FDAnews Drug Daily Bulletin
Pharmaceuticals / Commercial Operations

Branded Sovaldi to Debut in India in Coming Months, Distributed by Mylan Subsidiary

March 2, 2015

The branded version of Gilead’s pricey blockbuster hepatitis C therapy Sovaldi is expected on Indian pharmacy shelves in the second quarter of this year, distributed under an exclusive licensing agreement with Mylan’s Indian subsidiary.

In addition to the $1,000-a-pill Sovaldi (sofosbuvir), the subsidiary will be the exclusive distributor of branded Harvoni (sofosbuvir/ledipasvir) in the country, the generics maker said. Harvoni is used to treat chronic hepatitis C genotype 1 infection in adults.

Financial terms of the deal were not disclosed.

Sovaldi received regulatory approval in India in January, making it the first Asian country to sign off on the product, which costs $84,000 for a full 12-week treatment in the U.S.

The exclusive distribution agreement is in addition to nonexclusive generic licensing agreements signed with Gilead by the Mylan subsidiary and a number of other Indian generics makers.

Those deals, first announced in September, call for the generics makers to pay Gilead an undisclosed royalty in exchange for the technological know-how to produce — and a licensing agreement allowing them to sell — generic Sovaldi in India and 90 other developing countries. The deals also allow the generics makers to set their own price for the therapy.

Gilead is engaged in patent challenges in India and Europe that are pushing for unfettered generic competition to Sovaldi. — Bryan Koenig