Generics

Misunderstandings regarding generics in Pakistan

This article is the third of three articles covering the results of a survey investigating the knowledge, perception and attitude of general practitioners (GPs) towards generic medicines in Karachi, Pakistan [1].

Injectables may be next on Big Pharma shopping list

The injectables division of Indian pharmaceutical company Strides Arcolab (Strides), known as Agila, is becoming an increasingly attractive potential acquisition for Big Pharma who are looking to expand their portfolios. Strides, based in Bangalore, may already be considering selling Agila, which produces a range of injectable generic medicines for the treatment of cancer and infections, with Pfizer as one possible purchaser.

Pfizer reaches agreement with Impax over generic Detrol

Pfizer has reached an agreement with Impax Laboratories (Impax) over the production and marketing of a generic drug alternative to the bladder-control treatment Detrol LA (tolterodine tartrate). The two companies have ‘settled a patent lawsuit’ based on a licence agreement dated 16 August 2012 that prohibits Impax from selling generic versions of Detrol LA ‘except as permitted under the settlement and license agreement.’

Coupons help Big Pharma to fend off generics

Pfizer’s success at using co-pay coupons to prevent patients switching from brand-name products to generics is encouraging other pharmaceutical giants to follow suit.

Wockhardt gains approvals for ‘steady stream’ of generics

Wockhardt has won FDA approval for four generics products in a matter of days. On 16 August 2012, the India-based company announced the final approval and immediate product launch of the anti-blood clotting drug clopidogrel bisulfate in 75 mg tablet form, and tentative approval for 300 mg-containing tablets.

Facts about generics for patients

The costs of health care are rising across Europe through ageing populations resulting in more patients with chronic diseases, stricter clinical targets for managing patients with long term (chronic) diseases, the continued launch of new and more expensive drugs as well as rising patient expectations.

Attitude of general practitioners towards generics in Pakistan

The second of a series of three articles reports on a survey aimed at exploring the knowledge, perception and attitude of general practitioners towards generic medicines in Karachi, Pakistan [1].

FDA approval for generic diabetes drug Actos

On 17 August 2012, FDA gave final approval to Mylan Pharmaceuticals for the first generic version of Actos (pioglitazone hydrochloride tablets), for the treatment of type 2 diabetes. The approval covers tablets containing 15 mg, 30 mg and 45 mg pioglitazone.

Generics in Pakistan

This is the first of a series of three articles on the problems facing Pakistan in making health care affordable to ordinary people.

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.’

More downs than ups for Ranbaxy

A further problem with Indian generics manufacturer Ranbaxy Laboratories (Ranbaxy) could affect its reputation yet again with US FDA. This time, Ranbaxy fell foul of an Indian state regulator, the Maharashtra FDA (FDA, Maharashtra State, India). The Indian crack-down on Ranbaxy follows in the wake of a consent decree issued by US FDA in January 2012 which tightens scrutiny of Ranbaxy’s quality control and reporting measures.

Apotex gains reprieve after Merck loses ruling―but for how long

Toronto-based pharmaceutical firm Apotex has won a stay of execution for its nasal spray generic product after a US District Court in New Jersey, USA, turned down a patent infringement claim by Merck & Co’s Schering-Plough unit.

Generic Adderall XR approved in the US

Shire announced on 23 June 2012 that it had lost its battle to protect its attention deficit hyperactivity disorder (ADHD) drug Adderall XR (amphetamine, dextroamphetamine mixed salts). FDA approved the abbreviated new drug application (ANDA) from Actavis, a unit of US generics company Watson Pharmaceuticals, for the ADHD drug on 22 June 2012.

China follows the Indian and Thai route to affordable drugs

China announced measures for the Compulsory Licensing for Patent Implementation in a statement on 1 May 2012. The country is saying that it intends to become a generics producer for the domestic and possibly the international market.

Management of drugs shortages

The number, range and duration of drug shortages in the US appear to be, at best, maintaining the levels seen in the recent past. It is now becoming essential for institutions to draft formal policies and procedures to manage them. An article by two hospital pharmacists summarises the information available and outlines the steps needed to make the best of the situation [1].

Mylan moving ahead

Three announcements in three days, in four different countries―Mylan is continuing to make progress in generics.

Attitudes and beliefs are powerful influences on generics use

While generic drugs have the potential to provide significant savings in healthcare costs, and numerous financial incentives are in place, the generics substitution rate in Switzerland was, until recently, lower than expected. A report by Decollogny et al. shows that attitudes and beliefs among patients and physicians have a powerful influence on prescribing practice, suggesting that educational campaigns could potentially provide a significant boost to generics use [1].

Which antiplatelet agent? The debate intensifies

Plavix (clopidogrel) has been a blockbuster drug. The lower cost of generic clopidogrel, available for the first time since 17 May 2012 [1], is intensifying debate among cardiologists over how to make sure patients get optimal benefit from any blood-thinning treatment.

Teva won’t sell generic atorvastatin

Teva has decided not to market its own generic version of Lipitor (atorvastatin), Pfizer’s blockbuster cholesterol-lowering drug that recently came off patent. The decision comes despite the fact that FDA granted tentative approval for Teva’s generic version of atorvastatin at the end of 2011. Teva America’s CEO, Mr William Marth told The Economic Times, ‘we’ve made a really hard choice on not launching atorvastatin.’ He forecasts that the decision not to launch certain products such as atorvastatin and simvastatin will cost the firm about US$150 million.

Hospira recalls overfilled hydromorphone hydrochloride vials

Hospira first alerted FDA in April and May 2012 of overfilled cartridges containing morphine and hydromorphone. Subsequent investigation by the company has revealed that as many as 280 batches of 15 different Carpuject pre-filled cartridge products, which were manufactured between June 2010 and February 2012, could have contained more medication than is stated on the label [1].

Efficacy and tolerability of generic and brand-name atorvastatin

A generic formulation of atorvastatin was developed in Korea and approved by Korea Food and Drug Administration on 1 July 2008. This clinical trial was conducted at ten clinical centres in Korea between September 2008 and May 2010 for the purposes of marketing the generic formulation [1].

Increased use of generic statins proves cost effective in Australia

A recent study concluded that closing the statin ‘treatment gap’ using generics was cost-effective in the secondary prevention of coronary artery disease (CAD) in Australia [1].

Generics makers cannot gain access to some brand-name drugs

Generics manufacturers trying to create generics for certain drugs are having problems gaining access to samples of the brand-name drugs due to restrictions on supply put in place by FDA.

Generics sustainability to be investigated by UK DoH and industry

The British Generic Manufacturers Association (BGMA) and the UK Department of Health (DoH) have agreed to work together to investigate potential challenges to the sustainability of the generics industry in the UK.

Clopidogrel goes off-patent: last of the old-style blockbusters

The blockbuster drug Plavix (clopidogrel), used to prevent clotting in some heart patients, comes off patent in the US on 17 May 2012, bringing to an end the run of spectacularly well-selling traditional medicines.

Generic atorvastatin could save NHS GBP 350 million a year

Generics of Pfizer’s blockbuster cholesterol treatment Lipitor (atorvastatin) could save the National Health Service (NHS) in the UK a whopping GBP 250 million or more during the coming years, following loss of patent exclusivity.

Can generic competition succeed at reducing cost of atorvastatin?

The generic form of the cholesterol-lowering drug Lipitor (atorvastatin) has the potential for significant cost savings for payers following its introduction in November 2011. However, ‘aggressive business tactics’ by Pfizer may stifle generics competition and so prevent prices from falling as much as predicted.