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Last Updated: September 24, 2020

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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 eleven 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: 11
Suppliers / Packagers: 1
Clinical Trials: 1
DailyMed Link:rifamycin sodium at DailyMed
Recent Clinical Trials for rifamycin sodium

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

SponsorPhase
University of Sao PauloPhase 3

See all rifamycin sodium clinical trials

Pharmacology for rifamycin sodium

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   Start Trial   Start Trial Y   Start Trial
Redhill AEMCOLO rifamycin sodium TABLET, DELAYED RELEASE;ORAL 210910-001 Nov 16, 2018 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Redhill AEMCOLO rifamycin sodium TABLET, DELAYED RELEASE;ORAL 210910-001 Nov 16, 2018 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Redhill AEMCOLO rifamycin sodium TABLET, DELAYED RELEASE;ORAL 210910-001 Nov 16, 2018 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Supplementary Protection Certificates for rifamycin sodium

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1763339 C201930053 Spain   Start Trial 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   Start Trial 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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Serving leading biopharmaceutical companies globally:

Colorcon
McKesson
Boehringer Ingelheim
Harvard Business School
Mallinckrodt
AstraZeneca

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