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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
| 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 | 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 |
International Patents for rifamycin sodium
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| South Korea | 20080059337 | Start Trial |
| Mexico | PA06014698 | Start Trial |
| Germany | 602005006278 | Start Trial |
| Canada | 2628005 | Start Trial |
| Poland | 1763339 | Start Trial |
| World Intellectual Property Organization (WIPO) | 2006003043 | Start Trial |
| Slovenia | 1763339 | Start Trial |
| >Country | >Patent Number | >Estimated 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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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.
ISSN: 2162-2639
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