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 Cosmo Technologies 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. 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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Questions you can ask:
- What is the 5 year forecast for AEMCOLO?
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Summary for AEMCOLO
International Patents: | 28 |
US Patents: | 4 |
Applicants: | 1 |
NDAs: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 54 |
Clinical Trials: | 2 |
Patent Applications: | 2,406 |
Drug Prices: | Drug price information for AEMCOLO |
What excipients (inactive ingredients) are in AEMCOLO? | AEMCOLO excipients list |
DailyMed Link: | AEMCOLO at DailyMed |


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
Sponsor | Phase |
---|---|
Bradley Connor | Phase 2 |
Bradley A. Connor, M.D. | Phase 2 |
Hunter Holmes Mcguire Veteran Affairs Medical Center | Phase 2 |
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 for Free.
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.
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Cosmo Technologies | AEMCOLO | rifamycin sodium | TABLET, DELAYED RELEASE;ORAL | 210910-001 | Nov 16, 2018 | DISCN | Yes | No | 8,741,948 | ⤷ Try for Free | Y | ⤷ Try for Free | |||
Cosmo Technologies | AEMCOLO | rifamycin sodium | TABLET, DELAYED RELEASE;ORAL | 210910-001 | Nov 16, 2018 | DISCN | Yes | No | 8,486,446 | ⤷ Try for Free | Y | ⤷ Try for Free | |||
Cosmo Technologies | AEMCOLO | rifamycin sodium | TABLET, DELAYED RELEASE;ORAL | 210910-001 | Nov 16, 2018 | DISCN | Yes | No | 8,529,945 | ⤷ Try for Free | Y | ⤷ Try for Free | |||
Cosmo Technologies | AEMCOLO | rifamycin sodium | TABLET, DELAYED RELEASE;ORAL | 210910-001 | Nov 16, 2018 | DISCN | Yes | No | 8,263,120 | ⤷ Try for Free | Y | ⤷ Try for Free | |||
Cosmo Technologies | AEMCOLO | rifamycin sodium | TABLET, DELAYED RELEASE;ORAL | 210910-001 | Nov 16, 2018 | DISCN | Yes | No | ⤷ Try for Free | ⤷ Try for Free | ⤷ Try for Free | ||||
Cosmo Technologies | AEMCOLO | rifamycin sodium | TABLET, DELAYED RELEASE;ORAL | 210910-001 | Nov 16, 2018 | DISCN | Yes | No | ⤷ Try for Free | ⤷ Try for Free | ⤷ Try for Free | ||||
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
Expired US Patents for AEMCOLO
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Cosmo Technologies | AEMCOLO | rifamycin sodium | TABLET, DELAYED RELEASE;ORAL | 210910-001 | Nov 16, 2018 | 8,529,945 | ⤷ Try for Free |
Cosmo Technologies | AEMCOLO | rifamycin sodium | TABLET, DELAYED RELEASE;ORAL | 210910-001 | Nov 16, 2018 | 8,263,120 | ⤷ Try for Free |
Cosmo Technologies | AEMCOLO | rifamycin sodium | TABLET, DELAYED RELEASE;ORAL | 210910-001 | Nov 16, 2018 | 8,741,948 | ⤷ Try for Free |
Cosmo Technologies | AEMCOLO | rifamycin sodium | TABLET, DELAYED RELEASE;ORAL | 210910-001 | Nov 16, 2018 | 8,486,446 | ⤷ Try for Free |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for AEMCOLO
See the table below for patents covering AEMCOLO around the world.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
European Patent Office | 1894560 | Compositions pharmaceutiques antimicrobiennes orales comprenant du métronidazole (Oral antimicrobial pharmaceutical compositions comprising metronidazole) | ⤷ Try for Free |
Japan | 2008503540 | ⤷ Try for Free | |
China | 1976685 | Oral antimicrobial pharmceutical compositions | ⤷ Try for Free |
Italy | MI20041295 | COMPOSIZIONI FARMACEUTICHE ANTIMICROBICHE ORALI | ⤷ Try for Free |
Japan | 5026262 | ⤷ Try for Free | |
South Korea | 101157486 | ⤷ Try for Free | |
>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 for Free | 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 for Free | PRODUCT NAME: RIFAMYCIN SV; REGISTERED: UK PL08637/0028 20181218 |
1763339 | 122019000048 | Germany | ⤷ Try for Free | 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 |
Market Dynamics and Financial Trajectory for AEMCOLO
More… ↓