Get our Free Patent Expiration Newsletter

Serving leading biopharmaceutical companies globally:

Express Scripts
Boehringer Ingelheim

Last Updated: January 17, 2020

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 204442

Join the DrugPatentWatch Referral Program
Get access to a free drug patent landscape report or a free one-month subscription

« Back to Dashboard

NDA 204442 describes PROBUPHINE, which is a drug marketed by Titan Pharms 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-nine drug master file entries for this compound. Sixteen suppliers are listed for this compound. Additional details are available on the buprenorphine hydrochloride profile page.
Summary for 204442
Applicant:Titan Pharms
Ingredient:buprenorphine hydrochloride
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 Titan Pharmaceuticals, Inc. 52440-100 52440-100-14 4 POUCH in 1 CARTON (52440-100-14) > 1 IMPLANT in 1 POUCH

Profile for product number 001

Approval Date:May 26, 2016TE:RLD:Yes
Regulatory Exclusivity Expiration:May 26, 2019
Regulatory Exclusivity Use:NEW PRODUCT
Patent:  Start TrialPatent Expiration:Apr 25, 2024Product Flag?Substance Flag?Delist Request?

Complete Access Available with Subscription

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

Johnson and Johnson
Harvard Business School

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.