topiramate · Supernus Pharms · NDA 201635

Trokendi Xr

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

4 Apr 2028

Blocked by patent: US 8298576.

Listed patents · 10 unexpired

20 Orange Book listing rows for 10 patents. FDA lists a patent once for each use code, and lists its pediatric extension as a separate row.

Patent	Claims	Expires	Notes
US 8298576	drug product, use U-106, U-1992	4 Apr 2028	2 listing rows
US 8298576 listing row	drug product, use U-106 · sets the listed date	4 Apr 2028	4 strengths · listed 22 Aug 2013
US 8298576 listing row	drug product, use U-1992 · sets the listed date	4 Apr 2028	4 strengths · listed 22 Aug 2013
US 10314790	drug product, use U-1675, U-1992	16 Nov 2027	2 listing rows
US 10314790 listing row	drug product, use U-1675	16 Nov 2027	4 strengths · listed 9 Jul 2019
US 10314790 listing row	drug product, use U-1992	16 Nov 2027	4 strengths · listed 9 Jul 2019
US 8298580	drug product, use U-106, U-1992	16 Nov 2027	2 listing rows
US 8298580 listing row	drug product, use U-106	16 Nov 2027	4 strengths · listed 22 Aug 2013
US 8298580 listing row	drug product, use U-1992	16 Nov 2027	4 strengths · listed 22 Aug 2013
US 8663683	drug product, use U-106, U-1992	16 Nov 2027	2 listing rows
US 8663683 listing row	drug product, use U-106	16 Nov 2027	4 strengths
US 8663683 listing row	drug product, use U-1992	16 Nov 2027	4 strengths
US 8877248	drug product, use U-106, U-1992	16 Nov 2027	2 listing rows
US 8877248 listing row	drug product, use U-106	16 Nov 2027	4 strengths · listed 12 Nov 2014
US 8877248 listing row	drug product, use U-1992	16 Nov 2027	4 strengths · listed 12 Nov 2014
US 8889191	use U-106, U-1992	16 Nov 2027	2 listing rows
US 8889191 listing row	use U-106	16 Nov 2027	4 strengths · listed 17 Dec 2014
US 8889191 listing row	use U-1992	16 Nov 2027	4 strengths · listed 17 Dec 2014
US 8992989	drug product, use U-1675, U-1992	16 Nov 2027	2 listing rows
US 8992989 listing row	drug product, use U-1675	16 Nov 2027	4 strengths · listed 8 Apr 2015
US 8992989 listing row	drug product, use U-1992	16 Nov 2027	4 strengths · listed 8 Apr 2015
US 9549940	drug product, use U-1675, U-1992	16 Nov 2027	2 listing rows
US 9549940 listing row	drug product, use U-1675	16 Nov 2027	4 strengths · listed 27 Jan 2017
US 9549940 listing row	drug product, use U-1992	16 Nov 2027	4 strengths · listed 27 Jan 2017
US 9555004	drug product, use U-1675, U-1992	16 Nov 2027	2 listing rows
US 9555004 listing row	drug product, use U-1675	16 Nov 2027	4 strengths · listed 9 Feb 2017
US 9555004 listing row	drug product, use U-1992	16 Nov 2027	4 strengths · listed 9 Feb 2017
US 9622983	drug product, use U-1675, U-1992	16 Nov 2027	2 listing rows
US 9622983 listing row	drug product, use U-1675	16 Nov 2027	4 strengths · listed 20 Apr 2017
US 9622983 listing row	drug product, use U-1992	16 Nov 2027	4 strengths · listed 20 Apr 2017

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 · 4

NDA · product	Form	Strength	Approved	Listed expiry
201635 · 001 · RLD	capsule, extended release, oral	25MG	16 Aug 2013	4 Apr 2028
201635 · 002 · RLD	capsule, extended release, oral	50MG	16 Aug 2013	4 Apr 2028
201635 · 003 · RLD	capsule, extended release, oral	100MG	16 Aug 2013	4 Apr 2028
201635 · 004 · RLD	capsule, extended release, oral	200MG	16 Aug 2013	4 Apr 2028