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Rifamycin - Generic Drug Details
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What are the generic drug sources for rifamycin and what is the scope of freedom to operate?
Rifamycin
is the generic ingredient in one branded drug marketed by Cosmo Technologies 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 has twenty-six patent family members in nineteen countries.
There are eleven drug master file entries for rifamycin. One supplier is listed for this compound.
Summary for rifamycin
| International Patents: | 26 |
| US Patents: | 4 |
| Tradenames: | 1 |
| Applicants: | 1 |
| NDAs: | 1 |
| Drug Master File Entries: | 11 |
| Suppliers / Packagers: | 1 |
| Bulk Api Vendors: | 13 |
| Clinical Trials: | 30 |
| Patent Applications: | 581 |
| Formulation / Manufacturing: | see details |
| DailyMed Link: | rifamycin at DailyMed |
Recent Clinical Trials for rifamycin
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Infectious Diseases Institute, Makerere University College of Health Sciences, Kampala, Uganda | Phase 2/Phase 3 |
| University of Turin, Turin, Italy | Phase 2/Phase 3 |
| Joint Clinical Research Centre, Kampala, Uganda | Phase 2/Phase 3 |
Synonyms for rifamycin
| (2S,12Z,14E,16S,17S,18R,19R,20R,21S,22R,23S,24E)-5,6,9,17,19-pentahydroxy-23-methoxy-2,4,12,16,18,20,22-heptamethyl-1,11-dioxo-1,2-dihydro-2,7-(epoxypentadeca[1,11,13]trienoimino)naphtho[2,1-b]furan-21-yl acetate |
| (7S,11S,13S,17S,18S,12R,14R,15R,16R)-2,15,17,27,29-pentahydroxy-11-methoxy-3,7 ,12,14,16,18,22-heptamethyl-6,23-dioxo-8,30-dioxa-24-azatetracyclo[23.3.1.1<4, 7>.0<5,28>]triaconta-1(28),2,4,9,19,21,25( |
| (pentahydroxy-methoxy-heptamethyl-dioxo-[?]yl) acetate |
| 14897-39-3 (unspecified hydrochloride salt) |
| 15105-92-7 |
| 15105-92-7 (mono-hydrochloride salt) |
| 2,7-(Epoxy[1,11,13]pentadecatrienoimino)naphtho[2,1-b]furan-1,11(2H)-dione, 21-(acetyloxy)-5,6,9,17,19-pentahydroxy-23-methoxy-2,4,12,16,18,20,22-heptamethyl-, (2S,16S,17S,18R,19R,20R,21S,22R,23S)- |
| 2,7-(Epoxypentadeca(1,11,13)trienimino)naphtho(2,1-b)furan-1,11(2H)-dione, 5,6,9,17,19,21-hexahydroxy-23-methoxy-2,4,12,16,18,20,22-heptamethyl-, 21-acetate |
| 2,7-(Epoxypentadeca(1,11,13)trienimino)naphtho(2,1-b)furan-1,11(2H)-dione,5,6,9,17,19,21-hexahydroxy-23-methoxy-2,4,12,16,18,20,22-heptamethyl-, 21-acetate |
| 29),26-octaen-13-yl acetate |
| 5,6,9,17,19,21-hexahydroxy-23-methoxy-2,4,12,16,18,20,22-heptamethyl-2,7-(epoxypentadeca(1,11,13)trienimino)naphtho(2,1-b)furan-1,11(2-H)-dione, 21-acetate |
| 6998-60-3 |
| 8248AH |
| AKOS024281286 |
| AKOS027460740 |
| BDBM50391000 |
| C12044 |
| C37H47NO12 |
| CB-01-11 |
| CHEBI:29673 |
| CHEMBL437765 |
| D02549 |
| D0FX2Q |
| DTXSID1032014 |
| DU69T8ZZPA |
| EINECS 230-273-3 |
| GTPL4570 |
| HJYYPODYNSCCOU-ODRIEIDWSA-N |
| LMPK05000005 |
| LS-2172 |
| NSC133100 |
| Rifacin |
| Rifamicina |
| Rifamicina [INN-Spanish] |
| Rifamicine SV |
| Rifamycin (oral controlled-release, gastrointestinal-specific) |
| Rifamycin (oral controlled-release, gastrointestinal-specific), Cosmo/Dr Falk/Santarus |
| Rifamycin (USAN/INN) |
| Rifamycin [INN:BAN:DCF] |
| Rifamycin [USAN:INN:BAN:DCF] |
| RIFAMYCIN SODIUM |
| Rifamycin SV |
| Rifamycin SV MMX |
| Rifamycin SV, an antibiotic produced by certain strains of Streptomyces mediterranei, or the same substance produced by any other means |
| Rifamycine |
| Rifamycine [INN-French] |
| Rifamycinum |
| Rifamycinum [INN-Latin] |
| Rifocin |
| Rifocyn |
| RIFOMYCIN |
| Rifomycin SV |
| SC-49540 |
| SCHEMBL151824 |
| SR-01000872597 |
| SR-01000872597-1 |
| ST044225 |
| Tuborin |
| UNII-DU69T8ZZPA |
| ZINC169633673 |
US Patents and Regulatory Information for rifamycin
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Cosmo Technologies | AEMCOLO | rifamycin | TABLET, DELAYED RELEASE;ORAL | 210910-001 | Nov 16, 2018 | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | |||
| Cosmo Technologies | AEMCOLO | rifamycin | TABLET, DELAYED RELEASE;ORAL | 210910-001 | Nov 16, 2018 | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | |||
| Cosmo Technologies | AEMCOLO | rifamycin | TABLET, DELAYED RELEASE;ORAL | 210910-001 | Nov 16, 2018 | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | |||
| Cosmo Technologies | AEMCOLO | rifamycin | 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
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Spain | 2303255 | Start Trial |
| Japan | 5026262 | Start Trial |
| Cyprus | 1108196 | Start Trial |
| Japan | 2008163038 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for rifamycin
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1763339 | 122019000048 | Germany | Start Trial | PRODUCT NAME: RIFAMYCIN SV; REGISTRATION NO/DATE: DE/H/5379/001/DC 20190509 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
