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13 September 2011

Macleod-Novartis Patent row over Famvir put to rest


Swiss Pharma Novartis International, a biggie in pharmaceutical business, has finally made peace with Macleods Pharmaceutical, a growing generic manufacturer based in India. The patent row was concerning a herpes drug, Famvir (Famciclovir), which is a guanine analogue antiviral drug, indicated for the treatment of various herpes virus infections, most commonly for herpes zoster (shingles).

Plaintiff, Novartis, holds an Approved New Drug Application (NDA) relating to Famciclovir, the patent issued on February 2, 1999, marketed under the trade name Famvir. The Swiss drug maker had sued Macleods claiming that the latter was infringing upon its patents by attempting to manufacture and market a generic version of Famvir.

Patent details of Famciclovir listed in the Orange Book are provided below:
Patent No
Active Ingridient
Strength
Dosage Form, Route
Expiry
5866581

Famciclovir
125mg, 250mg, 500mg
Tablet, Oral
Oct 4, 2014

Novartis has finally offered the olive branch and agreed to settle the law suit with Macleods Pharmaceutical, on its plan to market a generic version. The terms of settlement between the two parties are confidential. Novartis was earlier also engaged in a Famvir infringement suit against Roxane Laboratories and Teva. The dispute was settled with Roxane Laboratories. However, Teva agreed to make a one-time payment and a royalty fee as well on the sales of Famvir to Macleods.

Image taken from here.

Author: Sneha Ashok

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