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Serving leading biopharmaceutical companies globally:

Citi
QuintilesIMS
US Department of Justice
Baxter
US Army
McKinsey
Fuji
Fish and Richardson
Queensland Health
UBS

Generated: February 23, 2018

DrugPatentWatch Database Preview

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?

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

There are sixteen drug master file entries for colchicine. Twelve suppliers are listed for this compound. There are two tentative approvals for this compound.
Pharmacology for colchicine
Medical Subject Heading (MeSH) Categories for colchicine
Tentative approvals for COLCHICINE
Applicant Application No. Strength Dosage Form
➤ Sign Up➤ Sign Up0.6MGTABLET;ORAL
➤ Sign Up➤ Sign Up0.6MGTABLET;ORAL

US Patents and Regulatory Information for colchicine

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Lederle PROBENECID W/ COLCHICINE colchicine; probenecid TABLET;ORAL 086954-001 Approved Prior to Jan 1, 1982 DISCN No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Hikma Intl Pharms MITIGARE colchicine CAPSULE;ORAL 204820-001 Sep 26, 2014 RX Yes Yes ➤ Sign Up ➤ Sign Up ➤ Sign Up
Ingenus Pharms Nj PROBENECID AND COLCHICINE colchicine; probenecid TABLET;ORAL 040618-001 May 13, 2008 AB RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Takeda Pharms Usa COLCRYS colchicine TABLET;ORAL 022352-001 Jul 29, 2009 RX Yes Yes ➤ Sign Up ➤ Sign Up ➤ Sign Up
Takeda Pharms Usa COLCRYS colchicine TABLET;ORAL 022352-001 Jul 29, 2009 RX Yes Yes ➤ Sign Up ➤ Sign Up ➤ Sign Up
Takeda Pharms Usa COLCRYS colchicine TABLET;ORAL 022352-001 Jul 29, 2009 RX Yes Yes ➤ Sign Up ➤ Sign Up ➤ Sign Up
Watson Labs COL-PROBENECID colchicine; probenecid TABLET;ORAL 084279-001 Approved Prior to Jan 1, 1982 AB RX No Yes ➤ Sign Up ➤ Sign Up ➤ Sign Up
Takeda Pharms Usa COLCRYS colchicine TABLET;ORAL 022352-001 Jul 29, 2009 RX Yes Yes ➤ Sign Up ➤ Sign Up ➤ Sign Up
Hikma Intl Pharms MITIGARE colchicine CAPSULE;ORAL 204820-001 Sep 26, 2014 RX Yes Yes ➤ Sign Up ➤ Sign Up ➤ Sign Up
Takeda Pharms Usa COLCRYS colchicine TABLET;ORAL 022352-001 Jul 29, 2009 RX Yes Yes ➤ Sign Up ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration

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Non-Orange Book US Patents for 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
8,445,541 Methods for concomitant administration of colchicine and a second active agent ➤ Sign Up
Patent No. Title Estimated Patent Expiration

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Serving hundreds of leading biopharmaceutical companies globally:

Accenture
Colorcon
Julphar
US Army
Fuji
Citi
Medtronic
McKinsey
Cerilliant

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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