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Last Updated: July 29, 2021

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Methadone hydrochloride - Generic Drug Details

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What are the generic drug sources for methadone hydrochloride and what is the scope of patent protection?

Methadone hydrochloride is the generic ingredient in five branded drugs marketed by Hikma, Lannett Co Inc, 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-three NDAs. Additional information is available in the individual branded drug profile pages.

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

Drug Prices for methadone hydrochloride

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Recent Clinical Trials for methadone hydrochloride

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
University of Sao Paulo General HospitalPhase 3
Milton S. Hershey Medical CenterEarly Phase 1
Aarhus University HospitalPhase 4

See all methadone hydrochloride clinical trials

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
Vistapharm METHADONE HYDROCHLORIDE methadone hydrochloride CONCENTRATE;ORAL 040088-001 Nov 30, 1994 AA RX No No ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Specgx Llc METHADOSE methadone hydrochloride CONCENTRATE;ORAL 017116-002 Approved Prior to Jan 1, 1982 AA RX Yes Yes ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Lannett Co Inc METHADONE HYDROCHLORIDE methadone hydrochloride CONCENTRATE;ORAL 212093-001 Nov 2, 2020 AA RX No No ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Hikma DOLOPHINE HYDROCHLORIDE methadone hydrochloride TABLET;ORAL 006134-010 Approved Prior to Jan 1, 1982 DISCN Yes No ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
>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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Serving leading biopharmaceutical companies globally:

AstraZeneca
McKesson
Merck
Baxter
Moodys
Colorcon

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