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Serving hundreds of leading biopharmaceutical companies globally:

UBS
US Army
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QuintilesIMS
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Healthtrust
Covington
Dow
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Generated: May 23, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 204820

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NDA 204820 describes MITIGARE, which is a drug marketed by Hikma Intl Pharms and is included in one NDA. It is available from four suppliers. There are five patents protecting this drug and one Paragraph IV challenge. Additional details are available on the MITIGARE profile page.

The generic ingredient in MITIGARE is colchicine. There are sixteen drug master file entries for this compound. Twelve suppliers are listed for this compound. Additional details are available on the colchicine profile page.
Summary for 204820
Tradename:MITIGARE
Applicant:Hikma Intl Pharms
Ingredient:colchicine
Patents:5
Therapeutic Class:Antigout Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 204820
Medical Subject Heading (MeSH) Categories for 204820
Suppliers and Packaging for NDA: 204820
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
MITIGARE colchicine CAPSULE;ORAL 204820 NDA West-Ward Pharmaceuticals Corp 0143-3018 N 0143-3018-01
MITIGARE colchicine CAPSULE;ORAL 204820 NDA West-Ward Pharmaceuticals Corp 0143-3018 N 0143-3018-10

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength0.6MG
Approval Date:Sep 26, 2014TE:RLD:Yes
Patent:➤ Try a Free TrialPatent Expiration:Aug 22, 2033Product Flag?Substance Flag?Delist Request?
Patented Use:METHOD OF USING COLCHICINE FOR THE PROPHYLAXIS OF GOUT FLARES
Patent:➤ Try a Free TrialPatent Expiration:Aug 22, 2033Product Flag?Substance Flag?Delist Request?
Patented Use:METHOD OF USING COLCHICINE FOR THE PROPHYLAXIS OF GOUT FLARES
Patent:➤ Try a Free TrialPatent Expiration:Aug 22, 2033Product Flag?Substance Flag?Delist Request?
Patented Use:METHOD OF USING COLCHICINE FOR THE PROPHYLAXIS OF GOUT FLARES

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Serving hundreds of leading biopharmaceutical companies globally:

Express Scripts
Citi
McKinsey
Cerilliant
Daiichi Sankyo
Argus Health
Teva
Covington
Fish and Richardson

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