Details for New Drug Application (NDA): 022291

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NDA 022291 describes PROMACTA, which is a drug marketed by Novartis and is included in two NDAs. It is available from one supplier. There are six patents protecting this drug and two Paragraph IV challenges. Additional details are available on the PROMACTA profile page.

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

Summary for 022291

Tradename:	PROMACTA
Applicant:	Novartis
Ingredient:	eltrombopag olamine
Patents:	6

Pharmacology for NDA: 022291

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: 022291

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
PROMACTA	eltrombopag olamine	TABLET;ORAL	022291	NDA	Novartis Pharmaceuticals Corporation	0078-0684	0078-0684-15	30 TABLET, FILM COATED in 1 BOTTLE (0078-0684-15)
PROMACTA	eltrombopag olamine	TABLET;ORAL	022291	NDA	Novartis Pharmaceuticals Corporation	0078-0685	0078-0685-15	30 TABLET, FILM COATED in 1 BOTTLE (0078-0685-15)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	EQ 25MG ACID
Approval Date:	Nov 20, 2008	TE:		RLD:	Yes
Regulatory Exclusivity Expiration:	Nov 16, 2025
Regulatory Exclusivity Use:	INDICATED IN COMBINATION WITH STANDARD IMMUNOSUPPRESSIVE THERAPY FOR THE FIRST-LINE TREATMENT OF ADULT AND PEDIATRIC PATIENTS 2 YEARS AND OLDER WITH SEVERE APLASTIC ANEMIA
Patent:	⤷ Sign Up	Patent Expiration:	Jan 13, 2026	Product Flag?		Substance Flag?		Delist Request?	Y
Patent:	⤷ Sign Up	Patent Expiration:	Feb 1, 2028	Product Flag?		Substance Flag?		Delist Request?	Y

Expired US Patents for NDA 022291

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Novartis	PROMACTA	eltrombopag olamine	TABLET;ORAL	022291-002	Nov 20, 2008	⤷ Sign Up	⤷ Sign Up
Novartis	PROMACTA	eltrombopag olamine	TABLET;ORAL	022291-003	Sep 8, 2009	⤷ Sign Up	⤷ Sign Up
Novartis	PROMACTA	eltrombopag olamine	TABLET;ORAL	022291-002	Nov 20, 2008	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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