Elite Pharmaceuticals Inc (ELTP)

[WeeZuhl]

TEVA is still selling plenty of Adderall XR

Our product is we have the authorized generic for Adderall XR. Our product is made for us by Takeda, which was formally Shire. Takeda acquired Shire. Our product is the authorized generic. It is the brand product Adderall XR, marketed as a generic.

We did have the Teva label product back when we first started getting the authorized generic. Teva did have an agreement with, at that time, Shire, with marketing the authorized generic.

Yes, TEVA's ANDA for generic Adderall XR has been offically discontinued in the FDA Orange Book (see below), but that does not mean they have stopped selling it. First, as far as I am aware, no drug was ever sold under that ANDA. FDA approved TEVA's ANDA, but there was a scheme with Shire/TEVA/Impax to sit on the newly-approved ANDA's and instead sell Shire's brand name NDA product as "Authorized Generics." When TEVA/Actavis merged, Prasco picked up TEVA's distribution deal with Shire and **NOT TEVA's ADDERALL XR ANDA**. When those distribution rights expired, Prasco then made a new deal directly with Shire to continue to distribute the NDA product as an Authorized Generic. Prasco never had an ANDA and has only sold Shire's NDA product. Meanwhile, TEVA started selling a true generic version of Adderall XR using the Actavis ANDA, and they continue to do that without interruption.


Clear as mud. TEVA's ANDA is officially discontinued, but it was never used. TEVA continues to make a true generic Adderall XR with the Actavis ANDA. Prasco has never manufactured anything, and they never had anything to do with any ANDA for Adderall XR.