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Generated: July 21, 2017
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, Ingenus Pharms Nj, Impax Labs, Beecham, Watson Labs, Sandoz, Ani Pharms Inc, Lederle, and Merck, and is included in twelve NDAs. There are twenty-two patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.| Tradenames: | 7 |
| Patents: | 22 |
| Applicants: | 10 |
| NDAs: | 12 |
| Drug Master File Entries: see list | 15 |
| Suppliers / Packagers: see list | 11 |
| Bulk Api Vendors: see list | 59 |
| Clinical Trials: see list | 115 |
| Patent Applications: see list | 24,912 |
| Therapeutic Class: | Antigout Agents |
| Formulation / Manufacturing: | see details |
| Drug Prices: | see low prices |
| DailyMed Link: | colchicine at DailyMed |
| Mechanism of Action | Cytochrome P450 3A4 Inhibitors P-Glycoprotein Interactions |
| Applicant | Application No. | Strength | Dosage Form |
| ► Subscribe | ► Subscribe | 0.6MG | TABLET;ORAL |
| ► Subscribe | ► Subscribe | 0.6MG | TABLET;ORAL |
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Hikma Intl Pharms | MITIGARE | colchicine | CAPSULE;ORAL | 204820-001 | Sep 26, 2014 | RX | Yes | Yes | 9,675,613 | ► Subscribe | ► Subscribe | ||||||||||||||||||
Takeda Pharms Usa | COLCRYS | colchicine | TABLET;ORAL | 022352-001 | Jul 29, 2009 | RX | Yes | Yes | 7,906,519 | ► Subscribe | ► Subscribe | ||||||||||||||||||
Takeda Pharms Usa | COLCRYS | colchicine | TABLET;ORAL | 022352-001 | Jul 29, 2009 | RX | Yes | Yes | 8,093,296 | ► Subscribe | ► Subscribe | ||||||||||||||||||
Ani Pharms Inc | PROBENECID AND COLCHICINE | colchicine; probenecid | TABLET;ORAL | 083734-001 | Approved Prior to Jan 1, 1982 | DISCN | No | No | ► Subscribe | ► Subscribe | |||||||||||||||||||
Takeda Pharms Usa | COLCRYS | colchicine | TABLET;ORAL | 022352-001 | Jul 29, 2009 | RX | Yes | Yes | 8,415,395 | ► Subscribe | ► Subscribe | ||||||||||||||||||
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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 | ► Subscribe | |||||||||||||||||||||||||||
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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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