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MITIGARE Drug Profile
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Which patents cover Mitigare, and when can generic versions of Mitigare launch?
Mitigare is a drug marketed by Hikma Intl Pharms and is included in one NDA. There are five patents protecting this drug and one Paragraph IV challenge.
The generic ingredient in MITIGARE 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 Mitigare
A generic version of MITIGARE was approved as colchicine by AMNEAL PHARMS on September 28th, 2016.
Summary for MITIGARE
| US Patents: | 5 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 5 |
| Bulk Api Vendors: | 87 |
| Patent Applications: | 4,207 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for MITIGARE |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for MITIGARE |
| What excipients (inactive ingredients) are in MITIGARE? | MITIGARE excipients list |
| DailyMed Link: | MITIGARE at DailyMed |
Pharmacology for MITIGARE
| Mechanism of Action | Cytochrome P450 3A4 Inhibitors P-Glycoprotein Interactions |
Paragraph IV (Patent) Challenges for MITIGARE
| Tradename | Dosage | Ingredient | NDA | Submissiondate |
|---|---|---|---|---|
| MITIGARE | CAPSULE;ORAL | colchicine | 204820 | 2016-06-10 |
US Patents and Regulatory Information for MITIGARE
| 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 | 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 | ||||
| Hikma Intl Pharms | MITIGARE | colchicine | CAPSULE;ORAL | 204820-001 | Sep 26, 2014 | 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 | ||||
| Hikma Intl Pharms | MITIGARE | colchicine | CAPSULE;ORAL | 204820-001 | Sep 26, 2014 | 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 |
