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Serving leading biopharmaceutical companies globally:

Mallinckrodt
US Department of Justice
Johnson and Johnson
Chubb
Medtronic
Healthtrust
Novartis
Deloitte
Baxter
US Army

Generated: February 24, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 207027

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NDA 207027 describes PROMACTA, which is a drug marketed by Novartis Pharms Corp and is included in two NDAs. It is available from two suppliers. There are fourteen 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. Two suppliers are listed for this compound. Additional details are available on the eltrombopag olamine profile page.
Summary for 207027
Tradename:PROMACTA
Applicant:Novartis Pharms Corp
Ingredient:eltrombopag olamine
Patents:8
Formulation / Manufacturing:see details

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:FOR SUSPENSION;ORALStrengthEQ 25MG ACID/PACKET
Approval Date:Aug 24, 2015TE:RLD:Yes
Regulatory Exclusivity Expiration:Jun 11, 2018
Regulatory Exclusivity Use:DOSING INFORMATION ADDED TO THE LABELING REGARDING PEDIATRIC PATIENTS 6 YEARS AND OLDER WITH ITP
Regulatory Exclusivity Expiration:Jun 11, 2018
Regulatory Exclusivity Use:INCLUSION OF PEDIATRIC PATIENTS AGES 6 YRS AND OLDER FOR THE TREATMENT OF THROMBOCYTOPENIA IN PATIENTS WITH CHRONIC ITP WHO HAVE HAD AN INSUFFICIENT RESPONSE TO CORTICOSTEROIDS, IMMUNOGLOBULINS, OR SPLENECTOMY.
Regulatory Exclusivity Expiration:Dec 11, 2018
Regulatory Exclusivity Use:PEDIATRIC EXCLUSIVITY

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Serving hundreds of leading biopharmaceutical companies globally:

Argus Health
Federal Trade Commission
US Army
Medtronic
Healthtrust
Daiichi Sankyo
Julphar
Dow
McKesson

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