Last Updated: November 8, 2026

Details for New Drug Application (NDA): 215429

NDA 215429 describes VENLAFAXINE BESYLATE, which is a drug marketed by Almatica and is included in one NDA. It is available from one supplier. There is one patent protecting this drug. Additional details are available on the VENLAFAXINE BESYLATE profile page.

The generic ingredient in VENLAFAXINE BESYLATE is venlafaxine besylate. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the venlafaxine besylate profile page.

Summary for 215429

Tradename:	VENLAFAXINE BESYLATE
Applicant:	Almatica
Ingredient:	venlafaxine besylate
Patents:	1

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for 215429

Generic Entry Date for 215429^: ⤷ Start Trial* Constraining patent/regulatory exclusivity: ⤷ Start Trial Dosage: TABLET, EXTENDED RELEASE;ORAL

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Pharmacology for NDA: 215429

Mechanism of Action	Norepinephrine Uptake Inhibitors Serotonin Uptake Inhibitors

Suppliers and Packaging for NDA: 215429

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
VENLAFAXINE BESYLATE	venlafaxine besylate	TABLET, EXTENDED RELEASE;ORAL	215429	NDA	Almatica Pharma LLC	52427-632	52427-632-30	30 TABLET, EXTENDED RELEASE in 1 BOTTLE (52427-632-30)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET, EXTENDED RELEASE;ORAL			Strength	EQ 112.5MG BASE
Approval Date:	Jun 29, 2022	TE:		RLD:	Yes
Patent:	⤷ Start Trial	Patent Expiration:	May 16, 2028	Product Flag?	Y	Substance Flag?		Delist Request?

Expired US Patents for NDA 215429

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Almatica	VENLAFAXINE BESYLATE	venlafaxine besylate	TABLET, EXTENDED RELEASE;ORAL	215429-001	Jun 29, 2022	⤷ Start Trial	⤷ Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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