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Serving leading biopharmaceutical companies globally:

Dow
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AstraZeneca
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Cipla
UBS
Julphar
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Generated: January 22, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 021520

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NDA 021520 describes SYMBYAX, which is a drug marketed by Lilly and is included in one NDA. It is available from one supplier. There are two patents protecting this drug and two Paragraph IV challenges. Additional details are available on the SYMBYAX profile page.

The generic ingredient in SYMBYAX is fluoxetine hydrochloride; olanzapine. There are twenty-seven drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the fluoxetine hydrochloride; olanzapine profile page.
Summary for 021520
Tradename:SYMBYAX
Applicant:Lilly
Ingredient:fluoxetine hydrochloride; olanzapine
Patents:2
Formulation / Manufacturing:see details
Pharmacology for NDA: 021520
Mechanism of ActionSerotonin Uptake Inhibitors
Suppliers and Packaging for NDA: 021520
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
SYMBYAX fluoxetine hydrochloride; olanzapine CAPSULE;ORAL 021520 NDA Eli Lilly and Company 0002-3230 0002-3230-30 30 CAPSULE in 1 BOTTLE (0002-3230-30)
SYMBYAX fluoxetine hydrochloride; olanzapine CAPSULE;ORAL 021520 NDA Eli Lilly and Company 0002-3231 0002-3231-30 30 CAPSULE in 1 BOTTLE (0002-3231-30)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrengthEQ 25MG BASE;EQ 3MG BASE
Approval Date:Apr 9, 2007TE:ABRLD:Yes
Regulatory Exclusivity Expiration:Oct 10, 2017
Regulatory Exclusivity Use:ADDITIONS TO THE LABELING DESCRIBING RESULTS FROM STUDY H6P-MC-HDAY
Regulatory Exclusivity Expiration:Jul 26, 2016
Regulatory Exclusivity Use:NEW PATIENT POPULATION
Patent:➤ SubscribePatent Expiration:Nov 1, 2017Product Flag?Substance Flag?Delist Request?
Patented Use:SYMBYAX IS INDICATED FOR THE ACUTE TREATMENT OF TREATMENT RESISTANT DEPRESSION IN ADULTS

Expired US Patents for NDA 021520

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Serving leading biopharmaceutical companies globally:

Moodys
Baxter
Julphar
Federal Trade Commission
Daiichi Sankyo
Fuji
US Department of Justice
Queensland Health
Argus Health

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