Generics/News

Generic prices in Australia slashed

In response to an article by Professor Philip Clarke in the Australian Financial Review titled Time to slash cost of generics, Medicines Australia Chief Executive Dr Brendan Shaw hit back saying that ‘the price of generic medicines on the Pharmaceutical Benefits Scheme (PBS) is already being reduced by as much as 70%.’

Branded generics and generics branding for Merck and sanofi-aventis

While Merck is getting a firm foothold in emerging markets with a branded generics deal with India-based Sun Pharma, sanofi-aventis has decided to unify its generics business under the brand name Zentiva.

FDA rejects pseudoephedrine application due to deficiencies

On 11 March 2011 SCOLR Pharmaceuticals announced it had received a letter from the FDA identifying deficiencies regarding its Abbreviated New Drug Application (ANDA) for its generic extended-release pseudoephedrine.

Indian generics companies to strengthen in 2011

Dispute with EU resolved

The EU and India have resolved a dispute about the seizure of generic medicines passing through Europe en route to Africa and Latin America. In 2009, the EU repeatedly seized generic drugs originating in India as they passed through European ports on their way to Brazil.

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.

Germany tightens controls on pharmaceutical prices

The German government is contemplating pharmaceutical price control legislation as it battles soaring drug spending. On the one hand Germany is keen to promote the use of generic drugs and generic medicines have already achieved high penetration—75% by volume in 2009. This highlights opportunities for generic manufacturers in Europe's largest, albeit competitive, drug market.

India under attack

India is coming under attack from Big Pharma from all angles it seems. On the one hand the Indian Government has alleged that multinational companies are campaigning against the country’s domestic pharmaceutical industry due to India’s increasing generic global presence. Then on the other hand Novartis has been asked to end its challenge to Indian patent law, with claims that its action could hinder global access to medicine.

Sun Pharma continues to expand its generics portfolio

Sun Pharma is keeping up the momentum in the generics market with several new generics recently gaining FDA approval and with an extensive pipeline on the way. The latest generics to come out of the company include drugs for the treatment of hypertension, allergic rhinitis and depression.

Strong lobbying by Canadian Generics Association

The President of the Canadian Generic Pharmaceutical Association (CGPA), Mr Jim Keon, has been speaking up on behalf of Canadian generic companies in two recent statements. Canada and the EU are currently in negotiations for a comprehensive economic and trade agreement, which they hope to conclude before the end of 2011.

European Parliament gives go-ahead for EU patent

Despite doubts over the legality of the proposed linguistic regime, the European Parliament gave its green light on 15 February 2011 for use of a rarely used provision of the Lisbon Treaty known as ‘enhanced cooperation’ to launch a common EU patent system without Italy and Spain on board.

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.

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).

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).

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.

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.

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).

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.

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).

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.

Teva brings another action against Mylan

In October 2009, Teva Pharmaceutical Industries filed a lawsuit against Mylan for infringement of multiple patents, with respect to patents on its glatiramer acetate drug–Copaxone. The patents cover pharmaceutical compositions containing it, methods of using it and processes for making it. Those patents expire in May 2014 and September 2015. No trial date is scheduled.

Ranbaxy beats Teva to Alzheimer’s drug

Aricept (donepezil hydrochloride), Eisai Pharmaceutical’s biggest selling drug, comes off patent in the US in November 2010. Thereafter donepezil hydrochloride may be sold as a generic drug. Teva has applied to sell donepezil, but the FDA granted Ranbaxy first access to the lucrative market in a letter dated 17 September 2010.

Go Perrigo!

Generic drug maker Perrigo has made it to Fortune magazine's top 100 fastest growing companies in the US. Fortune is a business magazine especially known for ranking companies by revenue. So there is some rejoicing in Michigan as the local hero has now received national acclaim.

An ageing population: generics and biosimilars could be the solution

On 17 October 2010 the European Generic Medicines Association (EGA) organised an event to discuss patient access to affordable treatments and healthcare sustainability in view of an increasingly ageing population.

FDA user fees for assessing generic drugs

The FDA is beginning a long-awaited attempt to create a system of user fees for assessing generic drugs. The US agency has a backlog of more than 2,000 products to review and has been short of funds for years. But things are never straightforward…

Teva continues to expand

The world's largest generic pharmaceutical company, Israeli-based Teva Pharmaceutical Industries, is investing Euros 42 million to expand its production plant in Stouffville, Canada. At the same time Ontario is providing a Euros 4.8-million grant to Teva Canada, which will retain 182 high-skilled workers and hire 20 new employees.

Teva challenged over 180-day marketing exclusivity

Canadian generics’ manufacturer Apotex has asked the US Supreme Court to hear a case that could have a lasting impact on how marketing exclusivity is awarded to generic-drug manufacturers by the FDA.

Big shifts in generics shares due to Dutch preference policy

The percentage of generic prescribing in The Netherlands increased in 2009 from 56.3– 57.1% according to the Dutch Stichting Farmaceutische Kengetallen (SFK), as published in Pharmaceutisch Weekblad of 12 March 2010.

Celgene and Natco in generic lenalidomide battle

Indian generics’ manufacturer Natco Pharma (Natco) has filed an abbreviated new drug application (ANDA) with the FDA seeking approval to sell a generic version of Celgene Corporation’s (Celgene’s) flagship blood cancer drug Revlimid (lenalidomide), before its patent protection expires.

Sun Pharma adds generic tamsulosin and rivastigmine to portfolio

Sun Pharma is gathering speed with a barrage of generic versions recently coming onto the market and with an extensive pipeline on the way. The latest generics to come out of the company include versions of tamsulosin and rivastigmine.

Sun and Teva losing battle over generic Protonix

On 19 July 2010, it was announced that a US court had denied a motion by India’s Sun Pharmaceutical Industries and Israel-based Teva Pharmaceutical Industries to reverse the earlier verdict of patent infringement on Pfizer/Nycomed’s gastrointestinal drug Protonix (pantoprazole).

New EGA chair to study generic medicines policies

On 8 July 2010, Professor Steven Simoens was inaugurated as the new European Generic medicines Association (EGA) chair for ‘European policy towards generic medicines’ at the Catholic University in Leuven, Belgium. This chair is funded by the EGA in collaboration with Mylan, Ratiopharm, Sandoz International and TEVA Pharmaceuticals for a five-year period.

Generics lose battle against AstraZeneca’s Crestor (rosuvastatin)

On 30 June 2010, AstraZeneca announced that a court in the US had overruled challenges, from a number of generic producers, to the patent on its blockbuster cholesterol drug, Crestor (rosuvastatin).