MITIGARE Drug Patent 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-nine 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 |
| Finished Product Suppliers / Packagers: | 6 |
| Raw Ingredient (Bulk) Api Vendors: | 113 |
| Clinical Trials: | 2 |
| Patent Applications: | 2,263 |
| 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 |
Recent Clinical Trials for MITIGARE
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Helwan University | Phase 3 |
| St. Vincent Cardiovascular Research Institute | Phase 2 |
Pharmacology for MITIGARE
| Drug Class | Alkaloid |
| Mechanism of Action | Cytochrome P450 3A4 Inhibitors P-Glycoprotein Interactions |
Anatomical Therapeutic Chemical (ATC) Classes for MITIGARE
Paragraph IV (Patent) Challenges for MITIGARE
| Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
|---|---|---|---|---|---|---|
| MITIGARE | Capsules | colchicine | 0.6 mg | 204820 | 1 | 2016-06-10 |
US Patents and Regulatory Information for MITIGARE
MITIGARE is protected by five US patents.
Patents protecting MITIGARE
Methods of colchicine administration
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: METHOD OF USING COLCHICINE FOR THE PROPHYLAXIS OF GOUT FLARES
Methods of colchicine administration
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: METHOD OF USING COLCHICINE FOR THE PROPHYLAXIS OF GOUT FLARES
Methods of colchicine administration
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: METHOD OF USING COLCHICINE FOR THE PROPHYLAXIS OF GOUT FLARES
Methods of colchicine administration
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: METHOD OF USING COLCHICINE FOR THE PROPHYLAXIS OF GOUT FLARES
Methods of colchicine administration
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: METHOD OF USING COLCHICINE FOR THE PROPHYLAXIS OF GOUT FLARES
| 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 | AB | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Hikma Intl Pharms | MITIGARE | colchicine | CAPSULE;ORAL | 204820-001 | Sep 26, 2014 | AB | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Hikma Intl Pharms | MITIGARE | colchicine | CAPSULE;ORAL | 204820-001 | Sep 26, 2014 | AB | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
