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Serving leading biopharmaceutical companies globally:

Boehringer Ingelheim
Citi
Healthtrust
Farmers Insurance
US Department of Justice
Dow
Teva
Deloitte
Mallinckrodt
US Army

Generated: December 17, 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 nine approved drugs.

There are forty-eight US patents protecting ASTRAZENECA AB drugs.

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

Summary for Astrazeneca Ab

International Patents:716
US Patents:48
Tradenames:10
Ingredients:8
NDAs:9
Drug Master File Entries: 2
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Astrazeneca AbXIGDUO XRdapagliflozin propanediol; metformin hydrochlorideTABLET, EXTENDED RELEASE;ORAL205649-001Oct 29, 2014RXYesNo► Subscribe► Subscribe► Subscribe
Astrazeneca AbBYDUREON BCISEexenatideSUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS209210-001Oct 20, 2017RXYesYes► Subscribe► SubscribeY► Subscribe
Astrazeneca AbFARXIGAdapagliflozin propanediolTABLET;ORAL202293-002Jan 8, 2014RXYesYes► Subscribe► Subscribe► Subscribe
Astrazeneca AbXIGDUO XRdapagliflozin propanediol; metformin hydrochlorideTABLET, EXTENDED RELEASE;ORAL205649-003Oct 29, 2014RXYesNo► Subscribe► Subscribe► Subscribe
Astrazeneca AbBYDUREON PENexenatide syntheticFOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS022200-002Feb 28, 2014RXYesYes► Subscribe► Subscribe► Subscribe
Astrazeneca AbBYDUREON PENexenatide syntheticFOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS022200-002Feb 28, 2014RXYesYes► Subscribe► Subscribe► Subscribe
Astrazeneca AbFARXIGAdapagliflozin propanediolTABLET;ORAL202293-001Jan 8, 2014RXYesNo► Subscribe► SubscribeY► Subscribe
Astrazeneca AbXIGDUO XRdapagliflozin propanediol; metformin hydrochlorideTABLET, EXTENDED RELEASE;ORAL205649-002Oct 29, 2014RXYesNo► Subscribe► SubscribeY► Subscribe
Astrazeneca AbSYMLINpramlintide acetateINJECTABLE;SUBCUTANEOUS021332-001Mar 16, 2005DISCNNoNo► Subscribe► SubscribeYY► Subscribe
Astrazeneca AbBYDUREON PENexenatide syntheticFOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS022200-002Feb 28, 2014RXYesYes► 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 AbSYMLINpramlintide acetateINJECTABLE;SUBCUTANEOUS021332-003Sep 25, 2007► Subscribe► Subscribe
Astrazeneca AbSYMLINpramlintide acetateINJECTABLE;SUBCUTANEOUS021332-001Mar 16, 2005► Subscribe► Subscribe
Astrazeneca AbSYMLINpramlintide acetateINJECTABLE;SUBCUTANEOUS021332-003Sep 25, 2007► Subscribe► Subscribe
Astrazeneca AbSYMLINpramlintide acetateINJECTABLE;SUBCUTANEOUS021332-002Sep 25, 2007► Subscribe► Subscribe
Astrazeneca AbBYDUREON PENexenatide syntheticFOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS022200-002Feb 28, 2014► Subscribe► Subscribe
Astrazeneca AbSYMLINpramlintide acetateINJECTABLE;SUBCUTANEOUS021332-002Sep 25, 2007► Subscribe► Subscribe
Astrazeneca AbBYETTAexenatide syntheticINJECTABLE;SUBCUTANEOUS021773-001Apr 28, 2005► Subscribe► Subscribe
Astrazeneca AbSYMLINpramlintide acetateINJECTABLE;SUBCUTANEOUS021332-001Mar 16, 2005► Subscribe► Subscribe
Astrazeneca AbSYMLINpramlintide acetateINJECTABLE;SUBCUTANEOUS021332-003Sep 25, 2007► Subscribe► Subscribe
Astrazeneca AbBYDUREONexenatide syntheticFOR 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
exenatideInjection250 mg/mL, 1.2 mL and 2.4 mL prefilled syringeBYETTA6/11/2014
saxagliptin hydrochlorideTablets2.5 mg and 5 mgONGLYZA7/31/2013
saxagliptin hydrochloride and metformin hydrochlorideExtended-release Tablets5 mg/500 mg, 2.5 mg/1000 mg, and 5 mg/1000 mgKOMBIGLYZE XR7/31/2013

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
7,157,555Exendin agonist compounds► Subscribe
7,115,569Exendins, exendin agonists, and methods for their use► Subscribe
7,407,934Methods for regulating postprandial blood glucose► Subscribe
8,389,472Exendin-4 to treat nonalcoholic steatohepatitis and nonalcoholic fatty liver disease► Subscribe
7,223,725Exendin agonist compounds► Subscribe
8,535,715Bilayer tablet formulations► Subscribe
8,187,672Residual solvent extraction method and microparticles produced thereby► Subscribe
8,721,615Ampoule comprising an ampoule holder► Subscribe
5,424,394 Synthetic preparation of amylin and amylin analogues► Subscribe
8,617,613Polymer-based sustained release device► 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
Poland373369► Subscribe
Taiwan200609002► Subscribe
Germany60032331► Subscribe
South Korea20100129799► Subscribe
Turkey200200986► Subscribe
European Patent Office2252351► Subscribe
Greece3035387► Subscribe
Japan3821839► Subscribe
South Africa200409295► Subscribe
European Patent Office1734935► 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
00524Netherlands► SubscribePRODUCT NAME: COMBINATIE VAN SAXAGLIPTINE EN METFORMINE, DESGEWENST IN DE VORM VAN FARMACEUTISCH AANVAARDBARE AFGELEIDEN DAARVAN; NAT. REGISTRATION NO/DATE: EU/1/11/731/001-012 20111124; FIRST REGISTRATION:
90013-0Sweden► SubscribePRODUCT NAME: SAXAGLIPTIN/METFORMIN; REG. NO/DATE: EU/1/11/731/001 20111124
C0010France► SubscribePRODUCT NAME: SAXAGLIPTINE ET SES SELS PHARMACEUTIQUEMENT ACCEPTABLES, Y COMPRIS LE CHLORHYDRATE DE SAXAGLIPTINE; NAT. REGISTRATION NO/DATE: EU/1/09/545/001 20091001; FIRST REGISTRATION: EU/1/09/454/001 20091001
343Luxembourg► Subscribe91343, EXPIRES: 20211120
0140021 00131Estonia► SubscribePRODUCT NAME: DAPAGLIFLOSIIN/METFORMIIN;REG NO/DATE: K(2014)308 (LOPLIK) 21.01.2014
1261586/01Switzerland► SubscribeFORMER OWNER: BRISTOL-MYERS SQUIBB COMPANY, US
8 5006-2012Slovakia► SubscribePRODUCT NAME: EXENATID; REGISTRATION NO/DATE: EU/1/11/696/001 - EU/1/11/696/002 20110623
2014000071Germany► 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
1734971/01Switzerland► SubscribePRODUCT NAME: EXENATIDE; REGISTRATION NO/DATE: SWISSMEDIC 61629 17.02.2012
0120006 00104Estonia► SubscribePRODUCT NAME: EKSENATIID;REG NO/DATE: K(2011)4479 LOPLIK 23.06.2011
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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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Serving leading biopharmaceutical companies globally:

Boehringer Ingelheim
US Army
Healthtrust
Farmers Insurance
Fuji
Argus Health
Federal Trade Commission
Chubb
Cerilliant
Express Scripts

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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