Generics

Impact of coupons on adherence to statins

Generics/Research | Posted 14/02/2014

Once patents expire, in an effort to maintain market share, originator manufacturers often initiate promotional activities such as drug samples and co-pay discount coupons that reduce patients out-of-pocket costs associated with the purchase of brand-name drugs.

Effects of income, competition and procurement on drug prices in emerging markets

Generics/Research | Posted 07/02/2014

Drugs are least affordable relative to income in low-income countries, according to an analysis of income, competition and procurement on drug prices in emerging markets [1].

Forest Labs files lawsuit to stop generic memantine

Generics/News | Posted 07/02/2014

Forest Laboratories and Forest Laboratories Holdings (Forest) announced on 31 January 2014 that the company has filed a lawsuit in the US against several generics makers for their generic versions of Forest’s blockbuster Alzheimer’s disease treatment Namenda XR (memantine).

Access to medicines in Shaanxi province China

Generics/Research | Posted 31/01/2014

Although generics in the Shaanxi province of China are significantly cheaper than their brand-name equivalents there is still room for improvement, according to a study of the prices and availability of selected medicines in the province [1].

Generics game changer for Ireland

Generics/General | Posted 31/01/2014

A new pharmacy in Dublin, Ireland, is offering customers savings of up to 80% on the price of drugs by focussing on generics. The news comes in light of legislation passed by both houses of Ireland’s parliament in May 2013, which encourages wider use of generics and generics substitution [1].

Switching to generic cyclosporine A after heart transplant safe

Generics/Research | Posted 24/01/2014

Cyclosporine A is an immunosuppressant drug widely used in organ transplantation to prevent rejection. A study of switching between originator and generic drugs showed that the generic was well tolerated and that there were no differences between the originator and generic drugs [1].

FDA issues Ranbaxy with Form 483 for violations at Toansa plant

Generics/News | Posted 24/01/2014

Ranbaxy Pharmaceuticals (Ranbaxy) is coming under scrutiny from US Food and Drug Administration (FDA) once again. One of the company’s key Indian facilities at Toansa, Punjab, has been issued a Form 483 by FDA.

ANI Pharmaceuticals acquires 31 generics from Teva

Generics/News | Posted 17/01/2014

US-based brand-name and generics manufacturer ANI Pharmaceuticals (ANI) announced on 26 December 2013 that it had acquired 31 previously marketed generic drugs from Teva Pharmaceutical Industries (Teva).

Sandoz gains Danish approval for innovative asthma inhaler

Generics/News | Posted 10/01/2014

Sandoz, the generics unit of Swiss pharma giant Novartis, announced on 18 December 2013 that it had received Danish marketing authorization for AirFluSal Forspiro, a novel inhaler for patients with asthma and/or chronic obstructive pulmonary disease (COPD).

Generics applications under review by EMA – 2013 Q4

Generics/General | Posted 10/01/2014

Last update: 20 January 2014

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].

First generics of Cymbalta approved by FDA

Generics/News | Posted 10/01/2014

The US Food and Drug Administration (FDA) announced on 11 December 2013 that it had approved the first generic versions of duloxetine delayed-release capsules, a prescription medicine used to treat depression and other conditions.

Recent reforms and initiatives in Scotland to encourage the prescribing of generic drugs and the implications

Generics/Research | Posted 13/12/2013

Scotland has introduced a number of reforms and initiatives in recent years to enhance the prescribing of low cost generics, thereby saving money to help fund increased volumes and new premium priced drugs [1, 2]. However, there have been situations where no specific initiatives have been introduced [3, 4]. Consequently, analysis of the various initiatives in Scotland could provide examples to other countries seeking additional measures to further enhance their prescribing efficiency.

Sandoz makes deal with Shire for authorized Adderall XR generic

Generics/News | Posted 13/12/2013

Shire announced on 2 December 2013 that its subsidiary Shire US had entered into an agreement to supply an authorized generic version of its attention deficit hyperactivity disorder (ADHD) drug Adderall XR (amphetamine, dextroamphetamine mixed salts) to Sandoz.

Understanding pharmaceutical expenditure

Generics/Research | Posted 06/12/2013

In the previous three articles by Vogler and co-authors price and volume components of pharmaceutical expenditure were discussed. In the final article of the series, some of the methodological challenges that can be faced in interpreting and analysing expenditure data are addressed and the challenges faced by the authors’ own survey of pharmaceutical expenditure data across European Union Member States are discussed [1].

Rising generics use triggers increased worldwide regulation

Generics/General | Posted 06/12/2013

The increasing use of lower cost generics is prompting regulators across the globe to introduce stricter regulations focusing on the quality of these products.

Hikma makes deal to enhance delivery of generic injectables

Generics/News | Posted 06/12/2013

Hikma Pharmaceuticals (Hikma) announced on 20 November 2013 that it had signed a long-term commercial supply contract with Unilife Corporation (Unilife) for the use of Unifill pre-filled syringes with a range of generic injectable drugs.

Volume components of pharmaceutical expenditure

Generics/Research | Posted 29/11/2013

In the third of a series of four articles on pharmaceutical expenditure, Vogler and co-authors explain the different methodological approaches to measuring pharmaceutical utilization and outline some of the volume-control policies in place across Europe [1].

FDA approves first rabeprazole generics for treatment of GERD

Generics/News | Posted 29/11/2013

On 8 November 2013, the US Food and Drug Administration (FDA) announced that the agency had approved the first generics of Aciphex (rabeprazole) delayed-release tablets, used to treat gastroesophageal reflux disease (GERD) in adults and adolescents (ages 12 and up).