Generics

Actavis submits generic dalfampridine ANDA

Generics/News | Posted 08/08/2014

Acorda Therapeutics (Acorda), announced on 26 June 2014 that it had received a Paragraph IV Certification Notice Letter advising the company that Actavis Laboratories (Actavis) had submitted an abbreviated new drug application (ANDA) to the US Food and Drug Administration (FDA) for the approval of a generic version of the company’s multiple sclerosis drug, Ampyra (dalfampridine).

Data protection provisions in CETA

Generics/Research | Posted 01/08/2014

The trade agreement between the European Union (EU) and Canada has the potential to have a negative affect on the generics industry in Canada [1]. In particular, certain intellectual property provisions are seen as the main culprits.

Generic valsartan approved in US

Generics/News | Posted 01/08/2014

India’s largest generics maker Ranbaxy Laboratories announced on 27 June 2014 that its subsidiary, US-based Ohm Laboratories (Ohm), had received approval from the US Food and Drug Administration (FDA) for generic valsartan.

India planning to extend pricing control to more drugs

Generics/General | Posted 01/08/2014

India is thought likely to increase the number of drugs it considers ‘essential’ and therefore for which it controls the maximum retail price in the country.

Patent term restoration provisions in CETA

Generics/Research | Posted 04/07/2014

Some of the provisions included in the Comprehensive Economic and Trade Agreement (CETA) between the European Union (EU) and Canada are seen as having the potential to have a negative affect on the generics industry in Canada [1].

Teva settles patent litigation over ProAir HFA

Generics/News | Posted 04/07/2014

The world’s biggest generics maker, Teva Pharmaceutical Industries (Teva), announced on 20 June 2014 that it had reached a settlement with Perrigo Pharmaceutical (Perrigo) and Catalent Pharma Solutions (Catalent) with respect to Teva’s respiratory product ProAir HFA (albuterol sulfate).

Influence of CETA on generics

Generics/Research | Posted 27/06/2014

On 18 October 2013, the European Union (EU) and Canada reached a political agreement on the key elements for a Comprehensive Economic and Trade Agreement (CETA). However, CETA has been criticized for the fact that it affects intellectual property rights in Canada, but not the EU. Some of the provisions included in the agreement are seen as having the potential to have a negative affect on the generics industry in Canada.

Factors influencing use of generic asthma drugs in Morocco

Generics/Research | Posted 20/06/2014

Despite the introduction of methods to promote the use of generics, use of generic anti-asthmatic drugs remains limited in Morocco. The Moroccan market therefore remains largely dominated by patent-protected originator drugs [1].

Actavis settles Nuvigil patent litigation, challenges Onglyza patent

Generics/News | Posted 20/06/2014

US generics major Actavis has settled patent litigation related to Actavis’ generic version of Nuvigil (armodafinil) and confirmed its generic Onglyza (saxagliptin) patent challenge.

Promoting generics prescribing in the UK

Generics/Research | Posted 13/06/2014

Possible ways to encourage more prescribing of generics in the UK include financial incentives with educational intervention and audit/feedback, according to a review of data on prescribing behaviour [1].

European regulators give green light to Ranbaxy plant

Generics/General | Posted 13/06/2014

In what comes as good news for generics maker Ranbaxy, European Regulators have cleared the company’s Toansa plant.

First generic celecoxib approved by FDA

Generics/News | Posted 13/06/2014

The US Food and Drug Administration (FDA) announced on 30 May 2014 that it had approved the first generic versions of celecoxib capsules.

Impact of price cuts on spending on hyperlipidaemic drugs in South Korea

Generics/Research | Posted 06/06/2014

Rapidly increasing pharmaceutical expenditures have become a constant challenge to the sustainability of healthcare systems across countries including Korea.

Sun Pharma’s Gujarat site under FDA import alert

Generics/News | Posted 06/06/2014

Sun Pharmaceutical Industries’ (Sun Pharma) response to the US import ban on products produced at the company’s Gujarat site is inadequate, according to a warning letter issued by the US Food and Drug Administration (FDA) on 7 May 2014.

Generic atypical antipsychotic drugs in Belgium

Generics/Research | Posted 02/06/2014

Health authorities are continually looking to increase the utilization of low cost generics to save considerable monies without compromising care, given the ever increasing pressure on available resources. Pressures are driven by ageing populations, the continual launch of new premium-priced drugs and stricter clinical management targets. The quest is enhanced by the number of standard drugs losing their patents in recent years.