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Astra Zeneca losing generic esomeprazole battle

On 17 June 2010, AstraZeneca announced that its efforts in Canada to stop the launch of a generic version of its patented, stomach-acid-relief drug Nexium (esomeprazole), were rejected by the Canadian court.

Ranbaxy launches generic antiplatelet agent Prasita in India

On 10 June 2010, Indian-based Ranbaxy Laboratories Limited (Ranbaxy) announced the launch of a generic version of Prasugrel in India. The product, called Prasita, is an antiplatelet agent for the prevention of atherothrombotic events in patients with acute coronary syndrome undergoing percutaneous coronary intervention.

Teva forces Dutch market to use pre-filled MTX syringes

Until recently, the generic disease-modifying anti-rheumatic drug methotrexate (MTX) was available in The Netherlands in large vials, of which (hospital) pharmacists prepared ready-to-use (RTU) syringes for the weekly treatment of patients with rheumatoid arthritis (RA).

Sanofi-aventis blocks generic Allegra

On 14 June 2010, a US court backed sanofi-aventis and Albany Molecular Research in their bid to prevent Dr Reddy’s selling a generic version of the anti-allergenic medication, Allegra-D 24 Hour (fexofenadine HCl/pseudoephedrine HCl).

Is the quality of generic medicines under pressure?

“You get what you pay for” runs the old adage, and concerns are being expressed that a number of firms providing clopidogrel in Europe have all sourced the active ingredient from the same Indian firm, Glochem Industries Ltd, which has failed a quality inspection.

Financial incentives to prescribe cheaper medicinal products

On 22 April 2010, the Court of Justice of the EU (ECJ) ruled that public authorities may offer financial incentives encouraging doctors to prescribe cheaper medicinal products. Adding that “those authorities are required, first, to ensure that the incentive scheme is based on non-discriminatory objective criteria and, second, to make public the therapeutic evaluations relating to the scheme”. This is good news for the generics sector, as this can only lead to increased sales of cheaper generic medicines.

EMA wants recall of Acino’s generic clopidogrel with active substance of Indian Glochem

The European Medicines Agency (EMA)’s Committee for Medicinal Products for Human Use (CHMP) recommended the recall of all batches of eight centrally-authorised generic clopidogrel-containing medicines, for which the active substance was manufactured by Glochem Industries Ltd in its factory in Visakhapatnam, India. The medicines concerned are Clopidogrel A1 Pharma, Clopidogrel Acino, Clopidogrel Acino Pharma, Clopidogrel Acino Pharma GmbH, Clopidogrel Hexal, Clopidogrel Ratiopharm, Clopidogrel Ratiopharm GmbH and Clopidogrel Sandoz. The Marketing Authorisation Holder of all these medicines is Acino Pharma GmbH.

Pay-for-delay ban dropped from US healthcare reform bill

The pay-for-delay ban amendment has been dropped from part of the US healthcare reform bill because of concerns it would not pass muster with congressional rules, according to a spokeswoman for US Senator Ms Herb Kohl, a Wisconsin Democrat who chairs the Special Committee on Aging, which held a hearing on drug prices on 18 March 2010, as reported by Pharmalot.

Teva with ratiopharm market leader in European generics

On 18 March 2010 Teva announced that it has entered into a definitive agreement to acquire ratiopharm, Germany's second largest generics producer and the sixth largest generic drug company worldwide, for an enterprise value of Euros 3.625 billion. The transaction is subject to certain conditions including relevant regulatory approvals. On a pro forma basis, the combined company would have had 2009 revenues of US$16.2 billion. Teva expects to complete the transaction by year-end 2010.

FDA adds Boxed Warning to clopidogrel label: drug less effective in poor metabolizers with CYP2C19 gene variant

Sanofi-aventis and Bristol-Myers Squibb announced on 12 March 2010 revisions to the US prescribing information for its anti-blood clotting drug Plavix (clopidogrel bisulfate).

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