Details for New Drug Application (NDA): 203585

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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 are two drug master file entries 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

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for 203585

Generic Entry Date for 203585^: ⤷ Sign Up* Constraining patent/regulatory exclusivity: ⤷ Sign Up 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.

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:	⤷ Sign Up	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

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

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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.

Summary for 203585

DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 203585

Profile for product number 001

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DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for 203585