General

During 2012–2018 over US$290 billion of sales are at risk from patent expirations.  In fact, in 2013 alone patents will expire on drugs with yearly sales of US$29 billion. Generics are expected to grab 70% of those sales.

The Commissioner of Indian Food and Drug Administration (FDA) has denied allegations by physicians and pharmacists in India that the bioavailability of generic drugs is doubtful.

Last update:  29 April 2013 

Generic medicines in Europe can be approved either centrally via EMA or nationally via the local regulatory body [1]. Approval via EMA can take place by using a centralised procedure, decentralised procedure or mutual recognition procedure [2].

The US patent for Purdue Pharma’s (Purdue’s) blockbuster painkiller OxyContin (oxycodone) expired on 16 April 2013, but FDA has yet to approve any generic versions. Now, FDA has announced that it will not approve any generics of the original formulation OxyContin.

The Australian Generic Medicines Industry Association (GMiA) and the Pharmacy Guild of Australia announced on 22 March 2013 the launch of a joint initiative: Why choose generic medicines?

The Indian Government, in a move that goes away from recent decisions, has suggested that the prices of patented pharmaceutical drugs be controlled by linking them to the country’s per capita income rather than by issuing compulsory licences.

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.

Last update:  18 January 2013 

Generic medicines in Europe can be approved either centrally via EMA or nationally via the local regulatory body [1]. Approval via EMA can take place by using a centralised procedure, decentralised procedure or mutual recognition procedure [2].

The French are in general mistrusting of generics with many choosing to stay with brand-name drugs. However, with rising healthcare costs and austerity measures hitting healthcare budgets, the French Government has had to introduce measures to increase generic drug use in the country.

Indian industry trade group the Associated Chambers of Commerce and Industry of India (ASSOCHAM) has urged the Indian Government to drop its cost-based price controls on both brand-name and generic drugs and instead introduce a market-based pricing policy.