Make Better Decisions - Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Last Updated: December 9, 2019

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 five 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. Eighteen 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
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 Hikma Pharmaceuticals USA Inc. 0143-3018 0143-3018-01 100 CAPSULE in 1 BOTTLE, PLASTIC (0143-3018-01)
MITIGARE colchicine CAPSULE;ORAL 204820 NDA Hikma Pharmaceuticals USA Inc. 0143-3018 0143-3018-10 1000 CAPSULE in 1 BOTTLE, PLASTIC (0143-3018-10)
Paragraph IV (Patent) Challenges for 204820
Tradename Dosage Ingredient NDA Submissiondate
MITIGARE CAPSULE;ORAL colchicine 204820 2016-06-10

Profile for product number 001

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