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Last Updated: April 4, 2020

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AEMCOLO Drug Profile


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Which patents cover Aemcolo, and when can generic versions of Aemcolo launch?

Aemcolo is a drug marketed by Redhill 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. One supplier is listed for this compound. Additional details are available on the rifamycin sodium profile page.

US ANDA Litigation and Generic Entry Outlook for Aemcolo

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

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Summary for AEMCOLO
International Patents:27
US Patents:4
Applicants:1
NDAs:1
Suppliers / Packagers: 1
Bulk Api Vendors: 14
Clinical Trials: 1
Patent Applications: 364
DailyMed Link:AEMCOLO at DailyMed
Drug patent expirations by year for AEMCOLO
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

SponsorPhase
Hunter Holmes Mcguire Veteran Affairs Medical CenterPhase 2

See all AEMCOLO clinical trials

Pharmacology for AEMCOLO
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
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

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Serving leading biopharmaceutical companies globally:

Harvard Business School
McKinsey
McKesson
Johnson and Johnson
AstraZeneca
Mallinckrodt

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.