Details for New Drug Application (NDA): 205637
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NDA 205637 describes BUNAVAIL, which is a drug marketed by Bdsi and is included in one NDA. There are four patents protecting this drug and two Paragraph IV challenges. Additional details are available on the BUNAVAIL profile page.
The generic ingredient in BUNAVAIL is buprenorphine hydrochloride; naloxone hydrochloride. There are twenty-nine drug master file entries for this compound. Twenty-six suppliers are listed for this compound. Additional details are available on the buprenorphine hydrochloride; naloxone hydrochloride profile page.
The generic ingredient in BUNAVAIL is buprenorphine hydrochloride; naloxone hydrochloride. There are twenty-nine drug master file entries for this compound. Twenty-six suppliers are listed for this compound. Additional details are available on the buprenorphine hydrochloride; naloxone hydrochloride profile page.
Summary for 205637
| Tradename: | BUNAVAIL |
| Applicant: | Bdsi |
| Ingredient: | buprenorphine hydrochloride; naloxone hydrochloride |
| Patents: | 4 |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | FILM;BUCCAL | Strength | EQ 2.1MG BASE;EQ 0.3MG BASE | ||||
| Approval Date: | Jun 6, 2014 | TE: | RLD: | Yes | |||||
| Patent: | 8,147,866 | Patent Expiration: | Jul 23, 2027 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patented Use: | MAINTENANCE TREATMENT OF OPIOID DEPENDENCE | ||||||||
| Patent: | 8,703,177 | Patent Expiration: | Aug 20, 2032 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patent: | 9,522,188 | Patent Expiration: | Apr 24, 2035 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
Expired US Patents for NDA 205637
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Bdsi | BUNAVAIL | buprenorphine hydrochloride; naloxone hydrochloride | FILM;BUCCAL | 205637-001 | Jun 6, 2014 | 6,159,498 | ⤷ Get Started Free |
| Bdsi | BUNAVAIL | buprenorphine hydrochloride; naloxone hydrochloride | FILM;BUCCAL | 205637-003 | Jun 6, 2014 | 6,159,498 | ⤷ Get Started Free |
| Bdsi | BUNAVAIL | buprenorphine hydrochloride; naloxone hydrochloride | FILM;BUCCAL | 205637-003 | Jun 6, 2014 | 7,579,019 | ⤷ Get Started Free |
| Bdsi | BUNAVAIL | buprenorphine hydrochloride; naloxone hydrochloride | FILM;BUCCAL | 205637-001 | Jun 6, 2014 | 7,579,019 | ⤷ Get Started Free |
| Bdsi | BUNAVAIL | buprenorphine hydrochloride; naloxone hydrochloride | FILM;BUCCAL | 205637-002 | Jun 6, 2014 | 6,159,498 | ⤷ Get Started Free |
| Bdsi | BUNAVAIL | buprenorphine hydrochloride; naloxone hydrochloride | FILM;BUCCAL | 205637-002 | Jun 6, 2014 | 7,579,019 | ⤷ Get Started Free |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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