Difference between At-Risk and Authorized Generics

[diana.papshev]

During the June 2010 Webinar (see more details here), the following question was submitted, we’d like to open it for a general discussion in our community:

“How are at-risk generics different from authorized generics?”

[diana.papshev]

There are significant differences between at-risk and authorized generic.

The main difference is that at-risk generics are fully-approved ANDA-based generics, whereas authorized generics are marketed under the brand's NDA (based on a licensing agreement).

For instance, the following figure depicts market entry pathways for generic products:

o Those generics that are launched at-risk (as highlighted by the red rectangle) follow the ANDA with paragraph IV certification pathway, in which a generic company contests brand product's patent(s). During this process, the generic company receives final FDA approval (either because the 30-month stay expires or because patent(s) is(are) defeated in court) and launches its product while litigation is still ongoing
o Those products that are launched as authorized generics, never go through the formal FDA review. As indicated on this figure, these products are marketed under the brand product's NDA with a private label (with the permission/license of the brand company). By definition, authorized generics have the same active and inactive ingredients, formulation, etc. as the brand product; the only difference is the label.

Good examples of each of these are the generic Yasmin/Yaz products:

o Ocella is the authorized generic for Yasmin, which was launched by Barr/Teva under a license from Bayer in 2008 (it is marketed under Yasmin's NDA and has not been approved by the FDA as an ANDA-based generic product). Ocella will remain on the market based on the terms of the licensing agreement between the companies
o Gianvi is the generic for Yaz, which has been launched by Barr/Teva at-risk in June 2010 despite unresolved litigation pertaining to one of the patents covering Yaz. Bayer is currently pursuing Teva in court and depending on the outcome of this case, Gianvi could be pulled from the market.