Last Updated: November 8, 2026

DOLOPHINE HYDROCHLORIDE Drug Patent Profile

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When do Dolophine Hydrochloride patents expire, and when can generic versions of Dolophine Hydrochloride launch?

Dolophine Hydrochloride is a drug marketed by Hikma and is included in one NDA.

The generic ingredient in DOLOPHINE HYDROCHLORIDE is methadone hydrochloride. There is one drug master file entry for this compound. Nineteen suppliers are listed for this compound. Additional details are available on the methadone hydrochloride profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Dolophine Hydrochloride

A generic version of DOLOPHINE HYDROCHLORIDE was approved as methadone hydrochloride by HIKMA on March 8th, 1983.

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Recent Clinical Trials for DOLOPHINE HYDROCHLORIDE

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

SponsorPhase
Bruyere Research InstitutePhase 3
Ottawa Hospital Research InstitutePhase 3
The Ottawa HospitalPhase 3

See all DOLOPHINE HYDROCHLORIDE clinical trials

US Patents and Regulatory Information for DOLOPHINE 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 SYRUP;ORAL 006134-004 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
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 DOLOPHINE HYDROCHLORIDE methadone hydrochloride TABLET;ORAL 006134-010 Approved Prior to Jan 1, 1982 DISCN Yes 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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