Generics
Data protection provisions in CETA
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
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
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
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
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
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
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
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
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
In what comes as good news for generics maker Ranbaxy, European Regulators have cleared the company’s Toansa plant.