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Last Updated: December 5, 2019

DrugPatentWatch Database Preview

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 thirteen 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:13
Formulation / Manufacturing:see details
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)
Paragraph IV (Patent) Challenges for 022291
Tradename Dosage Ingredient NDA Submissiondate
PROMACTA TABLET;ORAL eltrombopag olamine 022291 2014-02-04
PROMACTA TABLET;ORAL eltrombopag olamine 022291 2014-01-07

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 25MG ACID
Approval Date:Nov 20, 2008TE: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
Regulatory Exclusivity Expiration:Feb 26, 2022
Regulatory Exclusivity Use:PEDIATRIC EXCLUSIVITY
Regulatory Exclusivity Expiration:Aug 26, 2021
Regulatory Exclusivity Use:TREATMENT OF PATIENTS WITH SEVERE APLASTIC ANEMIA WHO HAVE HAD AN INSUFFICIENT RESPONSE TO IMMUNOSUPPRESSIVE THERAPY.

Expired US Patents for NDA 022291

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Novartis PROMACTA eltrombopag olamine TABLET;ORAL 022291-004 Oct 20, 2011   Start Trial   Start Trial
Novartis PROMACTA eltrombopag olamine TABLET;ORAL 022291-001 Nov 20, 2008   Start Trial   Start Trial
Novartis PROMACTA eltrombopag olamine TABLET;ORAL 022291-002 Nov 20, 2008   Start Trial   Start Trial
Novartis PROMACTA eltrombopag olamine TABLET;ORAL 022291-005 Nov 16, 2012   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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