Drybench Patent.

BUPRENORPHINE, NDA 209819

The patents and exclusivities FDA's Orange Book lists for NDA 209819 as captured on 14 October 2026, each date named by its rule and its rows, and any rows of FDA's Paragraph IV list captured on 17 October 2026 that give this NDA's number. Listed protection is a range of dates, never one date.

FDA capture · review pending. Each row is shown as captured from FDA's Orange Book files and Paragraph IV list. Dates are FDA's own; spreadsheet day numbers are shown as dates, and a cell that cannot be read as one date is shown as written and left out of the range. Where FDA lists a *PED row without flags, its flags are read from the base row and marked so. A Paragraph IV row is placed here only by the number in its RLD/NDA cell; nothing is joined by name. How this page reads FDA's files has not been independently reviewed by a regulatory-affairs reviewer.

Orange Book captured: 14 October 2026
Paragraph IV list captured: 17 October 2026
Last checked: 30 October 2026
Data-branch commit: dadcab56563716abea6c5e31a5e1970080c778ef

Listed protection is a range of the dates FDA lists, not a forecast of market entry, and not legal, regulatory or investment advice.

Dates as listed in FDA's Orange Book capture of 14 October 2026. This page does not say whether a date has passed; compare it with today's date and FDA's current Orange Book. This page shows only what the capture of 14 October 2026 lists. It does not show patents or exclusivities listed before and since removed.

Open in the app BUPRENORPHINE in the molecule app

Listed protection

Listed dates run from 21 Feb 2028 to 22 Jun 2038, each by its own rule; no one date stands for this product.

Earliest listed date: 21 Feb 2028M-314 exclusivityRule R3 · Products 001, 002
Source lines
exclusivity.txt lines 809–810
Latest listed date: 22 Jun 2038US 10,646,484, use patentRule R1 · Product 002
Source lines
patent.txt line 10,864
Latest substance patent: None listed
Latest listed patent: 22 Jun 2038US 10,646,484, use patentRule R1 · Product 002
Source lines
patent.txt line 10,864
Latest exclusivity: 21 Feb 2028M-314 exclusivityRule R3 · Products 001, 002
Source lines
exclusivity.txt lines 809–810

Listed dates of other NDAs in the same years:2028 2031 2032 2035 2038

47 use-code patents, blocking the coded use only

Products

Each product number FDA lists under NDA 209819, as listed. The sections below name products by these numbers.

Product 001 · SUBLOCADE
Dosage form; route
SOLUTION, EXTENDED RELEASE;SUBCUTANEOUS
Strength
100MG/0.5ML (100MG/0.5ML)
Approval date as listed
30 Nov 2017
Type as listed
RX
Applicant as listed
INDIVIOR INC
Product 002 · SUBLOCADE
Dosage form; route
SOLUTION, EXTENDED RELEASE;SUBCUTANEOUS
Strength
300MG/1.5ML (200MG/ML)
Approval date as listed
30 Nov 2017
Type as listed
RX
Applicant as listed
INDIVIOR INC

Listed patents

Every patent the FDA lists for this product, as the application holder submitted it, with its flags. The FDA does not verify listings.

25 entries from 49 rows as listed; rows merge only where every cell shown is the same, each with its product numbers.

