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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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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:	2,360
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

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for AEMCOLO

Generic Entry Date for AEMCOLO^: ⤷ Sign Up* Constraining patent/regulatory exclusivity: GENERATING ANTIBIOTIC INCENTIVES NOW NDA: 210910 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

See all AEMCOLO clinical trials

Pharmacology for AEMCOLO

Drug Class	Rifamycin Antibacterial

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 ⤷ Sign Up.

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: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up

Oral antimicrobial pharmaceutical compositions
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
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: ⤷ Sign Up

GENERATING ANTIBIOTIC INCENTIVES NOW
Exclusivity Expiration: ⤷ Sign Up

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Glossary

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

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

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Country	Patent Number	Title	Estimated Expiration
Denmark	1763339		⤷ Sign Up
Serbia	50581	ORALNE ANTIMIKROBIJALNE FARMACEUTSKE KOMPOZICIJE (ORAL ANTIMICROBIAL PHARMACEUTICAL COMPOSITIONS)	⤷ Sign Up
Portugal	1763339		⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for AEMCOLO

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1763339	C201930053	Spain	⤷ Sign Up	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	⤷ Sign Up	PRODUCT NAME: RIFAMYCIN SV; REGISTERED: UK PL08637/0028 20181218
1763339	122019000048	Germany	⤷ Sign Up	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