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US Department of Justice
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Generated: November 16, 2018

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Details for New Drug Application (NDA): 208351

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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.
Generic Entry Opportunity Date for 208351
Generic Entry Date for 208351*:
Constraining patent/regulatory exclusivity:
Dosage:
TABLET;ORAL

*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

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 61958-2101-1 30 TABLET in 1 BOTTLE, PLASTIC (61958-2101-1)
ODEFSEY emtricitabine; rilpivirine hydrochloride; tenofovir alafenamide fumarate TABLET;ORAL 208351 NDA REMEDYREPACK INC. 70518-0695 70518-0695-0 30 TABLET in 1 BLISTER PACK (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 ➤ Sign Up ➤ Sign Up
Gilead Sciences Inc ODEFSEY emtricitabine; rilpivirine hydrochloride; tenofovir alafenamide fumarate TABLET;ORAL 208351-001 Mar 1, 2016 ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Serving hundreds of leading biopharmaceutical companies globally:

Argus Health
Cerilliant
Harvard Business School
Fuji
Julphar
US Department of Justice
Healthtrust
Cipla
Medtronic

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