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Lupin Ltd. launched its generic version of Allergan’s Minastrin 24 Fe, a chewable oral contraceptive, March 16, but it’s getting an unwelcome competitor.
Teva said it started selling an authorized generic version of the drug March 16, the same day as Lupin’ generic launch. Authorized generics are drugs sold under a license from the patent holder. Brand companies frequently license authorized generics as a way to limit other generics’ market share.
The authorized generic is the result of an Allergan standalone distribution agreement with Teva, Mark Marmur, director of corporate affairs for Allergan plc in Parsippany, N.J., told Bloomberg BNA March 17.
Teva’s authorized generic launch is likely to have negative financial implications for Lupin, which has 180 days of exclusivity on the product. Teva’s competing product diminishes the value of Lupin’s exclusivity rights.
Under the Hatch-Waxman Act, the first applicant to file an abbreviated new drug application (ANDA) challenging the patents on a brand-name product qualifies for the valuable 180 days of market exclusivity on the generic drug. During those six months, no other generics can come on the market other than those licensed by the brand-name company.
India-based Lupin is going to market the generic under the name Mibelas 24 Fe. Bloomberg BNA contacted Lupin for comment on Teva’s authorized generic launch but no one at the company was available to comment.
It’s not clear how each of the generics will be priced. Elizabeth Deluca, a spokesperson for Teva, told Bloomberg BNA March 16 Teva “will consider market dynamics and other relevant factors in establishing the price for this product.”
Allergan’s Minastrin 24 Fe had annual sales of approximately $361 million in the U.S. in 2016, according to IMS figures.
Minastrin Fe has a somewhat checkered back story. Allegations regarding the drug are at the heart of multiple antitrust class action suits pending against Allergan subsidiary Warner Chilcott.
The suits against Warner Chilcott allege it delayed cheaper generic versions of its oral contraceptive Loestrin 24 by reformulating it into Minastrin 24, discontinuing Loestrin 24, and switching patients to Minastrin Fe, a process called product hopping.
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