E-DRUG: Cheaper branded or generic TDF+FTC+EFV FDC?
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[The recently FDA approved fixed dose combination of tenofovir, emcitrabine and efavirenz enables a once-a-day single dosage-form ART regimen. But, will we be able to afford it? Below the analysis from MSF and a Times of India article (copied as fair use). WB]
Dear E-druggers
Generic versions of the new once-a-day FDC of TDF/FTC/EFV are being developed in India and their approximate market launch in India (to start with) could be expected within the coming months (see Times of India article below). This new combination is crucial as an improved first-line and alternative to the FDC containing d4T/3TC/NVP, which is commonly used in the developing world today. WHO recommends combinations containing TDF, as they have fewer side effects than those containing d4T.
Generic companies have already applied for marketing approval in India and therefore the generic equivalent of this new once-a-day FDC could be available within months of US FDA approval of Gilead/BMS’s version of the new FDC. The generic price of US$ 2,160 per patient per year as reported by the Times of India is much more affordable than the US market price of nearly US$14,000. The price is still very high compared to current first-line FDC prices, but when generic competition exists, prices can be expected to fall over time.
However, Gilead’s patent application on TDF is being examined in India. In May 2006, MSF supported PLWHA groups and the lawyers that represent them in filing a pre-grant opposition to this patent application. If the patent is granted on TDF, for which there was no generic production pre-2005, any generic production could be effectively blocked by the patent holder until the patent expires, which could be as late as 2018. Also, the development of FDCs containing TDF, such as the new once-a-day combination of TDF/FTC/EFV, could be blocked until the patent term is up.
Because many developing countries depend on Indian producers for affordable, quality medicines, a patent in India could dramatically affect access to medicines in the rest of the world, and it is critical to make sure that patents are not granted erroneously.
Sheila Shettle Sheila
Communications Officer
Médecins Sans Frontières
Campaign for Access to Essential Medicines
Rue de Lausanne 78
1211 Geneva
Switzerland
+ 41.22.849.8403
sheila.shettle@geneva.msf.org
www.accessmed-msf.org
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Times of India
Firms ready with cheaper AIDS drugs
Rupali Mukherjee
13 Jul, 2006 2250hrs ISTTIMES NEWS NETWORK
NEW DELHI: There is good news for HIV patients. The first three-in-one combination single pill to treat AIDS will soon be launched by Indian drug companies at around Rs 1 lakh (per annum, per patient) - or around Rs 274 per day - which will be 80-85% cheaper than the global price of nearly Rs 7 lakh per patient per year ($15,000).
The single once-a-day pill will make the treatment cheaper and easier as against struggling with dozens of pills in a day.
The single pill, which is a combination of three drugs, also got US FDA nod on Wednesday. The pill, Atripla, which contains Bristol-Myers Squibb Co's drug Sustiva and Gilead Inc's medicines Viread and Emtriva, is the latest step in making it easier for AIDS patients to keep HIV in check.
Sources said that major Indian companies including Cipla and Hetero Drugs are already working on it, and may launch it close to the worldwide launch by foreign companies.
Cipla joint MD Amar Lula said, "We are ready with the formulation for the three-in-one single pill, and are applying to the Drug Controller of India for approval". The company's single once-a-day pill will be branded as Viraday.
He added that foreign companies have started following the example set by Cipla in launching fixed dose combinations to treat HIV.
In 2001, Cipla launched the first fixed-dose combination, Triomune that combined three antiretroviral drugs in one pill (twice a day), and offered it at $350 (Rs 15,000) per patient, per year as against global price of $10,439 (Rs 5 lakh).
This also became one of the frequently prescribed treatments in developing countries, making the treatment simpler and cheaper.
Hyderabad-based Hetero Drugs is also working on the fixed dose single pill and will launch it in a few months. The company's director-marketing, M Srinivas Reddy said: "We are waiting for the licence to initiate studies on the drug, and will launch it substantially cheaper than the global price".
Experts say that with more competition coming in, prices of these drugs would go down. Recently, Aurobindo Pharma got FDA approval to produce a generic version of a three-combination drug.
They added that the single dose pill is a new and better combination, and may soon become the preferred treatment for AIDS, because of its simplicity and lack of side-effects. The fixed-dose combination is based on the recent protocol by WHO for developing countries.