Generics/News

Teva gains tentative approval for generic atorvastatin

Generics/News | Posted 13/01/2012

Teva announced on 1 December 2011 that it had received tentative approval from FDA for its generic version of Pfizer’s blockbuster cholesterol-reducing medication Lipitor (atorvastatin).

Pfizer continues to fight for Lipitor

Generics/News | Posted 16/12/2011

With the patent expiry of Pfizer’s blockbuster cholesterol-reducing drug Lipitor (atorvastatin) on 30 November 2011, Pfizer it seems is pulling out all the stops to delay generic erosion of its market share.

Ranbaxy may settle with FDA for generic atorvastatin launch

Generics/News | Posted 16/12/2011

According to The Times of India, generics giant Ranbaxy Laboratories and FDA are getting closer to reaching an agreement to solve the Indian drugmaker’s regulatory troubles.

Ranbaxy gets FDA approval and launches generic atorvastatin

Generics/News | Posted 02/12/2011

After all the speculation India-based Ranbaxy Laboratories (Ranbaxy) has resolved all outstanding issues and finally managed to gain approval from FDA for its generic version of the blockbuster cholesterol-reducing drug Lipitor (atorvastatin).

Strides Arcolab gains FDA approval for two cancer generics

Generics/News | Posted 02/12/2011

India-based generics manufacturer Strides Arcolab announced on 24 November 2011 that its wholly-owned subsidiary, Onco Therapies, had gained FDA approval for generic versions of cancer treatments carboplatin and oxaliplatin.

Mylan poised to enter generic inhalers market

Generics/News | Posted 25/11/2011

The global market for respiratory asthma and chronic obstructive pulmonary disorder (COPD) inhalers, a specialist field, is valued at more than US$34 billion (Euros 25.1 billion) and is averaging 7% growth per year according to IMS Health. More than 50% of this market is expected to lose patent protection by the end of 2016, including several blockbuster products, many of which are inhaler based.

Actavis launches generic valsartan in Europe

Generics/News | Posted 25/11/2011

On 18 November 2011, Iceland-based generics company Actavis announced the launch of generic valsartan and valsartan HCT in nine European countries.

Generic atorvastatin partnership

Generics/News | Posted 18/11/2011

In early November 2011, there has been speculation that Ranbaxy Laboratories and Teva are about to join in manufacturing generic atorvastatin, better known as Lipitor, in the US.

Stada to buy Spirig’s generics business

Generics/News | Posted 18/11/2011

German generics giant Stada Arzneimittel announced on 9 November 2011 that it had signed a deal to buy Switzerland-based Spirig Pharma’s generics business for approximately Euros 78 million.

AstraZeneca settles patent dispute over Seroquel XR

Generics/News | Posted 10/11/2011

In an out-of-court deal, AstraZeneca has agreed with Accord Healthcare, Handa Pharmaceuticals and Intas Pharmaceuticals that the latter can sell generic forms of the antipsychotic blockbuster Seroquel XR (quetiapine fumarate) from 1 November 2016.

Generic olanzapine now approved in US

Generics/News | Posted 04/11/2011

Eli Lilly has no safe haven left as the FDA announced on 24 October 2011 that it had approved the first generic olanzapine (for treating schizophrenia and bipolar disorder) drugs, one day after the company lost its patent protection on Zyprexa (olanzapine) in the US on 23 October 2011 [1].

South Africa-India alliances for generics and drug delivery systems

Generics/News | Posted 04/11/2011

South Africa-based Litha Healthcare Group signed an exclusive agreement with Indian generic drugmaker Natco Pharma (Natco) on 19 September 2011. Under the group’s newly formed generics business unit, the agreement will include a range of generic pharmaceutical products developed and manufactured by Natco.

Access to generic medicines undermined in free trade agreement

Generics/News | Posted 28/10/2011

On 19 October 2011, several leading Congressional Democrats wrote a letter to the US Trade Representative urging him to ensure that access to generic medicines in the developing world is not undermined during negotiations for the Trans-Pacific Partnership (TPP), currently being carried out in Peru between the US and the Asia-Pacific region.

Injectable generics at Strides Arcolab

Generics/News | Posted 28/10/2011

India-based drug firm Strides Arcolab announced on 3 October 2011 that it had received FDA approval to market injectable clindamycin, used in the treatment of bacterial infections, in the American market.

Another olanzapine generic hits the market

Generics/News | Posted 28/10/2011

The competition is hotting up for Eli Lilly as yet another generics maker joins the list of those already producing copies of its blockbuster antipsychotic drug Zyprexa (olanzapine).

