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COLCRYS Drug Profile
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Which patents cover Colcrys, and what generic alternatives are available?
Colcrys is a drug marketed by Takeda Pharms Usa and is included in one NDA. There are seventeen patents protecting this drug and one Paragraph IV challenge.
The generic ingredient in COLCRYS is colchicine. There are sixteen drug master file entries for this compound. Eighteen suppliers are listed for this compound. Additional details are available on the colchicine profile page.
US ANDA Litigation and Generic Entry Outlook for Colcrys
A generic version of COLCRYS was approved as colchicine by AMNEAL PHARMS on September 28th, 2016.
Summary for COLCRYS
Recent Clinical Trials for COLCRYS
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| University of California, Los Angeles | Phase 2 |
| National Center for Advancing Translational Science (NCATS) | Phase 2 |
| University of Pennsylvania | Phase 2 |
Pharmacology for COLCRYS
| Mechanism of Action | Cytochrome P450 3A4 Inhibitors P-Glycoprotein Interactions |
Paragraph IV (Patent) Challenges for COLCRYS
| Tradename | Dosage | Ingredient | NDA | Submissiondate |
|---|---|---|---|---|
| COLCRYS | TABLET;ORAL | colchicine | 022352 | 2019-07-19 |
| COLCRYS | TABLET;ORAL | colchicine | 022352 | 2011-12-23 |
US Patents and Regulatory Information for COLCRYS
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | |||
| 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 | |||
| 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 | |||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
