Teva Nicks Lupin’s Exclusivity Rights on Birth Control Generic


India-based Lupin Ltd. launched its generic version of Allergan Plc's chewable oral contraceptive Minastrin 24 Fe March 16 but it’s getting unwelcome competition.

The same day Lupin announced its launch, Teva Pharmaceutical Industries Ltd. announced it had launched an authorized generic of Minastrin Fe.

Authorized generics are drugs sold under a license from the patent holder.

Although Lupin has 180 days of market exclusivity on the product—during which no other generics can come on the market—there’s an exception for authorized generics.

Teva’s launch is bound to affect the market potential for the Lupin product.

Brand companies frequently license authorized generics as a way to limit other generics’ market share. It’s not known yet how Lupin and Teva will price their products, and pricing is bound to affect how the market will respond to each company’s generic.

Elizabeth DeLuca, a spokesperson for Teva, told me Teva “will consider market dynamics and other relevant factors in establishing the price for this product.”

Lupin is going to market its generic under the name Mibelas 24 Fe but no one at the company was available to comment on the potential impact of Teva’s authorized generic launch on the outlook for Mibelas Fe.

Allergan’s Minastrin 24 Fe had annual sales of about $361 million in the U.S. in 2016, according to IMS figures.

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