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Generated: November 20, 2018

DrugPatentWatch Database Preview

SYNRIBO Drug Profile

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When do Synribo patents expire, and when can generic versions of Synribo launch?

Synribo is a drug marketed by Teva Pharms Intl and is included in one NDA. There are two patents protecting this drug and one Paragraph IV challenge.

The generic ingredient in SYNRIBO is omacetaxine mepesuccinate. There are two drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the omacetaxine mepesuccinate profile page.

Drug patent expirations by year for SYNRIBO
Generic Entry Opportunity Date for SYNRIBO
Generic Entry Date for SYNRIBO*:
Constraining patent/regulatory exclusivity:
TREATMENT OF ADULT PATIENTS WITH CHRONIC OR ACCELERATED PHASE CHRONIC MYELOID LEUKEMIA (CML) WITH RESISTANCE AND/OR INTOLERANCE TO TWO OR MORE TYROSINE KINASE INHIBITORS (TKI)
NDA:
Dosage:
POWDER;SUBCUTANEOUS

*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.

Synonyms for SYNRIBO
(-)-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
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
Ambotz26833-87-4
BRD-K76674262-001-01-7
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
D0M4XY
DB04865
GTPL7454
HMS3267H22
Homoharringtonin
homoharringtonine
Homoharringtonine (8CI)
Homoharringtonine, >=98% (HPLC)
Homoharringtonine|||Omacetaxine mepesuccinate
HY-14944
HYFHYPWGAURHIV-JFIAXGOJSA-N
mepesuccinate d'omacetaxine
mepesuccinato de omacetaxina
MFCD05618221
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 (homoharringtonine)
Omacetaxine mepesuccinate
Omacetaxine mepesuccinate (USAN)
Omacetaxine mepesuccinate [USAN:INN]
omacetaxini mepesuccinas
Omapro
SAM001246822
SCHEMBL12745687
SMR000469230
SR-01000597562
SR-01000597562-1
ST056357
Synribo (TN)
Tekinex
TR-031859
UNII-6FG8041S5B
V0232
ZINC26011099
ZJ-C

US Patents and Regulatory Information for SYNRIBO

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 ➤ Sign Up ➤ Sign Up Y Y ➤ Sign Up
Teva Pharms Intl SYNRIBO omacetaxine mepesuccinate POWDER;SUBCUTANEOUS 203585-001 Oct 26, 2012 RX Yes Yes ➤ Sign Up ➤ Sign Up ➤ Sign Up
Teva Pharms Intl SYNRIBO omacetaxine mepesuccinate POWDER;SUBCUTANEOUS 203585-001 Oct 26, 2012 RX Yes Yes ➤ Sign Up ➤ Sign Up ➤ Sign Up
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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Paragraph IV (Patent) Challenges for SYNRIBO
Drugname Dosage Strength RLD Date
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Serving hundreds of leading biopharmaceutical companies globally:

Colorcon
Dow
UBS
Chubb
McKinsey
Chinese Patent Office
Boehringer Ingelheim
Accenture
Argus Health

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