Generics/General
Southeast Asian generics market to reach US$3.9 billion by 2016
Southeast Asia, with its fast-growing, young population and uninsured majority represent a great opportunity for generics in the pharmaceutical industry, according to Rhett Hemedes, Head of OTC Marketing, Great Eastern Drug Co.
FDA increases generic drug user fees in 2014
FDA has increased the amount that generics manufacturers will have to pay to register their finished drug formulation (FDF) facilities by more than US$40,000 for 2014 compared to 2013.
Indian generics companies top ANDA approvals
Indian generics companies are beating many other countries when it comes to gaining US FDA approval for their generic drugs.
Generics applications under review by EMA – 2013 Q1
Last update: 6 September 2013
Generic medicines in Europe can be approved either centrally via the European Medicines Agency (EMA) or nationally via the local regulatory body [1]. Approval by EMA takes place by using a centralized procedure. This leads to approval of the product in all 27 EU member states and in Norway, Iceland and Liechtenstein. At a country level, if approval in a single EU Member State only is required, this can take place using the national procedure. However, as soon as a company seeks approval in two or more Member States, a decentralized procedure or mutual recognition procedure must be used [2].
Generics applications under review by EMA – 2012 Q4
Last update: 6 September 2013
Generic medicines in Europe can be approved either centrally via the European Medicines Agency (EMA) or nationally via the local regulatory body [1]. Approval by EMA takes place by using a centralized procedure. This leads to approval of the product in all 27 EU member states and in Norway, Iceland and Liechtenstein. At a country level, if approval in a single EU Member State only is required, this can take place using the national procedure. However, as soon as a company seeks approval in two or more Member States, a decentralized procedure or mutual recognition procedure must be used [2].
Generics applications under review by EMA
Last update: 6 September 2013
Generic medicines in Europe can be approved either centrally via the European Medicines Agency (EMA) or nationally via the local regulatory body [1]. Approval by EMA takes place by using a centralized procedure. This leads to approval of the product in all 27 EU member states and in Norway, Iceland and Liechtenstein. At a country level, if approval in a single EU Member State only is required, this can take place using the national procedure. However, as soon as a company seeks approval in two or more Member States, a decentralized procedure or mutual recognition procedure must be used [2].
Lipitor generics saved UK NHS £350 million in first 12 months
Generics of the blockbuster cholesterol-lowering drug Lipitor (atorvastatin) saved the UK’s National Health Service (NHS) more than GBP 350 million in the first 12 months following the expiration of Pfizer’s patent exclusivity.
The biggest drug patent losses for 2013
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.
Indian FDA wants to increase use of generics
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.
FDA is dragging its feet over oxycodone generics
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.
