New User:

-or-
Username:
Password:
Forgot your password?

Stock Market & Financial Investment News

News Breaks
August 6, 2014
08:16 EDTMNK, DEPOMallinckrodt receives patent from U.S. PTO
Mallinckrodt (MNK) announced that on July 29 the U.S. Patent and Trademark Office granted the company a new patent related to MNK-155. The patent, U.S. Patent Number 8,790,694 contains composition claims directed to unique design, formulation, pharmacokinetic, and release characteristics of MNK-155 and conveys the same period of exclusivity as did the patent granted in 2013 for the company’s product XARTEMIS XR Extended-Release Tablets. MNK-155 is Mallinckrodt’s investigational extended-release oral formulation of hydrocodone and acetaminophen studied for the management of moderate to moderately severe acute pain where the use of an opioid analgesic is appropriate. The release profile of MNK-155 combines Mallinckrodt-proprietary technology and Depomed’s (DEPO) advanced Acuform drug delivery technology.
News For MNK;DEPO From The Last 14 Days
Check below for free stories on MNK;DEPO the last two weeks.
Sign up for a free trial to see the rest of the stories you've been missing.
September 17, 2014
16:18 EDTDEPODepomed says FDA recognizing 7 years orphan-drug exclusivity for Gralise in PHN
Depomed (DEPO) disclosed in a filing that on September 16 the company received a letter from the FDA informing the company that pursuant to the order issued on September 5 by a judge of the U.S. District Court for the District of Columbia, the FDA is recognizing seven years of orphan-drug exclusive approval for the company’s Gralise for the management of postherpetic neuralgia. The letter also confirms the FDA will not approve any abbreviated New Drug Application referencing Gralise during the period of orphan-drug exclusive approval, which began on January 28, 2011. The FDA has 60 days after issuance of the order in Depomed, Inc. v. HHS to file a notice appealing the order to the United States Court of Appeals for the Federal Circuit. The period of orphan drug exclusivity applicable to Gralise for PHN is separate from marketing exclusivity arising from the previously disclosed decision issued on August 19 in the company’s patent litigation lawsuit against Actavis (ACT) related to an ANDA filed by Actavis seeking to market generic versions of Gralise. The decision found that Actavis infringed all seven of the company’s patents asserted in the litigation, upheld the validity of the patents and enjoined FDA approval of the Actavis ANDA until February 26, 2024, the latest expiration date of the infringed patents. On September 15, Actavis filed a notice appealing the decision to the United States Court of Appeals for the Federal Circuit, Depomed stated. Previously disclosed settlement agreements between the Company and two other Gralise ANDA filers permit the sale of generic Gralise beginning on January 1, 2024.
September 16, 2014
07:30 EDTMNKCRT Capital to hold a conference
2nd Annual Investor Conference to be held in Greenwich, CT on September 16.

Sign up for a free trial to see the rest of the stories you've been missing.

I agree to the theflyonthewall.com disclaimer & terms of use