Rifamycin sodium - Generic Drug Details

What are the generic sources for rifamycin sodium and what is the scope of freedom to operate?

Rifamycin sodium is the generic ingredient in one branded drug marketed by Redhill and is included in one NDA. There are four patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Rifamycin sodium has twenty-eight patent family members in twenty-one countries.

There are two drug master file entries for rifamycin sodium. One supplier is listed for this compound.

Summary for rifamycin sodium

International Patents:	28
US Patents:	4
Tradenames:	1
Applicants:	1
NDAs:	1
Drug Master File Entries:	2
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	59
Clinical Trials:	1
Patent Applications:	6,470
DailyMed Link:	rifamycin sodium at DailyMed

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

Constraining patent/regulatory exclusivity:

GENERATING ANTIBIOTIC INCENTIVES NOW

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 rifamycin sodium

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
University of Sao Paulo	Phase 3

See all rifamycin sodium clinical trials

Pharmacology for rifamycin sodium

Drug Class

Rifamycin Antibacterial

Anatomical Therapeutic Chemical (ATC) Classes for rifamycin sodium

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 rifamycin sodium

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
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

International Patents for rifamycin sodium

Country	Patent Number	Title	Estimated Expiration
Denmark	1763339
Serbia	50581	ORALNE ANTIMIKROBIJALNE FARMACEUTSKE KOMPOZICIJE (ORAL ANTIMICROBIAL PHARMACEUTICAL COMPOSITIONS)
Portugal	1763339
Poland	1763339
Croatia	P20080252
Hungary	S1900037

Supplementary Protection Certificates for rifamycin sodium

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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	SPC/GB19/037	United Kingdom		PRODUCT NAME: RIFAMYCIN SV; REGISTERED: UK PL08637/0028 20181218
1763339	122019000048	Germany		PRODUCT NAME: RIFAMYCIN SV; NAT. REGISTRATION NO/DATE: 2200986.00.00 20190509; FIRST REGISTRATION: GB PL 08637/0028 20181218