Replies to post #20798 on Elite Pharmaceuticals Inc (ELTP)

[Drugdoctor]

There is probably not any un-approved long acting oxycodone products on the market, since they required FDA approval in the first place. Being a DEA class II narcotic, I am surprised there are unapproved immediate release products out there.

[tangerine]

Anyone know a little pharma company working on making generics like oxycodone abuse resistant and looking to perform BE studies for FDA approval for commercialization on these products? ELTP.

Seriously take a second listen to that call. Friggn awesome

[lasers]

Elite's Hydromorphone will benefit immediately.

FDA removal of unapproved oxycodone will mean immediate sales increase for Elite's Hydromorphone.


https://spreadsheets.google.com/spreadsheet/lv?key=0AgI9WYgqHk9mdEZWLTlVdmJSQzJsZmw0YkdGTFlYN0E&hl=en_US

For the twelve months ending September 2011, Dilaudid(R) 8 mg tablets and its generic equivalents had total U.S. sales of approximately $30 million according to IMS Health Data. and there are currently four other approved generic manufacturers plus the innovator. 30/6 =5….I'll use $1,500,000 to be conservative

Hike's very conservative $1.5 mil Hydromorphone share from a $30 mil total market means approx $400k rev per Qtr. The Jun Qtr 2012 which is 1Q13 will be the full qtr revenue for Hydromorphone. MarQtr2012 which is 4Q12 had a mere 2 weeks revenue starting from Mar 13.

[Hike]

Companies subject to Action:

Warning Letters
Boehringer Ingelheim Roxane, Inc.
Boehringer Ingelheim Roxane, Inc. Follow-Up letter, 3/1/2010 (PDF - 33KB)
Boehringer Ingelheim Roxane, Inc. Follow-Up letter, 4/9/2009 (PDF - 30KB)
Cody Laboratories, Inc.
Cody Laboratories, Inc. Follow-Up letter, 3/1/2010 (PDF - 33KB)
Cody Laboratories, Inc. Follow-Up letter, 4/9/2009 (PDF - 30KB)
Glenmark Generics Inc.
Glenmark Generics, Inc. Follow-Up letter, 3/1/2010 (PDF - 33KB)
Glenmark Generics, Inc. Follow-Up letter, 4/9/2009 (PDF - 30KB)
Lannett Company, Inc.
Lannett Company, Inc. Follow-Up letter, 3/1/2010 (PDF - 33KB)
Lannett Company, Inc. Follow-Up letter, 4/9/2009 (PDF - 30KB)
Lehigh Valley Technologies, Inc.
Lehigh Valley Technologies, Inc. Follow-Up letter, 3/1/2010 (PDF - 34KB)
Lehigh Valley Technologies, Inc. Follow-Up letter, 4/9/2009 (PDF - 30KB)
Mallinckrodt Inc. Pharmaceuticals Group
Mallinckrodt, Inc. Pharmaceuticals Group Follow-Up letter, 3/1/2010 (PDF - 24KB)
Mallinckrodt, Inc. Pharmaceuticals Group Follow-Up letter, 4/9/2009 (PDF - 29KB)
Paddock Laboratories, Inc.
Physicians Total Care, Inc.
Roxane Laboratories, Inc.
Xanodyne Pharmaceuticals, Inc.
Xanodyne Pharmaceuticals, Inc. Follow-Up letter, 4/9/2009 (PDF - 30KB)