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Re: DewDiligence post# 69348

Tuesday, 12/02/2008 6:01:38 PM

Tuesday, December 02, 2008 6:01:38 PM

Post# of 257253
Dew, re: Hospira

According to my information, paragraph IV certifications have been filed for generic enoxaparin sodium pre-filled syringes 100mg/mL strength in 0.3mL, 0.4mL, 0.6mL, 0.8mL and 1mL sizes and for pre-filled syringes 150mg/mL strength in 0.6mL, 0.8mL and 1mL sizes.

ANDAs with Paragraph IV certification have also been filed for enoxaparin sodium 100mg/mL strength in 3mL vials.

I think Hospira may have only filed for the 100mg/mL, 3mL vial product. But they have definitely filed and were sued by Aventis on December 14, 2007 in a California court.

I haven't taken the time to look at where the market is (i.e., how much of the overall enoxaparin market does the 100mg/mL, 3mL vial account for). So if this presentation is small (which I doubt because why would they only file against the small presentation), it may be a non issue.

I get my information from Newport Horizons.

Regards

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