Upgrade to enjoy subscriber-only features like email alerts and data export. See the Plans and Pricing

Serving hundreds of leading biopharmaceutical companies globally:

Harvard Business School
Queensland Health
Merck
Baxter
Boehringer Ingelheim
Chinese Patent Office
Julphar
Dow
Colorcon

Generated: May 26, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 205637

« Back to Dashboard

NDA 205637 describes BUNAVAIL, which is a drug marketed by Bdsi and is included in one NDA. It is available from one supplier. There are five 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-two 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:5
Formulation / Manufacturing:see details
Pharmacology for NDA: 205637
Suppliers and Packaging for NDA: 205637
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
BUNAVAIL buprenorphine hydrochloride; naloxone hydrochloride FILM;BUCCAL 205637 NDA BioDelivery Sciences International, Inc. 59385-012 N 59385-012-30
BUNAVAIL buprenorphine hydrochloride; naloxone hydrochloride FILM;BUCCAL 205637 NDA BioDelivery Sciences International, Inc. 59385-014 N 59385-014-30

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:FILM;BUCCALStrengthEQ 2.1MG BASE;EQ 0.3MG BASE
Approval Date:Jun 6, 2014TE:RLD:Yes
Patent:➤ Sign UpPatent Expiration:Jan 22, 2020Product Flag?Substance Flag?Delist Request?
Patented Use:MAINTENANCE TREATMENT OF OPIOID DEPENDENCE
Patent:➤ Sign UpPatent Expiration:Jul 23, 2027Product Flag?YSubstance Flag?Delist Request?
Patented Use:MAINTENANCE TREATMENT OF OPIOID DEPENDENCE
Patent:➤ Sign UpPatent Expiration:Aug 20, 2032Product Flag?YSubstance 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 ➤ Sign Up ➤ Sign Up
Bdsi BUNAVAIL buprenorphine hydrochloride; naloxone hydrochloride FILM;BUCCAL 205637-002 Jun 6, 2014 ➤ Sign Up ➤ Sign Up
Bdsi BUNAVAIL buprenorphine hydrochloride; naloxone hydrochloride FILM;BUCCAL 205637-003 Jun 6, 2014 ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

This preview shows a limited data set. Subscribe for full access, or try a Free Trial

Complete Access Available with Subscription

For more information try a trial or see the plans and pricing

Serving hundreds of leading biopharmaceutical companies globally:

Chubb
Farmers Insurance
Mallinckrodt
Baxter
US Army
Johnson and Johnson
Julphar
Express Scripts
Accenture

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.