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Generated: November 18, 2018

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 Sales Llc 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 ten drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the levomilnacipran hydrochloride profile page.
Summary for 204168
Tradename:FETZIMA
Applicant:Allergan Sales Llc
Ingredient:levomilnacipran hydrochloride
Patents:3
Generic Entry Opportunity Date for 204168
Generic Entry Date for 204168*:
Constraining patent/regulatory exclusivity:
Dosage:
CAPSULE, 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: 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 USA, 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 USA, Inc. 0456-2212 0456-2212-30 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0456-2212-30)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, EXTENDED RELEASE;ORALStrengthEQ 20MG BASE
Approval Date:Jul 25, 2013TE:RLD:Yes
Regulatory Exclusivity Expiration:Jul 25, 2018
Regulatory Exclusivity Use:NEW CHEMICAL ENTITY (AN ENANTIOMER OF PREVIOUSLY APPROVED RACEMIC MIXTURE. SEE SECTION 505(U) OF THE FEDERAL FOOD AND DRUG COSMETIC ACT).
Patent:➤ Sign UpPatent Expiration:Mar 2, 2031Product Flag?Substance Flag?Delist Request?
Patented Use:TREATMENT OF MAJOR DEPRESSIVE DISORDER (MDD)
Patent:➤ Sign UpPatent Expiration:May 23, 2032Product Flag?YSubstance Flag?YDelist Request?

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