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Last Updated: November 30, 2021

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 204168


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NDA 204168 describes FETZIMA, which is a drug marketed by Allergan and is included in one NDA. It is available from one supplier. There are three patents protecting this drug and one Paragraph IV challenge. Additional details are available on the FETZIMA profile page.

The generic ingredient in FETZIMA is levomilnacipran hydrochloride. There are eleven drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the levomilnacipran hydrochloride profile page.
Summary for 204168
Tradename:FETZIMA
Applicant:Allergan
Ingredient:levomilnacipran hydrochloride
Patents:3
Pharmacology for NDA: 204168
Suppliers and Packaging for NDA: 204168
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
FETZIMA levomilnacipran hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 204168 NDA Allergan, Inc. 0456-2202 0456-2202-28 1 KIT in 1 BLISTER PACK (0456-2202-28)
FETZIMA levomilnacipran hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 204168 NDA Allergan, Inc. 0456-2212 0456-2212-30 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0456-2212-30)
Paragraph IV (Patent) Challenges for 204168
Tradename Dosage Ingredient NDA Submissiondate
FETZIMA CAPSULE, EXTENDED RELEASE;ORAL levomilnacipran hydrochloride 204168 2017-07-25

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, EXTENDED RELEASE;ORALStrengthEQ 20MG BASE
Approval Date:Jul 25, 2013TE:ABRLD:Yes
Regulatory Exclusivity Expiration:Oct 7, 2022
Regulatory Exclusivity Use:INFORMATION ADDED TO THE LABELING TO DESCRIBE STUDY LVM-MD-15 TO FULFILL POSTMARKETING COMMITMENT 1943-4
Patent:⤷  Free Forever TrialPatent Expiration:Mar 2, 2031Product Flag?Substance Flag?Delist Request?
Patented Use:TREATMENT OF MAJOR DEPRESSIVE DISORDER (MDD)
Patent:⤷  Free Forever TrialPatent Expiration:May 23, 2032Product Flag?YSubstance Flag?YDelist Request?

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