AEMCOLO Drug Patent Profile

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

Summary for AEMCOLO

International Patents:	28
US Patents:	4
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	27
Clinical Trials:	2
Patent Applications:	3,578
Drug Prices:	Drug price information for AEMCOLO
What excipients (inactive ingredients) are in AEMCOLO?	AEMCOLO excipients list
DailyMed Link:	AEMCOLO at DailyMed

See drug prices for AEMCOLO

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

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

Anatomical Therapeutic Chemical (ATC) Classes for AEMCOLO

A07AA	Antibiotics
A07A	INTESTINAL ANTIINFECTIVES
A07	ANTIDIARRHEALS, INTESTINAL ANTIINFLAMMATORY/ANTIINFECTIVE AGENTS
A	Alimentary tract and metabolism

D06AX	Other antibiotics for topical use
D06A	ANTIBIOTICS FOR TOPICAL USE
D06	ANTIBIOTICS AND CHEMOTHERAPEUTICS FOR DERMATOLOGICAL USE
D	Dermatologicals

J04AB	Antibiotics
J04A	DRUGS FOR TREATMENT OF TUBERCULOSIS
J04	ANTIMYCOBACTERIALS
J	Antiinfectives for systemic use

S01AA	Antibiotics
S01A	ANTIINFECTIVES
S01	OPHTHALMOLOGICALS
S	Sensory organs

S02AA	Antiinfectives
S02A	ANTIINFECTIVES
S02	OTOLOGICALS
S	Sensory organs

US Patents and Regulatory Information for AEMCOLO

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

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

FDA Regulatory Exclusivity protecting 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			Y
Redhill	AEMCOLO	rifamycin sodium	TABLET, DELAYED RELEASE;ORAL	210910-001	Nov 16, 2018		RX	Yes	Yes			Y
Redhill	AEMCOLO	rifamycin sodium	TABLET, DELAYED RELEASE;ORAL	210910-001	Nov 16, 2018		RX	Yes	Yes			Y
Redhill	AEMCOLO	rifamycin sodium	TABLET, DELAYED RELEASE;ORAL	210910-001	Nov 16, 2018		RX	Yes	Yes			Y
Redhill	AEMCOLO	rifamycin sodium	TABLET, DELAYED RELEASE;ORAL	210910-001	Nov 16, 2018		RX	Yes	Yes
Redhill	AEMCOLO	rifamycin sodium	TABLET, DELAYED RELEASE;ORAL	210910-001	Nov 16, 2018		RX	Yes	Yes

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

Canada

China

Croatia

Cyprus

Denmark

European Patent Office

Finland

Germany

Hungary

Italy

Japan

Mexico

Poland

Portugal

Serbia

Slovenia

South Africa

South Korea

Spain

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
China	101317826	Oral antimicrobial pharmceutical compositions
Portugal	1763339
Hungary	S1900037
Denmark	1763339
Cyprus	1108196
Spain	2303255

Supplementary Protection Certificates for AEMCOLO

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1763339	SPC/GB19/037	United Kingdom		PRODUCT NAME: RIFAMYCIN SV; REGISTERED: UK PL08637/0028 20181218
1763339	C201930053	Spain		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		PRODUCT NAME: RIFAMYCIN SV; NAT. REGISTRATION NO/DATE: 2200986.00.00 20190509; FIRST REGISTRATION: GB PL 08637/0028 20181218