.

Pharmaceutical Business Intelligence

  • Anticipate P&T budget requirements
  • Evaluate market entry opportunities
  • Find generic sources and suppliers
  • Predict branded drug patent expiration

► Plans and Pricing

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

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 205637

« Back to Dashboard
NDA 205637 describes BUNAVAIL, which is a drug marketed by Biodelivery Sci Intl and is included in one NDA. It is available from one supplier. There are four patents protecting this drug and one Paragraph IV challenge. Additional details are available on the BUNAVAIL profile page.

The generic ingredient in BUNAVAIL is buprenorphine hydrochloride; naloxone hydrochloride. There are twenty-eight drug master file entries for this compound. Nineteen suppliers are listed for this compound. Additional details are available on the buprenorphine hydrochloride; naloxone hydrochloride profile page.

Summary for NDA: 205637

Tradename:
BUNAVAIL
Applicant:
Biodelivery Sci Intl
Ingredient:
buprenorphine hydrochloride; naloxone hydrochloride
Patents:4
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 59385-012-30 30 POUCH in 1 BOX (59385-012-30) > 1 FILM in 1 POUCH (59385-012-01)
BUNAVAIL
buprenorphine hydrochloride; naloxone hydrochloride
FILM;BUCCAL 205637 NDA BioDelivery Sciences International, Inc. 59385-014 59385-014-30 30 POUCH in 1 BOX (59385-014-30) > 1 FILM in 1 POUCH (59385-014-01)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:FILM;BUCCALStrengthEQ 2.1MG BASE;EQ 0.3MG BASE
Approval Date:Jun 6, 2014TE:RLD:No
Patent:6,159,498Patent Expiration:Oct 18, 2016Product Flag?YSubstance Flag?Delist Request?
Patent:8,703,177Patent Expiration:Aug 20, 2032Product Flag?YSubstance Flag?Delist Request?
Patent:7,579,019Patent Expiration:Jan 22, 2020Product Flag?Substance Flag?Delist Request?
Patented Use:MAINTENANCE TREATMENT OF OPIOID DEPENDENCE

Expired Orange Book Patents for NDA: 205637

These historical archives are available as an add-on to one-year subscriptions.
See the Subscription Options for more information.

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Biodelivery Sci Intl
BUNAVAIL
buprenorphine hydrochloride; naloxone hydrochloride
FILM;BUCCAL205637-001Jun 6, 20146,159,498► subscribe
Biodelivery Sci Intl
BUNAVAIL
buprenorphine hydrochloride; naloxone hydrochloride
FILM;BUCCAL205637-003Jun 6, 20146,159,498► subscribe
Biodelivery Sci Intl
BUNAVAIL
buprenorphine hydrochloride; naloxone hydrochloride
FILM;BUCCAL205637-002Jun 6, 20146,159,498► subscribe
This preview shows a limited data set
Subscribe for full access, or try a Trial

Export unavailable in trial.
Subscribe for complete access.



Complete Access Available with Subscription
« Back to Dashboard

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

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.

`abc