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
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
University of Sao Paulo | Phase 3 |
Pharmacology for rifamycin sodium
Drug Class | Rifamycin Antibacterial |
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 | 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
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
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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