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Generated: May 29, 2017

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Colchicine - Generic Drug Details

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What are the generic sources for colchicine and what is the scope of colchicine freedom to operate?

is the generic ingredient in seven branded drugs marketed by Hikma Intl Pharms, Takeda Pharms Usa, Ingenus Pharms Nj, Impax Labs, Beecham, Watson Labs, Sandoz, Ani Pharms Inc, Lederle, and Merck, and is included in twelve NDAs. There are twenty-one patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

There are fifteen drug master file entries for colchicine. Ten suppliers are listed for this compound. There are two tentative approvals for this compound.

Summary for Generic Name: colchicine

Drug Master File Entries: see list15
Suppliers / Packagers: see list10
Bulk Api Vendors: see list59
Clinical Trials: see list53
Patent Applications: see list24,912
Therapeutic Class:Antigout Agents
Formulation / Manufacturing:see details
Drug Prices:see low prices
DailyMed Link:colchicine at DailyMed

Pharmacology for Ingredient: colchicine

Tentative approvals for COLCHICINE

Applicant Application No. Strength Dosage Form
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Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Takeda Pharms Usa
TABLET;ORAL022352-001Jul 29, 2009RXYesYes8,097,655► Subscribe ► Subscribe
Takeda Pharms Usa
TABLET;ORAL022352-001Jul 29, 2009RXYesYes7,964,647► Subscribe ► Subscribe
Hikma Intl Pharms
CAPSULE;ORAL204820-001Sep 26, 2014RXYesYes9,399,036► Subscribe ► Subscribe
Watson Labs
colchicine; probenecid
TABLET;ORAL083221-001Approved Prior to Jan 1, 1982DISCNNoNo► Subscribe► Subscribe
colchicine; probenecid
TABLET;ORAL084321-001Approved Prior to Jan 1, 1982DISCNNoNo► Subscribe► Subscribe
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