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Last Updated: April 13, 2024

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AEMCOLO Drug Patent 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-eight patent family members in twenty-one 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

Aemcolo was eligible for patent challenges on November 16, 2022.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be November 16, 2028. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

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  Try a Trial

Summary for AEMCOLO
International Patents:28
US Patents:4
Applicants:1
NDAs:1
Finished Product Suppliers / Packagers: 1
Raw Ingredient (Bulk) Api Vendors: 54
Clinical Trials: 2
Patent Applications: 2,852
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 Loss of Exclusivity (LOE) Date for AEMCOLO
Generic Entry Date for AEMCOLO*:
Constraining patent/regulatory exclusivity:
GENERATING ANTIBIOTIC INCENTIVES NOW
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 ConnorPhase 2
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

AEMCOLO is protected by four US patents and two FDA Regulatory Exclusivities.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of AEMCOLO is ⤷  Try a Trial.

This potential generic entry date is based on GENERATING ANTIBIOTIC INCENTIVES NOW.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Patents protecting AEMCOLO

Oral antimicrobial pharmaceutical compositions
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Oral antimicrobial pharmaceutical compositions
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Oral antimicrobial pharmaceutical compositions
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Oral antimicrobial pharmaceutical compositions
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF TRAVELERS' DIARRHEA CAUSED BY NON-INVASIVE STRAINS OF ESCHERICHIA COLI IN ADULTS

FDA Regulatory Exclusivity protecting AEMCOLO

NEW CHEMICAL ENTITY
Exclusivity Expiration: ⤷  Try a Trial

GENERATING ANTIBIOTIC INCENTIVES NOW
Exclusivity Expiration: ⤷  Try a Trial

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 ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Redhill AEMCOLO rifamycin sodium TABLET, DELAYED RELEASE;ORAL 210910-001 Nov 16, 2018 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Redhill AEMCOLO rifamycin sodium TABLET, DELAYED RELEASE;ORAL 210910-001 Nov 16, 2018 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Redhill AEMCOLO rifamycin sodium TABLET, DELAYED RELEASE;ORAL 210910-001 Nov 16, 2018 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Redhill AEMCOLO rifamycin sodium TABLET, DELAYED RELEASE;ORAL 210910-001 Nov 16, 2018 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Redhill AEMCOLO rifamycin sodium TABLET, DELAYED RELEASE;ORAL 210910-001 Nov 16, 2018 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
>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

When does loss-of-exclusivity occur for AEMCOLO?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Austria

Patent: 92889
Estimated Expiration: ⤷  Try a Trial

Canada

Patent: 69683
Estimated Expiration: ⤷  Try a Trial

Patent: 28005
Estimated Expiration: ⤷  Try a Trial

China

Patent: 76685
Estimated Expiration: ⤷  Try a Trial

Patent: 1317826
Estimated Expiration: ⤷  Try a Trial

Croatia

Patent: 0080252
Estimated Expiration: ⤷  Try a Trial

Cyprus

Patent: 08196
Estimated Expiration: ⤷  Try a Trial

Denmark

Patent: 63339
Estimated Expiration: ⤷  Try a Trial

European Patent Office

Patent: 63339
Estimated Expiration: ⤷  Try a Trial

Patent: 94560
Estimated Expiration: ⤷  Try a Trial

Finland

Patent: 0190031
Estimated Expiration: ⤷  Try a Trial

Germany

Patent: 2005006278
Estimated Expiration: ⤷  Try a Trial

Hungary

Patent: 900037
Estimated Expiration: ⤷  Try a Trial

Italy

Patent: 20041295
Estimated Expiration: ⤷  Try a Trial

Japan

Patent: 26262
Estimated Expiration: ⤷  Try a Trial

Patent: 08163038
Estimated Expiration: ⤷  Try a Trial

Patent: 08503540
Estimated Expiration: ⤷  Try a Trial

Mexico

Patent: 06014698
Estimated Expiration: ⤷  Try a Trial

Poland

Patent: 63339
Estimated Expiration: ⤷  Try a Trial

Portugal

Patent: 63339
Estimated Expiration: ⤷  Try a Trial

Serbia

Patent: 581
Estimated Expiration: ⤷  Try a Trial

Slovenia

Patent: 63339
Estimated Expiration: ⤷  Try a Trial

South Africa

Patent: 0610577
Estimated Expiration: ⤷  Try a Trial

South Korea

Patent: 1157486
Estimated Expiration: ⤷  Try a Trial

Patent: 070028441
Estimated Expiration: ⤷  Try a Trial

Patent: 080059337
Estimated Expiration: ⤷  Try a Trial

Spain

Patent: 03255
Estimated Expiration: ⤷  Try a Trial

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering AEMCOLO around the world.

Country Patent Number Title Estimated Expiration
Japan 5026262 ⤷  Try a Trial
Finland C20190031 ⤷  Try a Trial
China 1976685 Oral antimicrobial pharmceutical compositions ⤷  Try a Trial
Spain 2303255 ⤷  Try a Trial
Italy MI20041295 COMPOSIZIONI FARMACEUTICHE ANTIMICROBICHE ORALI ⤷  Try a Trial
Poland 1763339 ⤷  Try a Trial
Japan 2008163038 ORAL ANTIMICROBIAL PHARMACEUTICAL COMPOSITION ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for AEMCOLO

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1763339 C201930053 Spain ⤷  Try a Trial 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 SPC/GB19/037 United Kingdom ⤷  Try a Trial PRODUCT NAME: RIFAMYCIN SV; REGISTERED: UK PL08637/0028 20181218
1763339 122019000048 Germany ⤷  Try a 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

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

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.