drugset / Press release

Court Grants AstraZeneca Temporary Restraining Order Against Apotex in Pulmicort Respules Patent Litigation

2009-04-17 · AstraZeneca · original astrazeneca.com ↗

Friday, 17 April 2009 On 16 April 2009, the US District Court for the District of New Jersey granted AstraZeneca’s request for a temporary restraining order, barring Apotex (Apotex, Inc. and Apotex Corp.) from launching a generic version of AstraZeneca’s PULMICORT RESPULES until further order of the court. On 27 April 2009, the court will commence a hearing to determine whether the injunction should be continued. On 30 March 2009, the US FDA granted approval for a generic version of AstraZeneca's PULMICORT RESPULES (budesonide inhalation suspension) to Apotex. AstraZeneca then filed suit following Apotex’s indication of intent to market a generic version of AstraZeneca’s PULMICORT RESPULES in the US prior to the expiration of AstraZeneca’s patents. AstraZeneca has full confidence in the strength of its intellectual property rights protecting PULMICORT RESPULES and will continue to vigorously defend and enforce its intellectual property. Patents covering PULMICORT RESPULES expire in 2018 with pediatric exclusivity extending to 2019. 17 April 2009 NOTES TO EDITORS: About Pulmicort Respules PULMICORT RESPULES is a preventive, maintenance asthma medicine indicated for use in children 12 months to 8 years of age in the United States. Full-year US sales for PULMICORT in 2008 totalled $982 million, about 90 percent of which is accounted for by PULMICORT RESPULES. About AstraZeneca AstraZeneca is a major international healthcare business engaged in the research, development, manufacturing and marketing of meaningful prescription medicines and supplier for healthcare services. AstraZeneca is one of the world's leading pharmaceutical companies with healthcare sales of US$ 31.6 billion and is a leader in gastrointestinal, cardiovascular, neuroscience, respiratory, oncology and infectious disease medicines. For more information about AstraZeneca, please visit: www.astrazeneca.com CONTACTS: Media Enquiries UK: Neil McCrae +44 207 304 5045 (24 hours) Chris Sampson +44 20 7304 5130 (24 hours) Sarah Lindgreen +44 20 7304 5033 (24 hours) Media Enquiries US: Emily Denney +1 302 885 3451 Investor Enquiries UK: Jonathan Hunt +44 207 304 5087 mob: +44 7775 704032 Karl Hard +44 207 304 5322 mob: +44 7789 654364 Investor Enquiries US: Ed Seage +1 302 886 4065 mob: +1 302 373 1361 Jorgen Winroth +1 212 579 0506 mob: +1 917 612 4043 tags Corporate and financial AstraZeneca Websites This website is intended for people seeking information on AstraZeneca's worldwide business. Our country sites can be located in the AZ Network. Veeva ID: Z4-25396 Date of next review: August 2022 Resources All resources Open Innovation Externally sponsored scientific research Medical Information for HCPs US prescription assistance programmes Global clinical trials information Medicines Report a possible side effect Quick links Media Investor Relations Partnering Careers Sustainability Modern Slavery Statement AZethics – Report A Concern Supplier information Social Media Community Guidelines Social Media LinkedIn Twitter YouTube Instagram Glassdoor Facebook utility links Legal notice and Terms of Use Privacy notice Site map Contact us Cookie policy © AstraZeneca 2021 You are now leaving AstraZeneca.com You have selected a link that will take you to a site maintained by a third party who is solely responsible for its contents. AstraZeneca provides this link as a service to website visitors. AstraZeneca is not responsible for the privacy policy of any third party websites. We encourage you to read the privacy policy of every website you visit. Click ‘cancel’ to return to AstraZeneca’s site or ‘continue’ to proceed. Cancel Continue ? Important notice for users You are about to access AstraZeneca historic archive material. Any reference in these archives to AstraZeneca products or their uses may not reflect current medical knowledge and should not be used as a source of information on the present product label, efficacy data or safety data. Please refer to your approved national product label (SmPC) for current product information. I have read this warning and will not be using any of the contained product information for clinical purposes. I disagree I agree ? ?

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