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Last Updated: May 11, 2021

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AEMCOLO Drug Profile

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Which patents cover Aemcolo, and when can generic versions of Aemcolo launch?

Aemcolo is a drug marketed by Redhill and is included in one NDA. There are four patents protecting this drug.

This drug has twenty-seven patent family members in twenty countries.

The generic ingredient in AEMCOLO is rifamycin sodium. There are eleven drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the rifamycin sodium profile page.

DrugPatentWatch® Generic Entry Outlook for Aemcolo

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be May 3, 2025. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

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Summary for AEMCOLO
International Patents:27
US Patents:4
Applicants:1
NDAs:1
Finished Product Suppliers / Packagers: 1
Raw Ingredient (Bulk) Api Vendors: 17
Clinical Trials: 2
Patent Applications: 3,154
Drug Prices: Drug price information for AEMCOLO
What excipients (inactive ingredients) are in AEMCOLO?AEMCOLO excipients list
DailyMed Link:AEMCOLO at DailyMed
Drug patent expirations by year for AEMCOLO
Drug Prices for AEMCOLO

See drug prices for AEMCOLO

DrugPatentWatch® Estimated Generic Entry Opportunity Date for AEMCOLO
Generic Entry Date for AEMCOLO*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
TABLET, DELAYED RELEASE;ORAL

*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for AEMCOLO

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

SponsorPhase
Bradley A. Connor, M.D.Phase 2
Hunter Holmes Mcguire Veteran Affairs Medical CenterPhase 2

See all AEMCOLO clinical trials

Pharmacology for AEMCOLO

US Patents and Regulatory Information for AEMCOLO

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Redhill AEMCOLO rifamycin sodium TABLET, DELAYED RELEASE;ORAL 210910-001 Nov 16, 2018 RX Yes Yes   Get Started for $10   Get Started for $10 Y   Get Started for $10
Redhill AEMCOLO rifamycin sodium TABLET, DELAYED RELEASE;ORAL 210910-001 Nov 16, 2018 RX Yes Yes   Get Started for $10   Get Started for $10 Y   Get Started for $10
Redhill AEMCOLO rifamycin sodium TABLET, DELAYED RELEASE;ORAL 210910-001 Nov 16, 2018 RX Yes Yes   Get Started for $10   Get Started for $10 Y   Get Started for $10
Redhill AEMCOLO rifamycin sodium TABLET, DELAYED RELEASE;ORAL 210910-001 Nov 16, 2018 RX Yes Yes   Get Started for $10   Get Started for $10 Y   Get Started for $10
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

International Patents for AEMCOLO

Country Patent Number Estimated Expiration
South Africa 200610577   Get Started for $10
Slovenia 1763339   Get Started for $10
Canada 2569683   Get Started for $10
Mexico PA06014698   Get Started for $10
Cyprus 1108196   Get Started for $10
World Intellectual Property Organization (WIPO) 2006003043   Get Started for $10
Japan 5026262   Get Started for $10
>Country >Patent Number >Estimated Expiration

Supplementary Protection Certificates for AEMCOLO

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1763339 C201930053 Spain   Get Started for $10 PRODUCT NAME: RIFAMICINA SV; NATIONAL AUTHORISATION NUMBER: 84120-DE/H/5379/001/DC; DATE OF AUTHORISATION: 20190628; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): PL 08637/0028; DATE OF FIRST AUTHORISATION IN EEA: 20181218
1763339 122019000048 Germany   Get Started for $10 PRODUCT NAME: RIFAMYCIN SV; NAT. REGISTRATION NO/DATE: 2200986.00.00 20190509; FIRST REGISTRATION: GB PL 08637/0028 20181218
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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