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Last Updated: August 14, 2020

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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.

US ANDA Litigation and 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
Drug patent expirations by year for AEMCOLO
Drug Prices for AEMCOLO

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

Supplementary Protection Certificates for AEMCOLO

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1763339 122019000048 Germany   Start Trial 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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Serving leading biopharmaceutical companies globally:

Harvard Business School
McKinsey
McKesson
Johnson and Johnson
AstraZeneca
Mallinckrodt

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