BioMarin Pharmaceutical (BMRN) could receive a notification shortly regarding a patent challenge for its marketed Kuvan (sapropterin dihydrochloride) tablets. The company stated in its press release that a company, looking to launch a generic version of Kuvan, has submitted a paragraph IV certification notice letter to the FDA. This pertains to an Abbreviated New Drug Application (ANDA) filed with the U.S. regulatory body seeking to market a generic version of Kuvan.
The paragraph IV certification implies that the filer believes the relevant patent is invalid or will not be infringed by its generic version of the drug. BioMarin stated that it intends to defend the patents and will file a complaint alleging patent infringement against the applicant within 45 days of receiving the notification letter.
In the event of BioMarin filing the lawsuit within 45 days, a 30-month stay period will come into force. Consequently, the ANDA pertaining to Kuvan cannot be cleared by the U.S. regulatory body within that time frame or until a court rules the patents to be invalid or not infringed, whichever happens earlier.
Currently, Kuvan is covered by 8 issued patents which are listed on the FDA's approved drug products List (Orange Book). The patents will expire between 2024 and 2026. Kuvan has been co-developed by BioMarin and Merck KGaA (MKGAF). Kuvan was approved in the U.S. in 2007 for phenylketonuria, a genetic disease.
Kuvan is one of the most promising drugs at BioMarin. Kuvan has been performing well since its launch. Net product revenues from Kuvan climbed 14.7% to $46.9 million in the second quarter of 2014. The company expects 2014 Kuvan sales to be in the range of $180 million to $200 million. Consequently, genericization of the drug would hurt the top line of BioMarin. We expect investor focus to remain on updates relating to Kuvan.
BioMarin carries a Zacks Rank #3 (Hold). Better-ranked stocks in the health care space include Amgen (AMGN) and Endo International (ENDP). Both the stocks sport a Zacks Rank #1 (Strong Buy).
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