Desvenlafaxine - Generic Drug Details

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What are the generic drug sources for desvenlafaxine and what is the scope of patent protection?

Desvenlafaxine is the generic ingredient in four branded drugs marketed by Alembic Pharms Ltd, Osmotica Pharm Corp, Sun Pharm, Teva Pharms Usa, Actavis Labs Fl, Alembic, Hikma, Intellipharmaceutics, Lupin Ltd, Norvium Bioscience, Rubicon, Yichang Humanwell, Zydus Pharms, and Pf Prism Cv, and is included in fifteen NDAs. There is one patent protecting this compound. Additional information is available in the individual branded drug profile pages.

There are sixteen drug master file entries for desvenlafaxine. Two suppliers are listed for this compound. There is one tentative approval for this compound.

Sponsor	Phase
Universidade do Extremo Sul Catarinense - Unidade Academica de Ciecias da Saude	Phase 2
Sage Therapeutics	Phase 3
H. Lundbeck A/S	Phase 4

Sponsor

Phase

Universidade do Extremo Sul Catarinense - Unidade Academica de Ciecias da Saude

Phase 2

Sage Therapeutics

Phase 3

H. Lundbeck A/S

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
Actavis Labs Fl	DESVENLAFAXINE SUCCINATE	desvenlafaxine succinate	TABLET, EXTENDED RELEASE;ORAL	204065-002	Jul 29, 2016	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Actavis Labs Fl	DESVENLAFAXINE SUCCINATE	desvenlafaxine succinate	TABLET, EXTENDED RELEASE;ORAL	204065-001	Jul 29, 2016	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Sun Pharm	DESVENLAFAXINE	desvenlafaxine fumarate	TABLET, EXTENDED RELEASE;ORAL	205583-002	Jan 28, 2014		DISCN	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Teva Pharms Usa	DESVENLAFAXINE	desvenlafaxine fumarate	TABLET, EXTENDED RELEASE;ORAL	205208-002	Oct 11, 2013		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Alembic Pharms Ltd	DESVENLAFAXINE	desvenlafaxine	TABLET, EXTENDED RELEASE;ORAL	204150-002	Mar 4, 2013		RX	Yes	Yes	⤷ 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:	1
Tradenames:	4
Applicants:	14
NDAs:	15
Drug Master File Entries:	16
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	122
Clinical Trials:	71
Patent Applications:	4,183
Drug Prices:	Drug price trends for desvenlafaxine
What excipients (inactive ingredients) are in desvenlafaxine?	desvenlafaxine excipients list
DailyMed Link:	desvenlafaxine at DailyMed

Drug Class	Serotonin and Norepinephrine Reuptake Inhibitor
Mechanism of Action	Cytochrome P450 2D6 Inhibitors Norepinephrine Uptake Inhibitors Serotonin Uptake Inhibitors

Applicant	Application No.	Strength	Dosage Form
⤷ Sign Up	⤷ Sign Up	100MG	TABLET, EXTENDED RELEASE;ORAL
⤷ Sign Up	⤷ Sign Up	50MG	TABLET, EXTENDED RELEASE;ORAL