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studythosestocks

10/21/24 5:25 PM

#429772 RE: north40000 #429768

North, Ramfan's concerns have been mine for many years too. If the lawsuit went forward then the authorized generic V being sold would also be infringing since not approved but for severe HTG. What you have clarified is that with the authorized generic, it's label would list that it is also prescribed for CVD indication and that it would have all the patent protection which the brand carries. I was not aware of this nor have I ever heard anyone verify this. I don't want to misquote you but if you can find the time to just verify my understanding it would be VERY appreciated. Thank you for your expertise in the area of law. Many on the board have benefitted from your understanding and expertise.
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studythosestocks

10/21/24 5:58 PM

#429775 RE: north40000 #429768

To add onto what I just posted, I found this but it is AI generated so do not know how accurate it is, especially in AMRN's situation related to a skinny label/carve out indication. Once again, appreciate your expertise and insight.

An authorized generic can cover all the indications of a brand name drug because it is essentially the exact same medication, just marketed without the brand name, meaning it has the same active ingredients, fillers, dosage forms, and intended uses as the original brand drug; therefore, it can be used for all the same medical conditions.
Key points about authorized generics:
Identical to brand name:
An authorized generic is manufactured by the same company that makes the brand name drug, ensuring it has the same active ingredients, strength, and formulation.
No brand name label:
The only difference is that an authorized generic is sold without the brand name on the label.
Same indications:
Since it's essentially the same medication, an authorized generic can be used for all the same medical conditions as the brand name drug.