Methadone hydrochloride - Generic Drug Details

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What are the generic 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, 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.

Sponsor	Phase
The Netherlands Cancer Institute	Phase 2
Het Zwarte Gat	Phase 2
Radboud University Medical Center	Phase 2

Sponsor

Phase

The Netherlands Cancer Institute

Phase 2

Het Zwarte Gat

Phase 2

Radboud University Medical Center

Phase 2

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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
Mallinckrodt Inc	METHADONE HYDROCHLORIDE	methadone hydrochloride	POWDER;FOR RX COMPOUNDING	006383-003	Approved Prior to Jan 1, 1982		DISCN	No	No	⤷ 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
Ascent Pharms Inc	METHADONE HYDROCHLORIDE	methadone hydrochloride	TABLET;ORAL	211228-001	Jan 3, 2019	AA	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Sandoz	WESTADONE	methadone hydrochloride	TABLET, EFFERVESCENT;ORAL	017108-004	Approved Prior to Jan 1, 1982		DISCN	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Ascent Pharms Inc	METHADONE HYDROCHLORIDE	methadone hydrochloride	TABLET;ORAL	211228-002	Jan 3, 2019	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

US Patents:	0
Tradenames:	5
Applicants:	15
NDAs:	33
Drug Master File Entries:	8
Finished Product Suppliers / Packagers:	18
Raw Ingredient (Bulk) Api Vendors:	29
Clinical Trials:	369
Patent Applications:	7,810
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