Details for New Drug Application (NDA): 216774

NDA 216774 describes ALVAIZ, which is a drug marketed by Teva Pharms Inc and is included in one NDA. It is available from one supplier. There is one patent protecting this drug. Additional details are available on the ALVAIZ profile page.

The generic ingredient in ALVAIZ is eltrombopag choline. There are three drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the eltrombopag choline profile page.

Summary for 216774

Tradename:	ALVAIZ
Applicant:	Teva Pharms Inc
Ingredient:	eltrombopag choline
Patents:	1

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for 216774

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.

Pharmacology for NDA: 216774

Mechanism of Action	Breast Cancer Resistance Protein Inhibitors Organic Anion Transporting Polypeptide 1B1 Inhibitors Thrombopoietin Receptor Agonists UGT1A1 Inhibitors UGT1A3 Inhibitors UGT1A4 Inhibitors UGT1A6 Inhibitors UGT1A9 Inhibitors UGT2B15 Inhibitors UGT2B7 Inhibitors
Physiological Effect	Increased Megakaryocyte Maturation Increased Platelet Production

Suppliers and Packaging for NDA: 216774

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
ALVAIZ	eltrombopag choline	TABLET;ORAL	216774	NDA	Teva Pharmaceuticals, Inc.	0480-3273	0480-3273-56	30 TABLET, FILM COATED in 1 BOTTLE (0480-3273-56)
ALVAIZ	eltrombopag choline	TABLET;ORAL	216774	NDA	Teva Pharmaceuticals, Inc.	0480-3274	0480-3274-56	30 TABLET, FILM COATED in 1 BOTTLE (0480-3274-56)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	EQ 9MG BASE
Approval Date:	Nov 29, 2023	TE:		RLD:	Yes
Patent:		Patent Expiration:	Nov 5, 2038	Product Flag?	Y	Substance Flag?	Y	Delist Request?
Patented Use:	TREATMENT OF ADULT PATIENTS WITH SEVERE APLASTIC ANEMIA WHO HAVE HAD AN INSUFFICIENT RESPONSE TO IMMUNOSUPPRESSIVE THERAPY
Patent:		Patent Expiration:	Nov 5, 2038	Product Flag?	Y	Substance Flag?	Y	Delist Request?
Patented Use:	TREATMENT OF THROMBOCYTOPENIA IN ADULT AND PEDIATRIC PATIENTS 6 YEARS AND OLDER WITH PERSISTENT OR CHRONIC IMMUNE THROMBOCYTOPENIA (ITP)
Patent:		Patent Expiration:	Nov 5, 2038	Product Flag?	Y	Substance Flag?	Y	Delist Request?
Patented Use:	TREATMENT OF THROMBOCYTOPENIA IN ADULT PATIENTS WITH CHRONIC HEPATITIS C TO ALLOW THE INITIATION AND MAINTENANCE OF INTERFERON-BASED THERAPY

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