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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: September 21, 2018

DrugPatentWatch Database Preview

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 QTERN dapagliflozin; saxagliptin hydrochloride TABLET;ORAL 209091-001 Feb 27, 2017 RX Yes Yes 8,628,799 ➤ Sign Up Y ➤ Sign Up
Astrazeneca Ab BYDUREON PEN exenatide synthetic FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS 022200-002 Feb 28, 2014 RX Yes Yes 8,758,292 ➤ Sign Up Y ➤ Sign Up
Astrazeneca Ab BYDUREON BCISE exenatide SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS 209210-001 Oct 20, 2017 RX Yes Yes 7,223,440 ➤ Sign Up Y ➤ 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 BYETTA exenatide synthetic INJECTABLE;SUBCUTANEOUS 021773-001 Apr 28, 2005 7,297,761 ➤ Sign Up
Astrazeneca Ab SYMLIN pramlintide acetate INJECTABLE;SUBCUTANEOUS 021332-001 Mar 16, 2005 6,610,824 ➤ Sign Up
Astrazeneca Ab SYMLIN pramlintide acetate INJECTABLE;SUBCUTANEOUS 021332-001 Mar 16, 2005 7,407,934 ➤ 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

Non-Orange Book US 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
7,875,310 Residual solvent extraction method and microparticles produced thereby ➤ Sign Up
8,877,252 Polymer-based sustained release device ➤ Sign Up
8,187,672 Residual solvent extraction method and microparticles produced thereby ➤ Sign Up
Patent No. Title Estimated Patent Expiration

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Supplementary Protection Certificates for Astrazeneca Ab Drugs

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
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
C/GB14/085 United Kingdom ➤ Sign Up PRODUCT NAME: SAXAGLIPTIN; REGISTERED: UK EU/1/09/545/001-010 20091005
0130006 00074 Estonia ➤ Sign Up PRODUCT NAME: DAPAGLIFLOZIN;REG NO/DATE: K(2012)8378 12.11.2012
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.

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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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