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BioPharmaceutical Business Intelligence

  • Identify first generic entrants
  • Uncover prior art in expired and abandoned patents
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Serving leading biopharmaceutical companies globally:

US Department of Justice
Daiichi Sankyo
Accenture
Covington
Merck
Julphar
Argus Health
AstraZeneca
McKesson
Mallinckrodt

Generated: November 23, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 204768

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NDA 204768 describes TIVORBEX, which is a drug marketed by Iroko Pharms Llc 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 TIVORBEX profile page.

The generic ingredient in TIVORBEX is indomethacin. There are fifteen drug master file entries for this compound. Fifty-four suppliers are listed for this compound. Additional details are available on the indomethacin profile page.

Summary for 204768

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:3
Therapeutic Class:Analgesics
Anti-inflammatory Agents
Formulation / Manufacturing:see details

Suppliers and Packaging for NDA: 204768

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TIVORBEX
indomethacin
CAPSULE;ORAL 204768 NDA Iroko Pharmaceuticals, LLC 42211-201 42211-201-00 30 CAPSULE in 1 BOTTLE (42211-201-00)
TIVORBEX
indomethacin
CAPSULE;ORAL 204768 NDA Iroko Pharmaceuticals, LLC 42211-201 42211-201-23 30 CAPSULE in 1 BOTTLE (42211-201-23)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength20MG
Approval Date:Feb 24, 2014TE:RLD:Yes
Regulatory Exclusivity Expiration:Feb 24, 2017
Regulatory Exclusivity Use:NEW PRODUCT
Patent:► SubscribePatent Expiration:Apr 23, 2030Product Flag?YSubstance Flag?Delist Request?
Patent:► SubscribePatent Expiration:Apr 23, 2030Product Flag?YSubstance Flag?Delist Request?


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Serving leading biopharmaceutical companies globally:

Citi
McKesson
Colorcon
US Department of Justice
Fuji
Mallinckrodt
Novartis
Chubb
Dow
Harvard Business School

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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