Last Updated: November 9, 2026

Details for New Drug Application (NDA): 203585

NDA 203585 describes SYNRIBO, which 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. Additional details are available on the SYNRIBO profile page.

The generic ingredient in SYNRIBO is omacetaxine mepesuccinate. There is one drug master file entry for this compound. Additional details are available on the omacetaxine mepesuccinate profile page.

Summary for 203585

Tradename:	SYNRIBO
Applicant:	Teva Pharms Intl
Ingredient:	omacetaxine mepesuccinate
Patents:	1

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	POWDER;SUBCUTANEOUS			Strength	3.5MG/VIAL
Approval Date:	Oct 26, 2012	TE:		RLD:	Yes
Patent:	6,987,103	Patent Expiration:	Oct 26, 2026	Product Flag?		Substance Flag?		Delist Request?
Patented Use:	TREATMENT OF PATIENTS WITH TYROSINE KINASE INHIBITOR (TKI) RESISTANT OR INTOLERANT CHRONIC MYELOID/MYELOGENOUS LEUKEMIA (CML)

Expired US Patents for NDA 203585

Subscribe to access the full database, or Start Trial
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	6,987,103	⤷ Start Trial
Teva Pharms Intl	SYNRIBO	omacetaxine mepesuccinate	POWDER;SUBCUTANEOUS	203585-001	Oct 26, 2012	RE45128	⤷ Start Trial
Teva Pharms Intl	SYNRIBO	omacetaxine mepesuccinate	POWDER;SUBCUTANEOUS	203585-001	Oct 26, 2012	7,842,687	⤷ Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

Complete Access Available with Subscription

Make Better Decisions: Try a trial or see plans & pricing

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. We do not provide individual investment advice. This service is not registered with any financial regulatory agency. The information we publish is educational only and based on our opinions plus our models. By using DrugPatentWatch you acknowledge that we do not provide personalized recommendations or advice. 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.