Generics

Overview of clinical research on generics in 2012

Generics/Research | Posted 09/11/2012

Period: January to August 2012

Generic drug alternatives to brand-name prescription medications are becoming increasingly important in the global drug market as governments strive to contain healthcare costs and as an increasing number of prescription drugs lose patent protection.

FDA ordered to let Watson sell generic Actos

Generics/News | Posted 09/11/2012

Watson Pharmaceuticals (Watson) has finally won its legal battle to be able to sell a generic version of Takeda Pharmaceutical’s diabetes drug Actos (pioglitazone hydrochloride). A US judge ordered FDA to approve Watson’s generic pioglitazone against the agency’s decision to bar Watson during the first six months of generics availability.

Momenta versus Amphastar and the safe harbour provision

Generics/General | Posted 26/10/2012

On 3 August 2012, the US Federal Circuit issued a decision holding that the safe harbour* provision of the Hatch-Waxman Act 35 U.S.C. § 271(e)(1) covers post-approval testing as long as it is ‘reasonably related’ to the submission of information to FDA. The case involved was that of Momenta Pharmaceuticals (Momenta) versus Amphastar Pharmaceuticals (Amphastar) (Federal Circuit No. 2012-1062, 8/3/12).

Mylan sues FDA over Ranbaxy’s generic Diovan exclusivity

Generics/News | Posted 26/10/2012

US-based Mylan has sued FDA for refusing to grant approval to sell a generic version of Novartis’s heart treatment, Diovan HCT (valsartan/hydrochlorothiazide), ‘after a competitor failed to get the drug on the market in time’.

Teva withdraws generic antidepressant from US

Generics/News | Posted 19/10/2012

Israel-based Teva Pharmaceutical Industries (Teva), the world’s largest generics manufacturer, has removed its Budeprion XL 300 mg generic version of GlaxoSmithKline’s antidepressant Wellbutrin XL (bupropion) from the US market after regulators said it is not therapeutically equivalent to Wellbutrin XL 300 mg.

FDA gives generics greater importance

Generics/General | Posted 12/10/2012

The Office of Generic Drugs has been promoted to the highest position within FDA because of the great amount of work and income/expenditure now associated with 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.