One of the pharma major from India, Ranbaxy sues AstraZeneca for patent related to product, NEXIUM in United Kindom. Ranbaxy stated that the european patents related to NEXIUM, which is used for the treatment of ulcers are invalid and therefore the marketing or selling of its product will not initiate any infringement of the said patents.
NEXIUM is the brand name for the active esomeprazole which is a proton pump inhibitor and prescribed for the treatment of dyspepsia, peptic ulcer disease (PUD), gastroesophageal reflux disease (GORD/GERD) and Zollinger-Ellison syndrome.
(source:www.itagbs.com)
Showing posts with label AstraZeneca. Show all posts
Showing posts with label AstraZeneca. Show all posts
Tuesday, November 16, 2010
Thursday, October 28, 2010
AstraZeneca sues Watson for Crestor patent challenge
Watson has filed ANDA with paragraph IV certification for generic version of Crestor(TM) (Rosuvastatin Cacium) and in response of that, AStraZeneca has filed law suit against watson in U.S. District Court for the District of Delaware seeking to block the company from selling a generic product prior to the patent expiration set for March 30, 2013.
(Source: www.forbes.com)
(Source: www.forbes.com)
Friday, September 17, 2010
Intas Pharma confirms genric supply deal with Astrazeneca
After Torrent Pharmaceuticals, another Ahmedabad based pharma firm Intas Pharmaceuticals Ltd has entered into a licensing and supply agreement with UK-based drug maker Astrazeneca. Intas will supply generic, high-end oncological products manufactured at its Matoda site near Ahmedabad to Astrazeneca. Intas declined to share the financial details of the deal.
Jayesh Shah, chief financial officer of Intas Pharma, said, "We have a received a couple of million dollars upfront from Astrazeneca now, and volume of supply would depend on as and when the registration dossiers are filed in respective countries". He also added that while Astrazeneca will source exclusively from Intas, the former could supply to other companies as well. "We have sufficient capacity at our Matoda plant, and also space for expansion. We can also supply to other pharma companies, as the deal is non-exclusive from our end", Shah told Business Standard.
The deal supports Astrazeneca's target of expanding its offering of branded generic medicines to emerging markets. The medicines sourced from Intas would be sold under Astrazeneca's name and would add to the UK-based drug makers basket of high-end injectable and oral solid oncological products that are complimentary to its existing therapy areas. Shah informed that the medicines would cater to a mix of markets including Latin American, African and Commonwealth of Independent States(CIS) countries.
$ 32.8 billion Astrazeneca is the second largest drug maker in UK, and has already inked a long term supply deal with Ahmedabad's Torrent Pharma earlier this year for 18 products in nine countries. While the financial details of the Torrent deal were also not disclosed, Astrazeneca had indicated that further products and countries could be added.
Intas, that is planning a listing soon, has a presence across 42 countries worldwide. It focuses on areas of central nervous system(CNS) disorders, cardiovascular disease,diabetes,gastroenterology,urology, pain management,animal health care,oncology and biotechnology.
(Source: http://www.business-standard.com)
Jayesh Shah, chief financial officer of Intas Pharma, said, "We have a received a couple of million dollars upfront from Astrazeneca now, and volume of supply would depend on as and when the registration dossiers are filed in respective countries". He also added that while Astrazeneca will source exclusively from Intas, the former could supply to other companies as well. "We have sufficient capacity at our Matoda plant, and also space for expansion. We can also supply to other pharma companies, as the deal is non-exclusive from our end", Shah told Business Standard.
The deal supports Astrazeneca's target of expanding its offering of branded generic medicines to emerging markets. The medicines sourced from Intas would be sold under Astrazeneca's name and would add to the UK-based drug makers basket of high-end injectable and oral solid oncological products that are complimentary to its existing therapy areas. Shah informed that the medicines would cater to a mix of markets including Latin American, African and Commonwealth of Independent States(CIS) countries.
$ 32.8 billion Astrazeneca is the second largest drug maker in UK, and has already inked a long term supply deal with Ahmedabad's Torrent Pharma earlier this year for 18 products in nine countries. While the financial details of the Torrent deal were also not disclosed, Astrazeneca had indicated that further products and countries could be added.
Intas, that is planning a listing soon, has a presence across 42 countries worldwide. It focuses on areas of central nervous system(CNS) disorders, cardiovascular disease,diabetes,gastroenterology,urology, pain management,animal health care,oncology and biotechnology.
(Source: http://www.business-standard.com)
Tuesday, September 7, 2010
SEROQUEL XR got an add on treatment approval
AstraZeneca today announced that the European Commission (EC) has issued a positive decision for the approval of once-daily SEROQUEL XR (quetiapine fumarate) Extended Release Tablets as an add-on treatment of major depressive episodes in patients with Major Depressive Disorder (MDD) who have had sub-optimal response to antidepressant monotherapy. This decision follows a positive recommendation by the Committee for Medicinal Products for Human Use (CHMP) in April of this year.
