Generics

Commission urges Greece to make parallel trade fair

Generics/General | Posted 24/02/2012

The European Commission announced on 26 January 2012 that it wanted Greece ‘to establish fair play on parallel importation of medicinal products’.

Sun comes under fire from Pfizer

Generics/News | Posted 24/02/2012

Sun Pharmaceutical Industries (Sun Pharma) is coming under fire from Pfizer, as the generics major is sued for violating patents on Pfizer’s Protonix (pantoprazole).

WHO definitions of generics

Generics/General | Posted 24/02/2012

Confusion often surrounds terms used in the global field of generics and biosimilars.

Watson files ANDA for generic Beyaz

Generics/News | Posted 17/02/2012

Watson Pharmaceuticals (Watson) announced on 10 February 2012 that it had filed an Abbreviated New Drug Application (ANDA) with FDA for a generic version of Bayer HealthCare’s (Bayer) leading oral contraceptive Beyaz (drospirenone/ethinyl estradiol/levomefolate).

Italian physicians’ negative attitude to generics

Generics/General | Posted 17/02/2012

A row over generics prescribing has erupted in Italy, with the government and physicians at odds over changes to prescribing rules.

Sandoz submits ANDA for generic treprostinil

Generics/News | Posted 17/02/2012

US drugmaker United Therapeutics announced on 6 February 2012 that it had received a Paragraph IV Certification Notice Letter from Sandoz, the generics division of Swiss-based drug giant Novartis. The notice letter stated that Sandoz had submitted an Abbreviated New Drug Application (ANDA) to FDA requesting approval to market a generic version of the 10 mg/mL strength of Remodulin (treprostinil) injection.

Tentative FDA approval for generic HIV treatment

Generics/News | Posted 10/02/2012

FDA announced on 31 January 2012 that it had given tentative approval for generic versions of GlaxoSmithKline’s (GSK’s) blockbuster AIDs treatment Epzicom (abacavir sulfate and lamivudine). The tentative approval enables India-based generics companies Cipla and Mylan to sell their generics to US aid programmes, but not yet in the US.

Ranbaxy consent decree with FDA submitted to court

Generics/News | Posted 10/02/2012

Ranbaxy Laboratories (Ranbaxy) announced on 26 January 2012 that the consent decree with FDA that was signed on 20 December 2011 has been filed with the United States District Court for the District of Maryland.

Generic and biosimilar user fee recommendations sent to Congress

Generics/News | Posted 03/02/2012

FDA has sent recommendations for user fee programmes, including those covering generic and biosimilar drugs, to US Congress. It is hoped that the fees will help speed up the delivery of safe and effective drugs to patients.

Italy asked to comply with marketing rules for generics

Generics/News | Posted 03/02/2012

The news that the European Commission (EC) had finally issued a formal call on 26 January 2012 for Italy to comply with EU rules on the marketing authorisation of generic medicines was welcomed by the European Generic medicines Association (EGA) together with the Italian association for generic medicines (Assogenerici).

Generics market to experience strong growth in 2010–2017

Generics/Research | Posted 03/02/2012

The global market for generic drugs will experience strong growth in the coming years due to patent expiries of blockbuster drugs worth US$150 billion between 2010 and 2017. Cost containment strategies being implemented by governments and healthcare service providers are also given credit for shifting sales towards cheaper generics.

Watson expands in Asia with Ascent Pharmahealth

Generics/News | Posted 27/01/2012

US generics manufacturer Watson Pharmaceuticals announced on 24 January 2012 that it had acquired Ascent Pharmahealth, the Australia and Southeast Asia generics subsidiary of Strides Arcolab, in a deal worth Australian dollars (A$) 375 million.

Factors important for generics substitution in Finland

Generics/Research | Posted 20/01/2012

What factors do patients take into account when deciding to accept or reject generics substitution? This is the question asked in a recent research article [1].

Teva outlines expansion plans in Asia

Generics/News | Posted 20/01/2012

Generics giant Teva is looking for deals in Asia, which the company believes will see strong future expansion in the use of generics.

Generic nasal spray approved by FDA

Generics/News | Posted 20/01/2012

India-based generics manufacturer Wockhardt announced on 10 January 2012 that it had received final approval from FDA for marketing a generic version of GlaxoSmithKline’s nasal spray allergy treatment Flonase (fluticasone).

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.

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).