Is Indivior Inc. FDA approved?

Indivior Inc. holds 2 FDA-registered establishments across 2 countries. Registration puts a site on the FDA's register and open to inspection; it is not an approval of the company. Approvals attach to individual drug applications.

Where are Indivior Inc.'s drugs manufactured?

At registered sites in the United Kingdom, the United States. The FDA register lists Hull; Raleigh, NC. Registered operations: analytical testing, active ingredient (API) manufacture, finished drug manufacture, packaging.

What drugs does Indivior Inc. make?

9 products are listed under Indivior Inc. in the openFDA NDC Directory, most often as film, soluble; powder; solution. The full breakdown by dosage form and route is above. A listing count is not a sales figure.

Indivior Inc.

Data as of 24 Sept 2026 · How to read this entry

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Registered sites: 2
Active NDC listings: 9
Labeller names: 3
Live patents: 53
Exclusivities: 1
Countries: 2
Base: United States

Authorisation

Registered operations

Analytical testing2Active ingredient (API) manufacture1Finished drug manufacture1Packaging1

Sites

Registered establishments

Establishment	Address	Registered for	FEI / DUNS
Indivior LimitedRegistrant: Indivior Inc.	Dansom Lane, Hull, England HU8 7DS, United Kingdom (GBR)	Analytical testing, Active ingredient (API) manufacture	3010680503220392796
Indivior Manufacturing LLCRegistrant: Indivior Inc.	8900 Capital Blvd, Raleigh, North Carolina (NC) 27616, United States (USA)	Analytical testing, Finished drug manufacture, Packaging	3005208599119145517

Catalogue

Drug listings by form and route

9 active NDC listings: 7 human prescription drug, 2 bulk ingredient. By marketing category: NDA 7, BULK INGREDIENT 2.

Dosage form	NDCs
film, soluble	4
powder	2
solution	2
spray	1

Route	NDCs
buccal	4
sublingual	4
subcutaneous	2
nasal	1

Labeller name on the listing	NDCs
indivior inc.	4
indivior inc.	3
indivior uk limited	2

Exclusivity

Patents and exclusivities

Patent	Product	Covers	Expiry
11110093	PERSERIS KITrisperidone	product	Nov 2026
10010612	PERSERIS KITrisperidone	product	Feb 2028
10376590	PERSERIS KITrisperidone	use	Feb 2028
11013809	PERSERIS KITrisperidone	product	Feb 2028
11712475	PERSERIS KITrisperidone	use	Feb 2028
9180197	PERSERIS KITrisperidone	product	Feb 2028
9186413	PERSERIS KITrisperidone	use	Feb 2028
11135216	SUBOXONEbuprenorphine hydrochloride; naloxone hydrochloride	product	Aug 2029
9687454	SUBOXONEbuprenorphine hydrochloride; naloxone hydrochloride	product	Aug 2029
8475832	SUBOXONEbuprenorphine hydrochloride; naloxone hydrochloride	product	Mar 2030
10198218	SUBLOCADEbuprenorphine	use	Jun 2031
10592168	SUBLOCADEbuprenorphine	use	Jun 2031
9272044	SUBLOCADEbuprenorphine	use	Jun 2031
9498432	SUBLOCADEbuprenorphine	product	Jun 2031
9782402	SUBLOCADEbuprenorphine	product	Jun 2031
9827241	SUBLOCADEbuprenorphine	product	Jun 2031
10558394	SUBLOCADEbuprenorphine	product	Jun 2031
8975270	SUBLOCADEbuprenorphine	product	Sept 2031
8921387	SUBLOCADEbuprenorphine	product	Jan 2032
11000520	SUBLOCADEbuprenorphine	use	Nov 2035
11839611	SUBLOCADEbuprenorphine	use	Nov 2035
12622904	SUBLOCADEbuprenorphine	use	Nov 2035
10646484	SUBLOCADEbuprenorphine	use	Jun 2038
11458091	OPVEEnalmefene hydrochloride	product	Jul 2038
12290596	OPVEEnalmefene hydrochloride	use	Aug 2042

Product	Exclusivity	Until
SUBLOCADEBUPRENORPHINE	M-314 Miscellaneous	Feb 2028

Catalogue

Marketed products

Brand	Generic name	Form / route	NDC
-	Buprenorphine	powder	71795-2200BULK INGREDIENT
-	Buprenorphine Hydrochloride	powder	71795-1100BULK INGREDIENT
OPVEE	nalmefene hydrochloride	spray, nasal	12496-0003NDA
SUBLOCADE	buprenorphine	solution, subcutaneous	12496-0100NDA
SUBLOCADE	buprenorphine	solution, subcutaneous	12496-0300NDA
Suboxone	buprenorphine hydrochloride, naloxone hydrochloride	film, soluble, buccal, sublingual	12496-1202NDA
Suboxone	buprenorphine hydrochloride, naloxone hydrochloride	film, soluble, buccal, sublingual	12496-1204NDA
Suboxone	buprenorphine hydrochloride, naloxone hydrochloride	film, soluble, buccal, sublingual	12496-1208NDA
Suboxone	buprenorphine hydrochloride, naloxone hydrochloride	film, soluble, buccal, sublingual	12496-1212NDA

Neighbours

Registered in the same town

Ajinomoto Health & Nutrition North America, Inc.Raleigh, NC
Reckitt Benckiser LLCHULL, GBR
Eisai Inc.Raleigh, NC
SpecGx LLCRaleigh, NC
LIEBEL-FLARSHEIM COMPANY LLC.Raleigh, NC
Unit Dose Solutions, Inc.Raleigh, NC

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Enquiry

Common questions

Is Indivior Inc. FDA approved?: Indivior Inc. holds 2 FDA-registered establishments across 2 countries. Registration puts a site on the FDA's register and open to inspection; it is not an approval of the company. Approvals attach to individual drug applications.
Where are Indivior Inc.'s drugs manufactured?: At registered sites in the United Kingdom, the United States. The FDA register lists Hull; Raleigh, NC. Registered operations: analytical testing, active ingredient (API) manufacture, finished drug manufacture, packaging.
What drugs does Indivior Inc. make?: 9 products are listed under Indivior Inc. in the openFDA NDC Directory, most often as film, soluble; powder; solution. The full breakdown by dosage form and route is above. A listing count is not a sales figure.

Compiled from FDA establishment registrations, the openFDA NDC Directory, the Orange Book and the FDA drug shortage database. Not claimed by the company. Sources and methodology.