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Generated: November 14, 2018

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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 are two patents 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:2
Generic Entry Opportunity Date for 203585
Generic Entry Date for 203585*:
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)
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

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:POWDER;SUBCUTANEOUSStrength3.5MG/VIAL
Approval Date:Oct 26, 2012TE:RLD:Yes
Regulatory Exclusivity Expiration:Oct 26, 2019
Regulatory Exclusivity Use: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)
Patent:➤ Sign UpPatent 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)
Patent:➤ Sign UpPatent Expiration:Mar 16, 2019Product Flag?YSubstance Flag?YDelist Request?
Patented Use:TREATMENT OF LEUKEMIA

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Serving hundreds of leading biopharmaceutical companies globally:

Teva
Dow
Medtronic
AstraZeneca
Moodys
Boehringer Ingelheim
Daiichi Sankyo
Baxter
Argus Health

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