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
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
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
Sponsor | Phase |
---|---|
University of Sao Paulo | Phase 3 |
Pharmacology for RIFAMYCIN SODIUM
Drug Class | Rifamycin Antibacterial |
Anatomical Therapeutic Chemical (ATC) Classes 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 | DISCN | Yes | No | ⤷ Subscribe | ⤷ Subscribe | Y | ⤷ Subscribe | |||
Redhill | AEMCOLO | rifamycin sodium | TABLET, DELAYED RELEASE;ORAL | 210910-001 | Nov 16, 2018 | DISCN | Yes | No | ⤷ Subscribe | ⤷ Subscribe | ⤷ Subscribe | ||||
Redhill | AEMCOLO | rifamycin sodium | TABLET, DELAYED RELEASE;ORAL | 210910-001 | Nov 16, 2018 | DISCN | Yes | No | ⤷ Subscribe | ⤷ Subscribe | Y | ⤷ Subscribe | |||
>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 |
---|---|---|---|
Spain | 2303255 | ⤷ Subscribe | |
European Patent Office | 1894560 | Compositions pharmaceutiques antimicrobiennes orales comprenant du métronidazole (Oral antimicrobial pharmaceutical compositions comprising metronidazole) | ⤷ Subscribe |
Canada | 2628005 | COMPOSITIONS PHARMACEUTIQUES ANTIMICROBIENNES ORALES (ORAL ANTIMICROBIAL PHARMACEUTICAL COMPOSITIONS) | ⤷ Subscribe |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for RIFAMYCIN SODIUM
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
1763339 | 122019000048 | Germany | ⤷ Subscribe | PRODUCT NAME: RIFAMYCIN SV; NAT. REGISTRATION NO/DATE: 2200986.00.00 20190509; FIRST REGISTRATION: GB PL 08637/0028 20181218 |
1763339 | SPC/GB19/037 | United Kingdom | ⤷ Subscribe | PRODUCT NAME: RIFAMYCIN SV; REGISTERED: UK PL08637/0028 20181218 |
1763339 | C201930053 | Spain | ⤷ Subscribe | 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 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
RIFAMYCIN SODIUM Market Analysis and Financial Projection Experimental
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