Generics

Alzheimer generic launched in the US

Generics/News | Posted 28/08/2015

Indian generics giant Dr Reddy’s Laboratories announced on 13 July 2015 the launch of generic memantine hydrochloride tablets in dosages of 5 and 10 mg, following approval of the company’s abbreviated new drug application (ANDA) by the US Food and Drug Administration (FDA).

Generic Parkinson’s drug hits US market

Generics/News | Posted 21/08/2015

Indian generics giant Dr Reddy’s Laboratories announced on 12 August 2015 that it had launched generic pramipexole dihydrochloride extended-release tablets in dosages of 0.375, 0.75, 1.5, 3 and 4.5 mg, following approval of the company’s abbreviated new drug application by the US Food and Drug Administration on 7 August 2015.

ANI Pharmaceuticals acquires 22 generics from Teva

Generics/News | Posted 14/08/2015

US-based brand-name and generics manufacturer ANI Pharmaceuticals (ANI) announced on 13 July 2015 that it had acquired 22 previously marketed generics from Teva Pharmaceutical Industries (Teva).

Proposals to lessen the shortage of essential cancer drugs, generics and biosimilars in the US and the world

Generics/Research | Posted 07/08/2015

Essential cancer and supportive drug shortage in the US seriously affects cancer care, and increases cost pressure on the health system. These drugs are mostly off-patent generics. Collaborative efforts of FDA, pharmacists, physicians and pharmaceutical companies slightly improve this problem. However, these measures are partial. For an issue of multiple complexities there is no single magic stick that could solve it. The underlying economic issues and lack of incentives for production need to be addressed to arrive at innovative and permanent solutions for this multifactorial problem [1, 2].

Generic bivalirudin approved in US

Generics/News | Posted 07/08/2015

US-based injectables and biosimilars specialist Hospira announced on 16 July 2015 the approval of its abbreviated new drug application (ANDA) for generic bivalirudin for injection by the US Food and Drug Administration (FDA).

Effect of price caps and reference pricing on generics entry

Generics/Research | Posted 31/07/2015

In a study carried out by Brekke and co-authors on the impact of price caps in combination with reference pricing on generics entry was investigated [1].

Actavis hit with lawsuit over generic version of weight-loss drug

Generics/News | Posted 31/07/2015

US-based obesity specialist Orexigen Therapeutics (Orexigen) and its North American partner, Takeda Pharmaceuticals (Takeda), have sued Actavis (Allergan’s US generics business) over its generic version of the weight-loss drug Contrave (naltrexone/bupropion).

Effect of co-insurance and reference pricing on generics entry

Generics/Research | Posted 03/07/2015

To study the impact of reference pricing on generics entry Brekke and co-authors developed a novel Salop-type model where a brand-name producer competes with several generics makers in terms of prices [1].

Indian pharma industry to get government support

Generics/General | Posted 03/07/2015

In a bid to promote the manufacture of pharmaceuticals in the country, the Indian Government has announced plans to set up a Rs 500-crore venture capital fund to provide cheaper loans to firms looking to establish or upgrade manufacturing facilities.

Mylan launches generic asthma inhaler in UK

Generics/News | Posted 03/07/2015

US generics manufacturer Mylan announced on 8 June 2015 that it had launched the first bioequivalent alternative to GlaxoSmithKline (GSK)’s asthma inhaler Seretide/Advair (fluticasone/salmeterol) in the UK.

Effect of reference pricing on generics entry

Generics/Research | Posted 26/06/2015

Reference pricing can produce substantial savings, but what conditions are the most likely to result in cost savings? This was a question addressed by Brekke and co-authors from the University of Minho in Portugal in their Working Paper [1].

Generics of ADHD drug launched in US

Generics/News | Posted 26/06/2015

Shire Pharmaceutical’s (Shire’s) blockbuster attention deficit hyperactivity disorder (ADHD) drug Intuniv is now facing competition as four generics of the therapy have been launched on the US market.

Malaysian physicians have negative perceptions of generics

Generics/Research | Posted 12/06/2015

A study investigating the knowledge, perceptions and behaviour of physicians from private medical centres in Malaysia regarding generics found that the majority of physicians had negative perceptions about the safety, quality and efficacy of generics [1].

Osteoporosis and ADHD generics launched in USA

Generics/News | Posted 12/06/2015

On 1 and 2 June 2015, Israeli generics giant Teva Pharmaceutical Industries (Teva), launched its latest osteoporosis and ADHD generics, respectively.

Drug evergreening strategies in India

Generics/Research | Posted 05/06/2015

A study of drug patent evergreening in India found that this is a strategy that has been used by manufacturers of a particular drug to restrict or prevent competition from manufacturers of generic equivalents. It is also a strategy still being used in India despite the efforts of Section 3(d) of the Indian Patent Act to curb such practices [1].

Generics applications under review by EMA – April 2015

Generics/General | Posted 05/06/2015

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 28 European Union (EU) Member States and in Iceland, Liechtenstein and Norway. 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 receives application for first generic of HIV drug dolutegravir

Generics/News | Posted 05/06/2015

India-based Aurobindo Pharma (Aurobindo) has submitted an abbreviated new drug application (ANDA) for HIV treatment dolutegravir for tentative approval, to the US Food and Drug Administration (FDA).

Physicians’ perceptions of HIV generics in France

Generics/Research | Posted 29/05/2015

A study of French physicians in HIV clinics found that, while the majority of these physicians were willing to prescribe antiretroviral generics, a quarter of physicians were openly opposed to antiretroviral generics [1].