Indian Pharma Company, Natco Pharma in collaboration with its US-based partner, Alvogen became the first U.S. Food and Drug Administration (FDA) approved company who will manufacture the generic versions of Roche’s once-blockbuster drug for flu, Tamiflu®.
Tamiflu (oseltamivir phosphate) is an antiviral, oral medicine used for the treatment of flu in people above 2 weeks of age. It was discovered and developed by Gilead Sciences and later licensed to Roche in 1996.
FDA approved the Abbreviated New Drug Application (ANDA) of Natco for the generic versions of Tamiflu oral capsules, 30mg, 45mg, 75mg. According to a patent settlement among Gilead, Natco and Roche, Natco’s partner Alvogen received the exclusivity period of six months for the marketing of the oseltamivir phosphate capsules till the expiry of the patent in 23, Feb, 2017.
Therefore, this settlement will provide Natco at least six months competition free marketing of its generic version of Tamiflu.
Figure 1. Mechanism of action of oseltamivir, a neuraminidase inhibitor (photo credit: odec.ca).
The generic competition for Roche’s Tamiflu will certainly make a negative impact in the sales of the drug. The interim sales report of Roche shows 410 million Swiss francs sales of Tamiflu in the first half of 2016 which could see a decline in the second half due to its copycat version. Last year, US sales of Tamiflu was approximately $403 million.
The drug sales have already seen great variations in the flu and non-flu seasons. In 2009, during the H1N1 swine flu outbreak, the sales of Tamiflu spiked up to 3.2 billion Swiss francs. Tamiflu sales declined by 18% this year due to a comparatively weak flu season.
Roche’s Tamiflu is always being in the threat of potential competitors so it is being looking for its alternative flu-fighting candidate. Few months back, Roche tied up with Japan’s Shionogi for its anti-influenza drug, S-033188 which has gained fast track designation in Japan and could reach US market in 2018.
Featured Image credit: Natco Pharma