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Last Updated: March 29, 2024

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
Formulation / Manufacturing:see details
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 022291
Generic Entry Date for 022291*:
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: 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: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
Patent:⤷  Try a TrialPatent Expiration:Jan 13, 2026Product Flag?Substance Flag?Delist Request?Y
Patent:⤷  Try a TrialPatent Expiration:Feb 1, 2028Product Flag?Substance Flag?Delist Request?Y

Expired US Patents for NDA 022291

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Novartis PROMACTA eltrombopag olamine TABLET;ORAL 022291-003 Sep 8, 2009 ⤷  Try a Trial ⤷  Try a Trial
Novartis PROMACTA eltrombopag olamine TABLET;ORAL 022291-003 Sep 8, 2009 ⤷  Try a Trial ⤷  Try a Trial
Novartis PROMACTA eltrombopag olamine TABLET;ORAL 022291-003 Sep 8, 2009 ⤷  Try a Trial ⤷  Try a Trial
Novartis PROMACTA eltrombopag olamine TABLET;ORAL 022291-001 Nov 20, 2008 ⤷  Try a Trial ⤷  Try a Trial
Novartis PROMACTA eltrombopag olamine TABLET;ORAL 022291-005 Nov 16, 2012 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.