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

Serving leading biopharmaceutical companies globally:

Harvard Business School
Express Scripts
US Department of Justice
Citi
Fish and Richardson
Accenture
AstraZeneca
Moodys
Farmers Insurance
Julphar

Generated: February 22, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 208351

« Back to Dashboard

NDA 208351 describes ODEFSEY, which is a drug marketed by Gilead Sciences Inc and is included in one NDA. It is available from two suppliers. There are twelve patents protecting this drug. Additional details are available on the ODEFSEY profile page.

The generic ingredient in ODEFSEY is emtricitabine; rilpivirine hydrochloride; tenofovir alafenamide fumarate. There are seventeen drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the emtricitabine; rilpivirine hydrochloride; tenofovir alafenamide fumarate profile page.
Summary for 208351
Tradename:ODEFSEY
Applicant:Gilead Sciences Inc
Ingredient:emtricitabine; rilpivirine hydrochloride; tenofovir alafenamide fumarate
Patents:12
Formulation / Manufacturing:see details
Suppliers and Packaging for NDA: 208351
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ODEFSEY emtricitabine; rilpivirine hydrochloride; tenofovir alafenamide fumarate TABLET;ORAL 208351 NDA Gilead Sciences, Inc. 61958-2101 N 61958-2101-1
ODEFSEY emtricitabine; rilpivirine hydrochloride; tenofovir alafenamide fumarate TABLET;ORAL 208351 NDA REMEDYREPACK INC. 70518-0695 N 70518-0695-0

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength200MG;EQ 25MG BASE;EQ 25MG BASE
Approval Date:Mar 1, 2016TE:RLD:Yes
Regulatory Exclusivity Expiration:Aug 21, 2020
Regulatory Exclusivity Use:INFORMATION ADDED TO LABELING REGARDING 48 WEEK EFFICACY, RESISTANCE AND SAFETY DATA ON VIROLOGICALLY SUPPRESSED HIV-1 INFECTED ADULTS SWITCHING FROM ATRIPLA TO ODEFSEY
Regulatory Exclusivity Expiration:Aug 21, 2020
Regulatory Exclusivity Use:INFORMATION ADDED TO LABELING REGARDING 48 WEEK EFFICACY, RESISTANCE AND SAFETY DATA ON VIROLOGICALLY SUPPRESSED HIV-1 INFECTED ADULTS SWITCHING FROM COMPLERA TO ODEFSEY
Regulatory Exclusivity Expiration:Nov 5, 2020
Regulatory Exclusivity Use:NEW CHEMICAL ENTITY

Expired US Patents for NDA 208351

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Gilead Sciences Inc ODEFSEY emtricitabine; rilpivirine hydrochloride; tenofovir alafenamide fumarate TABLET;ORAL 208351-001 Mar 1, 2016 ➤ Try a Free Trial ➤ Try a Free Trial
Gilead Sciences Inc ODEFSEY emtricitabine; rilpivirine hydrochloride; tenofovir alafenamide fumarate TABLET;ORAL 208351-001 Mar 1, 2016 ➤ Try a Free Trial ➤ Try a Free Trial
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

This preview shows a limited data set. Subscribe for full access, or try a Free Trial

Complete Access Available with Subscription

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

Serving hundreds of leading biopharmaceutical companies globally:

Dow
Cantor Fitzgerald
McKinsey
Healthtrust
Fuji
Teva
QuintilesIMS
Chinese Patent Office
Farmers Insurance

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.

botpot