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Generated: November 13, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 203985

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NDA 203985 describes AFINITOR DISPERZ, which is a drug marketed by Novartis Pharm and is included in one NDA. It is available from one supplier. There are four patents protecting this drug and one Paragraph IV challenge. Additional details are available on the AFINITOR DISPERZ profile page.

The generic ingredient in AFINITOR DISPERZ is everolimus. There are twelve drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the everolimus profile page.
Summary for 203985
Tradename:AFINITOR DISPERZ
Applicant:Novartis Pharm
Ingredient:everolimus
Patents:4
Formulation / Manufacturing:see details
Suppliers and Packaging for NDA: 203985
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
AFINITOR DISPERZ everolimus TABLET, FOR SUSPENSION;ORAL 203985 NDA Novartis Pharmaceuticals Corporation 0078-0626 0078-0626-51 28 BLISTER PACK in 1 CARTON (0078-0626-51) > 1 TABLET, FOR SUSPENSION in 1 BLISTER PACK (0078-0626-61)
AFINITOR DISPERZ everolimus TABLET, FOR SUSPENSION;ORAL 203985 NDA Novartis Pharmaceuticals Corporation 0078-0627 0078-0627-51 28 BLISTER PACK in 1 CARTON (0078-0627-51) > 1 TABLET, FOR SUSPENSION in 1 BLISTER PACK (0078-0627-61)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, FOR SUSPENSION;ORALStrength2MG
Approval Date:Aug 29, 2012TE:RLD:Yes
Regulatory Exclusivity Expiration:Apr 10, 2021
Regulatory Exclusivity Use:FOR THE ADJUNCTIVE TREATMENT OF ADULT AND PEDIATRIC PATIENTS AGE 2 YEARS AND OLDER WITH TUBEROUS SCLEROSIS COMPLEX (TSC)-ASSOCIATED PARTIAL-ONSET SEIZURES
Regulatory Exclusivity Expiration:Apr 10, 2025
Regulatory Exclusivity Use:FOR THE ADJUNCTIVE TREATMENT OF ADULT AND PEDIATRIC PATIENTS AGED 2 YEARS AND OLDER WITH TUBEROUS SCLEROSIS COMPLEX (TSC)-ASSOCIATED PARTIAL-ONSET SEIZURES
Regulatory Exclusivity Expiration:Apr 29, 2018
Regulatory Exclusivity Use:PEDIATRIC EXCLUSIVITY

Expired US Patents for NDA 203985

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Novartis Pharm AFINITOR DISPERZ everolimus TABLET, FOR SUSPENSION;ORAL 203985-001 Aug 29, 2012 ➤ Try a Free Trial ➤ Try a Free Trial
Novartis Pharm AFINITOR DISPERZ everolimus TABLET, FOR SUSPENSION;ORAL 203985-003 Aug 29, 2012 ➤ Try a Free Trial ➤ Try a Free Trial
Novartis Pharm AFINITOR DISPERZ everolimus TABLET, FOR SUSPENSION;ORAL 203985-002 Aug 29, 2012 ➤ Try a Free Trial ➤ Try a Free Trial
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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