Register entry
Indivior Inc.
- Registered sites
- 2
- Drug products
- 9
- Live patents
- 57
- Countries
- 2
- Base
- United States
Authorisation
Registered operations
What the FDA has registered these sites to do. This is the regulatory record, not a marketing claim.
Analytical testingActive ingredient (API) manufactureFinished drug manufacturePackaging
Sites
Facilities
2| Site | Location | Operations | FEI |
|---|---|---|---|
| Indivior Limited | HullUnited Kingdom | Analytical testing, Active ingredient (API) manufacture | 3010680503 |
| Indivior Manufacturing LLC | Raleigh, NCUnited States | Analytical testing, Finished drug manufacture, Packaging | 3005208599 |
Exclusivity
Patents
57Unexpired Orange Book patents where this company is the application holder.
| Product | Active ingredient | Expiry |
|---|---|---|
| OPVEE | NALMEFENE HYDROCHLORIDE | Jul 2038 |
| OPVEE | NALMEFENE HYDROCHLORIDE | Aug 2042 |
| PERSERIS KIT | RISPERIDONE | Sept 2026 |
| PERSERIS KIT | RISPERIDONE | Nov 2026 |
| PERSERIS KIT | RISPERIDONE | Feb 2028 |
| SUBLOCADE | BUPRENORPHINE | Jun 2031 |
| SUBLOCADE | BUPRENORPHINE | Jun 2031 |
| SUBLOCADE | BUPRENORPHINE | Sept 2031 |
| SUBLOCADE | BUPRENORPHINE | Jan 2032 |
| SUBLOCADE | BUPRENORPHINE | Nov 2035 |
| SUBLOCADE | BUPRENORPHINE | Jun 2038 |
| SUBOXONE | BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE | Aug 2029 |
| SUBOXONE | BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE | Mar 2030 |
Catalogue
Marketed products
9Showing 9 of 9.
| Brand | Generic name | Form | Category |
|---|---|---|---|
| - | Buprenorphine | POWDER | BULK INGREDIENT |
| - | Buprenorphine Hydrochloride | POWDER | BULK INGREDIENT |
| OPVEE | nalmefene hydrochloride | SPRAY | NDA |
| SUBLOCADE | buprenorphine | SOLUTION | NDA |
| SUBLOCADE | buprenorphine | SOLUTION | NDA |
| Suboxone | buprenorphine hydrochloride, naloxone hydrochloride | FILM, SOLUBLE | NDA |
| Suboxone | buprenorphine hydrochloride, naloxone hydrochloride | FILM, SOLUBLE | NDA |
| Suboxone | buprenorphine hydrochloride, naloxone hydrochloride | FILM, SOLUBLE | NDA |
| Suboxone | buprenorphine hydrochloride, naloxone hydrochloride | FILM, SOLUBLE | NDA |
Provenance
Facility and operations data from the FDA Drug Establishments Current Registration Site. Product data from the openFDA National Drug Code Directory. Patent and exclusivity data from the FDA Orange Book. Shortage data from the FDA drug shortage database. Contact details the FDA publishes for registered establishments are deliberately not reproduced here. This entry is compiled from public records and has not been claimed by the company.