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Last Updated: August 4, 2020

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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, 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

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

SponsorPhase
The Emmes Company, LLCPhase 2/Phase 3
Hennepin Healthcare Research InstitutePhase 2/Phase 3
University of Alabama at BirminghamPhase 2/Phase 3

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
Sun Pharm Industries METHADONE HYDROCHLORIDE methadone hydrochloride TABLET;ORAL 208305-002 Mar 30, 2018 AA RX No No   Start Trial   Start Trial   Start Trial
Hikma DOLOPHINE HYDROCHLORIDE methadone hydrochloride TABLET;ORAL 006134-010 Approved Prior to Jan 1, 1982 AA RX Yes Yes   Start Trial   Start Trial   Start Trial
Ascent Pharms Inc METHADONE HYDROCHLORIDE methadone hydrochloride TABLET;ORAL 211228-002 Jan 3, 2019 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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Serving leading biopharmaceutical companies globally:

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Colorcon

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