Viewing a single comment thread. View all comments

RabbitFuzz t1_japxxdb wrote

It looks like there are a couple of companies that have applications in with the FDA for the generic version.

https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm

Look up the generic name lisdexamfetamine and it has a couple of companies that have tentative approvals, like Actavis, Roxane, TEVA, Amneal, Myan, Sandoz and Norwich.

Even with approval, depending on the company, it might come out later or as others have mentioned, the company could sue others.

123

the_fungible_man t1_japz7vm wrote

Following that link, it appears that the Vyvanse patents expired on February 24^th . It will be interesting to see whether and how quickly these other manufacturers are able to bring a generic to the market.

44

BellaBlue06 t1_jaq21lx wrote

The main patent expired Feb 24. But they are granted 6 months beyond that for exclusivity still for pediatric patients and supposed to use this time to study effects on kids. Basically most drug companies get a 6 month extension for pediatrics as they delay generics getting a chance and get extra time to rake in full price money and pretend to be studying effects on kids even if they’ve already had a decade to do so. So we have to wait til after Aug 24 2023.

46

Gwinntanamo t1_jaq79an wrote

That’s not how it works. The 6-month extension is granted if the company conducts a study in pediatrics at any point in time. I haven’t looked, but I assume Vyvanse is actually indicated for some pediatric patients already (most ADHD drugs are). The extension is simply an incentive young kids - a patient segment that is often under studied with new products.

25

itsnotamatuerhour t1_jaq2mdx wrote

Another company, which they sued around 2011, revamped production for the end date.

8