cliffwatch

buprenorphine hydrochloride; naloxone hydrochloride · Indivior · NDA 020733, 022410

Suboxone

Earliest generic entry, as listed · earliest of 4 marketed strengths
26 Mar 2030

Blocked by patent: US 8475832.

FDA has approved 1 generic application (ANDA) for Suboxone, though its earliest generic-entry date is 26 Mar 2030 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 · 3 unexpired

PatentClaimsExpires
US 8475832drug product, use U-1411 · sets the listed date26 Mar 2030
US 11135216drug product, use U-31117 Aug 2029
US 9687454drug product, use U-14647 Aug 2029

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 219850, Ascent Pharms Inc · 022410-001Approved 21 Jan 2026Detected 25 Oct 2026Historical import

Products covered · 6

NDA · productFormStrengthListed expiry
020733 · 001 · RLD · discontinuedtablet, sublingualEQ 2MG BASE;EQ 0.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**open
020733 · 002 · RLD · discontinuedtablet, sublingualEQ 8MG BASE;EQ 2MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**open
022410 · 001 · RLDfilm, buccal, sublingualEQ 2MG BASE;EQ 0.5MG BASE26 Mar 2030
022410 · 002 · RLDfilm, buccal, sublingualEQ 8MG BASE;EQ 2MG BASE26 Mar 2030
022410 · 003 · RLDfilm, buccal, sublingualEQ 4MG BASE;EQ 1MG BASE26 Mar 2030
022410 · 004 · RLDfilm, buccal, sublingualEQ 12MG BASE;EQ 3MG BASE26 Mar 2030