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Generated: November 15, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 210923

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NDA 210923 describes MULPLETA, which is a drug marketed by Shionogi Inc and is included in one NDA. It is available from one supplier. There are four patents protecting this drug. Additional details are available on the MULPLETA profile page.

The generic ingredient in MULPLETA is lusutrombopag. One supplier is listed for this compound. Additional details are available on the lusutrombopag profile page.
Summary for 210923
Tradename:MULPLETA
Applicant:Shionogi Inc
Ingredient:lusutrombopag
Patents:4
Generic Entry Opportunity Date for 210923
Generic Entry Date for 210923*:
Constraining patent/regulatory exclusivity:
Dosage:
TABLET;ORAL

*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: 210923
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
MULPLETA lusutrombopag TABLET;ORAL 210923 NDA SHIONOGI INC. 59630-551 59630-551-07 1 DOSE PACK in 1 CARTON (59630-551-07) > 7 TABLET, FILM COATED in 1 DOSE PACK

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength3MG
Approval Date:Jul 31, 2018TE:RLD:Yes
Regulatory Exclusivity Expiration:Jul 31, 2023
Regulatory Exclusivity Use:NEW CHEMICAL ENTITY
Patent:➤ Try a Free TrialPatent Expiration:Sep 5, 2024Product Flag?YSubstance Flag?YDelist Request?
Patented Use:TREATMENT OF THROMBOCYTOPENIA IN ADULT PATIENTS WITH CHRONIC LIVER DISEASE WHO ARE SCHEDULED TO UNDERGO A PROCEDURE
Patent:➤ Try a Free TrialPatent Expiration:Jan 21, 2030Product Flag?YSubstance Flag?YDelist Request?

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