Register entry
BioDelivery Sciences International Inc
Data as of · How to read this entry
- Registered sites
- 0
- Active NDC listings
- 8
- Live patents
- 38
- Countries
- 0
Catalogue
Drug listings by form and route
88 active NDC listings: 8 human prescription drug. By marketing category: NDA 8.
| Dosage form | NDCs |
|---|---|
| film, soluble | 7 |
| tablet | 1 |
| Route | NDCs |
|---|---|
| buccal | 7 |
| oral | 1 |
| Labeller name on the listing | NDCs |
|---|---|
| biodelivery sciences international inc | 8 |
Exclusivity
Patents and exclusivities
38| Patent | Product | Covers | Expiry |
|---|---|---|---|
| RE46375 | SYMPROICnaldemedine tosylate | substance, product | Oct 2026 |
| 8147866 | BELBUCA, BUNAVAILbuprenorphine hydrochloride; buprenorphine hydrochloride; naloxone hydrochloride | product | Jul 2027 |
| 9655843 | BELBUCA, BUNAVAILbuprenorphine hydrochloride; buprenorphine hydrochloride; naloxone hydrochloride | product | Jul 2027 |
| RE46365 | SYMPROICnaldemedine tosylate | substance, product | Feb 2031 |
| 9108975 | SYMPROICnaldemedine tosylate | substance, product | Nov 2031 |
| 8703177 | BUNAVAILbuprenorphine hydrochloride; naloxone hydrochloride | product | Aug 2032 |
| 9901539 | BELBUCAbuprenorphine hydrochloride | use | Dec 2032 |
| 10952968 | SYMPROICnaldemedine tosylate | substance, product | May 2033 |
| 12350377 | SYMPROICnaldemedine tosylate | product | May 2033 |
| 9522188 | BUNAVAILbuprenorphine hydrochloride; naloxone hydrochloride | product | Apr 2035 |
Catalogue
Marketed products
8| Brand | Generic name | Form / route | NDC |
|---|---|---|---|
| BELBUCA | buprenorphine hydrochloride | film, soluble, buccal | 59385-021NDA |
| BELBUCA | buprenorphine hydrochloride | film, soluble, buccal | 59385-022NDA |
| BELBUCA | buprenorphine hydrochloride | film, soluble, buccal | 59385-023NDA |
| BELBUCA | buprenorphine hydrochloride | film, soluble, buccal | 59385-024NDA |
| BELBUCA | buprenorphine hydrochloride | film, soluble, buccal | 59385-025NDA |
| BELBUCA | buprenorphine hydrochloride | film, soluble, buccal | 59385-026NDA |
| BELBUCA | buprenorphine hydrochloride | film, soluble, buccal | 59385-027NDA |
| SYMPROIC | naldemedine | tablet, oral | 59385-041NDA |
Compare
Other companies listing buprenorphine hydrochloride
- International Medication Systems, Ltd.3 sites · 2,801 NDC
- RemedyRepack, Inc1 site · 1,521 NDC
- PAI Holdings, LLC1 site · 146 NDC
- Advagen Pharma Limited0 sites · 213 NDC
Enquiry
Common questions
- Is BioDelivery Sciences International Inc FDA approved?
- BioDelivery Sciences International Inc holds no registered establishment of its own; 8 drug products are listed under its name in the National Drug Code Directory, made at sites registered to other firms.
- What drugs does BioDelivery Sciences International Inc make?
- 8 products are listed under BioDelivery Sciences International Inc in the openFDA NDC Directory, most often as film, soluble; tablet. 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.