METHADONE HYDROCHLORIDE Drug Patent Profile

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Methadone Hydrochloride is a drug marketed by Hikma, Lannett Co Inc, Specgx Llc, Vistapharm, Long Grove Pharms, Mylan Institutional, Mallinckrodt Inc, Ascent Pharms Inc, Aurolife Pharma Llc, Epic Pharma Llc, Nostrum Labs Inc, Roxane, Sun Pharm Industries, and Thepharmanetwork Llc. and is included in twenty-eight NDAs.

The generic ingredient in METHADONE HYDROCHLORIDE is methadone hydrochloride. There are thirteen drug master file entries for this compound. Eighteen suppliers are listed for this compound. Additional details are available on the methadone hydrochloride profile page.

A generic version of METHADONE HYDROCHLORIDE was approved as methadone hydrochloride by ROXANE on March 8^th, 1983.

US Patents:	0
Applicants:	14
NDAs:	28
Finished Product Suppliers / Packagers:	18
Raw Ingredient (Bulk) Api Vendors:	29
Clinical Trials:	369
Patent Applications:	3,259
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for METHADONE HYDROCHLORIDE
What excipients (inactive ingredients) are in METHADONE HYDROCHLORIDE?	METHADONE HYDROCHLORIDE excipients list
DailyMed Link:	METHADONE HYDROCHLORIDE at DailyMed

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

Sponsor	Phase
Radboud University Medical Center	Phase 2
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)	Phase 2
Parnassia Addiction Research Centre	Phase 2

Drug Class	Opioid Agonist
Mechanism of Action	Full Opioid Agonists

N07BC	Drugs used in opioid dependence
N07B	DRUGS USED IN ADDICTIVE DISORDERS
N07	OTHER NERVOUS SYSTEM DRUGS
N	Nervous system

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Specgx Llc	METHADONE HYDROCHLORIDE	methadone hydrochloride	TABLET;ORAL	040517-002	Apr 27, 2004	AA	RX	No	Yes	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Roxane	METHADONE HYDROCHLORIDE	methadone hydrochloride	TABLET;ORAL	088108-001	Mar 8, 1983	AA	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Sun Pharm Industries	METHADONE HYDROCHLORIDE	methadone hydrochloride	TABLET;ORAL	208305-001	Mar 30, 2018		DISCN	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
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
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
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration