DrugPatentWatch Database Preview
Details for New Drug Application (NDA): 204820
Join the DrugPatentWatch Referral Program Get access to a free drug patent landscape report or a free one-month subscription
The generic ingredient in MITIGARE 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.
Summary for 204820
Tradename: | MITIGARE |
Applicant: | Hikma Intl Pharms |
Ingredient: | colchicine |
Patents: | 5 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 204820
Mechanism of Action | Cytochrome P450 3A4 Inhibitors P-Glycoprotein Interactions |
Medical Subject Heading (MeSH) Categories for 204820
Suppliers and Packaging for NDA: 204820
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
MITIGARE | colchicine | CAPSULE;ORAL | 204820 | NDA | Hikma Pharmaceuticals USA Inc. | 0143-3018 | 0143-3018-01 | 100 CAPSULE in 1 BOTTLE, PLASTIC (0143-3018-01) |
MITIGARE | colchicine | CAPSULE;ORAL | 204820 | NDA | Hikma Pharmaceuticals USA Inc. | 0143-3018 | 0143-3018-10 | 1000 CAPSULE in 1 BOTTLE, PLASTIC (0143-3018-10) |
Paragraph IV (Patent) Challenges for 204820
Tradename | Dosage | Ingredient | NDA | Submissiondate |
---|---|---|---|---|
MITIGARE | CAPSULE;ORAL | colchicine | 204820 | 2016-06-10 |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 0.6MG | ||||
Approval Date: | Sep 26, 2014 | TE: | RLD: | Yes | |||||
Patent: | Start Trial | Patent Expiration: | Aug 22, 2033 | Product Flag? | Substance Flag? | Delist Request? | |||
Patented Use: | METHOD OF USING COLCHICINE FOR THE PROPHYLAXIS OF GOUT FLARES | ||||||||
Patent: | Start Trial | Patent Expiration: | Aug 22, 2033 | Product Flag? | Substance Flag? | Delist Request? | |||
Patented Use: | METHOD OF USING COLCHICINE FOR THE PROPHYLAXIS OF GOUT FLARES | ||||||||
Patent: | Start Trial | Patent Expiration: | Aug 22, 2033 | Product Flag? | Substance Flag? | Delist Request? | |||
Patented Use: | METHOD OF USING COLCHICINE FOR THE PROPHYLAXIS OF GOUT FLARES |
Complete Access Available with Subscription