METHADONE HYDROCHLORIDE - Generic Drug Details

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What are the generic drug sources for methadone hydrochloride and what is the scope of freedom to operate?

Methadone hydrochloride is the generic ingredient in five branded drugs marketed by Hikma, Lannett Co Inc, Specgx Llc, Vistapharm Llc, Long Grove Pharms, Mylan Institutional, Mallinckrodt Inc, Sandoz, Vistapharm, 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.

Sponsor	Phase
BC Centre on Substance Use	Phase 2
Canadian Institutes of Health Research (CIHR)	Phase 2
The University of Texas Health Science Center, Houston	Phase 4

Sponsor

Phase

BC Centre on Substance Use

Phase 2

Canadian Institutes of Health Research (CIHR)

Phase 2

The University of Texas Health Science Center, Houston

Phase 4

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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
Aurolife Pharma Llc	METHADONE HYDROCHLORIDE	methadone hydrochloride	TABLET;ORAL	203502-002	Aug 31, 2015	AA	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Sandoz	WESTADONE	methadone hydrochloride	TABLET, EFFERVESCENT;ORAL	017108-003	Approved Prior to Jan 1, 1982		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Specgx Llc	METHADOSE	methadone hydrochloride	TABLET, FOR SUSPENSION;ORAL	074184-001	Apr 29, 1993	AA	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Specgx Llc	METHADONE HYDROCHLORIDE	methadone hydrochloride	TABLET;ORAL	040517-002	Apr 27, 2004	AA	RX	No	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Vistapharm Llc	METHADONE HYDROCHLORIDE	methadone hydrochloride	TABLET;ORAL	040241-002	May 29, 1998	AA	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Epic Pharma Llc	METHADONE HYDROCHLORIDE	methadone hydrochloride	TABLET;ORAL	090065-002	Aug 18, 2015	AA	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

US Patents:	0
Tradenames:	5
Applicants:	16
NDAs:	33
Drug Master File Entries:	8
Finished Product Suppliers / Packagers:	18
Raw Ingredient (Bulk) Api Vendors:	29
Clinical Trials:	372
Patent Applications:	7,945
Formulation / Manufacturing:	see details
Drug Prices:	Drug price trends for METHADONE HYDROCHLORIDE
What excipients (inactive ingredients) are in METHADONE HYDROCHLORIDE?	METHADONE HYDROCHLORIDE excipients list
DailyMed Link:	METHADONE HYDROCHLORIDE at DailyMed

Drug Class	Opioid Agonist
Mechanism of Action	Full Opioid Agonists