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Last Updated: April 18, 2024

Methadone hydrochloride - Generic Drug Details


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What are the generic 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, Long Grove Pharms, 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 eight drug master file entries for methadone hydrochloride. Eighteen 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
Parnassia Addiction Research CentrePhase 2
Leiden University Medical CenterPhase 2
The Netherlands Cancer InstitutePhase 2

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
Long Grove Pharms METHADONE HYDROCHLORIDE methadone hydrochloride INJECTABLE;INJECTION 208306-001 Oct 27, 2017 AP RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Roxane METHADONE HYDROCHLORIDE methadone hydrochloride TABLET;ORAL 088109-001 Mar 8, 1983 AA RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Specgx Llc METHADONE HYDROCHLORIDE methadone hydrochloride TABLET;ORAL 040517-001 Apr 27, 2004 AA RX No Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Vistapharm METHADONE HYDROCHLORIDE methadone hydrochloride TABLET;ORAL 040241-001 May 29, 1998 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Specgx Llc METHADONE HYDROCHLORIDE methadone hydrochloride TABLET, FOR SUSPENSION;ORAL 077142-001 Jul 12, 2005 AA RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Epic Pharma Llc METHADONE HYDROCHLORIDE methadone hydrochloride TABLET;ORAL 090065-001 Aug 18, 2015 AA RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Hikma METHADONE HYDROCHLORIDE methadone hydrochloride CONCENTRATE;ORAL 040180-001 Apr 30, 1998 AA RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a 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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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 verification 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.