Swine flu prevention: oseltmavir generic makers in India sees greater demand

Oseltamavir (Tamiflu) generics see huge demand as countries start stockpiling flu drug.

Oseltamir generic makers from India see greater demand for their cheaper versions of the anti-flu drug, as the swine flu spreads across the continents.

Recently, the Indian Patent Office denied Gilead Science Inc. patent rights for its anti-influenza drug oseltamivir phosphate marketed as Tamiflu, in India.

India’s generic firm Cipla Ltd had earlier opposed granting of patents rights to Gilead’s Tamiflu did not have inventive step – a pre-requisite for products to gain patents in India.

The Mumbai-based Cipla filed a pre grant opposition suit with the Indian Patent Office against the applicant Gilead alleging that Tamiflu did not have the inventive step or obviousness.

Cipla had received marketing approval from the drug controller-general of India in January 2006.

Patent laws allow governments to authorise supply from generic companies, subject to remuneration to patent owners to address public health problems, including emergencies.

Cipla’s version of oseltamivir is priced at about Rs 1,000 per strip of ten 75 mg tablets. It is  less than half the current Tamiflu market price of $60.

Now Cipla claims that it can legally sell oseltamivir to India and 49 other developing countries.

With increasing fears about the potential for swine flu contagion, governments are stockpiling oseltamivir.

The US government has already declared the swine flu outbreak a public health emergency as swine flu has sickened at least 20 people in the U.S., by the CDC’s latest count.

“We are declaring today a public health emergency,” Secretary of Homeland Security Janet Napolitano said at a White House news briefing.

As part of the emergency, the Department of Homeland Security is releasing 25% of stockpiled antivirals — Tamiflu and Relenza — to the states.

Oseltamivir may be given as a preventive measure either during a community outbreak or following close contact with an infected individual. Standard prophylactic dosage is 75 mg once daily for patients aged 13 and older, which has been shown to be safe andeffective for up to six weeks.

US cases of swine flu have been milder than those seen in Mexico, where the World Health Organization has confirmed that at least 20 people have died from swine flu since its outbreak.  Health officials are investigating dozens more deaths in Mexico.

US health care officials said they expected more swine flu cases to be reported as public health officials heighten their hunt for the new strain of swine flu virus, which is a mix of swine, human, and bird flu viruses.

Almost all countries around the world are watching for the virus.

The global health community is taking the swine flu threat “very seriously”. However, they are still looking for more informationThe WHO has a scale ranging from phase 1 -low risk of a flu pandemic-to phase 6 -a full-blown pandemic.

Apart from Cipla, Hyderabad based Hetero Drugs is another company which is licensed to make generic version of oseltamavir.

While the dispute between Roche and Cipla reached a flashpoint, Roche granted a sub-license to the Hyderabad-based Hetero Drugs for the production of oseltamivir (Tamiflu), in December 2005.The agreement with Hetero is focused on providing oseltamivir for government pandemic use and will have an immediate effect on the availability in India and developing countries – both directly and through further agreements with local companies.

The demand for oseltamivir could be heightened only when the swine flu pandemic spread across all the regions. However, industry observers say Cipla and Hetero would be considering to increase their output as oseltamivir will be of great demand in the coming days.