Rifamycin sodium - Generic Drug Details

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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-seven patent family members in twenty countries.

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

Summary for rifamycin sodium

International Patents:	27
US Patents:	4
Tradenames:	1
Applicants:	1
NDAs:	1
Drug Master File Entries:	2
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	23
Clinical Trials:	1
Patent Applications:	16
DailyMed Link:	rifamycin sodium at DailyMed

Recent Clinical Trials for rifamycin sodium

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Sponsor	Phase
University of Sao Paulo	Phase 3

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Pharmacology for rifamycin sodium

Drug Class	Rifamycin Antibacterial

US Patents and Regulatory Information for rifamycin sodium

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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	See Plans and Pricing	See Plans and Pricing				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 rifamycin sodium

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Country	Patent Number	Title	Estimated Expiration
Portugal	1763339		See Plans and Pricing
European Patent Office	1763339	COMPOSITIONS PHARMACEUTIQUES ANTIMICROBIENNES ORALES (ORAL ANTIMICROBIAL PHARMCEUTICAL COMPOSITIONS)	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 rifamycin sodium

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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

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