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Serving hundreds of leading biopharmaceutical companies globally:

Argus Health
Cerilliant
US Army
McKinsey
UBS
Moodys
Merck
Johnson and Johnson
Boehringer Ingelheim

Generated: November 12, 2018

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Astrazeneca Ab Company Profile

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What is the competitive landscape for ASTRAZENECA AB, and when can generic versions of ASTRAZENECA AB drugs launch?

ASTRAZENECA AB has nine approved drugs.

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

Drugs and US Patents for Astrazeneca Ab

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 PEN exenatide synthetic FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS 022200-002 Feb 28, 2014 RX Yes Yes 9,238,076 ➤ Sign Up Y ➤ Sign Up
Astrazeneca Ab QTERN dapagliflozin; saxagliptin hydrochloride TABLET;ORAL 209091-001 Feb 27, 2017 RX Yes Yes 9,198,925 ➤ Sign Up ➤ Sign Up
Astrazeneca Ab BYDUREON PEN exenatide synthetic FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS 022200-002 Feb 28, 2014 RX Yes Yes 6,667,061 ➤ Sign Up Y ➤ Sign Up
Astrazeneca Ab XIGDUO XR dapagliflozin; metformin hydrochloride TABLET, EXTENDED RELEASE;ORAL 205649-002 Oct 29, 2014 RX Yes No 8,501,698 ➤ Sign Up Y ➤ Sign Up
Astrazeneca Ab BYDUREON PEN exenatide synthetic FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS 022200-002 Feb 28, 2014 RX Yes Yes 7,223,440 ➤ Sign Up Y ➤ Sign Up
Astrazeneca Ab ONGLYZA saxagliptin hydrochloride TABLET;ORAL 022350-002 Jul 31, 2009 RX Yes Yes RE44186 ➤ Sign Up Y Y ➤ Sign Up
Astrazeneca Ab FARXIGA dapagliflozin TABLET;ORAL 202293-001 Jan 8, 2014 RX Yes No 6,936,590 ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration

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Expired US Patents for Astrazeneca Ab

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Astrazeneca Ab BYDUREON PEN exenatide synthetic FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS 022200-002 Feb 28, 2014 5,424,286 ➤ Sign Up
Astrazeneca Ab BYDUREON PEN exenatide synthetic FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS 022200-002 Feb 28, 2014 6,956,026 ➤ Sign Up
Astrazeneca Ab BYETTA exenatide synthetic INJECTABLE;SUBCUTANEOUS 021773-002 Apr 28, 2005 7,521,423 ➤ Sign Up
Astrazeneca Ab BYETTA exenatide synthetic INJECTABLE;SUBCUTANEOUS 021773-002 Apr 28, 2005 6,858,576 ➤ Sign Up
Astrazeneca Ab SYMLIN pramlintide acetate INJECTABLE;SUBCUTANEOUS 021332-003 Sep 25, 2007 5,814,600 ➤ Sign Up
Astrazeneca Ab BYETTA exenatide synthetic INJECTABLE;SUBCUTANEOUS 021773-001 Apr 28, 2005 7,741,269 ➤ Sign Up
Astrazeneca Ab BYDUREON PEN exenatide synthetic FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS 022200-002 Feb 28, 2014 6,858,576 ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Paragraph IV (Patent) Challenges for ASTRAZENECA AB drugs
Drugname Dosage Strength Tradename Submissiondate
➤ Subscribe Extended-release Tablets 5 mg/500 mg, 2.5 mg/1000 mg, and 5 mg/1000 mg ➤ Subscribe 2013-07-31
➤ Subscribe Injection 250 mg/mL, 1.2 mL and 2.4 mL prefilled syringe ➤ Subscribe 2014-06-11
➤ Subscribe Tablets 2.5 mg and 5 mg ➤ Subscribe 2013-07-31

Supplementary Protection Certificates for Astrazeneca Ab Drugs

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
00569 Netherlands ➤ Sign Up PRODUCT NAME: LINAGLIPTINE, DESGEWENST IN DE VORM VAN EEN ZOUT, IN COMBINATIE MET METFORMINEHYDROCHLORIDE; REGISTRATION NO/DATE: EU/1/12/780/001-028 20120720
1084705/03 Switzerland ➤ Sign Up PRODUCT NAME: SAXAGLIPTIN; REGISTRATION NO/DATE: SWISSMEDIC 59390 05.02.2010
4/2010 Austria ➤ Sign Up PRODUCT NAME: SAXAGLIPTIN UND PHARMAZEUTISCH VERTRAEGLICHE SALZE DAVON, BEINHALTEND SAXAGLIPTINHYDROCHLORID
128 Luxembourg ➤ Sign Up PRODUCT 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
1506211/02 Switzerland ➤ Sign Up PRODUCT NAME: DAPAGLIFLOZIN + METFORMIN; REGISTRATION NO/DATE: SWISSMEDIC 65377 16.07.2015
00436 Netherlands ➤ Sign Up PRODUCT NAME: SAXAGLIPTINE, ALSMEDE; REGISTRATION NO/DATE: EU/1/09/545/001-010 20091001
2014 00037 Denmark ➤ Sign Up PRODUCT NAME: ET KOMBINATIONSPRODUKT AF DAPAGLIFLOZIN ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF, HERUNDER DAPAGLIFLOZINPROPANDIOLMONOHYDRAT OG METFORMIN ELLER SALTE DERAF, HERUNDER METFORMINHYDROCHLORID; REG. NO/DATE: EU/1/13/900 20140116
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Similar Applicant Names
Applicants may be listed under multiple names.
Here is a list of applicants with similar names.

For more information try a trial or see the plans and pricing

Serving hundreds of leading biopharmaceutical companies globally:

Merck
Fuji
Boehringer Ingelheim
McKesson
Covington
Chinese Patent Office
Argus Health
Farmers Insurance
Cerilliant

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