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Ranbaxy launches generic atorvastatin in South Africa

Generics/News | Posted 30/07/2010

Sales of Pfizer’s Lipitor (atorvastatin), the world's biggest-selling drug, are expected to take another blow as Ranbaxy South Africa (Ranbaxy SA) announced the launch of a generic version of atorvastatin onto the South African market on 8 June 2010.

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Approval of ‘hybrid generic’ PecFent (fentanyl) in EU

Generics/News | Posted 09/07/2010

On 25 June 2010, Archimedes Pharma (Archimedes) announced that it had received a positive opinion from the CHMP of the EMA for its ‘hybrid generic’ PecFent (fentanyl).

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Bayer sues Teva over generic Yaz contraceptive

Generics/News | Posted 02/07/2010

On 15 June 2010, German-based Bayer Schering Pharma (Bayer) announced that it was suing the Israeli generic giant, Teva Pharmaceuticals (Teva), for false advertising and patent infringement in connection with Teva’s generic oral contraceptive, Gianvi. Teva’s product is sold as a generic version of Bayer’s leading oral contraceptive Yaz.

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Teva changes generic Yaz contraceptive label

Generics/News | Posted 09/07/2010

Israeli generic giant Teva Pharmaceuticals has agreed to change the labelling on its generic oral contraceptive, Gianvi, after Bayer Schering Pharma (Bayer) filed a lawsuit accusing the company of falsely claiming its drug was identical to Bayer’s Yaz.

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Hospira’s generic antibiotic Meropenem approved in US

Generics/News | Posted 09/07/2010

On 22 June 2010, Hospira announced that it had received approval from the FDA for its generic antibiotic, Meropenem. This is the first generic launched in the antibiotic class and Hospira is the first to market.

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Teva gains approval for generic breast cancer and anti-depressant drugs

Generics/News | Posted 09/07/2010

The Israeli generics’ giant Teva Pharmaceuticals is racing ahead in the generics game with the announcement of the approval by the FDA of two new drugs for treatment of breast cancer and depression.

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Astra Zeneca losing generic esomeprazole battle

Generics/News | Posted 02/07/2010

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.

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Ranbaxy launches generic antiplatelet agent Prasita in India

Generics/News | Posted 25/06/2010

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.

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Teva forces Dutch market to use pre-filled MTX syringes

Generics/News | Posted 25/06/2010

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).

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Sanofi-aventis blocks generic Allegra

Generics/News | Posted 25/06/2010

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).

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Is the quality of generic medicines under pressure?

Generics/News | Posted 11/06/2010

“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.

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Financial incentives to prescribe cheaper medicinal products

Generics/News | Posted 28/05/2010

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.

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

Generics/News | Posted 02/04/2010

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.

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

Generics/News | Posted 29/03/2010

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.

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Teva with ratiopharm market leader in European generics

Generics/News | Posted 26/03/2010

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.

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

Generics/News | Posted 23/03/2010

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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AstraZeneca signs branded-generics deal with Torrent to boost emerging-markets presence

Generics/News | Posted 18/03/2010

AstraZeneca announced on 11 March 2010 a license and supply agreement with Torrent Pharmaceuticals. Torrent will supply to AstraZeneca a portfolio of generic medicines for which Torrent already has licenses in a range of countries. Working in partnership with Torrent, AstraZeneca intends to brand and market these products in many of its emerging markets, where it already has a strong commercial footprint.

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FDA warning letter to Chinese API supplier Xian Libang Pharmaceutical

Generics/News | Posted 17/03/2010

The FDA has warned Xian Libang Pharmaceutical Co. Ltd, a maker of active pharmaceutical ingredients (APIs); because its quality control unit failed to detect that an employee had manipulated testing data on incoming raw materials. The failure could affect drugmakers that use the company as a supplier. Xian Libang has been asked to provide a list of all lots of APIs shipped to the US that were released based on non-existent, inaccurate or unreliable test data, according to a warning letter of 28 January 2010 recently posted to the FDA’s website.

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Daiichi Sankyo unit to sell generic drugs in Japan

Generics/News | Posted 15/03/2010

Daiichi Sankyo Co. Ltd. said on 26 February 2010 it will set up a new subsidiary in April 2010 to produce and sell generic drugs in Japan, in – according to Mr Kazuhiro Shimamura in the Wall Street Journal Asia – a rare move by a domestic maker of branded prescription drugs to tap the growing market of low-priced pharmaceuticals.

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FDA: Counterfeit orlistat has risky sibutramine amount

Generics/News | Posted 22/02/2010

As reported by Scrip, the US FDA has re-iterated its concerns about a counterfeit version of GlaxoSmithKline's Alli (orlistat), which contains varying degrees of sibutramine rather than the correct active ingredient.