AstraZeneca Files Patent Infringement Actions in Response to Crestor™ ANDAs

AstraZenecaAstraZeneca announced that it has filed patent infringement actions in United States District Court, District of Delaware, against seven generic drug manufacturers, which have submitted Abbreviated New Drug Applications (ANDAs) for Crestor™.

On 1st November 2007, AstraZeneca announced its receipt of a notice-letter from Cobalt Pharmaceuticals, Inc., notifying AstraZeneca that Cobalt had submitted an ANDA to the U.S. Food and Drug Administration (FDA). Cobalt’s ANDA sought approval to market generic versions of Crestor™ tablets prior to the expiration of patents covering Crestor™ tablets. Cobalt's ANDA contained a Paragraph IV certification alleging that the U.S. patents owned or licensed by AstraZeneca, and listed in the FDA’s Orange Book referencing Crestor™, were not infringed or that the patents were otherwise invalid or unenforceable.

Since receiving Cobalt’s notice-letter, AstraZeneca has received similar Paragraph IV Certification notice-letters from eight additional generic drug manufacturers. AstraZeneca received notice letters from (1) Teva Pharmaceuticals, USA (Teva) on October 31, 2007; (2) Aurobindo Pharma Limited (Aurobindo) on November 5, 2007; (3) Apotex, Inc. (Apotex) on November 6, 2007 and December 5, 2007; (4) Par Pharmaceutical (Par) on November 6, 2007; (5) Sandoz Inc. (Sandoz) on November 12, 2007; (6) Mylan Pharmaceuticals Inc. (Mylan) on November 15, 2007; (7) Glenmark Pharmaceuticals, Inc. USA (Glenmark) on November 15, 2007; and (8) Sun Pharmaceutical Industries Ltd. (Sun) on November 19, 2007.

Each of the eight additional generic drug companies has notified AstraZeneca that it has submitted an ANDA to the FDA seeking approval to market generic versions of Crestor™ tablets before the expiration of the U.S. Patents owned or licensed by AstraZeneca. Each notice-letter contained a Paragraph IV certification notice alleging that one or more of the three Orange Book listed US patents referencing Crestor in the FDA's Orange Book was not infringed or otherwise invalid or unenforceable.

Based on these various ANDA filings and Paragraph IV certifications, on 11th December 2007 AstraZeneca filed individual patent infringement actions in United States District Court, District of Delaware, against Aurobindo, Apotex, Cobalt, Par, Sandoz, Mylan, and Sun, alleging infringement of U.S. No. RE 37,314 (the '314 patent). AstraZeneca licenses the '314 patent from Shionogi & Co. Ltd.

About AstraZeneca
AstraZeneca is a major international healthcare business engaged in the research, development, manufacture and marketing of prescription pharmaceuticals and the supply of healthcare services. It is one of the world's leading bio-pharmaceutical companies with healthcare sales of $26.47 billion and leading positions in sales of gastrointestinal, cardiovascular, neuroscience, respiratory, oncology and infection products. AstraZeneca is listed in the Dow Jones Sustainability Index (Global) as well as the FTSE4Good Index. For more information, visit www.astrazeneca.com.

Most Popular Now

FDA grants Breakthrough Therapy Designation to Pfi…

Pfizer Inc. (NYSE:PFE) today announced that its investigational Group B Streptococcus (GBS) vaccine candidate, GBS6 or PF-06760805, received Breakthrough Therapy Designat...

Novartis invests in early technical development ca…

Novartis today announced it is investing in next-generation biotherapeutics with the creation of a fully integrated, dedicated USD 300m scientific environment that will b...

Malaria booster vaccine shows durable high efficac…

Researchers from the University of Oxford and their partners have today reported new findings from their Phase 2b trial following the administration of a booster dose of ...

Research reveals widespread use of ineffective COV…

Monoclonal antibodies are laboratory-designed treatments tailor-made to fight specific infections. In early 2021, the U.S. Food & Drug Administration issued emergency use...

Strict COVID lockdowns in France improved cardiova…

A new paper in European Heart Journal - Digital Health, published by Oxford University Press, indicates that social-distancing measures like total lockdown have a measura...

Pfizer and BioNTech receive positive CHMP opinion …

Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) announced a 30-µg booster dose of their Omicron BA.4/BA.5 bivalent-adapted COVID-19 vaccine (COMIRNATY® Original/Om...

U.S. clinical trial evaluating antiviral for monke…

A Phase 3 clinical trial evaluating the antiviral tecovirimat, also known as TPOXX, is now enrolling adults and children with monkeypox infection in the United States. St...

Stem cell-gene therapy shows promise in ALS safety…

Cedars-Sinai investigators have developed an investigational therapy using support cells and a protective protein that can be delivered past the blood-brain barrier. This...

Drug turns cancer gene into "eat me" fla…

Tumor cells are notoriously good at evading the human immune system; they put up physical walls, wear disguises and handcuff the immune system with molecular tricks. Now...

Mucosal antibodies in the airways protect against …

High levels of mucosal antibodies in the airways reduce the risk of being infected by omicron, but many do not receive detectable antibodies in the airways despite three ...

WHO strongly advises against antibody treatments f…

The antibody drugs sotrovimab and casirivimab-imdevimab are not recommended for patients with COVID-19, says a WHO Guideline Development Group of international experts in...

WHO grants prequalification to GSK's Mosquirix - t…

GSK plc (LSE/NYSE: GSK) announced that the World Health Organization (WHO) has awarded prequalification to Mosquirix (also known as RTS,S/AS01), GSK's groundbreaking mala...