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-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
Summary for AEMCOLO
International Patents: | 27 |
US Patents: | 4 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 21 |
Clinical Trials: | 2 |
Patent Applications: | 3,482 |
Drug Prices: | Drug price information for AEMCOLO |
What excipients (inactive ingredients) are in AEMCOLO? | AEMCOLO excipients list |
DailyMed Link: | AEMCOLO at DailyMed |


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
Sponsor | Phase |
---|---|
Bradley Connor | Phase 2 |
Bradley A. Connor, M.D. | Phase 2 |
Hunter Holmes Mcguire Veteran Affairs Medical Center | Phase 2 |
Pharmacology for AEMCOLO
Drug Class | Rifamycin Antibacterial |
Anatomical Therapeutic Chemical (ATC) Classes for AEMCOLO
US Patents and Regulatory Information for AEMCOLO
AEMCOLO is protected by four US patents.
Based on analysis by DrugPatentWatch, the earliest date for a generic version of AEMCOLO is See Plans and Pricing.
This potential generic entry date is based on patent See Plans and Pricing.
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: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Oral antimicrobial pharmaceutical compositions
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Oral antimicrobial pharmaceutical compositions
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Oral antimicrobial pharmaceutical compositions
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF TRAVELERS' DIARRHEA CAUSED BY NON-INVASIVE STRAINS OF ESCHERICHIA COLI IN ADULTS
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 | See Plans and Pricing | See Plans and Pricing | Y | See Plans and Pricing | |||
Redhill | AEMCOLO | rifamycin sodium | TABLET, DELAYED RELEASE;ORAL | 210910-001 | Nov 16, 2018 | RX | Yes | Yes | See Plans and Pricing | See Plans and Pricing | Y | See Plans and Pricing | |||
Redhill | AEMCOLO | rifamycin sodium | TABLET, DELAYED RELEASE;ORAL | 210910-001 | Nov 16, 2018 | RX | Yes | Yes | See Plans and Pricing | See Plans and Pricing | Y | See Plans and Pricing | |||
Redhill | AEMCOLO | rifamycin sodium | TABLET, DELAYED RELEASE;ORAL | 210910-001 | Nov 16, 2018 | RX | Yes | Yes | See Plans and Pricing | See Plans and Pricing | Y | 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 |
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: 2889
Estimated Expiration: See Plans and Pricing
Canada
Patent: 69683
Estimated Expiration: See Plans and Pricing
Patent: 28005
Estimated Expiration: See Plans and Pricing
China
Patent: 76685
Estimated Expiration: See Plans and Pricing
Patent: 1317826
Estimated Expiration: See Plans and Pricing
Croatia
Patent: 0080252
Estimated Expiration: See Plans and Pricing
Cyprus
Patent: 08196
Estimated Expiration: See Plans and Pricing
Denmark
Patent: 63339
Estimated Expiration: See Plans and Pricing
European Patent Office
Patent: 63339
Estimated Expiration: See Plans and Pricing
Patent: 94560
Estimated Expiration: See Plans and Pricing
Germany
Patent: 2005006278
Estimated Expiration: See Plans and Pricing
Hungary
Patent: 900037
Estimated Expiration: See Plans and Pricing
Italy
Patent: 20041295
Estimated Expiration: See Plans and Pricing
Japan
Patent: 26262
Estimated Expiration: See Plans and Pricing
Patent: 08163038
Estimated Expiration: See Plans and Pricing
Patent: 08503540
Estimated Expiration: See Plans and Pricing
Mexico
Patent: 06014698
Estimated Expiration: See Plans and Pricing
Poland
Patent: 63339
Estimated Expiration: See Plans and Pricing
Portugal
Patent: 63339
Estimated Expiration: See Plans and Pricing
Serbia
Patent: 581
Estimated Expiration: See Plans and Pricing
Slovenia
Patent: 63339
Estimated Expiration: See Plans and Pricing
South Africa
Patent: 0610577
Estimated Expiration: See Plans and Pricing
South Korea
Patent: 1157486
Estimated Expiration: See Plans and Pricing
Patent: 070028441
Estimated Expiration: See Plans and Pricing
Patent: 080059337
Estimated Expiration: See Plans and Pricing
Spain
Patent: 03255
Estimated Expiration: See Plans and Pricing
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 | 2008503540 | See Plans and Pricing | |
World Intellectual Property Organization (WIPO) | 2006003043 | See Plans and Pricing | |
Japan | 5026262 | See Plans and Pricing | |
Poland | 1763339 | See Plans and Pricing | |
South Korea | 20080059337 | ORAL ANTIMICROBIAL PHARMACEUTICAL COMPOSITIONS | See Plans and Pricing |
>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 | See Plans and Pricing | 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 | See Plans and Pricing | 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 |