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Details for New Drug Application (NDA): 021086

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NDA 021086 describes ZYPREXA ZYDIS, which is a drug marketed by Lilly and is included in one NDA. It is available from two suppliers. There is one patent protecting this drug. Additional details are available on the ZYPREXA ZYDIS profile page.

The generic ingredient in ZYPREXA ZYDIS is olanzapine. There are thirty-three drug master file entries for this compound. Forty-five suppliers are listed for this compound. There is one tentative approval for this compound. Additional details are available on the olanzapine profile page.

Summary for NDA: 021086

Tradename:
ZYPREXA ZYDIS
Applicant:
Lilly
Ingredient:
olanzapine
Patents:1
Therapeutic Class:Antipsychotics
Bipolar Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 021086

Suppliers and Packaging for NDA: 021086

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ZYPREXA ZYDIS
olanzapine
TABLET, ORALLY DISINTEGRATING;ORAL 021086 NDA Eli Lilly and Company 0002-4453 0002-4453-85 30 DOSE PACK in 1 CARTON (0002-4453-85) > 1 BLISTER PACK in 1 DOSE PACK (0002-4453-01) > 1 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK
ZYPREXA ZYDIS
olanzapine
TABLET, ORALLY DISINTEGRATING;ORAL 021086 NDA Eli Lilly and Company 0002-4454 0002-4454-85 30 DOSE PACK in 1 CARTON (0002-4454-85) > 1 BLISTER PACK in 1 DOSE PACK (0002-4454-01) > 1 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, ORALLY DISINTEGRATING;ORALStrength5MG
Approval Date:Apr 6, 2000TE:ABRLD:Yes
Regulatory Exclusivity Expiration:Jul 26, 2016
Regulatory Exclusivity Use:NEW PATIENT POPULATION
Patent:6,960,577Patent Expiration:Nov 1, 2017Product Flag?Substance Flag?Delist Request?
Patented Use:ZYPREXA ZYDIS AND FLUOXETINE IN COMBINATION FOR THE ACUTE TREATMENT OF TREATMENT RESISTANT DEPRESSION IN ADULTS

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET, ORALLY DISINTEGRATING;ORALStrength10MG
Approval Date:Apr 6, 2000TE:ABRLD:No
Regulatory Exclusivity Expiration:Jul 26, 2016
Regulatory Exclusivity Use:NEW PATIENT POPULATION

Expired Orange Book Patents for NDA: 021086

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Lilly
ZYPREXA ZYDIS
olanzapine
TABLET, ORALLY DISINTEGRATING;ORAL021086-003Apr 6, 20005,229,382*PED► subscribe
Lilly
ZYPREXA ZYDIS
olanzapine
TABLET, ORALLY DISINTEGRATING;ORAL021086-002Apr 6, 20005,229,382*PED► subscribe
Lilly
ZYPREXA ZYDIS
olanzapine
TABLET, ORALLY DISINTEGRATING;ORAL021086-003Apr 6, 20005,817,656► subscribe
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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