DESVENLAFAXINE - Generic Drug Details

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What are the generic 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, Mylan, 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
Lupin Ltd	DESVENLAFAXINE SUCCINATE	desvenlafaxine succinate	TABLET, EXTENDED RELEASE;ORAL	204172-002	Jun 29, 2015	AB	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Intellipharmaceutics	DESVENLAFAXINE SUCCINATE	desvenlafaxine succinate	TABLET, EXTENDED RELEASE;ORAL	204805-001	May 7, 2019	AB	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Alembic	DESVENLAFAXINE SUCCINATE	desvenlafaxine succinate	TABLET, EXTENDED RELEASE;ORAL	204003-001	Jun 29, 2015	AB	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Sun Pharm	DESVENLAFAXINE	desvenlafaxine fumarate	TABLET, EXTENDED RELEASE;ORAL	205583-001	Jan 28, 2014		DISCN	Yes	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Zydus Pharms	DESVENLAFAXINE SUCCINATE	desvenlafaxine succinate	TABLET, EXTENDED RELEASE;ORAL	204020-001	Oct 11, 2017	AB	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:	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:	4,506
Formulation / Manufacturing:	see details
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
⤷ Try a Trial	⤷ Try a Trial	100MG	TABLET, EXTENDED RELEASE;ORAL
⤷ Try a Trial	⤷ Try a Trial	50MG	TABLET, EXTENDED RELEASE;ORAL