Representatives object to 7-year biologicals exclusivity

Generics/News | Posted 21/10/2011

In the ongoing debate about the exclusivity period for biologicals in the US, the latest group to voice their opinions are members of the US House of Representatives. In a letter to President Barack Obama, dated 14 October 2011, the 51 Representatives outlined their objections to the President’s continued efforts to reduce the exclusivity period for originator biologicals.

Pfizer settles with Teva but clashes with Watson over generics

Generics/News | Posted 14/10/2011

Pfizer has gained a small reprieve from generic competition against its blockbuster cholesterol-reducing drug Lipitor, at least in the UK, by making a deal with Teva UK. However, the pharma giant has sued Watson Pharmaceuticals (Watson) to try and stop it selling its generic version of Embeda (morphine and naltrexone).

Teva takes over joint venture solidifying its position in Japan

Generics/News | Posted 07/10/2011

Teva announced on 26 September 2011 that it will acquire the 50% interest formerly held by Kowa Company in Teva’s Japanese joint venture for US$150 million, giving it full control.

Actavis launches generic olanzapine in 11 European markets

Generics/News | Posted 07/10/2011

Eli Lilly is facing yet more pressure as generics makers queue up to produce copies of its blockbuster antipsychotic drug Zyprexa (olanzapine). On 30 September 2011, Actavis announced that it had launched generic olanzapine tablets in Austria, Denmark, Finland, France, Germany, Ireland, Italy, Romania, Sweden, The Netherlands and the UK, immediately after the patents on Zyprexa expired on 26 and 27 September.

Japanese government promoting generics

Generics/News | Posted 30/09/2011

Japan is currently the world’s second largest pharmaceutical market, surpassed only by the US. The Japanese prescription drug market was valued at US$96 billion in 2010, however, only around 23% of its prescription drug sales (by volume) are generics [1].

Debate over biosimilars exclusivity period in free trade agreement

Generics/News | Posted 23/09/2011

With the eighth round of negotiations of the Trans-Pacific Partnership (TPP) agreement underway in Chicago, USA, on 12 September 2011 Democrat senators were split on the inclusion of intellectual property provisions that are consistent with US biologicals exclusivity standards, i.e. 12 years of data exclusivity.

FDA blocks Indian API supplier

Generics/News | Posted 30/09/2011

In a bid to get tough on foreign manufacturers, FDA has issued a warning letter and a US import ban to an Indian-based active pharmaceutical ingredient (API) manufacturer.

Generics production pulled in different directions

Generics/News | Posted 23/09/2011

A few months ago it was predicted that generics manufacturers were moving ahead with the development and commercialisation of better manufacturing technologies. The largest firms had now developed to the point at which they can start to develop new manufacturing technologies and thus lower their costs. This was going to lead, on the one hand, to lower prices for products and at the same time, higher profits for those firms able to develop in this way, who were then going to further consolidate their market position.

Ranbaxy to launch generic atorvastatin on time

Generics/News | Posted 16/09/2011

Ranbaxy Laboratories will release a generic version of the blockbuster cholesterol-lowering drug Lipitor (atorvastatin) in the US at the end of November 2011 as planned, according to a report in the Japanese newspaper Nikkei.

Ranbaxy launches generic esomeprazole in the UK

Generics/News | Posted 09/09/2011

India-based Ranbaxy Laboratories announced on 5 September 2011 that it had successfully launched esomeprazole magnesium 20 mg and 40 mg tablets in the UK.

Sanofi France to make generic atorvastatin

Generics/News | Posted 09/09/2011

The French daily newspaper, Les Echos, reported on 1 September 2011 that sanofi France (sanofi) had reached an agreement with Pfizer to produce generic versions of the blockbuster cholesterol drug Lipitor (atorvastatin).

Pfizer seeks 6-month paediatric exclusivity for Lipitor

Generics/News | Posted 26/08/2011

Pfizer is poised for a Lipitor (atorvastatin) reprieve in Europe. The company has asked for six months of additional exclusivity in most EU countries under regulations designed to promote drug trials for children. The extension could be worth almost US$800 million as it staves off generic competition until May 2012.

Pfizer in joint venture with Chinese generics maker Hisun

Generics/News | Posted 17/06/2011

US pharma giant Pfizer announced on 2 June 2011 that it had signed a memorandum of understanding (MOU) with Chinese generics manufacturer Zhejiang Hisun Pharmaceuticals (Hisun) on their intention to establish a joint venture. This potential partnership would aim to strengthen the ability of both companies to reach more patients with high-quality and low-cost medicines in the branded generics arena.

