Lupin wins first FDA approval for generic version of Boehringer Ingelheim blockbuster Spiriva

In­di­an drug­mak­er Lupin to­day said it won FDA ap­proval for the first gener­ic ver­sion of Spiri­va, a block­buster COPD drug from Boehringer In­gel­heim.

The gener­ic, known as tiotropi­um bro­mide in­hala­tion pow­der, first won ap­proval as a brand name prod­uct in 2004 as a main­te­nance treat­ment for COPD-re­lat­ed breath­ing prob­lems, be­fore ex­pand­ing its la­bel five years lat­er to re­duce COPD ex­ac­er­ba­tions.

Spiri­va — sold in a cap­sule form and de­liv­ered via an in­haler sys­tem — made Boehringer In­gel­heim $1.7 bil­lion last year, ac­cord­ing to its an­nu­al re­port.

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