Generics

Generic substitution in Norway

Using a dataset extracted from the Norwegian prescription database containing all prescriptions written in the period January 2004 to June 2007, an analysis was carried out on two brand-name and two generic statin drugs used to treat high cholesterol and showed that prices have a clear impact on generic substitution [1].

Teva again files citizen petition against generic Copaxone

Teva Pharmaceutical Industries announced on 12 December 2010 that the company had filed another Citizen’s Petition (CP) with the FDA requesting that the agency refuse to approve any abbreviated new drug application (ANDA) for generic versions of Copaxone (glatiramer acetate injection).

Teva setbacks

Teva axes 200 jobs as facility remains closed

After stopping all production at its plant in Irvine, California, USA; in April 2010, Teva announced on 20 January 2011 that all 200 jobs will go.

Race you for US$1.8 billion

The market for proton pump inhibitor pantoprazole in the US is estimated to be worth Euros 1.3 billion a year, and drug companies are scrambling to sell generic versions now that Pfizer’s patent has expired.

Generics to cash in on swine flu epidemic

Indian drug manufacturer Natco Pharma has filed an abbreviated new drug application (ANDA) with the FDA for a generic version of Tamiflu (oseltamivir), challenging Gilead Science’s patent protection on the drug.

Impact of generic substitution in Finland

Mandatory generic substitution was introduced in Finland on 1 April 2003. A recent study compared the impact of generic substitution on both originator and generic pharmaceutical companies in Finland.

The biggest US patent expiries of 2010

While the much talked-about patent cliff will not hit until 2011, 2010 has been witness to patent expirations of some of the industry’s blockbuster drugs.

European Commission to investigate patent settlements again

The European Commission (EC) has once again requested information from pharmaceutical companies regarding patent settlement agreements concluded in the European Economic Area (EEA) in 2010 between originator and generic companies.

New ANDAs and patent challenges for Impax Laboratories

Impax Laboratories is facing a whole barrage of patent litigation following its latest Abbreviated New Drug Application (ANDA) filings and approvals with the FDA.

Birth pangs of the Medicines Patent Pool

The Medicines Patent Pool (MPP) is an initiative designed to streamline patent licensing for generic versions of patented HIV treatments, in order to obtain lower prices for medicines in countries where people are unable to afford the drugs.

Generic substitution causing confusion

How do customers and pharmacists really experience generic substitution? This is the question asked in a recent research article [1].

Generic and branded acetylcysteine bioequivalent

A single-dose study of acetylcysteine 600 mg found that three tablets of 200 mg of the generic formulation given orally were bioequivalent to a single 600 mg tablet of the branded drug.

Impax challenges Simcor patent

On 26 November 2010, generic drug maker Impax Laboratories announced that it is challenging the patent covering Abbott Laboratories’ cholesterol-treatment drug, Simcor (niacin/simvastatin).

The therapeutic equivalence of brand-name and generic narrow therapeutic index (NTI) cardiovascular drugs

There are many physicians and patients who have concerns that the bioequivalent generics may not have an equivalent nature in terms of their clinical effect and benefit. In the realm of cardiovascular disease, this can include such parameters as heart rate, blood pressure and laboratory measurements.

The therapeutic equivalence of antiplatelet agents, ACE-inhibitors, statins and alpha-blockers

The potential changes in pharmacy formulary policy, due to the availability of generic versions of cardiovascular drugs, should be based on as much evidence as possible.

Pharmacy chains in Norway do not stock generics

It turns out that pharmacy chains in Norway do not stock the cheapest generic products. This finding came after the Norwegian Medicines Agency (NoMA) investigated after receiving a complaint from the British generics manufacturer Arrow that its products were not sold in branches of the three largest pharmacy chains in Norway: Apotek1 (Phoenix), Vitusapotek (Celesio) and Alliance/Boots Apotek (Alliance Boots).

The clinical equivalence of generic and brand-name calcium channel blockers

Companies seeking to launch a generic drug are required to submit a dossier to authorities, which does not contain the results of extensive preclinical and clinical testing demonstrating safety and efficacy in the target population, as is the case with novel drugs, but only limited data and evidence demonstrating the fundamental premise that the generic is bioequivalent to its brand-name counterpart.

Medicines pricing policies in Europe: a review

The OECD countries spent 4.6% more per capita per year on pharmaceuticals from 1995 to 2005 although the annual average economic growth was only 2.2% during the same period [1].

Profits for generics’ giant Teva soar

Israel-based generics’ giant Teva Pharmaceutical Industries has reported a third quarter 2010 profit rise of 47%, mainly attributed to sales of its multiple sclerosis drug Copaxone (glatiramer acetate), its acquisition of Ratiopharm and generic launches in the US.

The generic drug wars: deeply discounted medication

Fierce competition among major pharmacy chains in the US, such as CVS, Walgreens and Walmart, has led to a generic prescription pricing war with unclear public health implications.

