buprenorphine hydrochloride; naloxone hydrochloride · Edenbridge Pharms · NDA 204242

Zubsolv

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

18 Sep 2032

Blocked by patent: US 10874661, US 10946010, US 11020387, US 11020388, US 11433066, US 8940330, US 9259421, US 9439900.

FDA has approved 1 generic application (ANDA) for Zubsolv, though its earliest generic-entry date is 18 Sep 2032 as listed. A generic can be approved before that date when it leaves out a patented use (a section viii carve-out), challenges a patent, or settles with the brand company. An approval is not a launch: cliffwatch does not track launches. Approval is not launch

Listed patents · 10 unexpired

Patent	Claims	Expires	Notes
US 10874661	drug product · sets the listed date	18 Sep 2032	listed 25 Jan 2021
US 10946010	drug product · sets the listed date	18 Sep 2032	6 strengths · listed 30 Mar 2021
US 11020387	drug product, use U-3131 · sets the listed date	18 Sep 2032	4 strengths · listed 21 Jun 2021
US 11020388	drug product, use U-3131 · sets the listed date	18 Sep 2032	6 strengths · listed 21 Jun 2021
US 11433066	use U-3131 · sets the listed date	18 Sep 2032	5 strengths · listed 20 Sep 2022
US 8940330	drug product · sets the listed date	18 Sep 2032	6 strengths · listed 5 Feb 2015
US 9259421	drug product · sets the listed date	18 Sep 2032	6 strengths · listed 10 Mar 2016
US 9439900	drug product · sets the listed date	18 Sep 2032	5 strengths · listed 3 Oct 2016
US 8470361	drug product, use U-1425	22 May 2030	6 strengths · listed 10 Jul 2013
US 8658198	drug product, use U-1494	3 Dec 2027	6 strengths · listed 29 Jun 2015

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

Generic approved · ANDA 219727, Ascent Pharms Inc · 204242-001Approved 15 Dec 2025Detected 25 Oct 2026Historical import

Products covered · 6

NDA · product	Form	Strength	Approved	Listed expiry
204242 · 001 · RLD	tablet, sublingual	EQ 1.4MG BASE;EQ 0.36MG BASE	3 Jul 2013	18 Sep 2032
204242 · 002 · RLD	tablet, sublingual	EQ 5.7MG BASE;EQ 1.4MG BASE	3 Jul 2013	18 Sep 2032
204242 · 003 · RLD	tablet, sublingual	EQ 8.6MG BASE;EQ 2.1MG BASE	11 Dec 2014	18 Sep 2032
204242 · 004 · RLD	tablet, sublingual	EQ 11.4MG BASE;EQ 2.9MG BASE	11 Dec 2014	18 Sep 2032
204242 · 005 · RLD	tablet, sublingual	EQ 2.9MG BASE;EQ 0.71MG BASE	4 Jun 2015	18 Sep 2032
204242 · 006 · RLD	tablet, sublingual	EQ 0.7MG BASE;EQ 0.18MG BASE	4 Oct 2016	18 Sep 2032