.

BioPharmaceutical Business Intelligence

  • Analyze global market entry opportunities
  • Identify first generic entrants
  • Uncover prior art in expired and abandoned patents

► See Plans & Pricing

Upgrade to enjoy subscriber-only features like email alerts and data export. See the Plans and Pricing

Serving 500+ biopharmaceutical companies globally:

Cerilliant
Merck
Accenture
Colorcon
Federal Trade Commission
Argus Health
Daiichi Sankyo
Dow
Moodys
Express Scripts

Generated: September 21, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 203100

« Back to Dashboard
NDA 203100 describes STRIBILD, which is a drug marketed by Gilead Sciences Inc and is included in one NDA. It is available from four suppliers. There are fifteen patents protecting this drug. Additional details are available on the STRIBILD profile page.

The generic ingredient in STRIBILD is cobicistat; elvitegravir; emtricitabine; tenofovir disoproxil fumarate. There are five drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the cobicistat; elvitegravir; emtricitabine; tenofovir disoproxil fumarate profile page.

Summary for NDA: 203100

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:15
Formulation / Manufacturing:see details

Suppliers and Packaging for NDA: 203100

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
STRIBILD
cobicistat; elvitegravir; emtricitabine; tenofovir disoproxil fumarate
TABLET;ORAL 203100 NDA State of Florida DOH Central Pharmacy 53808-0887 53808-0887-1 30 TABLET, FILM COATED in 1 BLISTER PACK (53808-0887-1)
STRIBILD
cobicistat; elvitegravir; emtricitabine; tenofovir disoproxil fumarate
TABLET;ORAL 203100 NDA Gilead Sciences, Inc. 61958-1201 61958-1201-1 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (61958-1201-1)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength150MG;150MG;200MG;300MG
Approval Date:Aug 27, 2012TE:RLD:Yes
Regulatory Exclusivity Expiration:Dec 17, 2017
Regulatory Exclusivity Use:EXPANDED INDICATION TO INCLUDE PATIENTS WHO ARE VIROLOGICALLY-SUPPRESSED (HIV-1 RNA
Regulatory Exclusivity Expiration:Aug 27, 2017
Regulatory Exclusivity Use:NEW CHEMICAL ENTITY
Regulatory Exclusivity Expiration:Jan 27, 2020
Regulatory Exclusivity Use:NEW PATIENT POPULATION

Expired Orange Book Patents for NDA: 203100

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Gilead Sciences Inc
STRIBILD
cobicistat; elvitegravir; emtricitabine; tenofovir disoproxil fumarate
TABLET;ORAL203100-001Aug 27, 2012► Subscribe► Subscribe
This preview shows a limited data set
Subscribe for full access, or try a Trial

Export unavailable in trial.
Subscribe for complete access.



Complete Access Available with Subscription
« Back to Dashboard

For more information try a trial or see the database preview and plans and pricing

Serving 500+ biopharmaceutical companies globally:

AstraZeneca
UBS
Healthtrust
Cipla
Covington
Daiichi Sankyo
Citi
Chubb
Deloitte
Harvard Business School

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.

Copyright 2002-2017 thinkBiotech LLC
ISSN: 2162-2639

Secure SSL Encrypted Heap | Mobile and Web Analytics
Privacy and Cookies
Terms & Conditions

Follow DrugPatentWatch:



Google
Twitter
Google Plus
botpot