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FDA Orange Book · active-ingredient family

Methadone hydrochloride

Methadone hydrochloride is approved as 6 brand and 28 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.

Reference-listed drug:METHADOSE · NDA 017116

6

Brand (NDA)

28

Generics (ANDA)

0

Listed patents

0

Exclusivity periods

Brand (NDA) products · concentrate, injectable, powder, solution, syrup, tablet, tablet, dispersible, tablet, effervescent, tablet, for suspension

ProductApplicantApplicationTEApproved
METHADOSERLDSPECGX LLCNDA 017116AAApproved Prior to Jan 1, 1982
METHADONE HYDROCHLORIDERLDMYLAN INSTITUTIONALNDA 021624APApproved Prior to Jan 1, 1982
DOLOPHINE HYDROCHLORIDERLD×3HIKMANDA 006134—Approved Prior to Jan 1, 1982
METHADONE HYDROCHLORIDERLDHIKMANDA 017058AAApproved Prior to Jan 1, 1982
METHADONE HYDROCHLORIDE×3MALLINCKRODT INCNDA 006383—Approved Prior to Jan 1, 1982
WESTADONE×4SANDOZNDA 017108—Approved Prior to Jan 1, 1982

Generic (ANDA) products (28)

ProductApplicantApplicationTEApproved
METHADONE HYDROCHLORIDEHIKMAANDA 218609APMay 05, 2025
METHADONE HYDROCHLORIDEBRECKENRIDGEANDA 218252APDec 16, 2024
METHADONE HYDROCHLORIDELANNETT CO INCANDA 212094—Mar 03, 2021
METHADONE HYDROCHLORIDELANNETT CO INCANDA 212093AANov 02, 2020
METHADONE HYDROCHLORIDE×2THEPHARMANETWORK LLCANDA 090635AASep 22, 2020
METHADONE HYDROCHLORIDEVISTAPHARM LLCANDA 204166AAMar 16, 2020
METHADONE HYDROCHLORIDE×2SPECGX LLCANDA 207537AAOct 02, 2019
METHADONE HYDROCHLORIDESPECGX LLCANDA 207368AAAug 22, 2019
METHADONE HYDROCHLORIDE×2ASCENT PHARMS INCANDA 211228AAJan 03, 2019
METHADONE HYDROCHLORIDE×2ELITE LABS INCANDA 210484AAAug 02, 2018
METHADONE HYDROCHLORIDE×2SUN PHARM INDUSTRIESANDA 208305—Mar 30, 2018
METHADONE HYDROCHLORIDELONG GROVE PHARMSANDA 208306APOct 27, 2017
METHADONE HYDROCHLORIDE×2AUROLIFE PHARMA LLCANDA 203502AAAug 31, 2015
METHADONE HYDROCHLORIDE×2EPIC PHARMA LLCANDA 090065AAAug 18, 2015
METHADONE HYDROCHLORIDE×2VISTAPHARM LLCANDA 090707AAJun 30, 2010
METHADONE HYDROCHLORIDESPECGX LLCANDA 077142AAJul 12, 2005
METHADONE HYDROCHLORIDE×2SPECGX LLCANDA 040517AAApr 27, 2004
METHADONE HYDROCHLORIDE×2VISTAPHARM LLCANDA 040241—May 29, 1998
METHADONE HYDROCHLORIDEHIKMAANDA 040180AAApr 30, 1998
METHADONE HYDROCHLORIDEVISTAPHARM LLCANDA 075082AAMar 25, 1998
METHADONE HYDROCHLORIDEROXANEANDA 074081—Apr 28, 1995
METHADONE HYDROCHLORIDEVISTAPHARM LLCANDA 040088AANov 30, 1994
METHADOSESPECGX LLCANDA 074184AAApr 29, 1993
METHADOSE×2SPECGX LLCANDA 040050—Apr 15, 1993
METHADONE HYDROCHLORIDE INTENSOLHIKMAANDA 089897AASep 06, 1988
METHADONE HYDROCHLORIDE×2HIKMAANDA 088109AAMar 08, 1983
METHADONE HYDROCHLORIDERLDHIKMAANDA 087997AAAug 30, 1982
METHADONE HYDROCHLORIDERLDHIKMAANDA 087393AAApproved Prior to Jan 1, 1982

Listed patents

No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.

Methadone hydrochloride — frequently asked questions

Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.

Agent CTA Background

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