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Serving 500+ biopharmaceutical companies globally:

Chubb
Citi
Argus Health
Chinese Patent Office
QuintilesIMS
Accenture
Cipla
Covington
Cerilliant
Medtronic

Generated: August 18, 2017

DrugPatentWatch Database Preview

Astrazeneca Ab Company Profile

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What is the competitive landscape for ASTRAZENECA AB, and what generic alternatives to ASTRAZENECA AB drugs are available?

ASTRAZENECA AB has eight approved drugs.

There are forty US patents protecting ASTRAZENECA AB drugs.

There are six hundred and fifty-six patent family members on ASTRAZENECA AB drugs in fifty-one countries.

Summary for Applicant: Astrazeneca Ab

Patents:40
Tradenames:9
Ingredients:7
NDAs:8
Drug Master File Entries: (click here to view)2
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Astrazeneca Ab
ONGLYZA
saxagliptin hydrochloride
TABLET;ORAL022350-001Jul 31, 2009RXYesNo► Subscribe► Subscribe► Subscribe
Astrazeneca Ab
BYDUREON PEN
exenatide synthetic
FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS022200-002Feb 28, 2014RXYesYes► Subscribe► Subscribe ► Subscribe
Astrazeneca Ab
XIGDUO XR
dapagliflozin propanediol; metformin hydrochloride
TABLET, EXTENDED RELEASE;ORAL205649-001Oct 29, 2014RXYesNo► Subscribe► Subscribe ► Subscribe
Astrazeneca Ab
QTERN
dapagliflozin propanediol; saxagliptin hydrochloride
TABLET;ORAL209091-001Feb 27, 2017RXYesYes► Subscribe► Subscribe► Subscribe
Astrazeneca Ab
BYETTA
exenatide synthetic
INJECTABLE;SUBCUTANEOUS021773-001Apr 28, 2005RXYesYes► Subscribe► Subscribe ► Subscribe
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Expired Patents for Astrazeneca Ab

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Astrazeneca Ab
SYMLIN
pramlintide acetate
INJECTABLE;SUBCUTANEOUS021332-003Sep 25, 2007► Subscribe► Subscribe
Astrazeneca Ab
SYMLIN
pramlintide acetate
INJECTABLE;SUBCUTANEOUS021332-001Mar 16, 2005► Subscribe► Subscribe
Astrazeneca Ab
SYMLIN
pramlintide acetate
INJECTABLE;SUBCUTANEOUS021332-001Mar 16, 2005► Subscribe► Subscribe
Astrazeneca Ab
BYETTA
exenatide synthetic
INJECTABLE;SUBCUTANEOUS021773-001Apr 28, 2005► Subscribe► Subscribe
Astrazeneca Ab
BYDUREON
exenatide synthetic
FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS022200-001Jan 27, 2012► Subscribe► Subscribe
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Paragraph IV activity for ASTRAZENECA AB drugs

Drugname Dosage Strength Tradename Submissiondate
exenatide
Injection250 mg/mL, 1.2 mL and 2.4 mL prefilled syringe
BYETTA
6/11/2014
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

Non-Orange Book Patents for Astrazeneca Ab

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
8,026,210Exendins and exendin agonist analogs to regulate gastrointestinal motility► Subscribe
6,608,029 Methods for regulating gastrointestinal motility► Subscribe
7,906,146Lyophilized formulations of exendins and exendin agonist analogs► Subscribe
7,696,161Exendin agonist compounds► Subscribe
7,157,555Exendin agonist 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 Ab Drugs

Country Document Number Estimated Expiration
Portugal2409707► Subscribe
Portugal2069374► Subscribe
China101092409► Subscribe
Norway20073265► Subscribe
South Korea100391399► 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 Ab Drugs

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
496Luxembourg► SubscribePRODUCT NAME: COMBINAISON DE DAPAGLIFLOZINE OU D UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELLE-CI ET DE METFORMINE OU D UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELLE-CI,TELLE QUE PROTEGEE PAR LE BREVET DE BASE EP1506211 B1
/2012Austria► SubscribePRODUCT NAME: KOMBINATIONSPRODUKT VON SAXAGLIPTIN UND METFORMIN UND PHARMAZEUTISCH VERTRAEGLICHE SALZE DAVON, BEINHALTEND DIE HYDROCHLORIDSALZE VON SAXAGLIPTIN UND METFORMIN; REGISTRATION NO/DATE: EU/1/11/731/001-EU/1/11/731/012 20111124
2008013Lithuania► SubscribePRODUCT NAME: SITAGLIPTINUM PHOSPHAS MONOHYDRICUS, METFORMINI HYDROCHLORIDUM; REG. NO/DATE: EU/1/08/455/001-014 20080716
C005/2010Ireland► SubscribeSPC005/2010: 20100702, EXPIRES: 20240930
00526Netherlands► SubscribePRODUCT NAME: EXENATIDE; REGISTRATION NO/DATE: EU/1/11/696/001-002 20110617
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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:

Moodys
McKesson
Cantor Fitzgerald
Harvard Business School
Covington
Queensland Health
Cerilliant
Express Scripts
Merck
UBS

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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