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FDA approval for generic diabetes drug Actos

Generics/News | Posted 24/08/2012

On 17 August 2012, FDA gave final approval to Mylan Pharmaceuticals for the first generic version of Actos (pioglitazone hydrochloride tablets), for the treatment of type 2 diabetes. The approval covers tablets containing 15 mg, 30 mg and 45 mg pioglitazone.

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Court upholds decision against AstraZeneca’s omeprazole

Generics/News | Posted 10/08/2010

On 1 July 2010, the General Court of the European Union (GCEU) upheld the decision of the European Commission (EC), which found that AstraZeneca had abused its dominant position by preventing the marketing of generic versions of Losec (omeprazole).

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Gilead makes HIV generics deal

Generics/News | Posted 17/08/2012

US-based drugmaker Gilead Sciences (Gilead) announced on 2 August 2012 a new collaboration with Indian generics manufacturers to provide low cost HIV medicine to developing countries.

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Ranbaxy forfeits exclusivity on generic Provigil

Generics/News | Posted 17/08/2012

As part of Ranbaxy’s consent decree with FDA, signed in January 2012, the Indian generics major had to agree to relinquish 180-day marketing exclusivity on three pending generic drug applications [1]. Now analysts believe that generic Provigil (modafinil) may have been one of those undisclosed drugs.

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FDA approves generics of Merck’s Singulair

Generics/News | Posted 10/08/2012

FDA announced on 3 August 2012 that the agency had approved not one, but ten generic versions of Merck’s blockbuster asthma-allergy drug Singulair (montelukast).

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Pfizer wins against generic versions of pain drug Lyrica

Generics/News | Posted 03/08/2012

The world’s largest drugmaker Pfizer has successfully blocked Israel-based Teva Pharmaceutical Industries (Teva) and other manufacturers from selling generic versions of its fibromyalgia treatment Lyrica (pregabalin) until patents on the drug expire in 2018. The ruling, announced on 19 July 2012, was the result of a lawsuit begun in 2009 contending that sales of generic Lyrica would infringe Pfizer’s patents and cause irreparable harm to sales.

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Watson gains FDA approval for morning after pill

Generics/News | Posted 03/08/2012

US generics company Watson Pharmaceuticals (Watson) announced on 13 July 2012 that its subsidiary Watson Laboratories, has received approval from FDA for its Abbreviated New Drug Application (ANDA) for Next Choice One Dose (levonorgestrel tablet, 1.5 mg), the generic equivalent to Teva Women’s Health’s Plan B One-Step. Watson plans to launch the product immediately.

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More downs than ups for Ranbaxy

Generics/News | Posted 29/06/2012

A further problem with Indian generics manufacturer Ranbaxy Laboratories (Ranbaxy) could affect its reputation yet again with US FDA. This time, Ranbaxy fell foul of an Indian state regulator, the Maharashtra FDA (FDA, Maharashtra State, India). The Indian crack-down on Ranbaxy follows in the wake of a consent decree issued by US FDA in January 2012 which tightens scrutiny of Ranbaxy’s quality control and reporting measures.

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Apotex gains reprieve after Merck loses ruling―but for how long

Generics/News | Posted 29/06/2012

Toronto-based pharmaceutical firm Apotex has won a stay of execution for its nasal spray generic product after a US District Court in New Jersey, USA, turned down a patent infringement claim by Merck & Co’s Schering-Plough unit.

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Generic Adderall XR approved in the US

Generics/News | Posted 29/06/2012

Shire announced on 23 June 2012 that it had lost its battle to protect its attention deficit hyperactivity disorder (ADHD) drug Adderall XR (amphetamine, dextroamphetamine mixed salts). FDA approved the abbreviated new drug application (ANDA) from Actavis, a unit of US generics company Watson Pharmaceuticals, for the ADHD drug on 22 June 2012.

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Mylan moving ahead

Generics/News | Posted 18/06/2012

Three announcements in three days, in four different countries―Mylan is continuing to make progress in generics.

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Teva won’t sell generic atorvastatin

Generics/News | Posted 08/06/2012

Teva has decided not to market its own generic version of Lipitor (atorvastatin), Pfizer’s blockbuster cholesterol-lowering drug that recently came off patent. The decision comes despite the fact that FDA granted tentative approval for Teva’s generic version of atorvastatin at the end of 2011. Teva America’s CEO, Mr William Marth told The Economic Times, ‘we’ve made a really hard choice on not launching atorvastatin.’ He forecasts that the decision not to launch certain products such as atorvastatin and simvastatin will cost the firm about US$150 million.

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Hospira recalls overfilled hydromorphone hydrochloride vials

Generics/News | Posted 01/06/2012

Hospira first alerted FDA in April and May 2012 of overfilled cartridges containing morphine and hydromorphone. Subsequent investigation by the company has revealed that as many as 280 batches of 15 different Carpuject pre-filled cartridge products, which were manufactured between June 2010 and February 2012, could have contained more medication than is stated on the label [1].

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Generics makers cannot gain access to some brand-name drugs

Generics/News | Posted 25/05/2012

Generics manufacturers trying to create generics for certain drugs are having problems gaining access to samples of the brand-name drugs due to restrictions on supply put in place by FDA.

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Generic atorvastatin could save NHS GBP 350 million a year

Generics/News | Posted 18/05/2012

Generics of Pfizer’s blockbuster cholesterol treatment Lipitor (atorvastatin) could save the National Health Service (NHS) in the UK a whopping GBP 250 million or more during the coming years, following loss of patent exclusivity.

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Sandoz to gain generic dermatology specialist Fougera

Generics/News | Posted 04/05/2012

Swiss pharma giant, Novartis, announced on 2 May 2012 that the company had signed a deal for Sandoz, its generics unit, to acquire speciality generics dermatology business Fougera Pharmaceuticals (Fougera) for US$1.525 billion in cash.

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Amgen buys Turkish generics manufacturer

Generics/News | Posted 27/04/2012

US biotechnology giant Amgen announced on 25 April 2012 that the company will pay US$700 million to gain a majority share (95.6%) in Turkish generics company Mustafa Nevzat Pharmaceuticals (MN).

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Watson now third largest generics company with Actavis acquisition

Generics/News | Posted 27/04/2012

Watson Pharmaceuticals (Watson) has confirmed a definitive agreement to acquire privately-owned generics firm Actavis for an upfront payment of Euros 4.25 billion. The acquisition of Actavis makes Watson the third largest generics company in the world, with US$8 billion in combined revenue expected during 2012.

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US Supreme Court rules against generics delaying tactics

Generics/News | Posted 23/04/2012

On 17 April 2012, the US Supreme Court ruled in favour of India-based generics company Sun Pharma in its case against Danish pharmaceutical company, Novo Nordisk, a case that could have provided a route for brand-name drug companies to delay generics competition.

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FDA approves generic vancomycin capsules

Generics/News | Posted 23/04/2012

On 11 April 2012 India-based Strides Arcolab (Strides) announced that it had received FDA approval for its generic version of Baxter’s antibiotic Vancocin (vancomycin).