Generics

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).

FDA awards grant to study generic transplant drug tacrolimus

Generics/Research | Posted 22/11/2013

The US Food and Drug Administration (FDA) has awarded a federal grant worth US$2.3 million to researchers at the University of Cincinnati, Ohio, USA, in order to continue studies into tacrolimus, a drug commonly used to stop rejection in transplant patients.

First generic 30 mg Focalin XR capsules approved

Generics/News | Posted 22/11/2013

On 18 November 2013, Mylan Pharmaceuticals announced the launch of generic dexmethylphenidate hydrochloride extended-release (ER) capsules, 30 mg.

Price components of pharmaceutical expenditure

Generics/Research | Posted 15/11/2013

In the second of a series of four articles on pharmaceutical expenditure, Vogler and co-authors take a top down approach to the concept of pharmaceutical expenditure and its use as an indicator in healthcare accounting. Here, they look at the differences in outpatient and inpatient price types [1].

Ranbaxy sues Actavis over generic acne drug

Generics/News | Posted 15/11/2013

Indian generics giant Ranbaxy Laboratories (Ranbaxy) is suing US generic drugmaker Actavis to try to stop the latter marketing a generic version of Ranbaxy’s acne drug Absorica (isotretinoin).

Pharmaceutical expenditure as a health-expenditure indicator

Generics/Research | Posted 08/11/2013

Pharmaceutical expenditure is a major indicator in health-expenditure accounting, and is particularly useful to policymakers and researchers in making regional, country and international comparisons, forecasting, and assessing the effect of pharmaceutical policies [1].

South African HCPs told to ‘get their facts straight’ on generics

Generics/General | Posted 08/11/2013

The South African National Association of Pharmaceutical Manufacturers (NAPM) urged healthcare professionals (HCPs) to ‘get their facts straight’ with respect to generics at a special workshop held at the Johannesburg Country Club on 17 October 2013.

Good news for Ranbaxy plant in US

Generics/News | Posted 08/11/2013

Ranbaxy Laboratory’s (Ranbaxy) US-based plant, Ohm Laboratories (Ohm), has successfully passed an FDA inspection, according to an announcement on the generic drugmaker’s website.

Canada-EU trade deal will extend patents for two years

Generics/General | Posted 31/10/2013

On 18 October 2013, Canada and the European Union (EU) reached agreement on a trade deal, which will free the movement of goods, services, investment and labour between the two regions, but has been criticized by generics makers for delaying access to medicines.

FDA approves generic tobramycin inhalation solution

Generics/News | Posted 31/10/2013

Teva Pharmaceutical Industries (Teva) announced on 14 October 2013 that the US Food and Drug Administration (FDA) had granted approval for its abbreviated new drug application (ANDA) for tobramycin inhalation solution.

Making generics of Advair could be difficult

Generics/News | Posted 25/10/2013

GlaxoSmithKline’s (GSK) fears of generics competition for its chronic obstructive pulmonary disorder treatment Advair (fluticasone/salmeterol) may be unfounded according to generics manufacturer Teva Pharmaceutical Industries (Teva).

US court paves way for Nexium competition

Generics/News | Posted 18/10/2013

AstraZeneca announced on 2 October 2013 that the US Court of Appeals for the Federal Circuit had lifted a temporary injunction against the US launch of Hanmi Pharmaceutical’s (Hanmi’s) esomeprazole strontium product.

Forest initiates lawsuits over generic Savella

Generics/News | Posted 18/10/2013

Forest Laboratories and Forest Laboratories Holdings (Forest) announced that Forest and Royalty Pharma Collection Trust (Royalty Pharma) are suing several generics manufacturers regarding generics of Savella (milnacipran).

Australians pay too much for generics

Generics/General | Posted 11/10/2013

According to the Consumers Health Forum of Australia (CHF), a body which represents healthcare consumers, Australians are paying way too much for their generic drugs.

FDA approves generic version of cancer drug

Generics/News | Posted 11/10/2013

FDA announced on 16 September 2013 that it had approved Teva Pharmaceutical Industries (Teva’s) generic version of Roche’s cancer drug Xeloda (capecitabine).