Generics

Quality by design for generics by 2013

Generics/General | Posted 09/12/2011

Quality by design (QbD) is already being implemented by FDA for new drug applications, but now, in an attempt to prepare generics manufacturers for QbD in 2013, FDA is preparing to publish immediate and modified release QbD examples.

The pharmaceutical market in Brazil

Generics/General | Posted 09/12/2011

The Brazilian pharmaceutical market is the third largest in the Americas region, after Canada and USA, it ranks first in the Latin American region. Pharmaceutical demand will continue to rise, fuelled by increasing disposable income, therefore, the market outlook is positive for the 2011–2016 period.

Advocates demand generic version of Abbott’s HIV drug Kaletra

Generics/News | Posted 09/12/2011

FDA watchdog Public Citizen, along with public health groups in a dozen countries, has launched a global campaign demanding the authorisation of generics competition for Abbott Laboratories’ HIV drug Kaletra (lopinavir/ritonavir) before its exclusivity expires.

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.

Translational research to uncover new uses for generics

Generics/Research | Posted 04/11/2011

On the surface, generic compounds and translational medicines could not appear more different. However, in April 2011, the US National Institutes of Health (NIH) met with academic, governmental, and industry R & D experts to discuss whether translational methods could help to rescue and re-position certain generics [1].

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.

Row continues over drug shortages

Generics/General | Posted 28/10/2011

Unhappiness about persistent drug shortages is becoming more acute, both in Europe and the US. Hospitals in The Netherlands are routinely short of around 40 products, whereas in the US 180 medications have now made it onto FDA’s list of scarce products. Hospital pharmacists spend an increasingly large amount of time trying to source scarce items and, despite their best efforts, doctors and patients are increasingly noticing the scarcities.

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.

European Commission investigates Johnson & Johnson and Novartis over delaying generics

Generics/General | Posted 28/10/2011

As part of its ongoing antitrust investigations, the European Commission (EC) announced on 21 October 2011 that it is looking into agreements between Johnson & Johnson (J&J) and Novartis to determine whether they delayed the entry of a generic version of the fentanyl painkiller in The Netherlands. If the drugmakers had ‘contractual arrangements’ that hindered a generic drug, this would ‘potentially’ breach EU antitrust rules.

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).