Generics
Gilead makes HIV generics deal
US-based drugmaker Gilead Sciences (Gilead) announced on 2 August 2012 a new collaboration with Indian generics manufacturers to provide low cost HIV medicine to developing countries.
Ranbaxy forfeits exclusivity on generic Provigil
As part of Ranbaxy’s consent decree with FDA, signed in January 2012, the Indian generics major had to agree to relinquish 180-day marketing exclusivity on three pending generic drug applications [1]. Now analysts believe that generic Provigil (modafinil) may have been one of those undisclosed drugs.
Canada grapples with drugs costs
Government report calls for the widening of the current scheme for brand-name medicines to include generics.
FDA approves generics of Merck’s Singulair
FDA announced on 3 August 2012 that the agency had approved not one, but ten generic versions of Merck’s blockbuster asthma-allergy drug Singulair (montelukast).
Pfizer wins against generic versions of pain drug Lyrica
The world’s largest drugmaker Pfizer has successfully blocked Israel-based Teva Pharmaceutical Industries (Teva) and other manufacturers from selling generic versions of its fibromyalgia treatment Lyrica (pregabalin) until patents on the drug expire in 2018. The ruling, announced on 19 July 2012, was the result of a lawsuit begun in 2009 contending that sales of generic Lyrica would infringe Pfizer’s patents and cause irreparable harm to sales.
Watson gains FDA approval for morning after pill
US generics company Watson Pharmaceuticals (Watson) announced on 13 July 2012 that its subsidiary Watson Laboratories, has received approval from FDA for its Abbreviated New Drug Application (ANDA) for Next Choice One Dose (levonorgestrel tablet, 1.5 mg), the generic equivalent to Teva Women’s Health’s Plan B One-Step. Watson plans to launch the product immediately.
UK spending on brand-name drugs predicted to reduce
Spending by the UK’s National Health Service (NHS) is under control according to a new report, and in fact spending on brand-name medicines is expected to reduce in real terms and as a proportion of the UK healthcare budget over the next three years.
Generics have their feet under the table in Malaysia
Generics manufacturing, prescribing and sales are becoming firmly part of the scene in Malaysia.
Generics companies turn to ‘third tier’ countries
With pharmaceutical growth in the doldrums in the west, and China and India are becoming increasingly confident, attention is turning to countries such as Indonesia and Turkey.
Is the pharmaceutical industry on the verge of as big a change as we have seen?
‘The old order changeth, yielding place to new’ [1]
For many years the Trade Related Intellectual Property Rights (TRIPS) negotiations have been criticised as being overly protective of the rights of large pharmaceutical companies. ‘It is unacceptable to threaten developing countries aiming to provide medicines to their populations, and disregarding international commitments to ensure access to medicines,’ ran a Médecins sans Frontières statement in 2010. ‘The US is using its trade laws to bully developing countries into applying arbitrary pharmaceutical industry requests at the expense of millions of people who depend on generic medicines in developing countries.’
