LEVORPHANOL TARTRATE - Generic Drug Details

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

Levorphanol tartrate is the generic ingredient in two branded drugs marketed by Valeant Pharm Intl, Hikma, Novitium Pharma, Specgx Llc, Sun Pharm Inds Inc, and Virtus, and is included in seven NDAs. Additional information is available in the individual branded drug profile pages.

There are five drug master file entries for levorphanol tartrate. Six suppliers are listed for this compound.

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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
Virtus	LEVORPHANOL TARTRATE	levorphanol tartrate	TABLET;ORAL	211484-001	Dec 13, 2018	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Valeant Pharm Intl	LEVO-DROMORAN	levorphanol tartrate	INJECTABLE;INJECTION	008719-001	Dec 19, 1991		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Sun Pharm Inds Inc	LEVORPHANOL TARTRATE	levorphanol tartrate	TABLET;ORAL	213906-002	Apr 25, 2023	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Novitium Pharma	LEVORPHANOL TARTRATE	levorphanol tartrate	TABLET;ORAL	213479-001	Jul 1, 2020	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Novitium Pharma	LEVORPHANOL TARTRATE	levorphanol tartrate	TABLET;ORAL	213479-002	Jan 12, 2021	AB	RX	No	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Hikma	LEVORPHANOL TARTRATE	levorphanol tartrate	TABLET;ORAL	074278-003	Jun 18, 2018		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Sun Pharm Inds Inc	LEVORPHANOL TARTRATE	levorphanol tartrate	TABLET;ORAL	213906-001	Jun 17, 2021	AB	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:	2
Applicants:	6
NDAs:	7
Drug Master File Entries:	5
Finished Product Suppliers / Packagers:	6
Raw Ingredient (Bulk) Api Vendors:	8
Drug Prices:	Drug price trends for LEVORPHANOL TARTRATE
What excipients (inactive ingredients) are in LEVORPHANOL TARTRATE?	LEVORPHANOL TARTRATE excipients list
DailyMed Link:	LEVORPHANOL TARTRATE at DailyMed

Drug Class	Opioid Agonist
Mechanism of Action	Full Opioid Agonists