Replies to post #121773 on Biotech Values

[investorgold2002]

the only applications we have heard are Teva and Amphastar...
And as far as we could tell Amphastar's application has problems(?)...Teva's ANDA nobody should undermine..they have the muscle to get this through...plus FDA replying to Sanofi's CP and detailing criteria for approval, prolly helps TEVA quite a bit. I am hoping mL's IP has potential to block tL...but that also does not seem very clear

[DewDiligence]

Has anyone seen approvals "come out of the blue" on other drugs under paragraph 3?

Yes, Paragraph-3 is the main approval path for US generic drugs. Such approvals can be “out of the blue” because there is no need for the applicant to notify anyone (as there is with Paragarph-4 submissions).

A Paragraph-3 submission could conceivably be pending for Lovenox, but that’s quite unlikely, IMO.