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Colchicine - Generic Drug Details

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Colchicine 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 eighteen 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. Nine suppliers are listed for this compound. There are two tentative approvals for this compound.

Summary for Generic Name: colchicine

Tradenames:7
Patents:18
Applicants:10
NDAs:12
Drug Master File Entries: see list15
Suppliers / Packaging: see list9
Therapeutic Class:Antigout Agents
Formulation / Manufacturing:see details

Pharmacology for Ingredient: colchicine

Tentative approvals for COLCHICINE

Applicant Application No. Form Dosage
<disabled><disabled>TABLET;ORAL0.6MG
<disabled><disabled>TABLET;ORAL0.6MG

Clinical Trials for: colchicine

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Takeda Pharms Usa
COLCRYS
colchicine
TABLET;ORAL022352-001Jul 29, 2009RXYes7,601,758<disabled> <disabled>
Takeda Pharms Usa
COLCRYS
colchicine
TABLET;ORAL022352-001Jul 29, 2009RXYes8,097,655<disabled> <disabled>
Takeda Pharms Usa
COLCRYS
colchicine
TABLET;ORAL022352-001Jul 29, 2009RXYes7,964,647<disabled> <disabled>
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Non-Orange Book Patents for Generic Ingredient: colchicine

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
8,445,541Methods for concomitant administration of colchicine and a second active agent<disabled in preview>
9,399,036Methods of colchicine administration<disabled in preview>
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.

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