Generics

Innovation in the generics industry

Generics/Research | Posted 10/05/2013

The decrease in innovation in the originator pharmaceutical industry is leading to an increase in innovation in the generics pharmaceutical industry, according to new research [1].

Indian FDA wants to increase use of generics

Generics/General | Posted 03/05/2013

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.

Actavis makes agreement for generic abuse-deterrent oxycodone

Generics/News | Posted 03/05/2013

US generics maker Actavis (formerly Watson) announced on 26 April 2013 that it had reached an agreement with Purdue Pharma (Purdue) to settle all outstanding patent litigation related to Actavis’ generic version of Purdue’s abuse-deterrent formulation of OxyContin (oxycodone).

Quality of generics in South Africa

Generics/Research | Posted 29/04/2013

A study of the quality of generic medicines in South Africa has shown large differences in the perception and the actual quality of generics [1].

Daiichi Sankyo and Ranbaxy announce synergy in Brazil

Generics/News | Posted 29/04/2013

India-based Ranbaxy Laboratories (Ranbaxy) and its Japanese parent company Daiichi Sankyo announced on 17 April 2013 plans to integrate their generic and brand-name drug business operations in Brazil.

Generics applications under review by EMA – 2013 Q1

Generics/General | Posted 29/04/2013

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].

FDA is dragging its feet over oxycodone generics

Generics/General | Posted 19/04/2013

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.

Mylan gains approval for generic of Valeant’s Zovirax

Generics/News | Posted 19/04/2013

Generics giant Mylan announced on 3 April 2013 that its subsidiary Mylan Pharmaceuticals had received final approval from FDA for its abbreviated new drug application (ANDA) for acyclovir ointment 5%.

AstraZeneca settles rosuvastatin lawsuit

Generics/News | Posted 19/04/2013

UK-based AstraZeneca announced on 25 March 2013 that it had entered into a deal concerning US patent infringement litigation against Actavis (formerly known as Watson Pharmaceuticals) and EGIS Pharmaceuticals with respect to Actavis’ generic rosuvastatin zinc product.

Cost savings from use of generic medicines in Ireland

Generics/Research | Posted 12/04/2013

Ireland has one of the lowest usages of generics in the EU. However, in order to try to address this, the country introduced a new bill – Health (Pricing and Supply of Medical Goods) Bill 2012 – on 16 September 2012. Authors Dunne et al. discuss how the proposed changes could affect health care in Ireland [1].

New entrant to generic injectables market

Generics/News | Posted 12/04/2013

Medical technology company Becton Dickinson announced on 28 March 2013 that FDA had approved the first drug in its line of prefilled generic injectables. This can only be good news for FDA who has been fighting to alleviate drug shortages in the US, most of which are due to shortages in generic sterile injectables.

Mylan launches generics and reaches settlement over metformin

Generics/News | Posted 05/04/2013

Generics giant Mylan has launched generic versions of fenofibrate capsules, cidofovir injection and levalbuterol. The company has also resolved patent litigation with Shionogi and Andrx related to metformin.

Why choose generic medicines initiative launched in Australia

Generics/General | Posted 29/03/2013

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?

Use of generic medicines in Ireland

Generics/Research | Posted 29/03/2013

Ireland’s Department of Health and Children intends to introduce a system of reference pricing and generics substitution in Ireland, which will greatly increase the utilization of generics and generate significant cost savings, whilst at the same time, increasing the accessibility and affordability of essential medicines. Authors Dunne et al. discuss Ireland’s history with the use of generic medicines [1].

Changes in risperidone use in Austria after introduction of generics

Generics/Research | Posted 22/03/2013

Currently, many governments have introduced austerity reforms to control pharmaceutical expenditure. In Austria, efforts have been made to both increase the use and lower the prices of generics. The problem is that antidepressants are not like other drugs, such as cholesterol-reducing medicines, where switching from originators to generics is not seen as a problem. For antidepressants the patient’s treatment is often tailored to meet their specific needs and there is resistance to switch products in stable patients.

Actavis confirms generic Alzheimer’s patch patent challenge

Generics/News | Posted 22/03/2013

US generics maker Actavis (formerly Watson) confirmed on 8 March 2013 that it had filed with FDA an amendment to its abbreviated new drug application (ANDA) for rivastigmine transdermal system to include the 13.3 mg/24 hr dosage strength. Actavis’ product is a generic version of Novartis’ Exelon Patch, which is used to treat people with mild to moderate dementia associated with Alzheimer’s or Parkinson’s disease.

Use of venlafaxine in Austria after introduction of generics

Generics/Research | Posted 15/03/2013

Trying to reduce expenditure on medicine is a major driving force for reforms by many governments. This includes Austria, where measures have been introduced to lower generics prices and enhance their use. However, the situation for newer antidepressants and atypical antipsychotic medicines (AAPs) is different to proton pump inhibitors (PPIs) (anti-reflux), statins (cholesterol-reducing), and renin-angiotensin inhibitor (blood-pressure reducing) drugs. For antidepressants therapy, it is more often tailored to meet the patient’s needs and there is resistance to switch products in stable patients.

India may move away from compulsory licensing

Generics/General | Posted 15/03/2013

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.