AstraZeneca will now move forward in obtaining local approvals. This is a 30 day process in the 17 member states that took part in the original Mutual Recognition Procedure. For other member states timelines will vary.
Within this application, the product information for SEROQUEL XR has been updated with respect to several individual safety topics such as: suicidality, weight gain, hyperglycaemia, extrapyramidal symptoms, akathisia, somnolence, orthostatic hypotension, and dizziness. Guidance is also provided on safe administration of SEROQUEL XR, including consideration of the safety profile with respect to the individual patient’s diagnosis and the dose being administered. Implementation of this updated product information will occur upon obtaining local approval. (Source: Astrazeneca press release)
AstraZeneca will now move forward in obtaining local approvals. This is a 30 day process in the 17 member states that took part in the original Mutual Recognition Procedure. For other member states timelines will vary.
Within this application, the product information for SEROQUEL XR has been updated with respect to several individual safety topics such as: suicidality, weight gain, hyperglycaemia, extrapyramidal symptoms, akathisia, somnolence, orthostatic hypotension, and dizziness. Guidance is also provided on safe administration of SEROQUEL XR, including consideration of the safety profile with respect to the individual patient’s diagnosis and the dose being administered. Implementation of this updated product information will occur upon obtaining local approval. (Source: Astrazeneca press release)
Sunday, August 29, 2010
ECJ DECISION HELPS TO ENSURE PATIENT ACCESS TO GENERIC MEDICINES
The European Generic medicines Association has welcomed the Decision from the European Court of Justice, which has endorsed the European Commission’s findings that Astra Zeneca abused its dominant position in the market for proton pump inhibitors. The Court confirmed there was clear evidence of anti-competitive activity, through misuse of the patent and regulatory systems, in order to delay the entry of generic Omeprazol, the active ingredient in the company’s blockbuster drug, Losec.
"This case is about the misuse of regulatory procedures which has the effect of blocking or delaying entry to the market of cheaper medicines, mainly by creating hurdles for generic products well beyond the period of protection granted by the legislator. Pharmaceutical companies are afforded legal protection for the innovative drugs they bring to the market. This is justified as it rewards innovation and generates revenues for further research in the sector. But companies should not misuse the patent system and the system for authorisation of medicines to extend the protection of their blockbuster products and delay the entry of generics into the market. Generic drugs benefit patients and governments that pay for medicines. I am determined to use competition rules whenever appropriate to fight such unfair and anticompetitive practices," Joaquín Almunia, Commission Vice President in charge of Competition Policy, July 2010.
"This case is about the misuse of regulatory procedures which has the effect of blocking or delaying entry to the market of cheaper medicines, mainly by creating hurdles for generic products well beyond the period of protection granted by the legislator. Pharmaceutical companies are afforded legal protection for the innovative drugs they bring to the market. This is justified as it rewards innovation and generates revenues for further research in the sector. But companies should not misuse the patent system and the system for authorisation of medicines to extend the protection of their blockbuster products and delay the entry of generics into the market. Generic drugs benefit patients and governments that pay for medicines. I am determined to use competition rules whenever appropriate to fight such unfair and anticompetitive practices," Joaquín Almunia, Commission Vice President in charge of Competition Policy, July 2010.
- More information on the AstraZeneca case is available under: http://curia.europa.eu/jcms/upload/docs/application/pdf/2010-07/cp100067en.pdf
Friday, August 27, 2010
Torrent gets another bad news and this time its by manufacturing partner:AstraZeneca
The UK-based drug major AstraZeneca has filed one more patent lawsuit against Gujarat-based Torrent Pharmaceuticals and its US subsidiary, for alleged move to manufacture and sell the generic version of its extended release anti-psychotic drug, Seroquel XR prior to the expiry of its patent.
AstraZenca, a UK based drug major company which has just entered as manufacturing partnership with Torrent pharma in March 2010.
AstraZeneca has filed a complaint against Torrent Pharma in the District Court of New Jersey, US, following the a Para IV filing to produce and market the quetiapine fumarate extended release drug, the generic form of AstraZeneca's Seroquel XR, used to treat schizophrenia and bipolar disorder, which is having sales value of $913 million.
Full article can be view at http://www.pharmabiz.com/article/detnews.asp?articleid=57084§ionid=
AstraZenca, a UK based drug major company which has just entered as manufacturing partnership with Torrent pharma in March 2010.
AstraZeneca has filed a complaint against Torrent Pharma in the District Court of New Jersey, US, following the a Para IV filing to produce and market the quetiapine fumarate extended release drug, the generic form of AstraZeneca's Seroquel XR, used to treat schizophrenia and bipolar disorder, which is having sales value of $913 million.
Full article can be view at http://www.pharmabiz.com/article/detnews.asp?articleid=57084§ionid=
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