cliffwatch

hydrocodone bitartrate · Knoa Pharma · NDA 206627

Hysingla Er

Earliest generic entry, as listed · earliest of 6 marketed strengths
21 Dec 2031

Blocked by patent: US 8808740, US 9572779, US 9750703, US 9861584, US 9872837.

Listed patents · 19 unexpired

PatentClaimsExpires
US 8808740product, use U-155621 Dec 2031
US 9572779product21 Dec 2031
US 9750703product21 Dec 2031
US 9861584product21 Dec 2031
US 9872837product21 Dec 2031
US 11304908product24 Aug 2027
US 11304909use U-155624 Aug 2027
US 9084816product24 Aug 2027
US 9095614use U-155624 Aug 2027
US 9095615product24 Aug 2027
US 9486412product24 Aug 2027
US 9486413product24 Aug 2027
US 9492389product24 Aug 2027
US 9492390use U-155624 Aug 2027
US 9492391use U-155624 Aug 2027
US 9545380use U-155624 Aug 2027
US 9763933product24 Aug 2027
US 9770416product24 Aug 2027
US 9775809product24 Aug 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 · 7

NDA · productFormStrengthListed expiry
206627 · 001 · RLDtablet, extended release, oral20MG21 Dec 2031
206627 · 002 · RLDtablet, extended release, oral30MG21 Dec 2031
206627 · 003 · RLDtablet, extended release, oral40MG21 Dec 2031
206627 · 004 · RLDtablet, extended release, oral60MG21 Dec 2031
206627 · 005 · RLDtablet, extended release, oral80MG21 Dec 2031
206627 · 006 · RLDtablet, extended release, oral100MG21 Dec 2031
206627 · 007 · RLD · discontinuedtablet, extended release, oral120MG21 Dec 2031