Register entry
BioDelivery Sciences International Inc
- Registered sites
- 0
- Drug products
- 8
- Live patents
- 38
- Countries
- 0
- Base
- Unknown
Sites
Facilities
0No registered facilities
This company holds drug listings or approvals but operates no registered establishment of its own, which is normal for an NDA holder that outsources manufacturing.
Exclusivity
Patents
38Unexpired Orange Book patents where this company is the application holder.
| Product | Active ingredient | Expiry |
|---|---|---|
| BELBUCA | BUPRENORPHINE HYDROCHLORIDE | Jul 2027 |
| BELBUCA | BUPRENORPHINE HYDROCHLORIDE | Dec 2032 |
| BUNAVAIL | BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE | Jul 2027 |
| BUNAVAIL | BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE | Aug 2032 |
| BUNAVAIL | BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE | Apr 2035 |
| SYMPROIC | NALDEMEDINE TOSYLATE | Oct 2026 |
| SYMPROIC | NALDEMEDINE TOSYLATE | Feb 2031 |
| SYMPROIC | NALDEMEDINE TOSYLATE | Nov 2031 |
| SYMPROIC | NALDEMEDINE TOSYLATE | May 2033 |
Catalogue
Marketed products
8Showing 8 of 8.
| Brand | Generic name | Form | Category |
|---|---|---|---|
| BELBUCA | buprenorphine hydrochloride | FILM, SOLUBLE | NDA |
| BELBUCA | buprenorphine hydrochloride | FILM, SOLUBLE | NDA |
| BELBUCA | buprenorphine hydrochloride | FILM, SOLUBLE | NDA |
| BELBUCA | buprenorphine hydrochloride | FILM, SOLUBLE | NDA |
| BELBUCA | buprenorphine hydrochloride | FILM, SOLUBLE | NDA |
| BELBUCA | buprenorphine hydrochloride | FILM, SOLUBLE | NDA |
| BELBUCA | buprenorphine hydrochloride | FILM, SOLUBLE | NDA |
| SYMPROIC | naldemedine | TABLET | 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.