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Details for New Drug Application (NDA): 021976

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NDA 021976 describes PREZISTA, which is a drug marketed by Janssen Prods and is included in two NDAs. It is available from five suppliers. There are ten patents protecting this drug and two Paragraph IV challenges. Additional details are available on the PREZISTA profile page.

The generic ingredient in PREZISTA is darunavir ethanolate. There are twenty-one drug master file entries for this compound. Five suppliers are listed for this compound. There are fourteen tentative approvals for this compound. Additional details are available on the darunavir ethanolate profile page.

Summary for NDA: 021976

Tradename:
PREZISTA
Applicant:
Janssen Prods
Ingredient:
darunavir ethanolate
Patents:10
Therapeutic Class:Antivirals
Formulation / Manufacturing:see details

Pharmacology for NDA: 021976

Suppliers and Packaging for NDA: 021976

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
PREZISTA
darunavir ethanolate
TABLET;ORAL 021976 NDA A-S Medication Solutions 50090-1327 50090-1327-0 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (50090-1327-0)
PREZISTA
darunavir ethanolate
TABLET;ORAL 021976 NDA A-S Medication Solutions 50090-1491 50090-1491-0 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (50090-1491-0)

Summary for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrengthEQ 300MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
Approval Date:Jun 23, 2006TE:RLD:No
Patent:5,843,946*PEDPatent Expiration:Jun 1, 2016Product Flag?Substance Flag?Delist Request?Y
Patent:6,037,157*PEDPatent Expiration:Dec 26, 2016Product Flag?Substance Flag?Delist Request?Y
Patent:6,703,403*PEDPatent Expiration:Dec 26, 2016Product Flag?Substance Flag?Delist Request?Y

Expired Orange Book Patents for NDA: 021976

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Janssen Prods
PREZISTA
darunavir ethanolate
TABLET;ORAL021976-005Dec 18, 20086,335,460*PED► subscribe
Janssen Prods
PREZISTA
darunavir ethanolate
TABLET;ORAL021976-003Oct 21, 20085,843,946*PED► subscribe
Janssen Prods
PREZISTA
darunavir ethanolate
TABLET;ORAL021976-002Feb 25, 20086,248,775*PED► subscribe
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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 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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