Details for New Drug Application (NDA): 207932
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NDA 207932 describes BELBUCA, which is a drug marketed by Bdsi and is included in one NDA. It is available from one supplier. There are three patents protecting this drug and three Paragraph IV challenges. Additional details are available on the BELBUCA profile page.
The generic ingredient in BELBUCA is buprenorphine hydrochloride. There are twenty-nine drug master file entries for this compound. Twenty-one suppliers are listed for this compound. Additional details are available on the buprenorphine hydrochloride profile page.
The generic ingredient in BELBUCA is buprenorphine hydrochloride. There are twenty-nine drug master file entries for this compound. Twenty-one suppliers are listed for this compound. Additional details are available on the buprenorphine hydrochloride profile page.
Summary for 207932
| Tradename: | BELBUCA |
| Applicant: | Bdsi |
| Ingredient: | buprenorphine hydrochloride |
| Patents: | 3 |
Pharmacology for NDA: 207932
| Mechanism of Action | Partial Opioid Agonists |
Suppliers and Packaging for NDA: 207932
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| BELBUCA | buprenorphine hydrochloride | FILM;BUCCAL | 207932 | NDA | BioDelivery Sciences International Inc | 59385-021 | 59385-021-60 | 60 POUCH in 1 CARTON (59385-021-60) / 1 FILM, SOLUBLE in 1 POUCH (59385-021-01) |
| BELBUCA | buprenorphine hydrochloride | FILM;BUCCAL | 207932 | NDA | BioDelivery Sciences International Inc | 59385-022 | 59385-022-60 | 60 POUCH in 1 CARTON (59385-022-60) / 1 FILM, SOLUBLE in 1 POUCH (59385-022-01) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | FILM;BUCCAL | Strength | EQ 0.075MG BASE | ||||
| Approval Date: | Oct 23, 2015 | TE: | RLD: | Yes | |||||
| Patent: | 8,147,866 | Patent Expiration: | Jul 23, 2027 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patented Use: | TREATMENT OF PAIN BY TRANSMUCOSAL DELIVERY OF BUPRENORPHINE | ||||||||
| Patent: | 9,655,843 | Patent Expiration: | Jul 23, 2027 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patented Use: | MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE | ||||||||
| Patent: | 9,901,539 | Patent Expiration: | Dec 21, 2032 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE | ||||||||
Expired US Patents for NDA 207932
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Bdsi | BELBUCA | buprenorphine hydrochloride | FILM;BUCCAL | 207932-007 | Oct 23, 2015 | 6,159,498 | ⤷ Subscribe |
| Bdsi | BELBUCA | buprenorphine hydrochloride | FILM;BUCCAL | 207932-005 | Oct 23, 2015 | 6,159,498 | ⤷ Subscribe |
| Bdsi | BELBUCA | buprenorphine hydrochloride | FILM;BUCCAL | 207932-003 | Oct 23, 2015 | 7,579,019 | ⤷ Subscribe |
| Bdsi | BELBUCA | buprenorphine hydrochloride | FILM;BUCCAL | 207932-001 | Oct 23, 2015 | 6,159,498 | ⤷ Subscribe |
| Bdsi | BELBUCA | buprenorphine hydrochloride | FILM;BUCCAL | 207932-006 | Oct 23, 2015 | 6,159,498 | ⤷ Subscribe |
| Bdsi | BELBUCA | buprenorphine hydrochloride | FILM;BUCCAL | 207932-004 | Oct 23, 2015 | 6,159,498 | ⤷ Subscribe |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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