US drug shortages prompt oncologists to go into drug manufacture

Generics/News | Posted 09/09/2011

Drug shortages in the US are at a record high and there appears to be no quick solution to the problem. Legislation, government stock-piling and physicians importing or even manufacturing drugs are just some of the solutions being proposed.

Mylan’s attempt to stop Ranbaxy’s Lipitor exclusivity fails

Generics/News | Posted 20/05/2011

On 2 May 2011 a federal judge dismissed Mylan’s attempt to block rival generic company Ranbaxy Laboratories from launching a generic version of Pfizer’s blockbuster cholesterol-lowering drug Lipitor (atorvastatin) and trying to terminate Ranbaxy’s rights to sell generic atorvastatin in the US on an exclusive basis for six months.

Mylan tries to block Ranbaxy’s Lipitor exclusivity

Generics/News | Posted 22/04/2011

Cholesterol fighter Lipitor (atorvastatin calcium) has been the worlds ‘best-selling drug’ for the last 10 years, and has been a major source of income for the world’s biggest drug company, Pfizer. Lipitor was released in 1998, and by 2006 it had reached peak sales of US$12.9 billion, accounting for 27% of the company’s revenue. In 2010, with US$10.8 billion in sales, Lipitor still accounted for 15.8% of total revenue, even with the addition of Wyeth’s operations.

Teva continues its fight to prevent generic glatiramer acetate

Generics/News | Posted 02/09/2011

Teva Pharmaceutical Industries (Teva) has not given up the fight to keep generics competition away from its blockbuster drug, Copaxone (glatiramer acetate). The company announced on 29 August 2011 that a US federal court had rejected interpretation claims from its challengers in patent infringement lawsuits over its proprietary multiple sclerosis treatment, setting a trial date of 7 September 2011.

Ranbaxy may sell its generic atorvastatin exclusivity

Generics/News | Posted 02/09/2011

According to Credit Suisse analysts, Ranbaxy Laboratories (Ranbaxy) may sell its rights to make a generic version of Pfizer’s cholesterol blockbuster Lipitor (atorvastatin), should it look unlikely to gain FDA approval in time for the planned November 2011 launch.

Generics manufacturers do not have to change drug safety labels in the US

Generics/News | Posted 26/08/2011

A landmark ruling from the US Supreme Court has decided that generic drug manufacturers do not have to change their drug’s safety label, even if stronger safety warnings are found to be required [1- 2]. This is the opposite of a ruling in 2009 that decided that patients could sue the manufacturer of a brand-name drug if its safety label is found to be inadequate, e.g. when new drug-related risks are discovered after the drug has made it to market [3, 4].

Domestic Indian market spawns generic agreements

Generics/News | Posted 29/07/2011

India’s population is growing rapidly—as is its economy—creating a large middle class with the resources to afford western medicines. This fact has seen a spate of western companies stepping forward to make agreements with Indian generics manufacturers in order to get a foothold in this developing market.

GPs in the UK to be banned from prescribing branded statins

Generics/News | Posted 19/08/2011

General Practitioners (GPs) in Cambridgeshire, UK, have been told by the national health service (NHS) that they are considering proposals to ban prescribing of branded statins in favour of cheaper generic alternatives according to a report in Pulse.

UK Government sues Servier for generic blocking

Generics/News | Posted 12/08/2011

The UK’s Health Secretary, Mr Andrew Lansley, has issued a GBP 220 million (Euros 246 million; US$360 million) lawsuit against French drug company Servier for allegedly ‘abusing’ its dominant position and delaying rivals from launching generic versions of its angiotensin-converting enzyme inhibitor, perindopril (Coversyl).

US drug shortages – FDA may hinder, but APP may help

Generics/News | Posted 08/07/2011

Drug shortages are at a record high, and some blame the policies of the FDA for causing some of these. However, good news is on the horizon as US drugmaker APP Pharmaceuticals has decided to boost its manufacturing capacity for injectable generic drugs. This could help to fight against the growing list of drug shortages reported by the FDA.

Generics will not have to change their labelling

Generics/News | Posted 08/07/2011

The US Supreme Court has decided that generics makers cannot be sued under state law for not changing their labels to warn of possible side effects. That is a big victory for Actavis, Mylan and Teva, which had faced appeals against court rulings that would have allowed them to be sued under state law.

Ranbaxy launches generic olanzapine in Spain

Generics/News | Posted 13/05/2011

Eli Lilly may be facing pressure as generics makers queue up to produce copies of its blockbuster antipsychotic drug Zyprexa (olanzapine). On 25 April 2011,the first day after Eli Lilly’s patent exclusivity expired in Spain, Ranbaxy Laboratories announced that it had launched its generic version of the treatment.