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BioPharmaceutical Business Intelligence

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Serving leading biopharmaceutical companies globally:

McKinsey
AstraZeneca
Harvard Business School
Chinese Patent Office
Cerilliant
Julphar
Fuji
QuintilesIMS
Boehringer Ingelheim
Express Scripts

Generated: November 22, 2017

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 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 022291

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:14
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 GlaxoSmithKline LLC 0007-4640 0007-4640-13 30 TABLET, FILM COATED in 1 BOTTLE (0007-4640-13)
PROMACTA
eltrombopag olamine
TABLET;ORAL 022291 NDA GlaxoSmithKline LLC 0007-4641 0007-4641-13 30 TABLET, FILM COATED in 1 BOTTLE (0007-4641-13)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 25MG ACID
Approval Date:Nov 20, 2008TE: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:Aug 26, 2021
Regulatory Exclusivity Use:ORPHAN DRUG EXCLUSIVITY


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Serving leading biopharmaceutical companies globally:

Farmers Insurance
Covington
Dow
Harvard Business School
Novartis
Daiichi Sankyo
Baxter
Medtronic
QuintilesIMS
Queensland Health

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 verifification 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.

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