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Last Updated: August 14, 2020

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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. It is available from one supplier. 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. One supplier is listed 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
Generic Entry Opportunity Date for 203585
Generic Entry Date for 203585*:
Constraining patent/regulatory exclusivity:
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.

Suppliers and Packaging for NDA: 203585
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
SYNRIBO omacetaxine mepesuccinate POWDER;SUBCUTANEOUS 203585 NDA Cephalon, Inc. 63459-177 63459-177-14 1 VIAL, SINGLE-USE in 1 CARTON (63459-177-14) > 1 mL in 1 VIAL, SINGLE-USE
Paragraph IV (Patent) Challenges for 203585
Tradename Dosage Ingredient NDA Submissiondate
SYNRIBO POWDER;SUBCUTANEOUS omacetaxine mepesuccinate 203585 2016-10-26

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:POWDER;SUBCUTANEOUSStrength3.5MG/VIAL
Approval Date:Oct 26, 2012TE:RLD:Yes
Patent:  Start TrialPatent Expiration:Oct 26, 2026Product 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

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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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.