Antares Pharma, Inc. (ATRS)

[jab91252]

Yes, Medac filed a 505(b)(2) NDA. Also, the lawsuit is asking the Court to enter an Order for the Medac NDA approval or effective date, to be a date not earlier than the expiration date of the two ('631 and '553) patents.

When an ANDA (or) a 505b2 is filed with a P IV certification, yes, the FDA is prohibited from approving for 30 month stay.

Example:

"A list of ANDA Paragraph IV drug challenges is maintained at FDA’s Office of Generic Drugs. There is no listing for 505(b)(2). Because of this, a sponsor of a 505(b)(2) needs to monitor court dockets for their proposed product.

Let’s look at an example 505(b)(2) Paragraph IV filing. Cipher Pharmaceuticals Limited developed a formulation of fenofibrate capsules that it believed did not infringe on the patents (there were two) held. Cipher developed a product that would not have the food effect that was characteristic of the RLD (TRICOR(R)). The RLD is a capsule containing micronized fenofibrate mixed with a surfactant. Cipher’s product dissolves fenofibrate in polyglyceride, HPMC and sodium starch glycollate.

Cipher filed their NDA in December 2002 and sent a notice on March 5, 2003. Abbott sued in April and October 2003 (messy because Abbott had a license from Laboratoires Fournier SA, so they both got involved). This suit triggered the 30-month stay until the matter was resolved. Cipher prevailed and was approved by FDA as Lipofen (TM) in January 2006."