Generics

Mylan debuts first generic Diovan HCT and Antivert in USA

Generics/News | Posted 12/10/2012

Mylan is first off the mark once again with its latest generics launch. Mylan announced on 21 September 2012 that its subsidiary Mylan Pharmaceuticals has received final approval from FDA for its Abbreviated New Drug Application (ANDA) for valsartan/hydrochlorothiazide tablets USP.

Generics applications under review by EMA

Generics/General | Posted 05/10/2012

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].

Bayer loses Nexavar compulsory licence appeal

Generics/News | Posted 05/10/2012

Bayer has lost its appeal to the Indian Government’s decision to grant a compulsory licence for its cancer drug Nexavar (sorafenib).

Suggestions for increasing generics use in Abu Dhabi

Generics/Research | Posted 05/10/2012

This concluding article in a series of three suggests ways of improving the use of generics in Abu Dhabi.

Use of generics in Abu Dhabi

Generics/Research | Posted 21/09/2012

The second of three articles examining how to increase generics use in Abu Dhabi.

Canada takes another step towards generics

Generics/General | Posted 21/09/2012

For the first time, two of Canada’s biggest health insurance companies are going to require that generics be prescribed if one is available.

Hospira acquires manufacturing, R & D facilities in India

Generics/News | Posted 21/09/2012

On 29 August 2012, US-based Hospira announced an agreement to acquire an API (active pharmaceutical ingredient) manufacturing facility, together with an associated research and development (R & D) facility, from Orchid Chemicals & Pharmaceuticals. The modern, FDA-approved facility is costing approximately US$200 million. Acquisition of this leading Indian pharmaceuticals company is expected to reduce Hospira’s costs, support continuity of supply of key antibiotic products and pave the way for future API development [1].

Maximising the potential of generics in Abu Dhabi

Generics/Research | Posted 14/09/2012

Introduction
All residents in Abu Dhabi have access to health care via mandatory health insurance. Nationals, who comprise 20% of the population with two-thirds under 30 years of age and half under 19 years of age, have automatic access to comprehensive health care funded by the government. In 2008, all nationals received cards giving free access to health care and choice of provider in both the public and private sectors [1].

Mylan generics launches in the US

Generics/News | Posted 14/09/2012

Mylan has 166 abbreviated new drug applications (ANDAs) pending Food and Drug Administration approval representing US$78.4 (Euros 61.3) billion in annual sales. Thirty-five of these are potential first-to-file opportunities, representing US$25.1 (Euros 19.6) billion in annual brand sales (2011 IMS Health figures).

Poor quality pharma ingredients abound in China

Generics/General | Posted 14/09/2012

Lack of regulatory enforcement in China is allowing poor quality pharmaceutical ingredients to be sold to drug manufacturers with potentially dangerous or even fatal consequences for patients.

Impax settles patent dispute with Genzyme

Generics/News | Posted 14/09/2012

Impax Laboratories (Impax) announced on 4 September 2012 that it had reached an agreement with Sanofi subsidiary, Genzyme Corporation (Genzyme), to settle pending US litigation with regard to the production and sale of generic versions of Renvela (sevelamer carbonate) and Renagel (sevelamer hydrochloride).

Austria could save Euros 256 million by using more generics

Generics/General | Posted 07/09/2012

A recent study by IMS Health Austria (IMS) revealed that in Austria healthcare payers could have saved more than a quarter billion Euros during 2011 if physicians would have prescribed more generics to their patients.

Misunderstandings regarding generics in Pakistan

Generics/Research | Posted 07/09/2012

This article is the third of three articles covering the results of a survey investigating the knowledge, perception and attitude of general practitioners (GPs) towards generic medicines in Karachi, Pakistan [1].

Injectables may be next on Big Pharma shopping list

Generics/News | Posted 07/09/2012

The injectables division of Indian pharmaceutical company Strides Arcolab (Strides), known as Agila, is becoming an increasingly attractive potential acquisition for Big Pharma who are looking to expand their portfolios. Strides, based in Bangalore, may already be considering selling Agila, which produces a range of injectable generic medicines for the treatment of cancer and infections, with Pfizer as one possible purchaser.

Pfizer reaches agreement with Impax over generic Detrol

Generics/News | Posted 07/09/2012

Pfizer has reached an agreement with Impax Laboratories (Impax) over the production and marketing of a generic drug alternative to the bladder-control treatment Detrol LA (tolterodine tartrate). The two companies have ‘settled a patent lawsuit’ based on a licence agreement dated 16 August 2012 that prohibits Impax from selling generic versions of Detrol LA ‘except as permitted under the settlement and license agreement.’

Coupons help Big Pharma to fend off generics

Generics/General | Posted 07/09/2012

Pfizer’s success at using co-pay coupons to prevent patients switching from brand-name products to generics is encouraging other pharmaceutical giants to follow suit.

Wockhardt gains approvals for ‘steady stream’ of generics

Generics/News | Posted 07/09/2012

Wockhardt has won FDA approval for four generics products in a matter of days. On 16 August 2012, the India-based company announced the final approval and immediate product launch of the anti-blood clotting drug clopidogrel bisulfate in 75 mg tablet form, and tentative approval for 300 mg-containing tablets.

Facts about generics for patients

Generics/Research | Posted 24/08/2012

The costs of health care are rising across Europe through ageing populations resulting in more patients with chronic diseases, stricter clinical targets for managing patients with long term (chronic) diseases, the continued launch of new and more expensive drugs as well as rising patient expectations.

Attitude of general practitioners towards generics in Pakistan

Generics/Research | Posted 24/08/2012

The second of a series of three articles reports on a survey aimed at exploring the knowledge, perception and attitude of general practitioners towards generic medicines in Karachi, Pakistan [1].

FDA approval for generic diabetes drug Actos

Generics/News | Posted 24/08/2012

On 17 August 2012, FDA gave final approval to Mylan Pharmaceuticals for the first generic version of Actos (pioglitazone hydrochloride tablets), for the treatment of type 2 diabetes. The approval covers tablets containing 15 mg, 30 mg and 45 mg pioglitazone.