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Last Updated: December 15, 2019

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Omacetaxine mepesuccinate - Generic Drug Details

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What are the generic sources for omacetaxine mepesuccinate and what is the scope of patent protection?

Omacetaxine mepesuccinate is the generic ingredient in one branded drug marketed by Teva Pharms Intl and is included in one NDA. There are two patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Omacetaxine mepesuccinate has forty-nine patent family members in nineteen countries.

There are two drug master file entries for omacetaxine mepesuccinate. One supplier is listed for this compound.

Summary for omacetaxine mepesuccinate
International Patents:49
US Patents:2
Tradenames:1
Applicants:1
NDAs:1
Drug Master File Entries: 2
Suppliers / Packagers: 1
Bulk Api Vendors: 40
Clinical Trials: 14
Patent Applications: 15
DailyMed Link:omacetaxine mepesuccinate at DailyMed
Recent Clinical Trials for omacetaxine mepesuccinate

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
University of Colorado, DenverPhase 1/Phase 2
The University of Hong KongPhase 2
Teva Pharmaceutical Industries, Ltd.Phase 2

See all omacetaxine mepesuccinate clinical trials

Synonyms for omacetaxine mepesuccinate
(-)-homoharringtonine
(2'R,3S,4S,5R)-(-)-homoharringtonine
(2S,3S,6S)-4-methoxy-16,18-dioxa-10-azapentacyclo[11.7.0.0<2,6>.0<6,10>.0<15,1 9>]icosa-1(20),4,13,15(19)-tetraen-3-yl methyl (2R)-2-hydroxy-2-(4-hydroxy-4-m ethylpentyl)butane-1,4-dioate
[3(R)]-4-methyl 2-hydroxy-2-(4-hydroxy-4-methylpentyl)butanedioate
1-((1S,3aR,14bS)-2-Methoxy-1,5,6,8,9,14b-hexahydro-4H- cyclopenta(a)(1,3)dioxolo(4,5-h)pyrrolo(2,1-b)(3)benzazepin-1-yl) 4-methyl (2R)-2- hydroxy-2-(4-hydroxy-4-methylpentyl)butanedioate
26833-87-4
6FG8041S5B
AB0019750
AB00642561-02
AC1L6273
AC1Q5YWQ
ACN-035229
AKOS024456585
BCP28190
BRD-K76674262-001-01-7
BRD-K76674262-001-02-5
BRN 5687925
C29H39NO9
Ceflatonin
Cephalotaxine 4-methyl (2R)-2-hydroxy-2-(4-hydroxy-4-methylpentyl)butanedioate
Cephalotaxine 4-Methyl (2R)-2-Hydroxy-2-(4-hydroxy-4-methylpentyl)butanedioate (Ester)
cephalotaxine 4-methyl 2-hydroxy-2-(4-hydroxy-4-methylpentyl)butanedioate
Cephalotaxine, 4-methyl (2R)-2-hydroxy-2-(4-hydroxy-4-methylpentyl)butanedioate (ester) (9CI)
Cephalotaxine, 4-methyl 2-hydroxy-2-(4-hydroxy-4-methylpentyl)butanedioate (ester), (3(R))- (9CI)
Cephalotaxine, 4-methyl-, 2-hydroxy-2-(4-hydroxy-4-methylpentyl)butanedioate (ester)
CGX 635
CGX-635
CGX-635-14 (formulation)
CHEBI:71019
CHEMBL46286
CS-2872
CTK8E8620
D08956
DB04865
GTPL7454
HMS3267H22
Homoharringtonin
homoharringtonine
Homoharringtonine (8CI)
Homoharringtonine, >=98% (HPLC)
Homoharringtonine|||Omacetaxine mepesuccinate
HY-14944
HYFHYPWGAURHIV-JFIAXGOJSA-N
mepesuccinate d'omacetaxine
mepesuccinato de omacetaxina
MLS001424293
MolPort-003-983-592
Myelostat
N1504
NC00395
NCGC00025155-01
NCGC00025155-02
NCGC00025155-03
NCGC00025155-04
NCI60_000917
NSC 141633
NSC-141633
NSC141633
o3-[(2r)-2,6-dihydroxy-2-(2-methoxy-2-oxoethyl)-6-methylheptanoyl]cephalotaxine
Omacetaxine
Omacetaxine mepesuccinate (USAN)
Omacetaxine mepesuccinate [USAN:INN]
omacetaxini mepesuccinas
Omapro
SAM001246822
SCHEMBL12745687
SMR000469230
SR-01000597562
SR-01000597562-1
ST056357
Synribo
Synribo (TN)
Tekinex
TR-031859
UNII-6FG8041S5B
V0232
ZINC26011099
ZJ-C
Paragraph IV (Patent) Challenges for OMACETAXINE MEPESUCCINATE
Tradename Dosage Ingredient NDA Submissiondate
SYNRIBO POWDER;SUBCUTANEOUS omacetaxine mepesuccinate 203585 2016-10-26

US Patents and Regulatory Information for omacetaxine mepesuccinate

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Teva Pharms Intl SYNRIBO omacetaxine mepesuccinate POWDER;SUBCUTANEOUS 203585-001 Oct 26, 2012 RX Yes Yes   Start Trial   Start Trial   Start Trial
Teva Pharms Intl SYNRIBO omacetaxine mepesuccinate POWDER;SUBCUTANEOUS 203585-001 Oct 26, 2012 RX Yes Yes   Start Trial   Start Trial   Start Trial
Teva Pharms Intl SYNRIBO omacetaxine mepesuccinate POWDER;SUBCUTANEOUS 203585-001 Oct 26, 2012 RX Yes Yes   Start Trial   Start Trial Y 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

Expired US Patents for omacetaxine mepesuccinate

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Teva Pharms Intl SYNRIBO omacetaxine mepesuccinate POWDER;SUBCUTANEOUS 203585-001 Oct 26, 2012   Start Trial   Start Trial
Teva Pharms Intl SYNRIBO omacetaxine mepesuccinate POWDER;SUBCUTANEOUS 203585-001 Oct 26, 2012   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for omacetaxine mepesuccinate

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Serving leading biopharmaceutical companies globally:

McKinsey
Harvard Business School
Moodys
Dow
Johnson and Johnson
McKesson

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 verifification 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.