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Serving 500+ biopharmaceutical companies globally:

Covington
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Federal Trade Commission
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Chinese Patent Office
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Generated: June 24, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 021503

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NDA 021503 describes VIRACEPT, which is a drug marketed by Agouron Pharms and is included in three NDAs. It is available from four suppliers. Additional details are available on the VIRACEPT profile page.

The generic ingredient in VIRACEPT is nelfinavir mesylate. There are three drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the nelfinavir mesylate profile page.

Summary for NDA: 021503

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:1
Therapeutic Class:Antivirals
Formulation / Manufacturing:see details

Pharmacology for NDA: 021503

Suppliers and Packaging for NDA: 021503

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
VIRACEPT
nelfinavir mesylate
TABLET;ORAL 021503 NDA State of Florida DOH Central Pharmacy 53808-0809 53808-0809-1 30 TABLET, FILM COATED in 1 BLISTER PACK (53808-0809-1)
VIRACEPT
nelfinavir mesylate
TABLET;ORAL 021503 NDA AGOURON 63010-027 63010-027-70 120 TABLET, FILM COATED in 1 BOTTLE (63010-027-70)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 625MG BASE
Approval Date:Apr 30, 2003TE:RLD:Yes

Expired Orange Book Patents for NDA: 021503

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Agouron Pharms
VIRACEPT
nelfinavir mesylate
TABLET;ORAL021503-001Apr 30, 20035,484,926*PED► Subscribe
Agouron Pharms
VIRACEPT
nelfinavir mesylate
TABLET;ORAL021503-001Apr 30, 20036,162,812*PED► Subscribe
Agouron Pharms
VIRACEPT
nelfinavir mesylate
TABLET;ORAL021503-001Apr 30, 20035,952,343*PED► Subscribe
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Serving 500+ biopharmaceutical companies globally:

Mallinckrodt
Colorcon
Moodys
Dow
Accenture
Covington
UBS
Fuji
AstraZeneca
Johnson and Johnson

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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