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AEMCOLO Drug Profile
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Which patents cover Aemcolo, and what generic alternatives are available?
Aemcolo is a drug marketed by Cosmo Technologies and is included in one NDA. There are four patents protecting this drug.
This drug has twenty-seven patent family members in twenty countries.
The generic ingredient in AEMCOLO is rifamycin sodium. There are eleven drug master file entries for this compound. Additional details are available on the rifamycin sodium profile page.
US ANDA Litigation and Generic Entry Outlook for Aemcolo
Aemcolo was eligible for patent challenges on December 31, 1968.
By analyzing the patents and regulatory protections it appears that the earliest date
for generic entry will be May 3, 2025. This may change due to patent challenges or generic licensing.
Indicators of Generic Entry
Summary for AEMCOLO
| International Patents: | 27 |
| US Patents: | 4 |
| Applicants: | 1 |
| NDAs: | 1 |
| Bulk Api Vendors: | 13 |
| Clinical Trials: | 1 |
| Patent Applications: | 364 |
| DailyMed Link: | AEMCOLO at DailyMed |
Generic Entry Opportunity Date for AEMCOLO
Generic Entry Date for AEMCOLO*:
Constraining patent/regulatory exclusivity:
NDA:
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 AEMCOLO
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Hunter Holmes Mcguire Veteran Affairs Medical Center | Phase 2 |
Synonyms for AEMCOLO
| (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 |
| 15105-92-7 |
| 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 |
| BDBM50391000 |
| C12044 |
| C37H47NO12 |
| CB-01-11 |
| CHEBI:29673 |
| CHEMBL437765 |
| D02549 |
| DTXSID1032014 |
| DU69T8ZZPA |
| EINECS 230-273-3 |
| GTPL4570 |
| HJYYPODYNSCCOU-ODRIEIDWSA-N |
| LMPK05000005 |
| LS-2172 |
| NSC133100 |
| Q26270990 |
| Rifacin |
| Rifamicina |
| Rifamicina [INN-Spanish] |
| Rifamicine SV |
| RIFAMYCIN |
| Rifamycin (USAN/INN) |
| Rifamycin [INN:BAN:DCF] |
| Rifamycin [USAN:INN:BAN:DCF] |
| Rifamycin SV |
| 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 AEMCOLO
| 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 sodium | TABLET, DELAYED RELEASE;ORAL | 210910-001 | Nov 16, 2018 | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | |||
| Cosmo Technologies | AEMCOLO | rifamycin sodium | TABLET, DELAYED RELEASE;ORAL | 210910-001 | Nov 16, 2018 | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | |||
| Cosmo Technologies | AEMCOLO | rifamycin sodium | TABLET, DELAYED RELEASE;ORAL | 210910-001 | Nov 16, 2018 | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | |||
| Cosmo Technologies | 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 AEMCOLO
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Mexico | PA06014698 | Start Trial |
| Japan | 5026262 | Start Trial |
| Denmark | 1763339 | Start Trial |
| Hungary | S1900037 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for AEMCOLO
| 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 |