Ranbaxy gets 180-day exclusivity for Alzheimer’s generic

On 30 November 2010, generics’ giant and India’s largest pharmaceutical manufacturer, Ranbaxy Laboratories, announced the launch of a generic version of Pfizer’s blockbuster Alzheimer’s treatment, Aricept (donepezil hydrochloride), in the US.

The clinical equivalence of brand-name beta-blockers and their generic counterparts

The healthcare systems of the world are all under pressure to reduce costs and using generic substitution for the initially prescribed, more expensive equivalents is an obvious area to investigate. However, as a report reiterated in 2010, treatment decisions should not be based on economic grounds alone, for this would not be in the patient's best interest and would therefore be unethical. What is needed is an opinion based on the evidence available regarding therapeutic equivalence [1].

Are generic diuretics clinically equivalent to their brand-name counterparts for the management of cardiovascular disease?

Prescription costs are rising, mainly due to brand-name drugs recouping their investment during the period of patent protection and market exclusivity. For this reason, many payers and prescribers encourage use of the cheaper generic versions [1]. This has been found to have another positive consequence, namely the increased accessibility to prescription treatments and an increased compliance with drug regimens, particularly in the case of chronic conditions [2, 3].

Sun gains tentative approval for generic Crestor

Indian-based Sun Pharmaceutical Industries announced on 29 September 2010 that the FDA had granted its subsidiary a tentative approval for its Abbreviated New Drug Application (ANDA) to market a generic version of IPR Pharmaceuticals’ (a part of AstraZeneca) anti-cholesterol drug Crestor (rosuvastatin calcium).

Generic or brand-name drugs for cardiovascular disease? Does the evidence match current opinion?

Cardiovascular drugs constitute a large proportion of outpatient prescription drug spending.

The rise in power of generic drugs

With shrinking pipelines, the impending expiration of many drug patents, and the global economic downturn experienced in the last two years causing prescription payers to face budget cuts, generic drugs are becoming an increasingly large player in the economics of the global pharmaceutical industry.

WHO prequalification programme for APIs

The WHO initiated on 21 October 2010 a pilot prequalification programme for selected active pharmaceutical ingredients (APIs) used in drugs for HIV and related diseases, antimalaria and anti-tuberculosis medications.

FDA considering tighter controls on generics

The FDA may tighten standards for how closely generic drugs resemble brand-name equivalents. This comes as a result of complaints from both patients and employees of generic drugmakers that some of the medicines do not work as well as the originals.

Generic combination antibiotic launched in US

On 26 October 2010, Hospira announced the launch of its combination antibiotic (piperacillin and tazobactam) for injection in the US. The medication is a generic version of Zosyn, the world’s leading injectable antibiotic, from Pfizer (Wyeth). Piperacillin and tazobactam injection posted sales in the US in 2009 of more than US$855 million.

Tackling counterfeit drugs in China

The Chinese State Council, or cabinet, said on 19 October 2010 it would “launch a special campaign to fight intellectual property rights infringement and the manufacture and sale of counterfeit goods” at a meeting chaired by Premier Wen Jiabao. The six-month campaign, which includes making sure government organisations use genuine software, will begin at the end of October 2010, said the State Council.

India’s top pharma company strengthens ties with South Africa

Generics’ manufacturer Cipla is a prominent Indian pharmaceutical company, best known outside its home country for manufacturing low-cost anti-AIDS drugs for HIV-positive patients in developing countries. Cipla exports to 170 countries and its manufacturing facilities are approved by WHO, US FDA, UK MHRA and other major agencies. Cipla was responsible for lowering the cost of triple therapy antiretroviral (ARV) to less than US$1 per day and is, in partnership with the Clinton Foundation, to supply ARVs to third world countries.

A view from South Africa

Aspen Pharmacare, Africa’s biggest generic drugs company, reported a 24% rise in full-year profit at the end of June 2010, boosted by its South African unit, and says it expects strong demand in the coming year.

Who are the GPhA and what do they do?

The Generic Pharmaceutical Association (GPhA) is a group that represents the interests of generic drug manufacturers in the US. To achieve this they pursue an active lobbying policy. They are currently in talks with the FDA to improve the process by which it approves generic medicines. Generic pharmaceuticals account for 75% of the prescriptions dispensed in the US but consume just 22% of the total drug spending.

Apotex loses fight over Plavix patents

Apotex was told to pay sanofi-aventis (sanofi) and Bristol-Meyers Squibb (BMS) a whopping US$442 million (plus interest) for violating patents on the blockbuster blood-thinner Plavix (clopidogrel bisulphate).

Brand loyalty, generic entry and price competition in the US

In a new working paper from the US National Bureau of Economic Research researchers investigated brand loyalty, generic entry and price competition in the 25 years since the 1984 Waxman-Hatch legislation came into force.

FDA grants approval for generic lansoprazole

Teva Pharmaceutical Industries announced on 18 October 2010 that it had received FDA approval for its Abbreviated New Drug Application for its generic version of Takeda's Prevacid (lansoprazole) SoluTab.