cliffwatch

buprenorphine · Indivior · NDA 209819

Sublocade

Earliest generic entry, as listed · earliest of 2 marketed strengths
6 Nov 2035

Other strengths are listed to 22 Jun 2038.

Blocked by patent: US 11000520, US 11839611, US 12622904. Only method-of-use patents remain, so a generic may carve out the protected indication and enter earlier.

Listed patents · 25 unexpired

PatentClaimsExpires
US 10646484use U-248922 Jun 2038
US 11000520use U-31116 Nov 2035
US 11839611use U-31116 Nov 2035
US 12622904use U-45286 Nov 2035
US 8921387product, use U-21736 Jan 2032
US 8921387product, use U-21746 Jan 2032
US 8975270product, use U-21755 Sep 2031
US 8975270product, use U-22065 Sep 2031
US 10558394product25 Jun 2031
US 10198218use U-24896 Jun 2031
US 10592168use U-24896 Jun 2031
US 9272044use U-21786 Jun 2031
US 9272044use U-21766 Jun 2031
US 9272044use U-22096 Jun 2031
US 9272044use U-21776 Jun 2031
US 9498432product, use U-21796 Jun 2031
US 9782402product, use U-22086 Jun 2031
US 9782402product, use U-21806 Jun 2031
US 9782402product, use U-22076 Jun 2031
US 9782402product, use U-21766 Jun 2031
US 9827241product, use U-21816 Jun 2031
US 9827241product, use U-21746 Jun 2031
US 9827241product, use U-22066 Jun 2031
US 9827241product, use U-22116 Jun 2031
US 9827241product, use U-22106 Jun 2031

Exclusivities · 1 unexpired

M-314miscellaneous (3 years)21 Feb 2028

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
209819 · 001 · RLDsolution, extended release, subcutaneous100MG/0.5ML (100MG/0.5ML)6 Nov 2035
209819 · 002 · RLDsolution, extended release, subcutaneous300MG/1.5ML (200MG/ML)22 Jun 2038