Cipla launches cut-price valgancilovir in India
This article was originally published in Scrip
Cipla has launched valganciclovir, a cut-price generic version of Roche's treatment for cytomegalovirus (CMV) retinitis in AIDS patients, Valcyte, on the Indian market. Cipla had earlier filed a post-grant opposition against Roche's patent for Valcyte in India.
Cipla's CEO, Amar Lulla, confirmed the launch of valganciclovir (marketed as Valcept), which has been priced at Rs245 ($5.7) per tablet as against about Rs1,000 per tablet for Roche's Valcyte. The company also expects to export its generic version to markets where no patents exist. Cipla's generic valganciclovir is formulated at its facility in Patalganga.
There has been some speculation on potential trademark challenges over Cipla's product name, though the company maintains its brand name is distinct. The patent on Valcyte, which was granted in 2007 in India, has been challenged by Cipla and Ranbaxy separately. Earlier, patient groups had filed a pre-grant opposition against Valcyte in India, though they are reported to have been denied a hearing. Ranbaxy, which has since been acquired by Daiichi-Sankyo, has also received tentative approval from the US FDA to manufacture and market valganciclovir hydrochloride tablets 450mg and claims to have first-to-file status on the generic product. Valcyte is the oral pro-drug of Roche's Cytovene (ganciclovir).
patent challenges
Cipla has been at the forefront of patent challenge initiatives in India. The company has in the past challenged Novartis's patent application for Glivec (imatinib mesilate), along with other domestic firms, including Natco Pharma and the Cancer Patients Aid Association. Novartis has since appealed to India's Intellectual Property Appellate Board (IPAB) in this much-publicised case.
Cipla, which has already launched its generic erlotinib in India, has challenged the patent on Roche's Tarceva (erlotinib) and filed a pre-grant patent opposition against Novartis' Exjade (deferasirox) in India. The Tarceva case, which is ongoing, is expected to come up for hearing at the division bench of the Delhi High Court by the end of July.