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Serving 500+ biopharmaceutical companies globally:

Teva
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Generated: September 26, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 207793

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NDA 207793 describes ONIVYDE, which is a drug marketed by Ipsen Inc and is included in one NDA. It is available from two suppliers. There are eleven patents protecting this drug. Additional details are available on the ONIVYDE profile page.

The generic ingredient in ONIVYDE is irinotecan hydrochloride. There are thirty-two drug master file entries for this compound. Sixteen suppliers are listed for this compound. Additional details are available on the irinotecan hydrochloride profile page.

Summary for NDA: 207793

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:11
Formulation / Manufacturing:see details

Pharmacology for NDA: 207793

Mechanism of ActionTopoisomerase Inhibitors

Suppliers and Packaging for NDA: 207793

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ONIVYDE
irinotecan hydrochloride
INJECTABLE, LIPOSOMAL;IV (INFUSION) 207793 NDA Ipsen Biopharmaceuticals, Inc. 15054-0043 15054-0043-1 1 VIAL, SINGLE-DOSE in 1 CARTON (15054-0043-1) > 10 mL in 1 VIAL, SINGLE-DOSE
ONIVYDE
irinotecan hydrochloride
INJECTABLE, LIPOSOMAL;IV (INFUSION) 207793 NDA Merrimack Pharmaceuticals 69171-398 69171-398-01 10 mL in 1 VIAL (69171-398-01)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE, LIPOSOMAL;IV (INFUSION)StrengthEQ 43MG BASE/10ML (EQ 4.3MG BASE/ML)
Approval Date:Oct 22, 2015TE:RLD:Yes
Regulatory Exclusivity Expiration:Oct 22, 2018
Regulatory Exclusivity Use:NEW PRODUCT
Regulatory Exclusivity Expiration:Oct 22, 2022
Regulatory Exclusivity Use:ORPHAN DRUG EXCLUSIVITY
Patent:► SubscribePatent Expiration:Aug 29, 2028Product Flag?YSubstance Flag?YDelist Request?


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Serving 500+ biopharmaceutical companies globally:

Farmers Insurance
Deloitte
UBS
Queensland Health
Federal Trade Commission
McKinsey
Cerilliant
QuintilesIMS
Daiichi Sankyo
Covington

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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