What if Abilify does not go generic?

Anonymous

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Otsuka has sued the FDA and Abilify may not go generic. If this happens, does this affect the launch here? Don't be an ass in your responses. I only want to make sure I understand if this will have any implications in Alkermes' plans.
 












No impact on AL pending approval. AL is a NCE per FDA. No impact on LAI marketplace. Only impact will be for Otsuka pill pushers. May keep job longer and other pill manufacturers will not have to deal with a further genericized market.
 






Otsuka has sued the FDA and Abilify may not go generic. If this happens, does this affect the launch here? Don't be an ass in your responses. I only want to make sure I understand if this will have any implications in Alkermes' plans.

Abilify oral formulation will go generic by the end of April if not sooner. If it doesn't I will eat my hat.
 






No impact on AL pending approval. AL is a NCE per FDA. No impact on LAI marketplace. Only impact will be for Otsuka pill pushers. May keep job longer and other pill manufacturers will not have to deal with a further genericized market.

Maybe. Yes, they accepted your NDA. However, if they lose this lawsuit, they may have to rethink it - they may have accepted it based on the assumption that Abilify was generic in April 2015. Think about it, you have ONE study. You are basing your safety on aripiprazole studies. You are pretending to be Abilify when it counts and your own drug when it suits you. Have you made offers to account managers yet?
 






Maybe. Yes, they accepted your NDA. However, if they lose this lawsuit, they may have to rethink it - they may have accepted it based on the assumption that Abilify was generic in April 2015. Think about it, you have ONE study. You are basing your safety on aripiprazole studies. You are pretending to be Abilify when it counts and your own drug when it suits you. Have you made offers to account managers yet?

Thank you for your commentary. You certainly sound like you have close ties with the FDA. We might as well fold it up. And, yes.
 






It looks like the initial hearing in 4/14 because they want to hurry up and decide if there is merit in the case. If there is an injunction, Abilify may be delayed in going generic. If you read the link in that article to the actual lawsuit, it's pretty sound legal work. Also, the lead attorney for the firm worked at the FDA, so he fully understands regulatory process, including complex orphan drug status.

At the end of the day, you know that if you sold a drug for something that wasn't in your label, your company would get fined in a heartbeat. What just happened is that the FDA basically ignored that these studies needed to be submitted in the SNDA and changed the label two months later because they claimed they made a mistake. No, no one submitted two well controlled studies in adults for Tourette's.

It's fascinating; but I would pay attention. Lauroxil is submitting one study because they are using the body of the aripiprazole evidence as support for their NDA. If Abilify is not generic, you are violating the patent. And, if you go at risk before this is resolved, and Otsuka wins, triple damages, baby.
 






It looks like the initial hearing in 4/14 because they want to hurry up and decide if there is merit in the case. If there is an injunction, Abilify may be delayed in going generic. If you read the link in that article to the actual lawsuit, it's pretty sound legal work. Also, the lead attorney for the firm worked at the FDA, so he fully understands regulatory process, including complex orphan drug status.

At the end of the day, you know that if you sold a drug for something that wasn't in your label, your company would get fined in a heartbeat. What just happened is that the FDA basically ignored that these studies needed to be submitted in the SNDA and changed the label two months later because they claimed they made a mistake. No, no one submitted two well controlled studies in adults for Tourette's.

It's fascinating; but I would pay attention. Lauroxil is submitting one study because they are using the body of the aripiprazole evidence as support for their NDA. If Abilify is not generic, you are violating the patent. And, if you go at risk before this is resolved, and Otsuka wins, triple damages, baby.

Sounds good. Good luck with that. Keep hanging on.
 






It looks like the initial hearing in 4/14 because they want to hurry up and decide if there is merit in the case. If there is an injunction, Abilify may be delayed in going generic. If you read the link in that article to the actual lawsuit, it's pretty sound legal work. Also, the lead attorney for the firm worked at the FDA, so he fully understands regulatory process, including complex orphan drug status.

At the end of the day, you know that if you sold a drug for something that wasn't in your label, your company would get fined in a heartbeat. What just happened is that the FDA basically ignored that these studies needed to be submitted in the SNDA and changed the label two months later because they claimed they made a mistake. No, no one submitted two well controlled studies in adults for Tourette's.

It's fascinating; but I would pay attention. Lauroxil is submitting one study because they are using the body of the aripiprazole evidence as support for their NDA. If Abilify is not generic, you are violating the patent. And, if you go at risk before this is resolved, and Otsuka wins, triple damages, baby.

Drunk dummy!
 






Otsuka has sued the FDA and Abilify may not go generic. If this happens, does this affect the launch here? Don't be an ass in your responses. I only want to make sure I understand if this will have any implications in Alkermes' plans.

don't be an ass? right back atcha sweetheart. Quid Pro quo darlin'. we owe you nothing. wait for it.....
 






Otsuka has sued the FDA and Abilify may not go generic. If this happens, does this affect the launch here? Don't be an ass in your responses. I only want to make sure I understand if this will have any implications in Alkermes' plans.

So, I take it that your question has been answered or is simply irrelevant?