Make Better Decisions - Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Last Updated: November 18, 2019

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 204442

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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. Eighteen suppliers are listed for this compound. Additional details are available on the buprenorphine hydrochloride profile page.
Summary for 204442
Tradename:PROBUPHINE
Applicant:Titan Pharms
Ingredient:buprenorphine hydrochloride
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 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

Active Rx/OTC/Discontinued:RXDosage:IMPLANT;IMPLANTATIONStrengthEQ 80MG BASE/IMPLANT
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?
Patented Use:FOR OPIOID DEPENDENCE

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