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Colchicine - Generic Drug Details
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What are the generic drug sources for colchicine and what is the scope of freedom to operate?
Colchicine
is the generic ingredient in nine branded drugs marketed by Par Pharm Inc, Hikma Intl Pharms, Avion Pharms, Alkem Labs Ltd, Amneal Pharms, Dr Reddys, Granules Pharms, Mylan, Watson Labs Inc, Zydus Pharms, Takeda Pharms Usa, Watson Labs, Merck, Ani Pharms Inc, Beecham, Impax Labs, Novast Labs, Sandoz, and Lederle, and is included in twenty-one NDAs. There are twenty-six patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.Colchicine has three patent family members in two countries.
There are sixteen drug master file entries for colchicine. Twenty suppliers are listed for this compound. There is one tentative approval for this compound.
Summary for colchicine
| International Patents: | 3 |
| US Patents: | 26 |
| Tradenames: | 9 |
| Applicants: | 19 |
| NDAs: | 21 |
| Drug Master File Entries: | 16 |
| Suppliers / Packagers: | 20 |
| Bulk Api Vendors: | 86 |
| Clinical Trials: | 168 |
| Patent Applications: | 6,235 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price trends for colchicine |
| Drug Sales Revenues: | Drug sales revenues for colchicine |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for colchicine |
| DailyMed Link: | colchicine at DailyMed |
Recent Clinical Trials for colchicine
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| University Hospital Inselspital, Berne | Phase 3 |
| Brigham and Women's Hospital | Phase 2 |
| Daiichi Sankyo Europe, GmbH, a Daiichi Sankyo Company | Phase 3 |
Generic filers with tentative approvals for COLCHICINE
| Applicant | Application No. | Strength | Dosage Form |
| Start Trial | Start Trial | 0.6MG | TABLET;ORAL |
The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.
Pharmacology for colchicine
| Mechanism of Action | Cytochrome P450 3A4 Inhibitors P-Glycoprotein Interactions |
Medical Subject Heading (MeSH) Categories for colchicine
Paragraph IV (Patent) Challenges for COLCHICINE
| Tradename | Dosage | Ingredient | NDA | Submissiondate |
|---|---|---|---|---|
| GLOPERBA | SOLUTION;ORAL | colchicine | 210942 | 2020-04-02 |
| COLCRYS | TABLET;ORAL | colchicine | 022352 | 2019-07-19 |
| MITIGARE | CAPSULE;ORAL | colchicine | 204820 | 2016-06-10 |
| COLCRYS | TABLET;ORAL | colchicine | 022352 | 2011-12-23 |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Avion Pharms | GLOPERBA | colchicine | SOLUTION;ORAL | 210942-001 | Jan 30, 2019 | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | |||
| Novast Labs | PROBENECID AND COLCHICINE | colchicine; probenecid | TABLET;ORAL | 040618-001 | May 13, 2008 | AB | RX | No | No | Start Trial | Start Trial | Start Trial | |||
| Takeda Pharms Usa | COLCRYS | colchicine | TABLET;ORAL | 022352-001 | Jul 29, 2009 | AB | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | |||
| Takeda Pharms Usa | COLCRYS | colchicine | TABLET;ORAL | 022352-001 | Jul 29, 2009 | AB | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | |||
| Sandoz | PROBENECID AND COLCHICINE | colchicine; probenecid | TABLET;ORAL | 086130-001 | Approved Prior to Jan 1, 1982 | DISCN | No | No | Start Trial | Start Trial | Start Trial | ||||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
International Patents for colchicine
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| World Intellectual Property Organization (WIPO) | 2017156392 | Start Trial |
| World Intellectual Property Organization (WIPO) | 2019126579 | Start Trial |
| European Patent Office | 3426227 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
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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 verification 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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