Remove trial restrictions ▶ Start for $1

Serving leading biopharmaceutical companies globally:

Johnson and Johnson
Colorcon
McKesson
Baxter
Mallinckrodt
Dow

Last Updated: May 21, 2022

MITIGARE Drug Patent Profile


✉ Email this page to a colleague

« Back to Dashboard

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-five 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.

  Try it Free

Drug patent expirations by year for MITIGARE
Drug Prices for MITIGARE

See drug prices for MITIGARE

Recent Clinical Trials for MITIGARE

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
St. Vincent Cardiovascular Research InstitutePhase 2

See all MITIGARE clinical trials

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: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: METHOD OF USING COLCHICINE FOR THE PROPHYLAXIS OF GOUT FLARES

Methods of colchicine administration
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: METHOD OF USING COLCHICINE FOR THE PROPHYLAXIS OF GOUT FLARES

Methods of colchicine administration
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: METHOD OF USING COLCHICINE FOR THE PROPHYLAXIS OF GOUT FLARES

Methods of colchicine administration
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: METHOD OF USING COLCHICINE FOR THE PROPHYLAXIS OF GOUT FLARES

Methods of colchicine administration
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Hikma Intl Pharms MITIGARE colchicine CAPSULE;ORAL 204820-001 Sep 26, 2014 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Hikma Intl Pharms MITIGARE colchicine CAPSULE;ORAL 204820-001 Sep 26, 2014 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Hikma Intl Pharms MITIGARE colchicine CAPSULE;ORAL 204820-001 Sep 26, 2014 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Hikma Intl Pharms MITIGARE colchicine CAPSULE;ORAL 204820-001 Sep 26, 2014 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

AstraZeneca
Mallinckrodt
Dow
Baxter
McKesson
Colorcon

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 verification 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.