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Last Updated: May 31, 2020

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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 is one patent protecting this drug and one Paragraph IV challenge.

This drug has twenty-one patent family members in twelve 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.

US ANDA Litigation and Generic Entry Outlook for Synribo

Synribo was eligible for patent challenges on October 26, 2016.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be October 26, 2026. This may change due to patent challenges or generic licensing.

There is one Paragraph IV patent challenge for this drug. This may lead to patent invalidation or a license for generic production.

Indicators of Generic Entry

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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:
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
M.D. Anderson Cancer CenterPhase 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
ACN-035229
AKOS024456585
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 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-635-14 (formulation)
CHEBI:71019
CHEMBL46286
CS-2872
CTK8E8620
D08956
DB04865
GTPL7454
HMS3267H22
HMS3414N05
HMS3678N03
Homoharringtonin
homoharringtonine
Homoharringtonine (8CI)
Homoharringtonine, >=98% (HPLC)
Homoharringtonine|||Omacetaxine mepesuccinate
HY-14944
HYFHYPWGAURHIV-JFIAXGOJSA-N
mepesuccinate d'omacetaxine
mepesuccinato de omacetaxina
MLS001424293
Myelostat
N1504
NC00395
NCGC00025155-01
NCGC00025155-02
NCGC00025155-03
NCGC00025155-04
NCI60_000917
NSC 141633
NSC-141633
NSC141633
Omacetaxine mepesuccinate
Omacetaxine mepesuccinate (USAN)
Omacetaxine mepesuccinate [USAN:INN]
omacetaxini mepesuccinas
Omapro
Q7089373
s9015
SAM001246822
SCHEMBL12745687
SMR000469230
SR-01000597562
SR-01000597562-1
ST056357
Synribo (TN)
Tekinex
TR-031859
UNII-6FG8041S5B
V0232
ZINC26011099
ZJ-C
Paragraph IV (Patent) Challenges for SYNRIBO
Tradename Dosage Ingredient NDA Submissiondate
SYNRIBO POWDER;SUBCUTANEOUS omacetaxine mepesuccinate 203585 2016-10-26

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   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

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Serving leading biopharmaceutical companies globally:

Johnson and Johnson
Moodys
McKesson
Merck
Colorcon
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.