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Serving 500+ biopharmaceutical companies globally:

QuintilesIMS
McKesson
Colorcon
Teva
Novartis
Cantor Fitzgerald
Mallinckrodt
Federal Trade Commission
Baxter
McKinsey

Generated: August 20, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 204442

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NDA 204442 describes PROBUPHINE, which is a drug marketed by Braeburn Pharms Inc and is included in one NDA. It is available from one supplier. There is one patent protecting this drug. Additional details are available on the PROBUPHINE profile page.

The generic ingredient in PROBUPHINE is buprenorphine hydrochloride. There are twenty-eight 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 NDA: 204442

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:1
Formulation / Manufacturing:see details

Pharmacology for NDA: 204442

Mechanism of ActionPartial Opioid Agonists

Suppliers and Packaging for NDA: 204442

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
PROBUPHINE
buprenorphine hydrochloride
IMPLANT;IMPLANTATION 204442 NDA Braeburn Pharmaceuticals 58284-100 58284-100-14 4 POUCH in 1 CARTON (58284-100-14) > 1 IMPLANT in 1 POUCH

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:IMPLANT;IMPLANTATIONStrengthEQ 80MG BASE/IMPLANT
Approval Date:May 26, 2016TE:RLD:Yes
Patent:► SubscribePatent Expiration:Apr 25, 2024Product Flag?Substance Flag?Delist Request?
Patented Use:FOR OPIOID DEPENDENCE
Regulatory Exclusivity Expiration:May 26, 2019
Regulatory Exclusivity Use:NEW PRODUCT


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Serving 500+ biopharmaceutical companies globally:

Teva
Fuji
Express Scripts
Farmers Insurance
Cantor Fitzgerald
Healthtrust
Johnson and Johnson
McKesson
US Army
Colorcon

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.

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