Replies to post #334065 on Elite Pharmaceuticals Inc (ELTP)

[sharkey1]

Yep, clear as mud, looks like Teva has Discontinued

https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=077488

When .? Don't know, but this is U.S. they could still make it in Israel..


Guess they sold it to Shire.

[The ELTP King]

DAM this guy is good.

Only one question remains, why did Teva wait several years until April 2020 to finally discontinue it???

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.