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Last Updated: February 29, 2020

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 022352


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NDA 022352 describes COLCRYS, which is a drug marketed by Takeda Pharms Usa and is included in one NDA. It is available from seven suppliers. There are seventeen patents protecting this drug and one Paragraph IV challenge. Additional details are available on the COLCRYS profile page.

The generic ingredient in COLCRYS is colchicine. There are sixteen drug master file entries for this compound. Seventeen suppliers are listed for this compound. Additional details are available on the colchicine profile page.
Summary for 022352
Tradename:COLCRYS
Applicant:Takeda Pharms Usa
Ingredient:colchicine
Patents:17
Formulation / Manufacturing:see details
Pharmacology for NDA: 022352
Medical Subject Heading (MeSH) Categories for 022352
Suppliers and Packaging for NDA: 022352
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
COLCRYS colchicine TABLET;ORAL 022352 NDA AUTHORIZED GENERIC Par Pharmaceutical, Inc. 0254-2008 0254-2008-01 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0254-2008-01)
COLCRYS colchicine TABLET;ORAL 022352 NDA AUTHORIZED GENERIC Par Pharmaceutical, Inc. 0254-2008 0254-2008-11 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0254-2008-11)
Paragraph IV (Patent) Challenges for 022352
Tradename Dosage Ingredient NDA Submissiondate
COLCRYS TABLET;ORAL colchicine 022352 2019-07-19
COLCRYS TABLET;ORAL colchicine 022352 2011-12-23

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength0.6MG
Approval Date:Jul 29, 2009TE:ABRLD:Yes
Patent:  Start TrialPatent Expiration:Feb 10, 2029Product Flag?Substance Flag?Delist Request?
Patented Use:METHOD OF TREATING GOUT FLARES
Patent:  Start TrialPatent Expiration:Dec 3, 2028Product Flag?Substance Flag?Delist Request?
Patented Use:METHOD OF USING COLCHICINE FOR THE PROPHYLAXIS OF GOUT FLARES
Patent:  Start TrialPatent Expiration:Feb 17, 2029Product Flag?Substance Flag?Delist Request?
Patented Use:METHOD OF USING COLCHICINE FOR THE PROPHYLAXIS OF GOUT FLARES

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