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Last Updated: May 18, 2024

RIFAMYCIN SODIUM - Generic Drug Details


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What are the generic sources for rifamycin sodium and what is the scope of patent protection?

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
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for RIFAMYCIN SODIUM
Generic Entry 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

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

Country Patent Number Title Estimated Expiration
Croatia P20080252 ⤷  Try a Trial
European Patent Office 1894560 Compositions pharmaceutiques antimicrobiennes orales comprenant du mĂ©tronidazole (Oral antimicrobial pharmaceutical compositions comprising metronidazole) ⤷  Try a Trial
Serbia 50581 ORALNE ANTIMIKROBIJALNE FARMACEUTSKE KOMPOZICIJE (ORAL ANTIMICROBIAL PHARMACEUTICAL COMPOSITIONS) ⤷  Try a Trial
South Korea 20080059337 ORAL ANTIMICROBIAL PHARMACEUTICAL COMPOSITIONS ⤷  Try a Trial
South Korea 20070028441 ORAL ANTIMICROBIAL PHARMACEUTICAL COMPOSITIONS ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for RIFAMYCIN SODIUM

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1763339 SPC/GB19/037 United Kingdom ⤷  Try a Trial PRODUCT NAME: RIFAMYCIN SV; REGISTERED: UK PL08637/0028 20181218
1763339 C201930053 Spain ⤷  Try a 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 ⤷  Try a 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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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.