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Serving leading biopharmaceutical companies globally:

Chinese Patent Office
Moodys
AstraZeneca
Teva
Cantor Fitzgerald
Federal Trade Commission
US Army
QuintilesIMS
Harvard Business School
Mallinckrodt

Generated: October 20, 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-one US patents protecting ASTRAZENECA AB drugs.

There are six hundred and seventy-three patent family members on ASTRAZENECA AB drugs in fifty-one countries and eighty supplementary protection certificates in fourteen countries.

Summary for Applicant: ASTRAZENECA AB

International Patents:673
US Patents:41
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
BYDUREON
exenatide synthetic
FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS022200-001Jan 27, 2012RXYesYes► Subscribe► SubscribeY ► Subscribe
Astrazeneca Ab
BYETTA
exenatide synthetic
INJECTABLE;SUBCUTANEOUS021773-001Apr 28, 2005RXYesYes► Subscribe► Subscribe ► Subscribe
Astrazeneca Ab
FARXIGA
dapagliflozin propanediol
TABLET;ORAL202293-002Jan 8, 2014RXYesYes► Subscribe► SubscribeYY ► Subscribe
Astrazeneca Ab
BYETTA
exenatide synthetic
INJECTABLE;SUBCUTANEOUS021773-001Apr 28, 2005RXYesYes► Subscribe► SubscribeY ► Subscribe
Astrazeneca Ab
XIGDUO XR
dapagliflozin propanediol; metformin hydrochloride
TABLET, EXTENDED RELEASE;ORAL205649-005Jul 28, 2017RXYesNo► Subscribe► SubscribeY ► Subscribe
Astrazeneca Ab
ONGLYZA
saxagliptin hydrochloride
TABLET;ORAL022350-001Jul 31, 2009RXYesNo► Subscribe► Subscribe► Subscribe
Astrazeneca Ab
ONGLYZA
saxagliptin hydrochloride
TABLET;ORAL022350-002Jul 31, 2009RXYesYes► Subscribe► SubscribeYY ► Subscribe
Astrazeneca Ab
BYETTA
exenatide synthetic
INJECTABLE;SUBCUTANEOUS021773-002Apr 28, 2005RXYesYes► Subscribe► Subscribe ► Subscribe
Astrazeneca Ab
XIGDUO XR
dapagliflozin propanediol; metformin hydrochloride
TABLET, EXTENDED RELEASE;ORAL205649-003Oct 29, 2014RXYesNo► Subscribe► Subscribe ► Subscribe
Astrazeneca Ab
KOMBIGLYZE XR
metformin hydrochloride; saxagliptin hydrochloride
TABLET, EXTENDED RELEASE;ORAL200678-002Nov 5, 2010RXYesYes► 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;SUBCUTANEOUS021332-002Sep 25, 2007► Subscribe► Subscribe
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
SYMLIN
pramlintide acetate
INJECTABLE;SUBCUTANEOUS021332-003Sep 25, 2007► Subscribe► Subscribe
Astrazeneca Ab
BYDUREON
exenatide synthetic
FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS022200-001Jan 27, 2012► 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
SYMLIN
pramlintide acetate
INJECTABLE;SUBCUTANEOUS021332-001Mar 16, 2005► 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
8,288,338Exendin and exendin agonists for eating disorders► Subscribe
5,795,861 Methods for regulating gastrointestinal motility► Subscribe
7,407,932Methods for glucagon suppression using modified exendins► Subscribe
6,395,767 Cyclopropyl-fused pyrrolidine-based inhibitors of dipeptidyl peptidase IV and method► Subscribe
7,115,569Exendins, exendin agonists, and methods for their use► Subscribe
8,187,672Residual solvent extraction method and microparticles produced thereby► Subscribe
8,293,871Poly(lactide-co-glycolide) based sustained release microcapsules comprising a polypeptide and a sugar► Subscribe
7,524,530Residual solvent extraction method and microparticles produced thereby► Subscribe
7,157,555Exendin agonist compounds► Subscribe
8,535,715Bilayer tablet formulations► 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
Spain2359031► Subscribe
Austria347901► Subscribe
Israel165119► Subscribe
Hong Kong1031120► Subscribe
Germany122012000023► Subscribe
European Patent Office1162207► Subscribe
European Patent Office1506211► Subscribe
Argentina027634► Subscribe
World Intellectual Property Organization (WIPO)2008122360► Subscribe
South Korea20090123964► 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
0130006 00074Estonia► SubscribePRODUCT NAME: DAPAGLIFLOZIN;REG NO/DATE: K(2012)8378 12.11.2012
1261586/01Switzerland► SubscribeFORMER OWNER: BRISTOL-MYERS SQUIBB COMPANY, US
00707Netherlands► SubscribePRODUCT NAME: SAXAGLIPTIN; REGISTRATION NO/DATE: EU/1/09/545/001-010 20091001
90013-0Sweden► SubscribePRODUCT NAME: SAXAGLIPTIN/METFORMIN; REG. NO/DATE: EU/1/11/731/001 20111124
0677Netherlands► SubscribePRODUCT NAME: COMBINATIE VAN DAPAGLIFLOZINE OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN EN METFORMINE OF EEN FARMACEITISCH AANVAARDBAAR ZOUT DAARVAN, ZOALS BESCHERMD DOOR HET BASISOCTROOI EP 1506211B1; REGISTRATION NO/DATE: EU/1/13/900 20140121
00585Netherlands► SubscribePRODUCT NAME: DAPAGLIFLOZINE, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT; REGISTRATION NO/DATE: EU/1/12/795/001-010 20121112
77; 5006-2008Slovakia► SubscribePRODUCT NAME: SITAGLIPTIN A METFORMIN; REGISTRATION NO/DATE: EU/1/08/455/001-014 20080716
8 5006-2012Slovakia► SubscribePRODUCT NAME: EXENATID; REGISTRATION NO/DATE: EU/1/11/696/001 - EU/1/11/696/002 20110623
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
/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
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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:

Deloitte
Julphar
Johnson and Johnson
Accenture
US Department of Justice
Chinese Patent Office
Fish and Richardson
Boehringer Ingelheim
US Army
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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