While the US Food and Drug Administration (FDA) has recently kicked out knockoff versions of Concerta, the attention deficit hyperactivity disorder (ADHD) drug from Johnson & Johnson (NYSE:JNJ) manufactured and commercialized by Lannett Company, Inc. (NYSE:LCI) and Mallinckrodt PLC (NYSE:MNK), the company is facing more competition with the recent approval of the knockoff version from Mylan NV (NASDAQ:MYL).
According to Umer Raffat, an Evercore ISI analyst, it appears that the FDA has approved the new Concerta competitor from Mylan with an AB rating. Should this be the case, it would be the first Concerta knockoff to get a coveted distinction from the FDA. This distinction means that the drug is an efficient substitute for the branded counterpart from Johnson & Johnson (NYSE:JNJ).
While Mylan NV (NASDAQ:MYL) is not widely expected to lead the Concerta—branded and generic— market, it is believed that it will get a bigger market share than Lannett and Mallinckrodt. Needless to say, this will affect the Concerta revenue for Johnson and Johnson.
The approval of its version of Concerta will give Mylan a much needed boost, especially at a time when it is embattled by the price hikes of EpiPen.
Booting Other Concerta Knockoffs
The FDA found out post-approval that the generic versions of Concerta from Lannett and Mallinckrodt wear off quicker than Concerta. The two companies have failed to prove the meaningful efficacy of the generic medicines within the timeframe given by the FDA. As a result, both drugs were denied approval for commercialization last week.
Analysts suspect that the timing of the two Concerta copies and approving the generic version from Mylan is not coincidental.
“We suspect the FDA wanted to ensure supply of the product before moving to remove the BX-rated products,” explained Douglas Tsao and Morgan Williams, Barclays analysts.
On Wednesday, Johnson & Johnson (NYSE:JNJ) has surged 0.53% to $114.56; Lannett has declined 2.51% to $21.40; Mallinckrodt has jumped 0.33% to $62.87; and Mylan NV (NASDAQ:MYL) has lost 1.55% to $38.08.
Note: This article is written by Adam Russell and originally published at Market Exclusive.