Biotech Values

[Biopharm investor]

Dew

"Is it correct that only Teva and PFE's Greenstone have launched generics for Neurontin?"

No. The following firms are actively selling the 100mg, 300mg, and 400mg gabapentin capsules:

Teva
Activis
Greenstone
Sandoz
Apotex
Ranbaxy
Sun
American Health
United Research Labs
Unit Dose Labs
Mutual Pharma
GSMS

The following firms are actively selling the 600mg and 800mg gabapentin tablets:

Teva
Greenstone
Activis
Glenmark
Apotex
Ranbaxy
Sun
American health

"A statutory review timeline for ANDA’s would have helped in the Lovenox case however."

Correct. But that delay isn't a staffing issue.

As for user fees, GPhA's position is that it does not want any user fee package to go for the backlog -- it can only be applied prospectively. Then, in addition, there are a number of other items on the table for negotiation, including rigorous performance metrics (including but not limited to statutory timelines), recruitment and retention of necessary personnel, final agency action, consults by OGD and FDA industry communication, critical path initiatives, labeling carve outs, citizen petitions, first generic review/inspections, etc. Then of course is the all important pathway for generic biologics, which some will try to tie to user fees when it comes up on the Hill.

Regards