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 · 13 unexpired

25 Orange Book listing rows for 13 patents. FDA lists a patent once for each use code, and lists its pediatric extension as a separate row.

Patent	Claims	Expires	Notes
US 10646484	use U-2489	22 Jun 2038	listed 12 May 2020
US 11000520	use U-3111 · sets the listed date	6 Nov 2035	2 strengths · listed 20 May 2021
US 11839611	use U-3111 · sets the listed date	6 Nov 2035	2 strengths · listed 8 Jan 2024
US 12622904	use U-4528 · sets the listed date	6 Nov 2035	2 strengths · listed 5 Jun 2026
US 8921387	drug product, use U-2173, U-2174	6 Jan 2032	2 listing rows
US 8921387 listing row	drug product, use U-2173	6 Jan 2032	2 strengths · listed 13 Dec 2017
US 8921387 listing row	drug product, use U-2174	6 Jan 2032	2 strengths · listed 13 Dec 2017
US 8975270	drug product, use U-2175, U-2206	5 Sep 2031	2 listing rows
US 8975270 listing row	drug product, use U-2175	5 Sep 2031	2 strengths · listed 13 Dec 2017
US 8975270 listing row	drug product, use U-2206	5 Sep 2031	2 strengths · listed 13 Dec 2017
US 10558394	drug product	25 Jun 2031	2 strengths · listed 16 Jul 2020
US 10198218	use U-2489	6 Jun 2031	2 strengths · listed 15 Feb 2019
US 10592168	use U-2489	6 Jun 2031	2 strengths · listed 19 Mar 2020
US 9272044	use U-2176, U-2177, U-2178, U-2209	6 Jun 2031	4 listing rows
US 9272044 listing row	use U-2176	6 Jun 2031	2 strengths · listed 13 Dec 2017
US 9272044 listing row	use U-2177	6 Jun 2031	2 strengths · listed 13 Dec 2017
US 9272044 listing row	use U-2178	6 Jun 2031	2 strengths · listed 13 Dec 2017
US 9272044 listing row	use U-2209	6 Jun 2031	2 strengths · listed 13 Dec 2017
US 9498432	drug product, use U-2179	6 Jun 2031	2 strengths · listed 13 Dec 2017
US 9782402	drug product, use U-2176, U-2180, U-2207, U-2208	6 Jun 2031	4 listing rows
US 9782402 listing row	drug product, use U-2176	6 Jun 2031	2 strengths · listed 13 Dec 2017
US 9782402 listing row	drug product, use U-2180	6 Jun 2031	2 strengths · listed 13 Dec 2017
US 9782402 listing row	drug product, use U-2207	6 Jun 2031	2 strengths · listed 13 Dec 2017
US 9782402 listing row	drug product, use U-2208	6 Jun 2031	2 strengths · listed 13 Dec 2017
US 9827241	drug product, use U-2174, U-2181, U-2206, U-2210, U-2211	6 Jun 2031	5 listing rows
US 9827241 listing row	drug product, use U-2174	6 Jun 2031	2 strengths · listed 13 Dec 2017
US 9827241 listing row	drug product, use U-2181	6 Jun 2031	2 strengths · listed 13 Dec 2017
US 9827241 listing row	drug product, use U-2206	6 Jun 2031	2 strengths · listed 13 Dec 2017
US 9827241 listing row	drug product, use U-2210	6 Jun 2031	2 strengths · listed 13 Dec 2017
US 9827241 listing row	drug product, use U-2211	6 Jun 2031	2 strengths · listed 13 Dec 2017

Exclusivities · 1 unexpired

M-314

miscellaneous (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 · product	Form	Strength	Approved	Listed expiry
209819 · 001 · RLD	solution, extended release, subcutaneous	100MG/0.5ML (100MG/0.5ML)	30 Nov 2017	6 Nov 2035
209819 · 002 · RLD	solution, extended release, subcutaneous	300MG/1.5ML (200MG/ML)	30 Nov 2017	22 Jun 2038