Ranbaxy Pharmaceuticals Inc (RPI) has received a tentative approval from the US FDA for Lisinopril tablets. Lisinopril is recommended for hypertension, either alone for initial therapy or with other classes of anti-hypertenive agents. It is also used as adjunctive therapy in the management of heart failure and patients who do not respond to diuretics.
However it expects to launch the product only in June 2002, when the original patent expires on the drug, Zestril. Zestril is a registered trademark of Astra Zeneca UK Ltd. A wholly-owned subsidiary of Ranbaxy Laboratories Ltd, RPI expects to be able to access retail pharmacy outlets, wholesalers, hospitals and generic distributors in the US, only post - June 2002.
Sales in 2000 for Lisinopril touched $ 1.2 billion. It is sold under two brands in the US market , of which Zestril alone sold $ 0.66 billion in 2000. The tentative approval has been given for a single entity form of Lisinopril. An Abbreviated New Drug Application (ANDA) submission by Ranbaxy, for Lisinopril and Hydrochlorithizide is still outstanding and pending approval from the US FDA.
The tentative US FDA approval has been given for Lisinopril tablets USP 2.5 mg, 5 mg, 10 mg 20 mg and 40 mg. Based on kinetic studies, it has been deemed to be a bio-equivalent and therapeutically equivalent to Zestril tablets. The tentatively approved formulation is the result of R&D efforts that focussed on the Active Pharmaceutical Ingredient and the bio-equivalent formulation, both of which were developed in-house.