized aerosol compositions comprising powdered medicament dispersed in hydrofluoroalkane► Subscribe
7,220,721Exendin agonist peptides► Subscribe
8,535,715Bilayer tablet formulations► Subscribe
7,692,006Phthalazinone derivatives► Subscribe
7,470,791Process for the preparation of roflumilast► Subscribe
8,129,405Quinuclidine derivatives and medicinal compositions containing the same► Subscribe
9,729,321Autonomous private key recovery► Subscribe
7,531,530Therapeutic compounds► 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
Australia7848300► Subscribe
South Africa200606229► Subscribe
Canada2763939► Subscribe
New Zealand539542► Subscribe
Sweden9700135► Subscribe
South Korea20020001719► Subscribe
European Patent Office1104417► Subscribe
Peru07132001► Subscribe
Israel242279► Subscribe
Uruguay28999► 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
00436Netherlands► SubscribePRODUCT NAME: SAXAGLIPTINE, ALSMEDE; REGISTRATION NO/DATE: EU/1/09/545/001-010 20091001
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
2011 00013Denmark► Subscribe
4 5008-2015Slovakia► SubscribePRODUCT NAME: OXALAT NALOXEGOLU; REGISTRATION NO/DATE: EU/1/14/962 20141210
11/012Ireland► SubscribePRODUCT NAME: TICAGRELOR OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REGISTRATION NO/DATE: EU/1/10/655/001-006 20101203
C0022France► SubscribePRODUCT NAME: DAPAGLIFLOZINE ET SES SELS PHARMACEUTIQUEMENT ACCEPTABLES; REGISTRATION NO/DATE: EU/1/12/795/001 20121112
2010 00028Denmark► Subscribe
C0052France► SubscribePRODUCT NAME: ROFLUMILAST, ROFLUMILAST-N-OXYDE ET LES SELS DE CES COMPOSES; NAT. REGISTRATION NO/DATE: EU/1/16/636/001 20100705; FIRST REGISTRATION: EU/1/10/636/001 20100705
650Luxembourg► Subscribe91650, EXPIRES: 20241001
C/GB11/016United Kingdom► SubscribePRODUCT NAME: TICAGRELOR OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF.; REGISTERED: UK EU/1/10/655/001 20101203; UK EU/1/10/655/002 20101203; UK EU/1/10/655/003 20101203; UK EU/1/10/655/004 20101203; UK EU/1/10/655/005 20101203; UK EU/1/10/655/006 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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For more information try a trial or see the database preview and plans and pricing

Serving leading biopharmaceutical companies globally:

Julphar
Mallinckrodt
Healthtrust
Federal Trade Commission
Medtronic
US Army
McKinsey
Colorcon
Fish and Richardson
AstraZeneca

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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