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Serving 500+ biopharmaceutical companies globally:

Merck
Fuji
AstraZeneca
Queensland Health
Daiichi Sankyo
Citi
Julphar
Farmers Insurance
Johnson and Johnson
McKinsey

Generated: July 21, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 204820

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NDA 204820 describes MITIGARE, which is a drug marketed by Hikma Intl Pharms and is included in one NDA. It is available from two suppliers. There are four patents protecting this drug. Additional details are available on the MITIGARE profile page.

The generic ingredient in MITIGARE is colchicine. There are fifteen drug master file entries for this compound. Eleven suppliers are listed for this compound. Additional details are available on the colchicine profile page.

Summary for NDA: 204820

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:1
Therapeutic Class:Antigout Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 204820

Mechanism of ActionCytochrome P450 3A4 Inhibitors
P-Glycoprotein Interactions

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 West-Ward Pharmaceuticals Corp 0143-3018 0143-3018-01 100 CAPSULE in 1 BOTTLE, PLASTIC (0143-3018-01)
MITIGARE
colchicine
 CAPSULE;ORAL 204820 NDA West-Ward Pharmaceuticals Corp 0143-3018 0143-3018-10 1000 CAPSULE in 1 BOTTLE, PLASTIC (0143-3018-10)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength0.6MG
Approval Date:Sep 26, 2014TE:RLD:Yes
Patent:8,927,607Patent Expiration:Aug 22, 2033Product Flag?Substance Flag?Delist Request?
Patented Use:METHOD OF USING COLCHICINE FOR THE PROPHYLAXIS OF GOUT FLARES
Patent:9,399,036Patent Expiration:Aug 22, 2033Product Flag?Substance Flag?Delist Request?
Patented Use:METHOD OF USING COLCHICINE FOR THE PROPHYLAXIS OF GOUT FLARES
Patent:9,555,029Patent Expiration:Aug 22, 2033Product Flag?Substance Flag?Delist Request?
Patented Use:METHOD OF USING COLCHICINE FOR THE PROPHYLAXIS OF GOUT FLARES


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Serving 500+ biopharmaceutical companies globally:

Covington
Daiichi Sankyo
Farmers Insurance
Johnson and Johnson
Teva
Harvard Business School
Chinese Patent Office
Dow
Cipla
Moodys

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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