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Serving 500+ biopharmaceutical companies globally:

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Teva
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Generated: September 21, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 202497

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NDA 202497 describes MARQIBO KIT, which is a drug marketed by Talon Therap and is included in one NDA. It is available from one supplier. There are three patents protecting this drug. Additional details are available on the MARQIBO KIT profile page.

The generic ingredient in MARQIBO KIT is vincristine sulfate. There are thirteen drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the vincristine sulfate profile page.

Summary for NDA: 202497

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:3
Formulation / Manufacturing:see details

Suppliers and Packaging for NDA: 202497

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
MARQIBO KIT
vincristine sulfate
INJECTABLE, LIPOSOMAL;INTRAVENOUS 202497 NDA Talon Therapeutics, Inc. 20536-322 20536-322-01 1 KIT in 1 CARTON (20536-322-01) * 1 mL in 1 VIAL, GLASS (20536-324-01) * 25 mL in 1 VIAL, GLASS (20536-325-01) * 5 mL in 1 VIAL, GLASS (20536-323-01)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE, LIPOSOMAL;INTRAVENOUSStrength5MG/5ML (1MG/ML)
Approval Date:Aug 9, 2012TE:RLD:Yes
Regulatory Exclusivity Expiration:Aug 9, 2019
Regulatory Exclusivity Use:ORPHAN DRUG EXCLUSIVITY
Patent:► SubscribePatent Expiration:Mar 31, 2020Product Flag?Substance Flag?Delist Request?
Patented Use:TREATMENT OF ADULT PATIENTS WITH PHILADELPHIA CHROMOSOME-NEGATIVE(PH-) ACUTE LYMPHOBLASTIC LEUKEMIA (ALL) IN SECOND OR GREATER RELAPSE OR WHOSE DISEASE HAS PROGRESSED FOLLOWING TWO OR MOR ANTI-LEUKEMIA THERAPIES
Patent:► SubscribePatent Expiration:Sep 25, 2020Product Flag?YSubstance Flag?Delist Request?

Expired Orange Book Patents for NDA: 202497

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Talon Therap
MARQIBO KIT
vincristine sulfate
INJECTABLE, LIPOSOMAL;INTRAVENOUS202497-001Aug 9, 2012► Subscribe► Subscribe
Talon Therap
MARQIBO KIT
vincristine sulfate
INJECTABLE, LIPOSOMAL;INTRAVENOUS202497-001Aug 9, 2012► Subscribe► Subscribe
Talon Therap
MARQIBO KIT
vincristine sulfate
INJECTABLE, LIPOSOMAL;INTRAVENOUS202497-001Aug 9, 2012► Subscribe► Subscribe
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Serving 500+ biopharmaceutical companies globally:

Fuji
Deloitte
Boehringer Ingelheim
Chubb
Chinese Patent Office
Julphar
US Army
QuintilesIMS
Express Scripts
Accenture

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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