cliffwatch

doxepin hydrochloride · Currax · NDA 022036

Silenor

Earliest generic entry, as listed · earliest of 2 marketed strengths
7 Sep 2030

Blocked by patent: US 8513299. Only method-of-use patents remain, so a generic may carve out the protected indication and enter earlier.

Listed patents · 16 unexpired

PatentClaimsExpires
US 8513299use U-6207 Sep 2030
US 9532971product1 Jun 2029
US 9107898use U-6201 May 2028
US 10548871use U-62011 Apr 2028
US 11096920use U-62011 Apr 2028
US 9907780product11 Apr 2028
US 11234954use U-62018 Jan 2028
US 7915307use U-62024 Aug 2027
US 10653660use U-62020 Jul 2027
US 11110074use U-62020 Jul 2027
US 9572814use U-62020 Jul 2027
US 10238620use U-62018 May 2027
US 10653662use U-62018 May 2027
US 12083090use U-62018 May 2027
US 9486437use U-62018 May 2027
US 9861607use U-62018 May 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 · 2

NDA · productFormStrengthListed expiry
022036 · 001 · RLDtablet, oralEQ 3MG BASE7 Sep 2030
022036 · 002 · RLDtablet, oralEQ 6MG BASE7 Sep 2030