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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. Twenty-two suppliers are listed for this compound. Additional details are available on the colchicine profile page.
DrugPatentWatch® 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
| US Patents: | 17 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 8 |
| Bulk Api Vendors: | 88 |
| Clinical Trials: | 18 |
| Patent Applications: | 4,205 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for COLCRYS |
| Drug Sales Revenues: | Drug sales revenues for COLCRYS |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for COLCRYS |
| What excipients (inactive ingredients) are in COLCRYS? | COLCRYS excipients list |
| DailyMed Link: | COLCRYS at DailyMed |
Recent Clinical Trials for COLCRYS
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| University of California, Los Angeles | Phase 2/Phase 3 |
| Miami Cardiac and Vascular Institute | Phase 2/Phase 3 |
| University of California, Los Angeles | 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 | |||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
