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Last Updated: September 29, 2020

DrugPatentWatch Database Preview

METHADONE HYDROCHLORIDE - Generic Drug Details

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What are the generic drug sources for methadone hydrochloride and what is the scope of freedom to operate?

Methadone hydrochloride is the generic ingredient in five branded drugs marketed by Hikma, Specgx Llc, Vistapharm, Akorn, Mylan Institutional, Mallinckrodt Inc, Sandoz, Ascent Pharms Inc, Aurolife Pharma Llc, Epic Pharma Llc, Nostrum Labs Inc, Roxane, Sun Pharm Industries, and Thepharmanetwork Llc, and is included in thirty-one NDAs. Additional information is available in the individual branded drug profile pages.

There are thirteen drug master file entries for methadone hydrochloride. Twenty suppliers are listed for this compound.

Drug Prices for METHADONE HYDROCHLORIDE

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Recent Clinical Trials for METHADONE HYDROCHLORIDE

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SponsorPhase
National Institute of Drug AbusePhase 2
Ho Chi Minh City CDCPhase 2
The Wistar InstitutePhase 2

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Pharmacology for METHADONE HYDROCHLORIDE
Drug ClassOpioid Agonist
Mechanism of ActionFull Opioid Agonists
Medical Subject Heading (MeSH) Categories for METHADONE HYDROCHLORIDE

US Patents and Regulatory Information for METHADONE HYDROCHLORIDE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Hikma DOLOPHINE HYDROCHLORIDE methadone hydrochloride TABLET;ORAL 006134-002 Approved Prior to Jan 1, 1982 DISCN Yes No   Start Trial   Start Trial   Start Trial
Hikma METHADONE HYDROCHLORIDE methadone hydrochloride SOLUTION;ORAL 087393-001 Approved Prior to Jan 1, 1982 AA RX No Yes   Start Trial   Start Trial   Start Trial
Vistapharm METHADONE HYDROCHLORIDE methadone hydrochloride SOLUTION;ORAL 090707-001 Jun 30, 2010 AA RX No No   Start Trial   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

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