Monday, September 03, 2012 6:30:50 PM
We don't know what this product is but we do know some things.
Naltrexone
"The brand product and its generic equivalents had annual sales of approximately $14 million in 2009 and there are currently three other approved generic manufacturers plus the innovator."
http://money.cnn.com/news/newsfeeds/articles/globenewswire/200584.htm
Hydromorphone
"Hydromorphone hydrochloride is a member of the opioid analgesic and antitussive class. It is a pure opioid agonist used primarily for pain relief or as a cough suppressant. For the twelve months ending September 2011, Dilaudid® 8 mg tablets and its generic equivalents had total U.S. sales of approximately $30 million according to IMS Health Data."
http://www.globenewswire.com/newsroom/news.html?d=249016
New ANDA Opioid - Inspections recently completed?
"Two of the Products, hydromorphone hydrochloride, 8 mg, and naltrexone hydrochloride, 50 mg, are approved products recently purchased by Elite and currently being transferred to Elite. Collectively, the brand products and their generic equivalents had total annual sales of approximately $120 million in 2009."
http://www.globenewswire.com/newsroom/news.html?d=201688
I believe the new ANDA will be an generic in an 80m market
Hydromorphone - 30m
Naltrexone 12m
= 42m
120m - 42m = 78m
I believe these numbers are actually low based on 2009 numbers and the market has continually grown.
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