cliffwatch

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, US 8298576.

Listed patents · 20 unexpired

PatentClaimsExpires
US 8298576product, use U-19924 Apr 2028
US 8298576product, use U-1064 Apr 2028
US 10314790product, use U-199216 Nov 2027
US 10314790product, use U-167516 Nov 2027
US 8298580product, use U-10616 Nov 2027
US 8298580product, use U-199216 Nov 2027
US 8663683product, use U-199216 Nov 2027
US 8663683product, use U-10616 Nov 2027
US 8877248product, use U-10616 Nov 2027
US 8877248product, use U-199216 Nov 2027
US 8889191use U-10616 Nov 2027
US 8889191use U-199216 Nov 2027
US 8992989product, use U-199216 Nov 2027
US 8992989product, use U-167516 Nov 2027
US 9549940product, use U-167516 Nov 2027
US 9549940product, use U-199216 Nov 2027
US 9555004product, use U-167516 Nov 2027
US 9555004product, use U-199216 Nov 2027
US 9622983product, use U-199216 Nov 2027
US 9622983product, use U-167516 Nov 2027

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 · productFormStrengthListed expiry
201635 · 001 · RLDcapsule, extended release, oral25MG4 Apr 2028
201635 · 002 · RLDcapsule, extended release, oral50MG4 Apr 2028
201635 · 003 · RLDcapsule, extended release, oral100MG4 Apr 2028
201635 · 004 · RLDcapsule, extended release, oral200MG4 Apr 2028