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Last Updated: October 22, 2019

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SYNRIBO Drug Profile

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Which patents cover Synribo, and what generic alternatives are available?

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.

This drug has forty-nine patent family members in nineteen countries.

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.

Summary for SYNRIBO
Drug patent expirations by year for SYNRIBO
Drug Prices for SYNRIBO

See drug prices 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.

Recent Clinical Trials for SYNRIBO

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

SponsorPhase
Teva Pharmaceutical Industries, Ltd.Phase 1/Phase 2
University of FloridaPhase 1/Phase 2
Teva Pharmaceuticals USAPhase 2

See all SYNRIBO clinical trials

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
[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
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   Start Trial   Start Trial Y Y   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   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 SYNRIBO

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
Paragraph IV (Patent) Challenges for SYNRIBO
Drugname Dosage Strength RLD Date
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Serving leading biopharmaceutical companies globally:

Moodys
Mallinckrodt
Medtronic
Baxter
Merck
Johnson and Johnson

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