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Serving leading biopharmaceutical companies globally:

Cantor Fitzgerald
McKesson
Cipla
Johnson and Johnson
Fish and Richardson
Medtronic
AstraZeneca
Julphar
Daiichi Sankyo
Chubb

Generated: October 20, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 021356

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NDA 021356 describes VIREAD, which is a drug marketed by Gilead Sciences Inc and is included in two NDAs. It is available from four suppliers. There are four patents protecting this drug and two Paragraph IV challenges. Additional details are available on the VIREAD profile page.

The generic ingredient in VIREAD is tenofovir disoproxil fumarate. There are thirty-six drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the tenofovir disoproxil fumarate profile page.

Summary for NDA: 021356

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:4
Therapeutic Class:Antivirals
Formulation / Manufacturing:see details

Pharmacology for NDA: 021356

Suppliers and Packaging for NDA: 021356

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
VIREAD
tenofovir disoproxil fumarate
TABLET;ORAL 021356 NDA State of Florida DOH Central Pharmacy 53808-0810 53808-0810-1 30 TABLET, COATED in 1 BLISTER PACK (53808-0810-1)
VIREAD
tenofovir disoproxil fumarate
TABLET;ORAL 021356 NDA Gilead Sciences, Inc. 61958-0401 61958-0401-1 30 TABLET, COATED in 1 BOTTLE, PLASTIC (61958-0401-1)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength300MG
Approval Date:Oct 26, 2001TE:ABRLD:Yes
Regulatory Exclusivity Expiration:Jul 24, 2016
Regulatory Exclusivity Use:CLINICAL TRIAL STUDY RESULTS
Regulatory Exclusivity Expiration:Mar 24, 2017
Regulatory Exclusivity Use:ORPHAN DRUG EXCLUSIVITY
Regulatory Exclusivity Expiration:Sep 24, 2017
Regulatory Exclusivity Use:PEDIATRIC EXCLUSIVITY

Expired Orange Book Patents for NDA: 021356

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Gilead Sciences Inc
VIREAD
tenofovir disoproxil fumarate
TABLET;ORAL021356-001Oct 26, 2001► Subscribe► Subscribe
Gilead Sciences Inc
VIREAD
tenofovir disoproxil fumarate
TABLET;ORAL021356-001Oct 26, 2001► Subscribe► Subscribe
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Serving leading biopharmaceutical companies globally:

Federal Trade Commission
Queensland Health
Moodys
AstraZeneca
Chubb
Fish and Richardson
Fuji
Covington
US Army
Julphar

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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