tiagabine hydrochloride · Cephalon · NDA 020646

Gabitril

Earliest generic entry, as listed · earliest of 4 marketed strengths

Open now

No unexpired patents or exclusivities are listed for this product.

Listed patents · 0 unexpired

No unexpired patents listed.

Exclusivities · 0 unexpired

No unexpired exclusivities listed.

Paragraph IV certifications · 0

No Paragraph IV certification listed by FDA for this drug.

The list shows that a generic applicant certified to FDA that a listed patent is invalid or not infringed. It does not show litigation, settlements or launch timing.

Event history

No events yet. The first ingestion only records products entering their 12-month window; changes appear from the next Orange Book update.

Products covered · 8

NDA · product	Form	Strength	Approved	Listed expiry
020646 · 001 · RLD	tablet, oral	4MG	30 Sep 1997	open
020646 · 002 · RLD	tablet, oral	12MG	30 Sep 1997	open
020646 · 003 · RLD	tablet, oral	16MG	30 Sep 1997	open
020646 · 004 · discontinued	tablet, oral	20MG	30 Sep 1997	open
020646 · 005 · RLD	tablet, oral	2MG	16 Apr 1999	open
020646 · 006 · discontinued	tablet, oral	6MG	29 Nov 2005	open
020646 · 007 · discontinued	tablet, oral	8MG	29 Nov 2005	open
020646 · 008 · discontinued	tablet, oral	10MG	29 Nov 2005	open