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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 nineteen 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:19
Applicants:10
NDAs:12
Drug Master File Entries: see list15
Suppliers / Packaging: see list9
Therapeutic Class:Antigout Agents
Formulation / Manufacturing:see details
Drug Prices:see low prices

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
Lederle
PROBENECID W/ COLCHICINE
colchicine; probenecid
TABLET;ORAL086954-001Approved Prior to Jan 1, 1982DISCNNo
Takeda Pharms Usa
COLCRYS
colchicine
TABLET;ORAL022352-001Jul 29, 2009RXYes8,093,297Oct 6, 2028
Takeda Pharms Usa
COLCRYS
colchicine
TABLET;ORAL022352-001Jul 29, 2009RXYes8,440,721Feb 17, 2029
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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>
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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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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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