Generics

Mylan to acquire Strides Arcolab’s injectable generics business

Generics/News | Posted 15/03/2013

Generics giant Mylan announced on 27 February 2013 that it has signed an agreement to acquire generic injectables maker Agila Specialties (Agila) from Strides Arcolab for US$1.6 billion in cash.

Patients’ knowledge and perceptions about generics in Australia

Generics/Research | Posted 08/03/2013

Most Australians know about generics but are not sure if they prefer brand-name or generic drugs, according to a survey carried out by Australian researchers and published in December 2012 in the Journal of Pharmacy Practice and Research [1].

UN urges WTO to keep cheap drug deal for poor countries

Generics/General | Posted 08/03/2013

Two United Nations (UNs) agencies are urging the extension of an exemption for least-developed countries on patent protection to ensure that HIV/AIDS and other lifesaving drugs remain affordable for the poor.

Pfizer delays generic celecoxib entry in US

Generics/News | Posted 08/03/2013

Pharma giant Pfizer announced on 5 March 2013 that the US Patent Office had given the company an extra 18 months of exclusivity for its blockbuster anti-inflammatory painkiller Celebrex (celecoxib).

FDA approves generic opiate-dependency drugs

Generics/News | Posted 08/03/2013

On 22 February 2013, FDA approved two generic versions of the drug Suboxone (buprenorphine/naloxone), a treatment for recovering heroin addicts.

Ranbaxy restarts generic atorvastatin production

Generics/News | Posted 01/03/2013

India-based generics giant Ranbaxy Laboratories (Ranbaxy) announced on 25 February 2013 that it has restarted production of its generic cholesterol lowering drug atorvastatin after solving contamination problems.

Pfizer asks US Court to reconsider generic Reglan ruling

Generics/News | Posted 22/02/2013

Pfizer has asked the US Supreme Court of Alabama to reconsider its decision of 4 January 2013, which would allow generics patients to sue brand-name drugmakers.

Generics policies in Europe have room for improvement

Generics/Research | Posted 15/02/2013

In Europe, generics policies have not yet been implemented to their full extent, according to authors Vogler and Zimmerman, reporting on the 2011 Pharmaceutical Pricing and Reimbursement Information (PPRI) Conference [1, 2].

Conflict-of-interest policies reduce brand-name prescribing

Generics/Research | Posted 08/02/2013

Psychiatrists who are exposed to conflict-of-interest (COI) policies during their residency are less likely to prescribe brand-name antidepressants after graduation than those who train in residency programmes without such policies, according to a new study by researchers from the Perelman School of Medicine at the University of Pennsylvania, USA [1].

Watson buys women’s health company Uteron

Generics/News | Posted 08/02/2013

Generics giant Watson Pharmaceuticals, now known as Actavis, announced on 23 January 2013 that it has completed the acquisition of Belgium-based Uteron Pharma for US$150 million in cash up front, and up to US$155 million in potential future milestone payments.

Watson becomes Actavis

Generics/News | Posted 01/02/2013

Watson Pharmaceuticals announced on 24 January 2013 that the company had officially adopted Actavis as its new global name under which it will now trade on the New York Stock Exchange.

HIV generics could significantly cut treatment costs

Generics/Research | Posted 01/02/2013

The US Government could save almost US$1 billion in the first year alone by using generic rather than brand-name drugs for the treatment of HIV patients, according to a study published in the Annals of Internal Medicine [1].

First generic versions of Duetact and Maxalt approved

Generics/News | Posted 01/02/2013

First-to-file generics from Mylan and Sandoz have been approved by FDA for rizatriptan benzoate and pioglitazone hydrochloride/glimepiride tablets, respectively.

Generic antiepileptic drugs bioequivalent to brand-name drugs

Generics/Research | Posted 24/01/2013

Results of a study, reported by Dr Ravi Juluru and co-authors at the American Epilepsy Society’s 66th Annual Meeting, held in San Diego, USA on 30 November–4 December 2012, shows that generic slow-release drugs for seizure disorders are ‘equivalent’ to their brand-name counterparts [1].

Overview of research on regulatory issues for generics in 2012

Generics/Research | Posted 24/01/2013

Period: January to August 2012

Regulatory issues are a challenge facing generics of all kinds, and one that may limit the competitiveness and sustainability of the generics industry. However, with the cost of medicines becoming a more and more important factor for patients and the healthcare industry as a whole there is a need for both harmonization of regulatory requirements between different regions, e.g. Canada, EU and US, as well as a need for clarity in the regulatory requirements for certain generics.

Pharmascience and Kolmar to create Korean generics joint venture

Generics/News | Posted 24/01/2013

Canadian generics maker Pharmascience and Korea-based Kolmar Holdings (Kolmar) announced on 2 January 2013 that they had entered into an agreement to create a new joint venture, Pharmascience Korea, for the marketing of Canadian-made bioequivalent medicines.

Brand-name and generics labels don’t match

Generics/Research | Posted 18/01/2013

According to US federal law generics manufacturers have to have the same labelling as their brand-named counterparts. However, a new study has found that in practice this is often not the case.

Watson submits ANDA for generic cancer drug

Generics/News | Posted 18/01/2013

Watson Pharmaceuticals confirmed on 28 December 2012 that Actavis, which was acquired by Watson in October 2012, has filed an Abbreviated New Drug Application (ANDA) with FDA seeking approval to market generic bortezomib. Actavis’ ANDA product is a generic version of Millennium Pharmaceuticals’ (Millennium) cancer drug Velcade (bortezomib).