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Colchicineis 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-four 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. Eighteen suppliers are listed for this compound. There is one tentative approval for this compound.
Summary for COLCHICINE
|Drug Master File Entries:||16|
|Suppliers / Packagers:||18|
|Bulk Api Vendors:||84|
|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
|Providence Health & Services||N/A|
|Vancouver Coastal Health||N/A|
|University Hospital, Rouen||Phase 3|
Generic filers with tentative approvals for COLCHICINE
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 |
|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|
|Hikma Intl Pharms||MITIGARE||colchicine||CAPSULE;ORAL||204820-001||Sep 26, 2014||RX||Yes||Yes||Start Trial||Start Trial||Start Trial|
|Dr Reddys||COLCHICINE||colchicine||TABLET;ORAL||209876-001||Sep 6, 2019||AB||RX||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|
|Country||Patent Number||Estimated Expiration|
|European Patent Office||3426227||Start Trial|
|World Intellectual Property Organization (WIPO)||2019126579||Start Trial|
|World Intellectual Property Organization (WIPO)||2017156392||Start Trial|
|>Country||>Patent Number||>Estimated Expiration|
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