Tropsium XR patents declared invalid
Watson Pharmaceuticals confirmed in early April 2012 that the United States District Court for the District of Delaware has ruled that four patents for Sanctura XR (trospium chloride extended-release capsules) are invalid. Watson’s Abbreviated New Drug Application for a generic version of the overactive bladder treatment is pending with FDA.
According to IMS Health data Sanctura XR had US sales of approximately US$68 million for the twelve months ending 29 February 2012.
Source: Watson
GSK and Pfizer sue Hikma over argatroban patent
GlaxoSmithKline (GSK) and Pfizer sued Hikma Pharmaceuticals for planning to sell an injectable blood-clot treatment that the drugmakers say infringes a patent licensed by GSK for argatroban.
Generics maker Hikma received FDA approval on 5 January 2012 for the generic version of argatroban, infringing on a patent that expires in 2014, according to the complaint filed on 30 March 2012 in federal court in Trenton, New Jersey, USA.
Source: Bloomberg, Hikma
Ranbaxy resumes export of atorvastatin from India to US
Ranbaxy Laboratories (Ranbaxy) announced on 2 April 2012 that it had started shipping generic atorvastatin to the US from its newly FDA-approved plant in India. The company had been selling generic atorvastatin in the US since December 2011 from its plant in the US but exports from its plants in India were banned in 2009 due to issues with Good Manufacturing Practice.
Mr Arun Sawhney, CEO and Managing Director at Ranbaxy, said this market is ‘a significant milestone for Ranbaxy’.
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Teva gains tentative approval for generic atorvastatin
Ranbaxy gets FDA approval and launches generic atorvastatin
Source: Ranbaxy
Teva launches generics of Sanofi blood pressure drugs
On 2 April 2012, Teva announced commercial launch of generic versions of sanofi-aventis’ high blood pressure treatments, Avapro (irbesartan) and Avalide (irbesartan-hydrochlorothiazide) tablets. According to IMS Health data, the brand-name products had annual sales in the US of approximately US$464 million and US$124 million, respectively.
As the first company to file Abbreviated New Drug Applications for both of these products, Teva will now enjoy a 180-day period of marketing exclusivity before other generics can enter the market.
Source: Teva
Ranbaxy launches rosuvastatin in Canada
Ranbaxy Laboratories (Ranbaxy) announced on 31 March 2012 that its Canadian subsidiary had received approval from Health Canada to manufacture and market a generic version of AstraZeneca’s blockbuster cholesterol-reducing drug Crestor (rosuvastatin) to the Canadian healthcare system.
According to Ranbaxy, sales of branded Crestor in Canada in 2011 were CA$742.2 million.
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Generic atorvastatin may be better than Crestor
Sun gains tentative approval for generic Crestor
Generics lose battle against AstraZeneca’s Crestor (rosuvastatin)
Source: Ranbaxy
Sun and Cipla drugs recalled in US
Some of India’s top drug manufacturers are having to deal with drug recalls after FDA found impurities in their drugs. Sun Pharma has recalled about 155,000 bottles of an eye solution. While Teva and US-based Eagle Pharmaceuticals have respectively recalled cancer therapy flutamide and anticoagulant argatroban injection, both made at India-based Cipla’s Goa plant.
Source: The Economic Times
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