US 10,198,218, use patent
patent.txt lines 10,837, 10,861
Expiry as listed
6 Jun 2031
Rule
R1
Flags
use code U-2489
Product numbers
001, 002
US 10,592,168, use patent
patent.txt lines 10,839, 10,863
Expiry as listed
6 Jun 2031
Rule
R1
Flags
use code U-2489
Product numbers
001, 002
US 9,272,044, use patent
patent.txt lines 10,847, 10,872
Expiry as listed
6 Jun 2031
Rule
R1
Flags
use code U-2176
Product numbers
001, 002
US 9,272,044, use patent
patent.txt lines 10,848, 10,873
Expiry as listed
6 Jun 2031
Rule
R1
Flags
use code U-2177
Product numbers
001, 002
US 9,272,044, use patent
patent.txt lines 10,849, 10,874
Expiry as listed
6 Jun 2031
Rule
R1
Flags
use code U-2178
Product numbers
001, 002
US 9,272,044, use patent
patent.txt lines 10,850, 10,875
Expiry as listed
6 Jun 2031
Rule
R1
Flags
use code U-2209
Product numbers
001, 002
US 9,498,432, product and use patent
patent.txt lines 10,851, 10,876
Expiry as listed
6 Jun 2031
Rule
R1
Flags
product · use code U-2179
Product numbers
001, 002
US 9,782,402, product and use patent
patent.txt lines 10,852, 10,877
Expiry as listed
6 Jun 2031
Rule
R1
Flags
product · use code U-2176
Product numbers
001, 002
US 9,782,402, product and use patent
patent.txt lines 10,853, 10,878
Expiry as listed
6 Jun 2031
Rule
R1
Flags
product · use code U-2180
Product numbers
001, 002
US 9,782,402, product and use patent
patent.txt lines 10,854, 10,879
Expiry as listed
6 Jun 2031
Rule
R1
Flags
product · use code U-2207
Product numbers
001, 002
US 9,782,402, product and use patent
patent.txt lines 10,855, 10,880
Expiry as listed
6 Jun 2031
Rule
R1
Flags
product · use code U-2208
Product numbers
001, 002
US 9,827,241, product and use patent
patent.txt lines 10,856, 10,881
Expiry as listed
6 Jun 2031
Rule
R1
Flags
product · use code U-2174
Product numbers
001, 002
US 9,827,241, product and use patent
patent.txt lines 10,857, 10,882
Expiry as listed
6 Jun 2031
Rule
R1
Flags
product · use code U-2181
Product numbers
001, 002
US 9,827,241, product and use patent
patent.txt lines 10,858, 10,883
Expiry as listed
6 Jun 2031
Rule
R1
Flags
product · use code U-2206
Product numbers
001, 002
US 9,827,241, product and use patent
patent.txt lines 10,859, 10,884
Expiry as listed
6 Jun 2031
Rule
R1
Flags
product · use code U-2210
Product numbers
001, 002
US 9,827,241, product and use patent
patent.txt lines 10,860, 10,885
Expiry as listed
6 Jun 2031
Rule
R1
Flags
product · use code U-2211
Product numbers
001, 002
US 10,558,394, product patent
patent.txt lines 10,838, 10,862
Expiry as listed
25 Jun 2031
Rule
R1
Flags
product
Product numbers
001, 002
US 8,975,270, product and use patent
patent.txt lines 10,845, 10,870
Expiry as listed
5 Sep 2031
Rule
R1
Flags
product · use code U-2175
Product numbers
001, 002
US 8,975,270, product and use patent
patent.txt lines 10,846, 10,871
Expiry as listed
5 Sep 2031
Rule
R1
Flags
product · use code U-2206
Product numbers
001, 002
US 8,921,387, product and use patent
patent.txt lines 10,843, 10,868
Expiry as listed
6 Jan 2032
Rule
R1
Flags
product · use code U-2173
Product numbers
001, 002
US 8,921,387, product and use patent
patent.txt lines 10,844, 10,869
Expiry as listed
6 Jan 2032
Rule
R1
Flags
product · use code U-2174
Product numbers
001, 002
US 11,000,520, use patent
patent.txt lines 10,840, 10,865
Expiry as listed
6 Nov 2035
Rule
R1
Flags
use code U-3111
Product numbers
001, 002
US 11,839,611, use patent
patent.txt lines 10,841, 10,866
Expiry as listed
6 Nov 2035
Rule
R1
Flags
use code U-3111
Product numbers
001, 002
US 12,622,904, use patent
patent.txt lines 10,842, 10,867
Expiry as listed
6 Nov 2035
Rule
R1
Flags
use code U-4528
Product numbers
001, 002
US 10,646,484, use patent
patent.txt line 10,864
Expiry as listed
22 Jun 2038
Rule
R1
Flags
use code U-2489
Product numbers
002

Listed exclusivities

Each exclusivity FDA lists for NDA 209819, with its code, FDA's definition of the code where the store's code list gives one, and its date as listed.

M-314 exclusivity
exclusivity.txt lines 809–810
Date
21 Feb 2028
Rule
R3
Definition
Miscellaneous (to be checked against FDA's list)
Product numbers
001, 002

Paragraph IV list rows giving NDA 209819

The rows of FDA's Paragraph IV certifications list as captured on 17 October 2026 whose RLD/NDA cell gives NDA 209819, each cell as listed.

Rows with no NDA number this page can match are kept apart on the list page; some may concern this product.

No row of the Paragraph IV list captured on 17 October 2026 gives NDA 209819 in its RLD/NDA cell. This does not mean no certification was submitted or that no application challenges a patent listed here.

Notes from the trace

R6 tentative approvals: not in the Orange Book data files as captured; the Drugs@FDA join is a later ruling.

Patents vs FDA exclusivity How to read the Orange Book data files Paragraph IV certification What changed, by week